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1. Renal Recovery for Patients with ANCA-Associated Vasculitis and Low eGFR in the ADVOCATE Trial of Avacopan

Author

Peh, C. Au, Chakera, A., Cooper, B., Kurtkoti, J., Langguth, D., Levidiotis, V., Luxton, G., Mount, P., Mudge, D., Noble, E., Phoon, R., Ranganathan, D., Ritchie, A., Ryan, J., Suranyi, M., Rosenkranz, A., Lhotta, K., Kronbichler, A., Demoulin, N., Bovy, C., Hellemans, R., Hougardy, J., Sprangers, B., Wissing, K., Pagnoux, C., Barbour, S., Brachemi, S., Cournoyer, S., Girard, L., Laurin, L., Liang, P., Philibert, D., Walsh, M., Tesar, V., Becvar, R., Horak, P., Rychlik, I., Szpirt, W., Dieperink, H., Gregersen, J., Ivarsen, P., Krarup, E., Lyngsoe, C., Rigothier, C., Augusto, J., Belot, A., Chauveau, D., Cornec, D., Jourde-Chiche, N., Ficheux, M., Karras, A., Klein, A., Maurier, F., Mesbah, R., Moranne, O., Neel, A., Quemeneur, T., Saadoun, D., Terrier, B., Zaoui, P., Schaier, M., Benck, U., Bergner, R., Busch, M., Floege, J., Grundmann, F., Haller, H., Haubitz, M., Hellmich, B., Henes, J., Hohenstein, B., Hugo, C., Iking-Konert, C., Arndt, F., Kubacki, T., Kotter, I., Lamprecht, P., Lindner, T., Halbritter, J., Mehling, H., Schönermarck, U., Venhoff, N., Vielhauer, V., Witzke, O., Szombati, I., Szucs, G., Garibotto, G., Alberici, F., Brunetta, E., Dagna, L., De Vita, S., Emmi, G., Gabrielli, A., Manenti, L., Pieruzzi, F., Roccatello, D., Salvarani, C., Dobashi, H., Atsumi, T., Fujimoto, S., Hagino, N., Ihata, A., Kaname, S., Kaneko, Y., Katagiri, A., Katayama, M., Kirino, Y., Kitagawa, K., Komatsuda, A., Kono, H., Kurasawa, T., Matsumura, R., Mimura, T., Morinobu, A., Murakawa, Y., Naniwa, T., Nanki, T., Ogawa, N., Oshima, H., Sada, K., Sugiyama, E., Takeuchi, T., Taki, H., Tamura, N., Tsukamoto, T., Yamagata, K., Yamamura, M., van Daele, P., Rutgers, A., Teng, Y., Walker, R., Chua, I., Collins, M., Rabindranath, K., de Zoysa, J., Svensson, M., Grevbo, B., Kalstad, S., Little, M., Clarkson, M., Molloy, E., Pamplona, I. Agraz, Anton, J., Lucia, V. Barrio, Ciggaran, S., Cid, M. Cinta, Encarnacion, M. Diaz, Oliveras, X. Fulladosa, Soler, M. Jose, Rusinol, H. Marco, Praga, M., Porras, L. Quintana, Segarra, A., Bruchfeld, A., Segelmark, M., Soveri, I., Thomaidi, E., Westman, K., Neumann, T., Burnier, M., Daikeler, T., Dudler, J., Hauser, T., Seeger, H., Vogt, B., Jayne, D., Burton, J., Al Jayyousi, R., Amin, T., Andrews, J., Baines, L., Brogan, P., Dasgupta, B., Doulton, T., Flossmann, O., Griffin, S., Harper, J., Harper, L., Kidder, D., Klocke, R., Lanyon, P., Luqmani, R., McLaren, J., Makanjuola, D., McCann, L., Nandagudi, A., Selvan, S., O'Riordan, E., Patel, M., Patel, R., Pusey, C., Rajakariar, R., Robson, J., Robson, M., Salama, A., Smyth, L., Sznajd, J., Taylor, J., Merkel, P., Sreih, A., Belilos, E., Bomback, A., Carlin, J., Chen Lin, Y. Chang, Derebail, V., Dragoi, S., Dua, A., Forbess, L., Geetha, D., Gipson, P., Gohh, R., Greenwood, G.T., Hugenberg, S., Jimenez, R., Kaskas, M., Kermani, T., Kivitz, A., Koening, C., Langford, C., Marder, G., Mohamed, A., Monach, P., Neyra, N., Niemer, G., Niles, J., Obi, R., Owens, C., Parks, D., Podoll, A., Rovin, B., Sam, R., Shergy, W., Silva, A., Specks, U., Spiera, R., Springer, J., Striebich, C., Swarup, A., Thakar, S., Tiliakos, A., Tsai, Y., Waguespack, D., Wasko, M. Chester, Cortazar, Frank B., Niles, John L., Jayne, David R.W., Merkel, Peter A., Bruchfeld, Annette, Yue, Huibin, Schall, Thomas J., and Bekker, Pirow

Published
2023
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2. POS1428 GIANT CELL ARTERITIS SIGNS AND SYMPTOMS LEXICON: AN INTERNATIONAL EXPERT CONSENSUS

Author

Soowamber, M., primary, Bond, M., additional, Touma, Z., additional, Ramiro, S., additional, Langford, C., additional, Sanchez-Alvarez, C., additional, Abril, A., additional, Aydin, S., additional, Buttgereit, F., additional, Camellino, D., additional, Cid, M. C., additional, Grayson, P., additional, Hellmich, B., additional, Kermani, T., additional, Khalidi, N., additional, Lichliter, W., additional, Mackie, S., additional, Matteson, E., additional, Maz, M., additional, Merkel, P. A., additional, Monach, P. A., additional, Neill, L., additional, Ponte, C., additional, Salvarani, C., additional, Schmidt, W. A., additional, Villiger, P., additional, Warrington, K. J., additional, Whitlock, M., additional, and Dejaco, C., additional

Published
2024
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3. Renal Recovery for Patients with ANCA-Associated Vasculitis and Low eGFR in the ADVOCATE Trial of Avacopan

Author

Cortazar, F. B., Niles, J. L., Jayne, D. R. W., Merkel, P. A., Bruchfeld, A., Yue, H., Schall, T. J., Bekker, P., Peh, C. A., Chakera, A., Cooper, B., Kurtkoti, J., Langguth, D., Levidiotis, V., Luxton, G., Mount, P., Mudge, D., Noble, E., Phoon, R., Ranganathan, D., Ritchie, A., Ryan, J., Suranyi, M., Rosenkranz, A., Lhotta, K., Kronbichler, A., Demoulin, N., Bovy, C., Hellemans, R., Hougardy, J., Sprangers, B., Wissing, K., Pagnoux, C., Barbour, S., Brachemi, S., Cournoyer, S., Girard, L., Laurin, L., Liang, P., Philibert, D., Walsh, M., Tesar, V., Becvar, R., Horak, P., Rychlik, I., Szpirt, W., Dieperink, H., Gregersen, J., Ivarsen, P., Krarup, E., Lyngsoe, C., Rigothier, C., Augusto, J., Belot, A., Chauveau, D., Cornec, D., Jourde-Chiche, N., Ficheux, M., Karras, A., Klein, A., Maurier, F., Mesbah, R., Moranne, O., Neel, A., Quemeneur, T., Saadoun, D., Terrier, B., Zaoui, P., Schaier, M., Benck, U., Bergner, R., Busch, M., Floege, J., Grundmann, F., Haller, H., Haubitz, M., Hellmich, B., Henes, J., Hohenstein, B., Hugo, C., Iking-Konert, C., Arndt, F., Kubacki, T., Kotter, I., Lamprecht, P., Lindner, T., Halbritter, J., Mehling, H., Schonermarck, U., Venhoff, N., Vielhauer, V., Witzke, O., Szombati, I., Szucs, G., Garibotto, G., Alberici, F., Brunetta, E., Dagna, L., De Vita, S., Emmi, G., Gabrielli, A., Manenti, L., Pieruzzi, F., Roccatello, D., Salvarani, C., Dobashi, H., Atsumi, T., Fujimoto, S., Hagino, N., Ihata, A., Kaname, S., Kaneko, Y., Katagiri, A., Katayama, M., Kirino, Y., Kitagawa, K., Komatsuda, A., Kono, H., Kurasawa, T., Matsumura, R., Mimura, T., Morinobu, A., Murakawa, Y., Naniwa, T., Nanki, T., Ogawa, N., Oshima, H., Sada, K., Sugiyama, E., Takeuchi, T., Taki, H., Tamura, N., Tsukamoto, T., Yamagata, K., Yamamura, M., van Daele, P., Rutgers, A., Teng, Y., Walker, R., Chua, I., Collins, M., Rabindranath, K., de Zoysa, J., Svensson, M., Grevbo, B., Kalstad, S., Little, M., Clarkson, M., Molloy, E., Pamplona, I. A., Anton, J., Lucia, V. B., Ciggaran, S., Cid, M. C., Encarnacion, M. D., Oliveras, X. F., Soler, M. J., Rusinol, H. M., Praga, M., Porras, L. Q., Segarra, A., Segelmark, M., Soveri, I., Thomaidi, E., Westman, K., Neumann, T., Burnier, M., Daikeler, T., Dudler, J., Hauser, T., Seeger, H., Vogt, B., Jayne, D., Burton, J., Al Jayyousi, R., Amin, T., Andrews, J., Baines, L., Brogan, P., Dasgupta, B., Doulton, T., Flossmann, O., Griffin, S., Harper, J., Harper, L., Kidder, D., Klocke, R., Lanyon, P., Luqmani, R., Mclaren, J., Makanjuola, D., Mccann, L., Nandagudi, A., Selvan, S., O'Riordan, E., Patel, M., Patel, R., Pusey, C., Rajakariar, R., Robson, J., Robson, M., Salama, A., Smyth, L., Sznajd, J., Taylor, J., Merkel, P., Sreih, A., Belilos, E., Bomback, A., Carlin, J., Chen Lin, Y. C., Derebail, V., Dragoi, S., Dua, A., Forbess, L., Geetha, D., Gipson, P., Gohh, R., Greenwood, G. T., Hugenberg, S., Jimenez, R., Kaskas, M., Kermani, T., Kivitz, A., Koening, C., Langford, C., Marder, G., Mohamed, A., Monach, P., Neyra, N., Niemer, G., Niles, J., Obi, R., Owens, C., Parks, D., Podoll, A., Rovin, B., Sam, R., Shergy, W., Silva, A., Specks, U., Spiera, R., Springer, J., Striebich, C., Swarup, A., Thakar, S., Tiliakos, A., Tsai, Y., Waguespack, D., Wasko, M. C., Cortazar, F, Niles, J, Jayne, D, Merkel, P, Bruchfeld, A, Yue, H, Schall, T, Bekker, P, Peh, C, Chakera, A, Cooper, B, Kurtkoti, J, Langguth, D, Levidiotis, V, Luxton, G, Mount, P, Mudge, D, Noble, E, Phoon, R, Ranganathan, D, Ritchie, A, Ryan, J, Suranyi, M, Rosenkranz, A, Lhotta, K, Kronbichler, A, Demoulin, N, Bovy, C, Hellemans, R, Hougardy, J, Sprangers, B, Wissing, K, Pagnoux, C, Barbour, S, Brachemi, S, Cournoyer, S, Girard, L, Laurin, L, Liang, P, Philibert, D, Walsh, M, Tesar, V, Becvar, R, Horak, P, Rychlik, I, Szpirt, W, Dieperink, H, Gregersen, J, Ivarsen, P, Krarup, E, Lyngsoe, C, Rigothier, C, Augusto, J, Belot, A, Chauveau, D, Cornec, D, Jourde-Chiche, N, Ficheux, M, Karras, A, Klein, A, Maurier, F, Mesbah, R, Moranne, O, Neel, A, Quemeneur, T, Saadoun, D, Terrier, B, Zaoui, P, Schaier, M, Benck, U, Bergner, R, Busch, M, Floege, J, Grundmann, F, Haller, H, Haubitz, M, Hellmich, B, Henes, J, Hohenstein, B, Hugo, C, Iking-Konert, C, Arndt, F, Kubacki, T, Kotter, I, Lamprecht, P, Lindner, T, Halbritter, J, Mehling, H, Schonermarck, U, Venhoff, N, Vielhauer, V, Witzke, O, Szombati, I, Szucs, G, Garibotto, G, Alberici, F, Brunetta, E, Dagna, L, De Vita, S, Emmi, G, Gabrielli, A, Manenti, L, Pieruzzi, F, Roccatello, D, Salvarani, C, Dobashi, H, Atsumi, T, Fujimoto, S, Hagino, N, Ihata, A, Kaname, S, Kaneko, Y, Katagiri, A, Katayama, M, Kirino, Y, Kitagawa, K, Komatsuda, A, Kono, H, Kurasawa, T, Matsumura, R, Mimura, T, Morinobu, A, Murakawa, Y, Naniwa, T, Nanki, T, Ogawa, N, Oshima, H, Sada, K, Sugiyama, E, Takeuchi, T, Taki, H, Tamura, N, Tsukamoto, T, Yamagata, K, Yamamura, M, van Daele, P, Rutgers, A, Teng, Y, Walker, R, Chua, I, Collins, M, Rabindranath, K, de Zoysa, J, Svensson, M, Grevbo, B, Kalstad, S, Little, M, Clarkson, M, Molloy, E, Pamplona, I, Anton, J, Lucia, V, Ciggaran, S, Cid, M, Encarnacion, M, Oliveras, X, Soler, M, Rusinol, H, Praga, M, Porras, L, Segarra, A, Segelmark, M, Soveri, I, Thomaidi, E, Westman, K, Neumann, T, Burnier, M, Daikeler, T, Dudler, J, Hauser, T, Seeger, H, Vogt, B, Burton, J, Al Jayyousi, R, Amin, T, Andrews, J, Baines, L, Brogan, P, Dasgupta, B, Doulton, T, Flossmann, O, Griffin, S, Harper, J, Harper, L, Kidder, D, Klocke, R, Lanyon, P, Luqmani, R, Mclaren, J, Makanjuola, D, Mccann, L, Nandagudi, A, Selvan, S, O'Riordan, E, Patel, M, Patel, R, Pusey, C, Rajakariar, R, Robson, J, Robson, M, Salama, A, Smyth, L, Sznajd, J, Taylor, J, Sreih, A, Belilos, E, Bomback, A, Carlin, J, Chen Lin, Y, Derebail, V, Dragoi, S, Dua, A, Forbess, L, Geetha, D, Gipson, P, Gohh, R, Greenwood, G, Hugenberg, S, Jimenez, R, Kaskas, M, Kermani, T, Kivitz, A, Koening, C, Langford, C, Marder, G, Mohamed, A, Monach, P, Neyra, N, Niemer, G, Obi, R, Owens, C, Parks, D, Podoll, A, Rovin, B, Sam, R, Shergy, W, Silva, A, Specks, U, Spiera, R, Springer, J, Striebich, C, Swarup, A, Thakar, S, Tiliakos, A, Tsai, Y, Waguespack, D, and Wasko, M

Subjects
avacopan, Clinical Research, renal recovery, Nephrology, low eGFR, complement 5a receptor, complement, ANCA-associated vasculiti
Abstract

INTRODUCTION: In the 330-patient ADVOCATE trial of avacopan for the treatment of antineutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis, in which 81% of patients had renal involvement, estimated glomerular filtration rate (eGFR) increased on average 7.3 ml/min per 1.73 m(2) in the avacopan group and 4.1 ml/min per 1.73 m(2) in the prednisone group (P = 0.029) at week 52. This new analysis examines the results in the patient subgroup with severe renal insufficiency at enrollment into the trial, i.e., eGFR ≤20 ml/min per 1.73 m(2). METHODS: eGFR was determined at baseline and over the course of the trial. Changes in eGFR were compared between the 2 treatment groups. RESULTS: In ADVOCATE, 27 of 166 patients (16%) in the avacopan group and 23 of 164 patients (14%) in the prednisone group had a baseline eGFR ≤20 ml/min per 1.73 m(2). At week 52, eGFR increased on average 16.1 and 7.7 ml/min per 1.73 m(2) in the avacopan and prednisone groups, respectively (P = 0.003). The last eGFR value measured during the 52-week treatment period was ≥2-fold higher than baseline in 41% of patients in the avacopan group compared to 13% in the prednisone group (P = 0.030). More patients in the avacopan group versus prednisone group had increases in eGFR above 20, 30, and 45 ml/min per 1.73 m(2), respectively. Serious adverse events occurred in 13 of 27 patients (48%) in the avacopan group and 16 of 23 patients (70%) in the prednisone group. CONCLUSION: Among patients with baseline eGFR ≤20 ml/min per 1.73 m(2) in the ADVOCATE trial, eGFR improved more in the avacopan group than in the prednisone group.

Published
2023

4. The provisional OMERACT ultrasonography score for giant cell arteritis

Author

Dejaco, C, Ponte, C, Monti, S, Rozza, D, Scire, C, Terslev, L, Bruyn, G, Boumans, D, Hartung, W, Hocevar, A, Milchert, M, Dohn, U, Mukhtyar, C, Aschwanden, M, Bosch, P, Camellino, D, Chrysidis, S, Ciancio, G, D'Agostino, M, Daikeler, T, Dasgupta, B, De Miguel, E, Diamantopoulos, A, Duftner, C, Agueda, A, Fredberg, U, Hanova, P, Hansen, I, Hauge, E, Iagnocco, A, Inanc, N, Juche, A, Karalilova, R, Kawamoto, T, Keller, K, Keen, H, Kermani, T, Kohler, M, Koster, M, Luqmani, R, Macchioni, P, Mackie, S, Naredo, E, Nielsen, B, Ogasawara, M, Pineda, C, Schafer, V, Seitz, L, Tomelleri, A, Torralba, K, Van Der Geest, K, Warrington, K, Schmidt, W, Dejaco C., Ponte C., Monti S., Rozza D., Scire C. A., Terslev L., Bruyn G. A. W., Boumans D., Hartung W., Hocevar A., Milchert M., Dohn U. Mo., Mukhtyar C. B., Aschwanden M., Bosch P., Camellino D., Chrysidis S., Ciancio G., D'Agostino M. A., Daikeler T., Dasgupta B., De Miguel E., Diamantopoulos A. P., Duftner C., Agueda A., Fredberg U., Hanova P., Hansen I. To., Hauge E. -M., Iagnocco A., Inanc N., Juche A., Karalilova R., Kawamoto T., Keller K. K., Keen H. I., Kermani T. A., Kohler M. J., Koster M., Luqmani R. A., Macchioni P., Mackie S. L., Naredo E., Nielsen B. D., Ogasawara M., Pineda C., Schafer V. S., Seitz L., Tomelleri A., Torralba K. D., Van Der Geest K. S. M., Warrington K. J., Schmidt W. A., Dejaco, C, Ponte, C, Monti, S, Rozza, D, Scire, C, Terslev, L, Bruyn, G, Boumans, D, Hartung, W, Hocevar, A, Milchert, M, Dohn, U, Mukhtyar, C, Aschwanden, M, Bosch, P, Camellino, D, Chrysidis, S, Ciancio, G, D'Agostino, M, Daikeler, T, Dasgupta, B, De Miguel, E, Diamantopoulos, A, Duftner, C, Agueda, A, Fredberg, U, Hanova, P, Hansen, I, Hauge, E, Iagnocco, A, Inanc, N, Juche, A, Karalilova, R, Kawamoto, T, Keller, K, Keen, H, Kermani, T, Kohler, M, Koster, M, Luqmani, R, Macchioni, P, Mackie, S, Naredo, E, Nielsen, B, Ogasawara, M, Pineda, C, Schafer, V, Seitz, L, Tomelleri, A, Torralba, K, Van Der Geest, K, Warrington, K, Schmidt, W, Dejaco C., Ponte C., Monti S., Rozza D., Scire C. A., Terslev L., Bruyn G. A. W., Boumans D., Hartung W., Hocevar A., Milchert M., Dohn U. Mo., Mukhtyar C. B., Aschwanden M., Bosch P., Camellino D., Chrysidis S., Ciancio G., D'Agostino M. A., Daikeler T., Dasgupta B., De Miguel E., Diamantopoulos A. P., Duftner C., Agueda A., Fredberg U., Hanova P., Hansen I. To., Hauge E. -M., Iagnocco A., Inanc N., Juche A., Karalilova R., Kawamoto T., Keller K. K., Keen H. I., Kermani T. A., Kohler M. J., Koster M., Luqmani R. A., Macchioni P., Mackie S. L., Naredo E., Nielsen B. D., Ogasawara M., Pineda C., Schafer V. S., Seitz L., Tomelleri A., Torralba K. D., Van Der Geest K. S. M., Warrington K. J., and Schmidt W. A.

Abstract

Objectives To develop an Outcome Measures in Rheumatology (OMERACT) ultrasonography score for monitoring disease activity in giant cell arteritis (GCA) and evaluate its metric properties. Methods The OMERACT Instrument Selection Algorithm was followed. Forty-nine members of the OMERACT ultrasonography large vessel vasculitis working group were invited to seven Delphi rounds. An online reliability exercise was conducted using images of bilateral common temporal arteries, parietal and frontal branches as well as axillary arteries from 16 patients with GCA and 7 controls. Sensitivity to change and convergent construct validity were tested using data from a prospective cohort of patients with new GCA in which ultrasound-based intima-media thickness (IMT) measurements were conducted at weeks 1, 3, 6, 12 and 24. Results Agreement was obtained (92.7%) for the OMERACT GCA Ultrasonography Score (OGUS), calculated as follows: sum of IMT measured in every segment divided by the rounded cut-off values of IMTs in each segment. The resulting value is then divided by the number of segments available. Thirty-five members conducted the reliability exercise, the interrater intraclass correlation coefficient (ICC) for the OGUS was 0.72-0.84 and the median intrareader ICC was 0.91. The prospective cohort consisted of 52 patients. Sensitivity to change between baseline and each follow-up visit up to week 24 yielded standardised mean differences from -1.19 to -2.16, corresponding to large and very large magnitudes of change, respectively. OGUS correlated moderately with erythrocyte sedimentation rate, C reactive protein and Birmingham Vasculitis Activity Score (corr coeff 0.37-0.48). Conclusion We developed a provisional OGUS for potential use in clinical trials.

Published
2023

5. Renal Recovery for Patients with ANCA-Associated Vasculitis and Low eGFR in the ADVOCATE Trial of Avacopan

Author

Cortazar, F, Niles, J, Jayne, D, Merkel, P, Bruchfeld, A, Yue, H, Schall, T, Bekker, P, Peh, C, Chakera, A, Cooper, B, Kurtkoti, J, Langguth, D, Levidiotis, V, Luxton, G, Mount, P, Mudge, D, Noble, E, Phoon, R, Ranganathan, D, Ritchie, A, Ryan, J, Suranyi, M, Rosenkranz, A, Lhotta, K, Kronbichler, A, Demoulin, N, Bovy, C, Hellemans, R, Hougardy, J, Sprangers, B, Wissing, K, Pagnoux, C, Barbour, S, Brachemi, S, Cournoyer, S, Girard, L, Laurin, L, Liang, P, Philibert, D, Walsh, M, Tesar, V, Becvar, R, Horak, P, Rychlik, I, Szpirt, W, Dieperink, H, Gregersen, J, Ivarsen, P, Krarup, E, Lyngsoe, C, Rigothier, C, Augusto, J, Belot, A, Chauveau, D, Cornec, D, Jourde-Chiche, N, Ficheux, M, Karras, A, Klein, A, Maurier, F, Mesbah, R, Moranne, O, Neel, A, Quemeneur, T, Saadoun, D, Terrier, B, Zaoui, P, Schaier, M, Benck, U, Bergner, R, Busch, M, Floege, J, Grundmann, F, Haller, H, Haubitz, M, Hellmich, B, Henes, J, Hohenstein, B, Hugo, C, Iking-Konert, C, Arndt, F, Kubacki, T, Kotter, I, Lamprecht, P, Lindner, T, Halbritter, J, Mehling, H, Schonermarck, U, Venhoff, N, Vielhauer, V, Witzke, O, Szombati, I, Szucs, G, Garibotto, G, Alberici, F, Brunetta, E, Dagna, L, De Vita, S, Emmi, G, Gabrielli, A, Manenti, L, Pieruzzi, F, Roccatello, D, Salvarani, C, Dobashi, H, Atsumi, T, Fujimoto, S, Hagino, N, Ihata, A, Kaname, S, Kaneko, Y, Katagiri, A, Katayama, M, Kirino, Y, Kitagawa, K, Komatsuda, A, Kono, H, Kurasawa, T, Matsumura, R, Mimura, T, Morinobu, A, Murakawa, Y, Naniwa, T, Nanki, T, Ogawa, N, Oshima, H, Sada, K, Sugiyama, E, Takeuchi, T, Taki, H, Tamura, N, Tsukamoto, T, Yamagata, K, Yamamura, M, van Daele, P, Rutgers, A, Teng, Y, Walker, R, Chua, I, Collins, M, Rabindranath, K, de Zoysa, J, Svensson, M, Grevbo, B, Kalstad, S, Little, M, Clarkson, M, Molloy, E, Pamplona, I, Anton, J, Lucia, V, Ciggaran, S, Cid, M, Encarnacion, M, Oliveras, X, Soler, M, Rusinol, H, Praga, M, Porras, L, Segarra, A, Segelmark, M, Soveri, I, Thomaidi, E, Westman, K, Neumann, T, Burnier, M, Daikeler, T, Dudler, J, Hauser, T, Seeger, H, Vogt, B, Burton, J, Al Jayyousi, R, Amin, T, Andrews, J, Baines, L, Brogan, P, Dasgupta, B, Doulton, T, Flossmann, O, Griffin, S, Harper, J, Harper, L, Kidder, D, Klocke, R, Lanyon, P, Luqmani, R, Mclaren, J, Makanjuola, D, Mccann, L, Nandagudi, A, Selvan, S, O'Riordan, E, Patel, M, Patel, R, Pusey, C, Rajakariar, R, Robson, J, Robson, M, Salama, A, Smyth, L, Sznajd, J, Taylor, J, Sreih, A, Belilos, E, Bomback, A, Carlin, J, Chen Lin, Y, Derebail, V, Dragoi, S, Dua, A, Forbess, L, Geetha, D, Gipson, P, Gohh, R, Greenwood, G, Hugenberg, S, Jimenez, R, Kaskas, M, Kermani, T, Kivitz, A, Koening, C, Langford, C, Marder, G, Mohamed, A, Monach, P, Neyra, N, Niemer, G, Obi, R, Owens, C, Parks, D, Podoll, A, Rovin, B, Sam, R, Shergy, W, Silva, A, Specks, U, Spiera, R, Springer, J, Striebich, C, Swarup, A, Thakar, S, Tiliakos, A, Tsai, Y, Waguespack, D, Wasko, M, Cortazar F. B., Niles J. L., Jayne D. R. W., Merkel P. A., Bruchfeld A., Yue H., Schall T. J., Bekker P., Peh C. A., Chakera A., Cooper B., Kurtkoti J., Langguth D., Levidiotis V., Luxton G., Mount P., Mudge D., Noble E., Phoon R., Ranganathan D., Ritchie A., Ryan J., Suranyi M., Rosenkranz A., Lhotta K., Kronbichler A., Demoulin N., Bovy C., Hellemans R., Hougardy J., Sprangers B., Wissing K., Pagnoux C., Barbour S., Brachemi S., Cournoyer S., Girard L., Laurin L., Liang P., Philibert D., Walsh M., Tesar V., Becvar R., Horak P., Rychlik I., Szpirt W., Dieperink H., Gregersen J., Ivarsen P., Krarup E., Lyngsoe C., Rigothier C., Augusto J., Belot A., Chauveau D., Cornec D., Jourde-Chiche N., Ficheux M., Karras A., Klein A., Maurier F., Mesbah R., Moranne O., Neel A., Quemeneur T., Saadoun D., Terrier B., Zaoui P., Schaier M., Benck U., Bergner R., Busch M., Floege J., Grundmann F., Haller H., Haubitz M., Hellmich B., Henes J., Hohenstein B., Hugo C., Iking-Konert C., Arndt F., Kubacki T., Kotter I., Lamprecht P., Lindner T., Halbritter J., Mehling H., Schonermarck U., Venhoff N., Vielhauer V., Witzke O., Szombati I., Szucs G., Garibotto G., Alberici F., Brunetta E., Dagna L., De Vita S., Emmi G., Gabrielli A., Manenti L., Pieruzzi F., Roccatello D., Salvarani C., Dobashi H., Atsumi T., Fujimoto S., Hagino N., Ihata A., Kaname S., Kaneko Y., Katagiri A., Katayama M., Kirino Y., Kitagawa K., Komatsuda A., Kono H., Kurasawa T., Matsumura R., Mimura T., Morinobu A., Murakawa Y., Naniwa T., Nanki T., Ogawa N., Oshima H., Sada K., Sugiyama E., Takeuchi T., Taki H., Tamura N., Tsukamoto T., Yamagata K., Yamamura M., van Daele P., Rutgers A., Teng Y., Walker R., Chua I., Collins M., Rabindranath K., de Zoysa J., Svensson M., Grevbo B., Kalstad S., Little M., Clarkson M., Molloy E., Pamplona I. A., Anton J., Lucia V. B., Ciggaran S., Cid M. C., Encarnacion M. D., Oliveras X. F., Soler M. J., Rusinol H. M., Praga M., Porras L. Q., Segarra A., Segelmark M., Soveri I., Thomaidi E., Westman K., Neumann T., Burnier M., Daikeler T., Dudler J., Hauser T., Seeger H., Vogt B., Jayne D., Burton J., Al Jayyousi R., Amin T., Andrews J., Baines L., Brogan P., Dasgupta B., Doulton T., Flossmann O., Griffin S., Harper J., Harper L., Kidder D., Klocke R., Lanyon P., Luqmani R., McLaren J., Makanjuola D., McCann L., Nandagudi A., Selvan S., O'Riordan E., Patel M., Patel R., Pusey C., Rajakariar R., Robson J., Robson M., Salama A., Smyth L., Sznajd J., Taylor J., Merkel P., Sreih A., Belilos E., Bomback A., Carlin J., Chen Lin Y. C., Derebail V., Dragoi S., Dua A., Forbess L., Geetha D., Gipson P., Gohh R., Greenwood G. T., Hugenberg S., Jimenez R., Kaskas M., Kermani T., Kivitz A., Koening C., Langford C., Marder G., Mohamed A., Monach P., Neyra N., Niemer G., Niles J., Obi R., Owens C., Parks D., Podoll A., Rovin B., Sam R., Shergy W., Silva A., Specks U., Spiera R., Springer J., Striebich C., Swarup A., Thakar S., Tiliakos A., Tsai Y., Waguespack D., Wasko M. C., Cortazar, F, Niles, J, Jayne, D, Merkel, P, Bruchfeld, A, Yue, H, Schall, T, Bekker, P, Peh, C, Chakera, A, Cooper, B, Kurtkoti, J, Langguth, D, Levidiotis, V, Luxton, G, Mount, P, Mudge, D, Noble, E, Phoon, R, Ranganathan, D, Ritchie, A, Ryan, J, Suranyi, M, Rosenkranz, A, Lhotta, K, Kronbichler, A, Demoulin, N, Bovy, C, Hellemans, R, Hougardy, J, Sprangers, B, Wissing, K, Pagnoux, C, Barbour, S, Brachemi, S, Cournoyer, S, Girard, L, Laurin, L, Liang, P, Philibert, D, Walsh, M, Tesar, V, Becvar, R, Horak, P, Rychlik, I, Szpirt, W, Dieperink, H, Gregersen, J, Ivarsen, P, Krarup, E, Lyngsoe, C, Rigothier, C, Augusto, J, Belot, A, Chauveau, D, Cornec, D, Jourde-Chiche, N, Ficheux, M, Karras, A, Klein, A, Maurier, F, Mesbah, R, Moranne, O, Neel, A, Quemeneur, T, Saadoun, D, Terrier, B, Zaoui, P, Schaier, M, Benck, U, Bergner, R, Busch, M, Floege, J, Grundmann, F, Haller, H, Haubitz, M, Hellmich, B, Henes, J, Hohenstein, B, Hugo, C, Iking-Konert, C, Arndt, F, Kubacki, T, Kotter, I, Lamprecht, P, Lindner, T, Halbritter, J, Mehling, H, Schonermarck, U, Venhoff, N, Vielhauer, V, Witzke, O, Szombati, I, Szucs, G, Garibotto, G, Alberici, F, Brunetta, E, Dagna, L, De Vita, S, Emmi, G, Gabrielli, A, Manenti, L, Pieruzzi, F, Roccatello, D, Salvarani, C, Dobashi, H, Atsumi, T, Fujimoto, S, Hagino, N, Ihata, A, Kaname, S, Kaneko, Y, Katagiri, A, Katayama, M, Kirino, Y, Kitagawa, K, Komatsuda, A, Kono, H, Kurasawa, T, Matsumura, R, Mimura, T, Morinobu, A, Murakawa, Y, Naniwa, T, Nanki, T, Ogawa, N, Oshima, H, Sada, K, Sugiyama, E, Takeuchi, T, Taki, H, Tamura, N, Tsukamoto, T, Yamagata, K, Yamamura, M, van Daele, P, Rutgers, A, Teng, Y, Walker, R, Chua, I, Collins, M, Rabindranath, K, de Zoysa, J, Svensson, M, Grevbo, B, Kalstad, S, Little, M, Clarkson, M, Molloy, E, Pamplona, I, Anton, J, Lucia, V, Ciggaran, S, Cid, M, Encarnacion, M, Oliveras, X, Soler, M, Rusinol, H, Praga, M, Porras, L, Segarra, A, Segelmark, M, Soveri, I, Thomaidi, E, Westman, K, Neumann, T, Burnier, M, Daikeler, T, Dudler, J, Hauser, T, Seeger, H, Vogt, B, Burton, J, Al Jayyousi, R, Amin, T, Andrews, J, Baines, L, Brogan, P, Dasgupta, B, Doulton, T, Flossmann, O, Griffin, S, Harper, J, Harper, L, Kidder, D, Klocke, R, Lanyon, P, Luqmani, R, Mclaren, J, Makanjuola, D, Mccann, L, Nandagudi, A, Selvan, S, O'Riordan, E, Patel, M, Patel, R, Pusey, C, Rajakariar, R, Robson, J, Robson, M, Salama, A, Smyth, L, Sznajd, J, Taylor, J, Sreih, A, Belilos, E, Bomback, A, Carlin, J, Chen Lin, Y, Derebail, V, Dragoi, S, Dua, A, Forbess, L, Geetha, D, Gipson, P, Gohh, R, Greenwood, G, Hugenberg, S, Jimenez, R, Kaskas, M, Kermani, T, Kivitz, A, Koening, C, Langford, C, Marder, G, Mohamed, A, Monach, P, Neyra, N, Niemer, G, Obi, R, Owens, C, Parks, D, Podoll, A, Rovin, B, Sam, R, Shergy, W, Silva, A, Specks, U, Spiera, R, Springer, J, Striebich, C, Swarup, A, Thakar, S, Tiliakos, A, Tsai, Y, Waguespack, D, Wasko, M, Cortazar F. B., Niles J. L., Jayne D. R. W., Merkel P. A., Bruchfeld A., Yue H., Schall T. J., Bekker P., Peh C. A., Chakera A., Cooper B., Kurtkoti J., Langguth D., Levidiotis V., Luxton G., Mount P., Mudge D., Noble E., Phoon R., Ranganathan D., Ritchie A., Ryan J., Suranyi M., Rosenkranz A., Lhotta K., Kronbichler A., Demoulin N., Bovy C., Hellemans R., Hougardy J., Sprangers B., Wissing K., Pagnoux C., Barbour S., Brachemi S., Cournoyer S., Girard L., Laurin L., Liang P., Philibert D., Walsh M., Tesar V., Becvar R., Horak P., Rychlik I., Szpirt W., Dieperink H., Gregersen J., Ivarsen P., Krarup E., Lyngsoe C., Rigothier C., Augusto J., Belot A., Chauveau D., Cornec D., Jourde-Chiche N., Ficheux M., Karras A., Klein A., Maurier F., Mesbah R., Moranne O., Neel A., Quemeneur T., Saadoun D., Terrier B., Zaoui P., Schaier M., Benck U., Bergner R., Busch M., Floege J., Grundmann F., Haller H., Haubitz M., Hellmich B., Henes J., Hohenstein B., Hugo C., Iking-Konert C., Arndt F., Kubacki T., Kotter I., Lamprecht P., Lindner T., Halbritter J., Mehling H., Schonermarck U., Venhoff N., Vielhauer V., Witzke O., Szombati I., Szucs G., Garibotto G., Alberici F., Brunetta E., Dagna L., De Vita S., Emmi G., Gabrielli A., Manenti L., Pieruzzi F., Roccatello D., Salvarani C., Dobashi H., Atsumi T., Fujimoto S., Hagino N., Ihata A., Kaname S., Kaneko Y., Katagiri A., Katayama M., Kirino Y., Kitagawa K., Komatsuda A., Kono H., Kurasawa T., Matsumura R., Mimura T., Morinobu A., Murakawa Y., Naniwa T., Nanki T., Ogawa N., Oshima H., Sada K., Sugiyama E., Takeuchi T., Taki H., Tamura N., Tsukamoto T., Yamagata K., Yamamura M., van Daele P., Rutgers A., Teng Y., Walker R., Chua I., Collins M., Rabindranath K., de Zoysa J., Svensson M., Grevbo B., Kalstad S., Little M., Clarkson M., Molloy E., Pamplona I. A., Anton J., Lucia V. B., Ciggaran S., Cid M. C., Encarnacion M. D., Oliveras X. F., Soler M. J., Rusinol H. M., Praga M., Porras L. Q., Segarra A., Segelmark M., Soveri I., Thomaidi E., Westman K., Neumann T., Burnier M., Daikeler T., Dudler J., Hauser T., Seeger H., Vogt B., Jayne D., Burton J., Al Jayyousi R., Amin T., Andrews J., Baines L., Brogan P., Dasgupta B., Doulton T., Flossmann O., Griffin S., Harper J., Harper L., Kidder D., Klocke R., Lanyon P., Luqmani R., McLaren J., Makanjuola D., McCann L., Nandagudi A., Selvan S., O'Riordan E., Patel M., Patel R., Pusey C., Rajakariar R., Robson J., Robson M., Salama A., Smyth L., Sznajd J., Taylor J., Merkel P., Sreih A., Belilos E., Bomback A., Carlin J., Chen Lin Y. C., Derebail V., Dragoi S., Dua A., Forbess L., Geetha D., Gipson P., Gohh R., Greenwood G. T., Hugenberg S., Jimenez R., Kaskas M., Kermani T., Kivitz A., Koening C., Langford C., Marder G., Mohamed A., Monach P., Neyra N., Niemer G., Niles J., Obi R., Owens C., Parks D., Podoll A., Rovin B., Sam R., Shergy W., Silva A., Specks U., Spiera R., Springer J., Striebich C., Swarup A., Thakar S., Tiliakos A., Tsai Y., Waguespack D., and Wasko M. C.

Abstract

Introduction: In the 330-patient ADVOCATE trial of avacopan for the treatment of antineutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis, in which 81% of patients had renal involvement, estimated glomerular filtration rate (eGFR) increased on average 7.3 ml/min per 1.73 m2 in the avacopan group and 4.1 ml/min per 1.73 m2 in the prednisone group (P = 0.029) at week 52. This new analysis examines the results in the patient subgroup with severe renal insufficiency at enrollment into the trial, i.e., eGFR ≤20 ml/min per 1.73 m2. Methods: eGFR was determined at baseline and over the course of the trial. Changes in eGFR were compared between the 2 treatment groups. Results: In ADVOCATE, 27 of 166 patients (16%) in the avacopan group and 23 of 164 patients (14%) in the prednisone group had a baseline eGFR ≤20 ml/min per 1.73 m2. At week 52, eGFR increased on average 16.1 and 7.7 ml/min per 1.73 m2 in the avacopan and prednisone groups, respectively (P = 0.003). The last eGFR value measured during the 52-week treatment period was ≥2-fold higher than baseline in 41% of patients in the avacopan group compared to 13% in the prednisone group (P = 0.030). More patients in the avacopan group versus prednisone group had increases in eGFR above 20, 30, and 45 ml/min per 1.73 m2, respectively. Serious adverse events occurred in 13 of 27 patients (48%) in the avacopan group and 16 of 23 patients (70%) in the prednisone group. Conclusion: Among patients with baseline eGFR ≤20 ml/min per 1.73 m2 in the ADVOCATE trial, eGFR improved more in the avacopan group than in the prednisone group.

Published
2023

7. POS0714 TREAT-TO-TARGET RECOMMENDATIONS IN GIANT CELL ARTERITIS AND POLYMYALGIA RHEUMATICA

Author

Dejaco, C., primary, Kerschbaumer, A., additional, Aletaha, D., additional, Bond, M., additional, Hysa, E., additional, Camellino, D., additional, Ehlers, L., additional, Abril, A., additional, Appenzeller, S., additional, Cid, M. C., additional, Dasgupta, B., additional, Duftner, C., additional, Grayson, P., additional, Hellmich, B., additional, Hocevar, A., additional, Kermani, T., additional, Matteson, E., additional, Mollan, S., additional, Neill, L., additional, Ponte, C., additional, Salvarani, C., additional, Sattui, S. E., additional, Schmidt, W. A., additional, Seo, P., additional, Smolen, J., additional, Thiel, J., additional, Toro Gutiérrez, C., additional, Whitlock, M., additional, and Buttgereit, F., additional

Published
2023
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8. OMERACT definition and reliability assessment of chronic ultrasound lesions of the axillary artery in giant cell arteritis

Author

Schafer, V, Chrysidis, S, Schmidt, W, Duftner, C, Iagnocco, A, Bruyn, G, Carrara, G, De Miguel, E, Diamantopoulos, A, Nielsen, B, Fredberg, U, Hartung, W, Hanova, P, Hansen, I, Hocevar, A, Juche, A, Kermani, T, Lorenzen, T, Macchioni, P, Milchert, M, Dohn, U, Mukhtyar, C, Monti, S, Ponte, C, Seitz, L, Scire, C, Terslev, L, Dasgupta, B, Keen, H, Pineda, C, Dejaco, C, Schafer V. S., Chrysidis S., Schmidt W. A., Duftner C., Iagnocco A., Bruyn G. A., Carrara G., De Miguel E., Diamantopoulos A. P., Nielsen B. D., Fredberg U., Hartung W., Hanova P., Hansen I. T., Hocevar A., Juche A., Kermani T. A., Lorenzen T., Macchioni P., Milchert M., Dohn U. M., Mukhtyar C., Monti S., Ponte C., Seitz L., Scire C. A., Terslev L., Dasgupta B., Keen H. I., Pineda C., Dejaco C., Schafer, V, Chrysidis, S, Schmidt, W, Duftner, C, Iagnocco, A, Bruyn, G, Carrara, G, De Miguel, E, Diamantopoulos, A, Nielsen, B, Fredberg, U, Hartung, W, Hanova, P, Hansen, I, Hocevar, A, Juche, A, Kermani, T, Lorenzen, T, Macchioni, P, Milchert, M, Dohn, U, Mukhtyar, C, Monti, S, Ponte, C, Seitz, L, Scire, C, Terslev, L, Dasgupta, B, Keen, H, Pineda, C, Dejaco, C, Schafer V. S., Chrysidis S., Schmidt W. A., Duftner C., Iagnocco A., Bruyn G. A., Carrara G., De Miguel E., Diamantopoulos A. P., Nielsen B. D., Fredberg U., Hartung W., Hanova P., Hansen I. T., Hocevar A., Juche A., Kermani T. A., Lorenzen T., Macchioni P., Milchert M., Dohn U. M., Mukhtyar C., Monti S., Ponte C., Seitz L., Scire C. A., Terslev L., Dasgupta B., Keen H. I., Pineda C., and Dejaco C.

Abstract

Objectives: To define chronic ultrasound lesions of the axillary artery (AA) in long-standing giant cell arteritis (GCA) and to evaluate the reliability of the new ultrasound definition in a web-based exercise. Methods: A structured Delphi, involving an expert panel of the Large Vessel Vasculitis subgroup of the Outcome Measures in Rheumatology (OMERACT) Ultrasound Working Group was carried out. The reliability of the new definition was tested in a 2-round web-based exercise involving 23 experts and using 50 still images each from AA of long-standing and acute GCA patients, as well as 50 images from healthy individuals. Results: The final OMERACT ultrasound definition of chronic changes was based on measurement and appearance of the intima-media complex. The overall reliability of the new definition for chronic ultrasound changes in longstanding GCA of the AA was good to excellent with Light's kappa values of 0.79-0.80 for inter-reader reliability and mean Light's-kappa of 0.88 for intra-reader reliability. The mean inter-rater and intra-rater agreements were 86-87% and 92%, respectively. Good reliabilities were observed comparing the vessels with longstanding versus acute GCA with a mean agreement and kappa values of 81% and 0.63, respectively. Conclusion: The new OMERACT ultrasound definition for chronic vasculitis of the AA in GCA revealed a good to excellent inter- and intra-reader reliability in a web-based exercise of experts.

Published
2021

10. Avacopan for the Treatment of ANCA-Associated Vasculitis

Author

Jayne, David R W, Merkel, Peter A, Schall, Thomas J, Bekker, Pirow, ADVOCATE Study Group:, C Au Peh, Chakera, A, Cooper, B, Kurtkoti, J, Langguth, D, Levidiotis, V, Luxton, G, Mount, P, Mudge, D, Noble, E, Phoon, R, Ranganathan, D, Ritchie, A, Ryan, J, Suranyi, M, Rosenkranz, A, Lhotta, K, Kronbichler, A, Demoulin, N, Bovy, C, Hellemans, R, Hougardy, J, Sprangers, B, Wissing, K, Pagnoux, C, Barbour, S, Brachemi, S, Cournoyer, S, Girard, L, Laurin, L, Liang, P, Philibert, D, Walsh, M, Tesar, V, Becvar, R, Horak, P, Rychlik, I, Szpirt, W, Dieperink, H, Gregersen, J, Ivarsen, P, Krarup, E, Lyngsoe, C, Rigothier, C, Augusto, J, Belot, A, Chauveau, D, Cornec, D, Jourde-Chiche, N, Ficheux, M, Karras, A, Klein, A, Maurier, F, Mesbah, R, Moranne, O, Neel, A, Quemeneur, T, Saadoun, D, Terrier, B, Zaoui, P, Schaier, M, Benck, U, Bergner, R, Busch, M, Floege, J, Grundmann, F, Haller, H, Haubitz, M, Hellmich, B, Henes, J, Hohenstein, B, Hugo, C, Iking-Konert, C, Arndt, F, Kubacki, T, Kotter, I, Lamprecht, P, Lindner, T, Halbritter, J, Mehling, H, Schönermarck, U, Venhoff, N, Vielhauer, V, Witzke, O, Szombati, I, Szucs, G, Garibotto, G, Alberici, F, Brunetta, E, Dagna, L, S De Vita, Emmi, G, Gabrielli, A, Manenti, L, Pieruzzi, F, Roccatello, D, Salvarani, C, Dobashi, H, Atsumi, T, Fujimoto, S, Hagino, N, Ihata, A, Kaname, S, Kaneko, Y, Katagiri, A, Katayama, M, Kirino, Y, Kitagawa, K, Komatsuda, A, Kono, H, Kurasawa, T, Matsumura, R, Mimura, T, Morinobu, A, Murakawa, Y, Naniwa, T, Nanki, T, Ogawa, N, Oshima, H, Sada, K, Sugiyama, E, Takeuchi, T, Taki, H, Tamura, N, Tsukamoto, T, Yamagata, K, Yamamura, M, P van Daele, Rutgers, A, Teng, Y, Walker, R, Chua, I, Collins, M, Rabindranath, K, J de Zoysa, Svensson, M, Grevbo, B, Kalstad, S, Little, M, Clarkson, M, Molloy, E, I Agraz Pamplona, Anton, J, V Barrio Lucia, Ciggaran, S, M Cinta Cid, M Diaz Encarnacion, X Fulladosa Oliveras, M Soler, J, H Rusinol, M, Praga, M, L Quintana Porras, Segarra, A, Bruchfeld, A, Segelmark, M, Soveri, I, Thomaidi, E, Westman, K, Neumann, T, Burnier, M, Daikeler, T, Dudler, J, Hauser, T, Seeger, H, Vogt, B, Jayne, D, Burton, J, R Al Jayyousi, Amin, T, Andrews, J, Baines, L, Brogan, P, Dasgupta, B, Doulton, T, Flossmann, O, Griffin, S, Harper, J, Harper, L, Kidder, D, Klocke, R, Lanyon, P, Luqmani, R, Mclaren, J, Makanjuola, D, Mccann, L, Nandagudi, A, Selvan, S, O'Riordan, E, Patel, M, Patel, R, Pusey, C, Rajakariar, R, Robson, J, Robson, M, Salama, A, Smyth, L, Sznajd, J, Taylor, J, Merkel, P, Sreih, A, Belilos, E, Bomback, A, Carlin, J, Y Chang Chen Lin, Derebail, V, Dragoi, S, Dua, A, Forbess, L, Geetha, D, Gipson, P, Gohh, R, T Greenwood, G, Hugenberg, S, Jimenez, R, Kaskas, M, Kermani, T, Kivitz, A, Koening, C, Langford, C, Marder, G, Mohamed, A, Monach, P, Neyra, N, Niemer, G, Niles, J, Obi, R, Owens, C, Parks, D, Podoll, A, Rovin, B, Sam, R, Shergy, W, Silva, A, Specks, U, Spiera, R, Springer, J, Striebich, C, Swarup, A, Thakar, S, Tiliakos, A, Tsai, Y, Waguespack, D, M Chester Wasko, Internal Medicine, Immunology, Jayne, D, Merkel, P, Schall, T, Bekker, P, Pieruzzi, F, Jayne, David RW [0000-0002-1712-0637], Apollo - University of Cambridge Repository, and Translational Immunology Groningen (TRIGR)

Subjects
Male, Receptor, Anaphylatoxin C5a/antagonists & inhibitors, Anaphylatoxin C5a, Anaphylatoxin C5a/antagonists & inhibitors, Nipecotic Acids, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculiti, Administration, Oral, Azathioprine, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, urologic and male genital diseases, Gastroenterology, C5a receptor, Cyclophosphamide/administration & dosage, Rituximab/administration & dosage, Immunosuppressive Agent, renal vasculitis, Prednisone/administration & dosage, 0302 clinical medicine, Glucocorticoid, immune system diseases, Prednisone, Recurrence, Medicine, 030212 general & internal medicine, skin and connective tissue diseases, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis/drug therapy, Aniline Compounds, Remission Induction, General Medicine, Aniline Compound, Middle Aged, Administration, Combination, Rituximab, Drug Therapy, Combination, Female, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Cyclophosphamide, Double-Blind Method, Glucocorticoids, Humans, Immunosuppressive Agents, Receptor, Anaphylatoxin C5a, Vasculitis, Receptor, medicine.drug, Human, Azathioprine/administration & dosage, Oral, medicine.medical_specialty, Nipecotic Acid, ANCA-Associated Vasculitis, 03 medical and health sciences, Drug Therapy, Internal medicine, Aniline Compounds/adverse effects, cardiovascular diseases, Immunosuppressive Agents/administration & dosage, Anti-neutrophil cytoplasmic antibody, business.industry, Glucocorticoids/administration & dosage, medicine.disease, Nipecotic Acids/adverse effects, respiratory tract diseases, business
Abstract

BACKGROUND: The C5a receptor inhibitor avacopan is being studied for the treatment of antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis.METHODS: In this randomized, controlled trial, we assigned patients with ANCA-associated vasculitis in a 1:1 ratio to receive oral avacopan at a dose of 30 mg twice daily or oral prednisone on a tapering schedule. All the patients received either cyclophosphamide (followed by azathioprine) or rituximab. The first primary end point was remission, defined as a Birmingham Vasculitis Activity Score (BVAS) of 0 (on a scale from 0 to 63, with higher scores indicating greater disease activity) at week 26 and no glucocorticoid use in the previous 4 weeks. The second primary end point was sustained remission, defined as remission at both weeks 26 and 52. Both end points were tested for noninferiority (by a margin of 20 percentage points) and for superiority.RESULTS: A total of 331 patients underwent randomization; 166 were assigned to receive avacopan, and 165 were assigned to receive prednisone. The mean BVAS at baseline was 16 in both groups. Remission at week 26 (the first primary end point) was observed in 120 of 166 patients (72.3%) receiving avacopan and in 115 of 164 patients (70.1%) receiving prednisone (estimated common difference, 3.4 percentage points; 95% confidence interval [CI], -6.0 to 12.8; PCONCLUSIONS: In this trial involving patients with ANCA-associated vasculitis, avacopan was noninferior but not superior to prednisone taper with respect to remission at week 26 and was superior to prednisone taper with respect to sustained remission at week 52. All the patients received cyclophosphamide or rituximab. The safety and clinical effects of avacopan beyond 52 weeks were not addressed in the trial. (Funded by ChemoCentryx; ADVOCATE ClinicalTrials.gov number, NCT02994927.).

Published
2021

11. Definitions and reliability assessment of elementary ultrasound lesions in giant cell arteritis: A study from the OMERACT large vessel vasculitis ultrasound working group

Author

Chrysidis, S, Duftner, C, Dejaco, C, Schafer, V, Ramiro, S, Carrara, G, Scire, C, Hocevar, A, Diamantopoulos, A, Iagnocco, A, Mukhtyar, C, Ponte, C, Naredo, E, De Miguel, E, Bruyn, G, Warrington, K, Terslev, L, Milchert, M, D'Agostino, M, Koster, M, Rastalsky, N, Hanova, P, Macchioni, P, Kermani, T, Lorenzen, T, Dohn, U, Fredberg, U, Hartung, W, Dasgupta, B, Schmidt, W, Chrysidis S., Duftner C., Dejaco C., Schafer V. S., Ramiro S., Carrara G., Scire C. A., Hocevar A., Diamantopoulos A. P., Iagnocco A., Mukhtyar C., Ponte C., Naredo E., De Miguel E., Bruyn G. A., Warrington K. J., Terslev L., Milchert M., D'Agostino M. A., Koster M. J., Rastalsky N., Hanova P., Macchioni P., Kermani T. A., Lorenzen T., Dohn U. Mo., Fredberg U., Hartung W., Dasgupta B., Schmidt W. A., Chrysidis, S, Duftner, C, Dejaco, C, Schafer, V, Ramiro, S, Carrara, G, Scire, C, Hocevar, A, Diamantopoulos, A, Iagnocco, A, Mukhtyar, C, Ponte, C, Naredo, E, De Miguel, E, Bruyn, G, Warrington, K, Terslev, L, Milchert, M, D'Agostino, M, Koster, M, Rastalsky, N, Hanova, P, Macchioni, P, Kermani, T, Lorenzen, T, Dohn, U, Fredberg, U, Hartung, W, Dasgupta, B, Schmidt, W, Chrysidis S., Duftner C., Dejaco C., Schafer V. S., Ramiro S., Carrara G., Scire C. A., Hocevar A., Diamantopoulos A. P., Iagnocco A., Mukhtyar C., Ponte C., Naredo E., De Miguel E., Bruyn G. A., Warrington K. J., Terslev L., Milchert M., D'Agostino M. A., Koster M. J., Rastalsky N., Hanova P., Macchioni P., Kermani T. A., Lorenzen T., Dohn U. Mo., Fredberg U., Hartung W., Dasgupta B., and Schmidt W. A.

Abstract

Objectives To define the elementary ultrasound (US) lesions in giant cell arteritis (GCA) and to evaluate the reliability of the assessment of US lesions according to these definitions in a web-based reliability exercise. Methods Potential definitions of normal and abnormal US findings of temporal and extracranial large arteries were retrieved by a systematic literature review. As a subsequent step, a structured Delphi exercise was conducted involving an expert panel of the Outcome Measures in Rheumatology (OMERACT) US Large Vessel Vasculitis Group to agree definitions of normal US appearance and key elementary US lesions of vasculitis of temporal and extracranial large arteries. The reliability of these definitions on normal and abnormal blood vessels was tested on 150 still images and videos in a web-based reliability exercise. Results Twenty-four experts participated in both Delphi rounds. From originally 25 statements, nine definitions were obtained for normal appearance, vasculitis and arteriosclerosis of cranial and extracranial vessels. The 'halo' and 'compression' signs were the key US lesions in GCA. The reliability of the definitions for normal temporal and axillary arteries, the 'halo' sign and the 'compression' sign was excellent with inter-rater agreements of 91-99% and mean kappa values of 0.83-0.98 for both inter-rater and intra-rater reliabilities of all 25 experts. Conclusions The 'halo' and the 'compression' signs are regarded as the most important US abnormalities for GCA. The inter-rater and intra-rater agreement of the new OMERACT definitions for US lesions in GCA was excellent.

Published
2018

12. Assessing vasculitis in giant cell arteritis by ultrasound: Results of OMERACT patient-based reliability exercises

Author

Schafer, V, Chrysidis, S, Dejaco, C, Duftner, C, Iagnocco, A, Bruyn, G, Carrara, G, D'Agostino, M, De Miguel, E, Diamantopoulos, A, Fredberg, U, Hartung, W, Hocevar, A, Juche, A, Kermani, T, Koster, M, Lorenzen, T, Macchioni, P, Milchert, M, Dohn, U, Mukhtyar, C, Ponte, C, Ramiro, S, Scire, C, Terslev, L, Warrington, K, Dasgupta, B, Schmidt, W, Schafer V. S., Chrysidis S., Dejaco C., Duftner C., Iagnocco A., Bruyn G. A., Carrara G., D'Agostino M. A., De Miguel E., Diamantopoulos A. P., Fredberg U., Hartung W., Hocevar A., Juche A., Kermani T. A., Koster M. J., Lorenzen T., Macchioni P., Milchert M., Dohn U. M., Mukhtyar C., Ponte C., Ramiro S., Scire C. A., Terslev L., Warrington K. J., Dasgupta B., Schmidt W. A., Schafer, V, Chrysidis, S, Dejaco, C, Duftner, C, Iagnocco, A, Bruyn, G, Carrara, G, D'Agostino, M, De Miguel, E, Diamantopoulos, A, Fredberg, U, Hartung, W, Hocevar, A, Juche, A, Kermani, T, Koster, M, Lorenzen, T, Macchioni, P, Milchert, M, Dohn, U, Mukhtyar, C, Ponte, C, Ramiro, S, Scire, C, Terslev, L, Warrington, K, Dasgupta, B, Schmidt, W, Schafer V. S., Chrysidis S., Dejaco C., Duftner C., Iagnocco A., Bruyn G. A., Carrara G., D'Agostino M. A., De Miguel E., Diamantopoulos A. P., Fredberg U., Hartung W., Hocevar A., Juche A., Kermani T. A., Koster M. J., Lorenzen T., Macchioni P., Milchert M., Dohn U. M., Mukhtyar C., Ponte C., Ramiro S., Scire C. A., Terslev L., Warrington K. J., Dasgupta B., and Schmidt W. A.

Abstract

Objective: To test the reliability of Outcome Measures in Rheumatology Clinical Trials (OMERACT) consensus-based ultrasound definitions for normal and vasculitic temporal and axillary arteries in patients with giant cell arteritis (GCA) and in controls. Methods: A preliminary 1-day meeting and a full 3-day meeting fulfilling OMERACT Ultrasound Group guidelines were held. Temporal and axillary arteries were examined at 2 timepoints by 12 sonographers on 4 patients with GCA and 2 controls. The aim was to test inter- and intrareader reliability for normal findings, halo sign, and compression sign. In both meetings, patients had established GCA. Pathology was more recent in the full meeting, which was preceded by 6 h of training. Scanning time was 15-20 min instead of 10-13 min. Results: In the preliminary exercise, interreader reliabilities were fair to moderate for the overall diagnosis of GCA (Light k 0.29-0.51), and poor to fair for identifying vasculitis in the respective anatomical segments (Light k 0.02-0.46). Intrareader reliabilities were moderate (Cohen k 0.32-0.64). In the main exercise, interreader reliability was good to excellent (Light k 0.76-0.86) for the overall diagnosis of GCA, and moderate to good (Light k 0.46-0.71) for identifying vasculitis in the respective anatomical segments. Intrareader reliability was excellent for diagnosis of GCA (Cohen k 0.91) and good (Cohen k 0.71-0.80) for the anatomical segments. Conclusion: OMERACT-derived definitions of halo and compression signs of temporal and axillary arteries are reliable in recent-onset GCA if experienced sonographers (> 300 examinations) have 15-20 min for a standardized examination with prior training and apply > 15 MHz probes.

Published
2018

13. Definitions and reliability assessment of elementary ultrasound lesions in giant cell arteritis: A study from the OMERACT large vessel vasculitis ultrasound working group

Author

Chrysidis, S., Duftner, C., Dejaco, C., Schafer, V. S., Ramiro, S., Carrara, G., Scire, C. A., Hocevar, A., Diamantopoulos, A. P., Iagnocco, A., Mukhtyar, C., Ponte, C., Naredo, E., De Miguel, E., Bruyn, G. A., Warrington, K. J., Terslev, L., Milchert, M., D'Agostino, Maria Antonietta, Koster, M. J., Rastalsky, N., Hanova, P., Macchioni, P., Kermani, T. A., Lorenzen, T., Dohn, U. Mo., Fredberg, U., Hartung, W., Dasgupta, B., Schmidt, W. A., D'Agostino M. A. (ORCID:0000-0002-5347-0060), Chrysidis, S., Duftner, C., Dejaco, C., Schafer, V. S., Ramiro, S., Carrara, G., Scire, C. A., Hocevar, A., Diamantopoulos, A. P., Iagnocco, A., Mukhtyar, C., Ponte, C., Naredo, E., De Miguel, E., Bruyn, G. A., Warrington, K. J., Terslev, L., Milchert, M., D'Agostino, Maria Antonietta, Koster, M. J., Rastalsky, N., Hanova, P., Macchioni, P., Kermani, T. A., Lorenzen, T., Dohn, U. Mo., Fredberg, U., Hartung, W., Dasgupta, B., Schmidt, W. A., and D'Agostino M. A. (ORCID:0000-0002-5347-0060)

Abstract

Objectives To define the elementary ultrasound (US) lesions in giant cell arteritis (GCA) and to evaluate the reliability of the assessment of US lesions according to these definitions in a web-based reliability exercise. Methods Potential definitions of normal and abnormal US findings of temporal and extracranial large arteries were retrieved by a systematic literature review. As a subsequent step, a structured Delphi exercise was conducted involving an expert panel of the Outcome Measures in Rheumatology (OMERACT) US Large Vessel Vasculitis Group to agree definitions of normal US appearance and key elementary US lesions of vasculitis of temporal and extracranial large arteries. The reliability of these definitions on normal and abnormal blood vessels was tested on 150 still images and videos in a web-based reliability exercise. Results Twenty-four experts participated in both Delphi rounds. From originally 25 statements, nine definitions were obtained for normal appearance, vasculitis and arteriosclerosis of cranial and extracranial vessels. The 'halo' and 'compression' signs were the key US lesions in GCA. The reliability of the definitions for normal temporal and axillary arteries, the 'halo' sign and the 'compression' sign was excellent with inter-rater agreements of 91-99% and mean kappa values of 0.83-0.98 for both inter-rater and intra-rater reliabilities of all 25 experts. Conclusions The 'halo' and the 'compression' signs are regarded as the most important US abnormalities for GCA. The inter-rater and intra-rater agreement of the new OMERACT definitions for US lesions in GCA was excellent.

Published
2018

14. Assessing vasculitis in giant cell arteritis by ultrasound: Results of OMERACT patient-based reliability exercises

Author

Schafer, V. S., Chrysidis, S., Dejaco, C., Duftner, C., Iagnocco, A., Bruyn, G. A., Carrara, G., D'Agostino, Maria Antonietta, De Miguel, E., Diamantopoulos, A. P., Fredberg, U., Hartung, W., Hocevar, A., Juche, A., Kermani, T. A., Koster, M. J., Lorenzen, T., Macchioni, P., Milchert, M., Dohn, U. M., Mukhtyar, C., Ponte, C., Ramiro, S., Scire, C. A., Terslev, L., Warrington, K. J., Dasgupta, B., Schmidt, W. A., D'Agostino M. A. (ORCID:0000-0002-5347-0060), Schafer, V. S., Chrysidis, S., Dejaco, C., Duftner, C., Iagnocco, A., Bruyn, G. A., Carrara, G., D'Agostino, Maria Antonietta, De Miguel, E., Diamantopoulos, A. P., Fredberg, U., Hartung, W., Hocevar, A., Juche, A., Kermani, T. A., Koster, M. J., Lorenzen, T., Macchioni, P., Milchert, M., Dohn, U. M., Mukhtyar, C., Ponte, C., Ramiro, S., Scire, C. A., Terslev, L., Warrington, K. J., Dasgupta, B., Schmidt, W. A., and D'Agostino M. A. (ORCID:0000-0002-5347-0060)

Abstract

Objective: To test the reliability of Outcome Measures in Rheumatology Clinical Trials (OMERACT) consensus-based ultrasound definitions for normal and vasculitic temporal and axillary arteries in patients with giant cell arteritis (GCA) and in controls. Methods: A preliminary 1-day meeting and a full 3-day meeting fulfilling OMERACT Ultrasound Group guidelines were held. Temporal and axillary arteries were examined at 2 timepoints by 12 sonographers on 4 patients with GCA and 2 controls. The aim was to test inter- and intrareader reliability for normal findings, halo sign, and compression sign. In both meetings, patients had established GCA. Pathology was more recent in the full meeting, which was preceded by 6 h of training. Scanning time was 15-20 min instead of 10-13 min. Results: In the preliminary exercise, interreader reliabilities were fair to moderate for the overall diagnosis of GCA (Light k 0.29-0.51), and poor to fair for identifying vasculitis in the respective anatomical segments (Light k 0.02-0.46). Intrareader reliabilities were moderate (Cohen k 0.32-0.64). In the main exercise, interreader reliability was good to excellent (Light k 0.76-0.86) for the overall diagnosis of GCA, and moderate to good (Light k 0.46-0.71) for identifying vasculitis in the respective anatomical segments. Intrareader reliability was excellent for diagnosis of GCA (Cohen k 0.91) and good (Cohen k 0.71-0.80) for the anatomical segments. Conclusion: OMERACT-derived definitions of halo and compression signs of temporal and axillary arteries are reliable in recent-onset GCA if experienced sonographers (> 300 examinations) have 15-20 min for a standardized examination with prior training and apply > 15 MHz probes.

Published
2018

16. Evaluation of Teratogenicity of Salvia leriifolia Benth. in Mice

Author

Moallem, S. A., Hossein Hosseinzadeh, Izadi, Z., Ziai, S. T., and Kermani, T.

Subjects
mice, RA1190-1270, Toxicology. Poisons, salvia leriifolia benth, Therapeutics. Pharmacology, RM1-950, teratogenicity
Abstract

Background: It has been shown that Salvia leriifolia Benth. has various pharmacological effects such as anti-hyperglycemia, anti-inflammatory, analgesic, muscle relaxant and sedative effect. There is a considerable potential for usage of this plant during pregnancy. However, its effects on embryonic development have not been examined. Objective: In this study, the in vivo fetotoxicity of S. leriifolia aqueous and alcoholic extracts were evaluated in mice. Method: For this purpose, 10% and 30% of the maximal tolerated dose (MTD) of aqueous or alcoholic extracts were daily injected intraperitoneally in pregnant mice on GD=6 (Gestation Day) to GD=14. On GD=18, embryos were harvested by Cesarean section and then morphological structures and skeletal anomalies were evaluated. Other embryos were fixed and stained for bone and cartilage assessments. Results: Both doses of alcoholic and aqueous extracts caused significant decrease in weight gain of pregnant mice length and weight of fetuses were also reduced remarkably compared to the control group. Alcoholic and aqueous extracts caused some abnormalities such as spina bifida, limb abnormalities, abdominal bleeding, and bone abnormalities. Conclusion: This study presents strong evidence that S. leriifolia can cause numerous embryotoxicities. Thus, pregnant women should be careful in using this herb during pregnancy and it is best to avoid its use until further studies are performed.

Published
2008

19. Specific IgG antibodies (total and subclasses) against Saffron pollen: a study of their correlation with specific IgE and immediate skin reactions

Author

Varasteh, A. -R, Vahedi, F., Sankian, M., hooman kaghazian, Tavallaie, S., Abolhassani, A., Kermani, T., and Mahmoudi, M.

Subjects
Adult, Hypersensitivity, Immediate, lcsh:R, lcsh:Medicine, Enzyme-Linked Immunosorbent Assay, Allergens, Immunoglobulin E, Middle Aged, Crocus, Specific IgE, Saffron pollen, Specific IgG, Immunoglobulin G, Humans, Pollen, Specific IgG subclasses, Skin Tests
Abstract

Saffron (Zaaferan), botanical name Crocus sativus, is the most expensive spice in the world. It is derived from the dried stigma and pistil of the purple saffron crocus flowers. Iran is the largest saffron producer accounting for more than 80% of the world's production. Saffron contains an aeroallergen that causes reactive respiratory allergic reactions in atopic subjects. IgG antibody to allergens in the serum of allergic patients is not routinely measured. In this study in order to find out more about mechanism of allergy against saffron pollen, specific antibodies (IgE and IgG, total and subclasses) in atopic subjects were assayed. We used an ELISA assay for measuring specific IgE and IgG against saffron pollen extract in the sera of 38 atopic subjects (test group) and 20 non allergic subjects (control group). The optical densities were compared between allergic subjects and non-allergic individuals. The prick test with saffron pollen extract was used to evaluate the cutaneous and specific antibody responses in the allergic subjects. The correlation was determined by statistical analysis. Specific saffron pollen IgE and IgG subclasses were found significantly higher in the allergic subjects than the control group. The immediate skin reaction was found positive in 70% of the test group. We report here, the existence of a positive correlation between specific IgE and skin reaction by prick test in atopic subjects (R=0.433). A negative correlation between specific IgE and IgG4 subclass was also found (R=-0.576). These data may be useful to understand the mechanism of allergy to saffron and may help in clarifying clinical manifestations and to prevent IgE production as well as therapeutic application.

Published
2007

24. Best Oral Presentations (OP01-OP12)

Author

Gecene, M., primary, Tuncay, F., additional, Borman, P., additional, Yucel, D., additional, Senes, M., additional, KaniyeYilmaz, B., additional, Franks, L., additional, Radusky, R., additional, Feig, J., additional, Fernandez, P., additional, Cronstein, B., additional, Chan, E., additional, Kim, G., additional, Han, S., additional, Jung, Y., additional, Usmani, S. E., additional, Ulici, V., additional, Beier, F., additional, Bell, M. J., additional, Veinot, P., additional, Embuldeniya, G., additional, Nyhof-Young, J., additional, Sale, J., additional, Sargeant, J., additional, Tugwell, P., additional, Brooks, S., additional, Ross, S., additional, Tonon, R., additional, Richards, D., additional, Boyle, J., additional, Knickle, K., additional, Sandhu, S., additional, Britten, N., additional, Bell, E., additional, Webster, F., additional, Cox-Dublanski, M., additional, Ntatsaki, E., additional, Watts, R. A., additional, Scott, D. G. I., additional, Tasbas, O., additional, Gurhan Karabulut, H., additional, Tukun, A., additional, Yorgancioglu, R., additional, Ferraz-Amaro, I., additional, Arce-Franco, M., additional, Hernandez-Hernandez, V., additional, Delgado-Frias, E., additional, Gantes, M., additional, Ramon Muniz, J., additional, Jesus Dominguez-Luis, M., additional, Herrera-Garcia, A., additional, Antonio Garcia-Dopico, J., additional, Medina, L., additional, Rodriguez-Vargas, A., additional, Diaz-Gonzalez, F., additional, Zampeli, E., additional, Protogerou, A., additional, Stamatelopoulos, K., additional, Fragiadaki, K., additional, Katsiari, C. G., additional, Kyrkou, K., additional, Papamichael, C. M., additional, Mavrikakis, M., additional, Nightingale, P., additional, Sfikakis, P. P., additional, Karanasos, A., additional, Felekos, I., additional, Aggeli, C., additional, Stefanadis, C., additional, Toutouzas, K., additional, Faezi, S. T., additional, Akbarian, M., additional, Jamshidi, A., additional, Hoseynialmodarresi, M., additional, Davatchi, F., additional, San Koo, B., additional, Wook So, M., additional, Kim, Y.-G., additional, Lee, C.-K., additional, Yoo, B., additional, Warrington, K. J., additional, Kermani, T. A., additional, Crowson, C. S., additional, Ytterberg, S. R., additional, Hunder, G. G., additional, Gabriel, S. E., additional, and Matteson, E. L., additional

Published
2012
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30. Histological Study of Toxic Effects of Solder Fumes on Thickness of Germinal Epithelium in Seminiferous Tubule in Rat.

Author

Arab, M. R., Mirzaei, R., Mashhadi, R., Jahantigh, M., Tabasi, M. A., and Kermani, T.

Abstract

Background: Toxic fumes generating during soldering contains various contaminants. The aim of the study was to determine toxic effects of solder fumes in thickness of semniferous tubule in Rat. Materials and Methods 48 male adult rats were randomly divided into experimental (n=30) and control (n=18) groups. Based on exposure time, each group was further divided into three subgroups such as 2, 4 and 6 weeks. The concentrations of toxic fumes were measured by standard method. Rats of experimental group were exposed to solder fumes for 1 hour/day. According to time table rats of experimental and control subgroups were killed. After fixation of testis, paraffin sections were stained by Hematoxylin & Eosin. The thicknesses of germinal epithelium were measured and data were analyzed by SPSS software version 17 with Mann Whitney test. Results: The results showed that the concentration of fumes was 0.193 mg/m³ for formaldehyde, 0.35 mg/m³ for Stanum (Sn) and 3 mg/m³ for Pb. Although there was no significant difference for weight of rats' testis between control and experimental subgroups, there was only a significant difference for the thickness of germinal epithelium between 6 week experimental and control subgroups (p<0.02). Conclusion: The results of study showed that solder fumes can change the structure and thickness of seminiferous epithelium in experimental groups in a time dependent manner. [ABSTRACT FROM AUTHOR]

Published
2014

31. Comparison of biopsy-proven giant cell arteritis in North America and Southern Europe: a population-based study

Author

Francesco Muratore, Crowson, C. S., Boiardi, L., Pinelli, A., Koster, M. J., Restuccia, G., Kermani, T. A., Matteson, E. L., Salvarani, C., and Warrington, K. J.

Subjects
Italy, Biopsy, Minnesota, Giant Cell Arteritis, Humans, Retrospective Studies
Abstract

To compare clinical characteristics, treatment and prognosis of two population-based cohorts of patients with biopsy-proven giant cell arteritis (GCA) from Olmsted County, Minnesota, USA (Olmsted cohort) and the Reggio Emilia area, Northern Italy (Reggio cohort).All patients residing in Olmsted County and the Reggio Emilia area with a new diagnosis of biopsy-proven GCA in 1986-2007 were retrospectively identified. Patients were followed from GCA diagnosis to death, migration or September 2011.The study included 110 patients in the Olmsted and 144 in the Reggio cohort. Compared with the Olmsted cohort, patients from the Reggio cohort had longer duration of symptoms prior to diagnosis (median 1.4 months vs. 0.7, p0.001) and were younger (mean 74.6 years vs. 77.8, p=0.002), more likely to have cranial symptoms (93% vs. 86%, p=0.048), permanent vision loss (21% vs. 6%, p=0.001) and systemic symptoms (67% vs. 46%, p=0.001). ESR and CRP were higher (mean 88 mm/h vs. 73, and 89.0 mg/L vs. 35.2, both p0.001) in the Reggio cohort. Patients from the Olmsted cohort received a higher initial prednisone dose (mean 53.6 mg/day vs. 49.5, p=0.001). There were no differences in relapse rates, cumulative glucocorticoid (GC) dosages at 1, 2 and 5 years, and time to first GC discontinuation.Geographical, genetic and/or environmental factors may contribute to the different clinical features at onset of GCA observed in this study.

32. OMERACT definition and reliability assessment of chronic ultrasound lesions of the axillary artery in giant cell arteritis

Author

Alojzija Hočevar, Pierluigi Macchioni, Chetan Mukhtyar, Lene Terslev, Greta Carrara, Tove Lorenzen, Carlo Alberto Scirè, Helen Keen, Cristina Ponte, Aaron Juche, Valentin S. Schäfer, Annamaria Iagnocco, Uffe Møller Døhn, Stavros Chrysidis, Luca Seitz, Christina Duftner, Eugenio de Miguel, Ulrich Fredberg, Wolfgang A. Schmidt, Andreas P. Diamantopoulos, Carlos Pineda, George A W Bruyn, Sara Monti, Petra Hanova, Wolfgang Hartung, Christian Dejaco, Berit Dalsgaard Nielsen, Ib Tønder Hansen, Marcin Milchert, Bhaskar Dasgupta, Tanaz A. Kermani, Schafer, V, Chrysidis, S, Schmidt, W, Duftner, C, Iagnocco, A, Bruyn, G, Carrara, G, De Miguel, E, Diamantopoulos, A, Nielsen, B, Fredberg, U, Hartung, W, Hanova, P, Hansen, I, Hocevar, A, Juche, A, Kermani, T, Lorenzen, T, Macchioni, P, Milchert, M, Dohn, U, Mukhtyar, C, Monti, S, Ponte, C, Seitz, L, Scire, C, Terslev, L, Dasgupta, B, Keen, H, Pineda, C, and Dejaco, C

Subjects
medicine.medical_specialty, 03 medical and health sciences, 0302 clinical medicine, Rheumatology, Axillary artery, Giant cell arteriti, Internal medicine, medicine.artery, Large vessel vasculitis, Ultrasound, medicine, Humans, 030212 general & internal medicine, Chronic, 610 Medicine & health, Reliability (statistics), Ultrasonography, Giant cell arteritis, 030203 arthritis & rheumatology, business.industry, Definition, OMERACT, Reproducibility of Results, medicine.disease, Anesthesiology and Pain Medicine, Radiology, business, Vasculitis, Kappa
Abstract

Objectives To define chronic ultrasound lesions of the axillary artery (AA) in long-standing giant cell arteritis (GCA) and to evaluate the reliability of the new ultrasound definition in a web-based exercise. Methods A structured Delphi, involving an expert panel of the Large Vessel Vasculitis subgroup of the Outcome Measures in Rheumatology (OMERACT) Ultrasound Working Group was carried out. The reliability of the new definition was tested in a 2-round web-based exercise involving 23 experts and using 50 still images each from AA of long-standing and acute GCA patients, as well as 50 images from healthy individuals. Results The final OMERACT ultrasound definition of chronic changes was based on measurement and appearance of the intima-media complex. The overall reliability of the new definition for chronic ultrasound changes in longstanding GCA of the AA was good to excellent with Light's kappa values of 0.79-0.80 for inter-reader reliability and mean Light's-kappa of 0.88 for intra-reader reliability. The mean inter-rater and intra-rater agreements were 86-87% and 92%, respectively. Good reliabilities were observed comparing the vessels with longstanding versus acute GCA with a mean agreement and kappa values of 81% and 0.63, respectively. Conclusion The new OMERACT ultrasound definition for chronic vasculitis of the AA in GCA revealed a good to excellent inter- and intra-reader reliability in a web-based exercise of experts.

Published
2021

33. The provisional OMERACT ultrasonography score for giant cell arteritis

Author

Christian Dejaco, Cristina Ponte, Sara Monti, Davide Rozza, Carlo Alberto Scirè, Lene Terslev, George A W Bruyn, Dennis Boumans, Wolfgang Hartung, Alojzija Hočevar, Marcin Milchert, Uffe Møller Døhn, Chetan B Mukhtyar, Markus Aschwanden, Philipp Bosch, Dario Camellino, Stavros Chrysidis, Giovanni Ciancio, Maria Antonietta D’Agostino, Thomas Daikeler, Bhaskar Dasgupta, Eugenio De Miguel, Andreas P Diamantopoulos, Christina Duftner, Ana Agueda, Ulrich Fredberg, Petra Hanova, Ib Tønder Hansen, Ellen-Margrethe Hauge, Annamaria Iagnocco, Nevsun Inanc, Aaron Juche, Rositsa Karalilova, Toshio Kawamoto, Kresten Krarup Keller, Helen Isobel Keen, Tanaz A Kermani, Minna J. Kohler, Matthew Koster, Raashid Ahmed Luqmani, Pierluigi Macchioni, Sarah Louise Mackie, Esperanza Naredo, Berit Dalsgaard Nielsen, Michihiro Ogasawara, Carlos Pineda, Valentin Sebastian Schäfer, Luca Seitz, Alessandro Tomelleri, Karina D Torralba, Kornelis S M van der Geest, Kenneth J Warrington, Wolfgang A Schmidt, Dejaco, C, Ponte, C, Monti, S, Rozza, D, Scire, C, Terslev, L, Bruyn, G, Boumans, D, Hartung, W, Hocevar, A, Milchert, M, Dohn, U, Mukhtyar, C, Aschwanden, M, Bosch, P, Camellino, D, Chrysidis, S, Ciancio, G, D'Agostino, M, Daikeler, T, Dasgupta, B, De Miguel, E, Diamantopoulos, A, Duftner, C, Agueda, A, Fredberg, U, Hanova, P, Hansen, I, Hauge, E, Iagnocco, A, Inanc, N, Juche, A, Karalilova, R, Kawamoto, T, Keller, K, Keen, H, Kermani, T, Kohler, M, Koster, M, Luqmani, R, Macchioni, P, Mackie, S, Naredo, E, Nielsen, B, Ogasawara, M, Pineda, C, Schafer, V, Seitz, L, Tomelleri, A, Torralba, K, Van Der Geest, K, Warrington, K, and Schmidt, W

Subjects
giant cell arteriti, Settore MED/16 - REUMATOLOGIA, giant cell arteritis, outcome assessment, health care, systemic vasculitis, ultrasonography, Immunology, health care, General Biochemistry, Genetics and Molecular Biology, Rheumatology, Immunology and Allergy, 610 Medizin und Gesundheit, systemic vasculiti, outcome assessment
Abstract

ObjectivesTo develop an Outcome Measures in Rheumatology (OMERACT) ultrasonography score for monitoring disease activity in giant cell arteritis (GCA) and evaluate its metric properties.MethodsThe OMERACT Instrument Selection Algorithm was followed. Forty-nine members of the OMERACT ultrasonography large vessel vasculitis working group were invited to seven Delphi rounds. An online reliability exercise was conducted using images of bilateral common temporal arteries, parietal and frontal branches as well as axillary arteries from 16 patients with GCA and 7 controls. Sensitivity to change and convergent construct validity were tested using data from a prospective cohort of patients with new GCA in which ultrasound-based intima–media thickness (IMT) measurements were conducted at weeks 1, 3, 6, 12 and 24.ResultsAgreement was obtained (92.7%) for the OMERACT GCA Ultrasonography Score (OGUS), calculated as follows: sum of IMT measured in every segment divided by the rounded cut-off values of IMTs in each segment. The resulting value is then divided by the number of segments available. Thirty-five members conducted the reliability exercise, the interrater intraclass correlation coefficient (ICC) for the OGUS was 0.72–0.84 and the median intrareader ICC was 0.91. The prospective cohort consisted of 52 patients. Sensitivity to change between baseline and each follow-up visit up to week 24 yielded standardised mean differences from −1.19 to −2.16, corresponding to large and very large magnitudes of change, respectively. OGUS correlated moderately with erythrocyte sedimentation rate, C reactive protein and Birmingham Vasculitis Activity Score (corrcoeff0.37–0.48).ConclusionWe developed a provisional OGUS for potential use in clinical trials.

Published
2022
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34. Assessing Vasculitis in Giant Cell Arteritis by Ultrasound: Results of OMERACT Patient-based Reliability Exercises

Author

Lene Terslev, Annamaria Iagnocco, Tanaz A. Kermani, Maria Antonietta D’Agostino, Eugenio de Miguel, Stavros Chrysidis, Sofia Ramiro, Alojzija Hočevar, Christian Dejaco, Marcin Milchert, Pierluigi Macchioni, Ulrich Fredberg, Matthew J. Koster, Bhaskar Dasgupta, George A. Bruyn, Cristina Ponte, Chetan Mukhtyar, Uffe Møller Døhn, Wolfgang A. Schmidt, Andreas P. Diamantopoulos, Wolfgang Hartung, Christina Duftner, Aaron Juche, Valentin S. Schäfer, Carlo A. Scirè, Kenneth J. Warrington, Tove Lorenzen, Greta Carrara, Schafer, V, Chrysidis, S, Dejaco, C, Duftner, C, Iagnocco, A, Bruyn, G, Carrara, G, D'Agostino, M, De Miguel, E, Diamantopoulos, A, Fredberg, U, Hartung, W, Hocevar, A, Juche, A, Kermani, T, Koster, M, Lorenzen, T, Macchioni, P, Milchert, M, Dohn, U, Mukhtyar, C, Ponte, C, Ramiro, S, Scire, C, Terslev, L, Warrington, K, Dasgupta, B, and Schmidt, W

Subjects
Vasculitis, Male, Vasculiti, medicine.medical_specialty, giant cell arteritis, ultrasound, reliability, diagnosis, vasculitis, Settore MED/16 - REUMATOLOGIA, Giant Cell Arteritis, Immunology, Sensitivity and Specificity, NO, 03 medical and health sciences, 0302 clinical medicine, Rheumatology, Diagnosis, Ultrasound Reliability, Immunology and Allergy, Internal medicine, medicine, Humans, In patient, 030212 general & internal medicine, Halo sign, Giant Cell Arteriti, Reliability (statistics), Aged, Ultrasonography, 030203 arthritis & rheumatology, reliability, ultrasound, business.industry, Ultrasound, Outcome measures, Reproducibility of Results, Middle Aged, medicine.disease, Temporal Arteries, Giant cell arteritis, Female, Radiology, medicine.symptom, business, Diagnosi
Abstract

Objective.To test the reliability of Outcome Measures in Rheumatology Clinical Trials (OMERACT) consensus-based ultrasound definitions for normal and vasculitic temporal and axillary arteries in patients with giant cell arteritis (GCA) and in controls.Methods.A preliminary 1-day meeting and a full 3-day meeting fulfilling OMERACT Ultrasound Group guidelines were held. Temporal and axillary arteries were examined at 2 timepoints by 12 sonographers on 4 patients with GCA and 2 controls. The aim was to test inter- and intrareader reliability for normal findings, halo sign, and compression sign. In both meetings, patients had established GCA. Pathology was more recent in the full meeting, which was preceded by 6 h of training. Scanning time was 15–20 min instead of 10–13 min.Results.In the preliminary exercise, interreader reliabilities were fair to moderate for the overall diagnosis of GCA (Light κ 0.29–0.51), and poor to fair for identifying vasculitis in the respective anatomical segments (Light κ 0.02–0.46). Intrareader reliabilities were moderate (Cohen κ 0.32–0.64). In the main exercise, interreader reliability was good to excellent (Light κ 0.76–0.86) for the overall diagnosis of GCA, and moderate to good (Light κ 0.46–0.71) for identifying vasculitis in the respective anatomical segments. Intrareader reliability was excellent for diagnosis of GCA (Cohen κ 0.91) and good (Cohen κ 0.71–0.80) for the anatomical segments.Conclusion.OMERACT-derived definitions of halo and compression signs of temporal and axillary arteries are reliable in recent-onset GCA if experienced sonographers (> 300 examinations) have 15–20 min for a standardized examination with prior training and apply > 15 MHz probes.

Published
2018

35. Definitions and reliability assessment of elementary ultrasound lesions in giant cell arteritis: A study from the OMERACT large vessel vasculitis ultrasound working group

Author

Eugenio de Miguel, George A W Bruyn, Marcin Milchert, Greta Carrara, Christina Duftner, Wolfgang Hartung, Lene Terslev, Bhaskar Dasgupta, Valentin S. Schäfer, Petra Hanova, Esperanza Naredo, Wolfgang A. Schmidt, Christian Dejaco, Annamaria Iagnocco, Tanaz A. Kermani, Pierluigi Macchioni, Chetan Mukhtyar, Maria Antonietta D'Agostino, Naina Rastalsky, Carlo Alberto Scirè, Cristina Ponte, Sofia Ramiro, Ulrich Fredberg, Stavros Chrysidis, Andreas P. Diamantopoulos, Tove Lorenzen, Mattew J. Koster, Kenneth J. Warrington, Alojzija Hočevar, Uffe Møller Døhn, Chrysidis, S, Duftner, C, Dejaco, C, Schafer, V, Ramiro, S, Carrara, G, Scire, C, Hocevar, A, Diamantopoulos, A, Iagnocco, A, Mukhtyar, C, Ponte, C, Naredo, E, De Miguel, E, Bruyn, G, Warrington, K, Terslev, L, Milchert, M, D'Agostino, M, Koster, M, Rastalsky, N, Hanova, P, Macchioni, P, Kermani, T, Lorenzen, T, Dohn, U, Fredberg, U, Hartung, W, Dasgupta, B, and Schmidt, W

Subjects
Vasculitis, giant cell arteriti, medicine.medical_specialty, Settore MED/16 - REUMATOLOGIA, giant cell arteritis, systemic vasculitis, ultrasonography, Rheumatology, Immunology and Allergy, Immunology, education, NO, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Large vessel vasculitis, medicine, 030212 general & internal medicine, systemic vasculiti, Reliability (statistics), 030203 arthritis & rheumatology, business.industry, Ultrasound, medicine.disease, Giant cell arteritis, Radiology, business, Kappa, Systemic vasculitis
Abstract

Objectives: To define the elementary ultrasound (US) lesions in giant cell arteritis (GCA) and to evaluate the reliability of the assessment of US lesions according to these definitions in a web-based reliability exercise.Methods: Potential definitions of normal and abnormal US findings of temporal and extracranial large arteries were retrieved by a systematic literature review. As a subsequent step, a structured Delphi exercise was conducted involving an expert panel of the Outcome Measures in Rheumatology (OMERACT) US Large Vessel Vasculitis Group to agree definitions of normal US appearance and key elementary US lesions of vasculitis of temporal and extracranial large arteries. The reliability of these definitions on normal and abnormal blood vessels was tested on 150 still images and videos in a web-based reliability exercise.Results: Twenty-four experts participated in both Delphi rounds. From originally 25 statements, nine definitions were obtained for normal appearance, vasculitis and arteriosclerosis of cranial and extracranial vessels. The 'halo' and 'compression' signs were the key US lesions in GCA. The reliability of the definitions for normal temporal and axillary arteries, the 'halo' sign and the 'compression' sign was excellent with inter-rater agreements of 91-99% and mean kappa values of 0.83-0.98 for both inter-rater and intra-rater reliabilities of all 25 experts.Conclusions: The 'halo' and the 'compression' signs are regarded as the most important US abnormalities for GCA. The inter-rater and intra-rater agreement of the new OMERACT definitions for US lesions in GCA was excellent.

Published
2018

36. Non-Physician Healthcare Workers During COVID-19 Pandemic and Association Between Work-Related Factors, Perceived Stress, Depressive Symptoms, and Fatigue.

Author

Mahony WL, Ostovar-Kermani T, Gonzalez S, Zoorob R, Rupp RE, and Hirth J

Subjects
Humans, Male, Female, Adult, United States epidemiology, Middle Aged, Surveys and Questionnaires, Pandemics, Workplace psychology, Workplace standards, Workplace statistics & numerical data, SARS-CoV-2, COVID-19 epidemiology, COVID-19 psychology, Depression psychology, Depression epidemiology, Depression etiology, Health Personnel psychology, Health Personnel statistics & numerical data, Stress, Psychological psychology, Stress, Psychological etiology, Stress, Psychological epidemiology, Fatigue psychology, Fatigue epidemiology, Fatigue etiology
Abstract

Objective: The purpose of this study is to examine the national impact of workplace factors during the SARS-CoV-2 pandemic on mental health experienced by non-physician healthcare workers (HCWs)., Methods: This study consisted of an online sample of non-physician HCWs across the United States, including nurses, medical assistants, and physician assistants. The survey consisted of 93 questions, which included the Perceived Stress Scale, the Center for Epidemiological Studies-Depression (CESD-10) scale, questions about COVID-19 vaccination, sources of trusted information, and questions about work environment and training during the COVID-19 pandemic. Descriptive statistics were used to evaluate associations., Results: In the final sample ( N = 220), (81.8%) reported receiving at least one dose of a COVID vaccine. Most respondents trusted the CDC's information on the SARS-CoV-2 virus and COVID-19 disease. Several workplace-related factors that occurred during the pandemic were associated with moderate to high levels of perceived stress, fatigue, and higher risk of developing depression. In particular, concerns about exposing others, experiencing discrimination related to their jobs, and caring for patients who died from COVID-19 were associated with increased perceived stress, depression, and fatigue., Conclusions: The importance of planning by healthcare facilities should include planning for workplace factors associated with poor mental health among all HCWs.

Published
2024
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37. Decreased SLC16A13 Expression Level Can Increase Apoptosis in KATO2 Cell Line, A Promising Biomarker.

Author

Zavarpour S, Zarredar H, Pedram N, Asvadi Kermani T, Soleimani Z, Hashemzadeh S, Ansarin A, and Raeisi M

Subjects
Humans, Monocarboxylic Acid Transporters genetics, Monocarboxylic Acid Transporters metabolism, Tumor Cells, Cultured, Gene Expression Regulation, Neoplastic, Cell Line, Tumor, RNA, Small Interfering genetics, Apoptosis, Stomach Neoplasms pathology, Stomach Neoplasms genetics, Stomach Neoplasms metabolism, Cell Movement, Cell Proliferation, Biomarkers, Tumor metabolism, Biomarkers, Tumor genetics
Abstract

Objective: Gastric cancer is a prevalent cancer type worldwide, and significant research efforts are focused on finding effective treatments. Recent studies have highlighted the importance of plasma membrane carriers, particularly solute carriers, in cancer progression. The SLC16A family, notably the SLC16A13 gene, plays a critical role in cancer development and tumor growth. This study aims to explore the impact of reducing SLC16A13 expression in gastric cancer cells on their survival, proliferation, and metastatic potential., Methods: Gastric cancer cells (KATO2) were cultured in RPMI medium supplemented with 10% fetal bovine serum. The cells were then transfected with SLC16A13 si-RNA to lower gene expression. The effects of this si-RNA on cell death and apoptosis were assessed using MTT and flow cytometry assays. Cell migration capabilities were evaluated using the scratch test. Western blot and Real-Time PCR were employed to measure SLC16A13 expression levels and protein detection. Additionally, RT-PCR was used to analyze changes in genes related to apoptosis and cell migration., Results: The reduction of SLC16A13 expression following si-RNA transfection significantly increased apoptosis and cell death in the KATO2 cell line after 72 hours (P < 0.0001). Furthermore, the study revealed that decreased SLC16A13 expression did not impact cancer cell migration. Cell viability, assessed by MTT assay, showed a significant decrease at 48 and 72 hours post-transfection (P < 0.0001)., Conclusion: The findings indicate that targeting SLC16A13 can effectively increase cell death and apoptosis in gastric cancer cells, making it a viable therapeutic target.

Published
2024
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38. Effect of age at initiation of the human papillomavirus vaccine on the association between race/ethnicity and completion of the vaccine series.

Author

Hirth J, Ostovar-Kermani T, Gutierrez JA, Thompson EL, Barnett TE, and Zoorob R

Subjects
Adolescent, Child, Humans, Ethnicity, Vaccination, Racial Groups, Papillomavirus Infections prevention & control, Papillomavirus Vaccines administration & dosage
Abstract

Background: Up-to-date (UTD) of the human papillomavirus (HPV) vaccine series has been low despite 2016 recommendations for 2 doses among initiators <15 years of age and 3 doses for 15+ year olds. This study examined how age at initiation affected the association between race/ethnicity and UTD among adolescent HPV vaccine initiators. We also examined how administration of other adolescent vaccines affected UTD., Methods: A secondary analysis of The National Immunization Survey - Teen data between 2016 and 2020 was conducted. Characteristics associated with initiation of the vaccine series was examined and used to evaluate UTD among initiators. All data were weighted. Associations between characteristics and HPV vaccine initiation were examined using Rao Scott chi-square tests and univariable logistic regression. Multivariable binary logistic regression models stratified by race/ethnicity calculated the strength of association between independent variables and odds of initiation and UTD among initiators., Results: The final sample size was 99,719 with 67,855 (68.1 %) initiating HPV vaccination. Among HPV vaccine initiators, Hispanic and black adolescents had lower odds of UTD. However, 9-10-year-old initiators had increased odds (aOR: 5.71; 95 %CI: 3.78-8.63) of UTD compared to 12-year-old initiators. Increased odds of UTD among initiators younger than 12 years were found across racial/ethnic groups. Flu vaccination was associated with decreased odds of UTD among white (aOR: 0.76; 95 %CI:0.65-0.88) and black adolescents (aOR: 0.67; 95 %CI: 0.46-0.96)., Conclusion: Strong recommendations to ensure patients are UTD on the HPV vaccine series are essential to improving UTD among all adolescents and follow-up should occur when administering other vaccines to reduce missed opportunities., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier Ltd.)

Published
2024
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39. Serum miR-23 and miR-150 Profiles as Biomarkers for Predicting Recurrence following Surgical Intervention in Colorectal Cancer Patients.

Author

Mahmoudivar S, Zarredar H, Asadi M, Zafari V, Hashemzadeh S, Farzaneh R, and Asvadi Kermani T

Abstract

Background: MicroRNAs (miRNAs) play pivotal roles in post-transcriptional regulation of gene expression and have emerged as crucial regulators in cancer development, progression, and metastasis. This study aimed to assess the expression profiles of miR-23, miR-223, miR-1246, and miR-150 in serum samples obtained from colorectal cancer (CRC) patients before and three months after surgery, in comparison to a healthy control group, to explore their biomarker potential., Methods: A total of 50 blood samples were collected from patients with CRC (pre- and post-surgery), along with 50 samples from healthy controls. The relative expression levels of miR-23, miR-223, miR-1246, and miR-150 in the serum were quantified using quantitative real-time PCR., Results: Our findings revealed upregulated expression levels of miR-23, miR-1246, and miR-223, while miR-150 exhibited significant downregulation in the serum of CRC subjects compared to healthy controls. Receiver operating characteristic (ROC) analysis indicated that miR-23 and miR-150 could distinguish CRC cases from controls with relatively high accuracy. Moreover, three months post-surgery, miR-23, miR-1246, and miR-223 serum levels were downregulated, and miR-150 was significantly upregulated. However, no significant correlations were observed between serum levels of the studied genes and the clinical features of our patients., Conclusions: The serum levels of miR-23 and miR-150 hold promise as potential biomarkers for the diagnosis and prognosis of CRC., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Published
2024
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40. Diagnostic Significance of Hypomethylated IGFBP3 and TWIST1 Genes in Patients with Colorectal Cancer.

Author

Shalmashi H, Safaei S, Zarredar H, Asvadi Kermani T, Hashemzadeh S, and Mehdi Navaz A

Abstract

Background: Colorectal cancer (CRC) has been often the main reason for dying worldwide. Many factors are implicated in the progress of colorectal carcinoma, one of the chiefs of which is DNA methylation. Insulin-like growth factor-binding protein 3 ( IGFBP3 ) and twist homolog 1 (TWIST1) genes have already been studied and are potential biomarkers for early colorectal diagnosis. Therefore, we designed this research to assess the levels of methylation of these genes in stool specimens of patients with CRC., Materials and Methods: A whole of 80 specimens containing 40 stool specimens from CRC patients and 40 specimens from healthy individuals as a control group was investigated. DNA was extracted using the bisulfate method and methylation of the candidate genes was assessed using methylation-sensitive high-resolution melting method. Differences in the methylation levels between CRC patients and controls were assessed by statistical analysis., Results: Our study showed significant hypomethylation in both IGFBP3 and TWIST1 promoters in patients' samples compared with normal individuals and notably the promoter hypomethylation found in these genes appeared to occur simultaneously ( P < 0.0001 and P < 0.0025, respectively). Meantime, hypomethylation of these genes had not any significant connection with medical results., Conclusion: Our results propose that the IGFBP3 and TWIST1 genes' methylation status can serve as potential biomarkers for early CRC diagnosis. However, more studies are still necessary to better appreciate the methylation pattern of these two genes in CRC and to prove their effects on protein levels., Competing Interests: There are no conflicts of interest., (Copyright: © 2023 Advanced Biomedical Research.)

Published
2023
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41. Effect of Pre-Incubation of Cryopreserved Sperm with either Kisspeptin or Glutathione to Mitigate Freeze-Thaw Damage.

Author

Kermani T, Hosseini SF, Talaei-Khozani T, and Aliabadi E

Subjects
Male, Humans, Freezing, Semen, Sperm Motility, Spermatozoa, Cryopreservation, Glutathione pharmacology, Kisspeptins pharmacology, Semen Preservation
Abstract

Background: Sperm cryopreservation reduces sperm quality. Kisspeptin (KP) has beneficial effects on sperm functions. This study compares the effect of KP and Glutathione (GSH) on mitigating the detrimental effects of the freeze-thaw cycle on sperm., Methods: An experimental study was conducted in Birjand (Iran) during 2018-2020. Thirty normal swim-up semen samples were treated with Ham's F10 medium (negative control), 1 mM GSH (positive control), or KP (10 µM) for 30 min before freezing. The motility, acrosome reaction, capacitation, and DNA quality of the frozen-thawed sperms were assessed according to the WHO guidelines. Statistical analysis was performed using paired t test, one-way analysis of variance, and least significant difference., Results: Pre-incubation with KP significantly increased the percentage of sperm motility (34.00±6.7, P=0.003) compared to the control (20.44±7.4) and GSH-treated (31.25±12.2) aliquots. The frequency of non-capacitated spermatozoa was significantly higher in the KP-treated group (98.73%) than in the control (96.46%) and GSH-treated (96.49%) aliquots (P<0.001). The percentage of acrosome-intact spermatozoa in the KP-treated group (77.44%) was significantly higher than the control (74.3%) and GSH-treated (74.54%) groups (P<0.001). The sperm frequency with normal histone in the KP-treated group (51.86%) and with normal protamine (65.39%) was significantly higher than the controls (P=0.001 and P=0.002, respectively). The percentage of TUNEL-positive sperm was significantly lower in the KP-treated group (9.09±2.71) than both GSH-treated (11.22±2.73) and control (11.31±2.2) groups (both P=0.002)., Conclusion: Pre-incubation with KP protects sperm motility and DNA integrity from the detrimental effect of the freeze-thaw cycle. KP is suitable as a pre-treatment to control sperm quality during freezing-thawing., Competing Interests: None declared., (Copyright: © Iranian Journal of Medical Sciences.)

Published
2023
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42. Survival and prognostic factors among hospitalized pancreatic cancer patients in northwestern Iran.

Author

Vahedi L, Asvadi Kermani T, Asghari-Jafarabadi M, Asghari E, Mohammadi SM, and Khameneh A

Abstract

Background: Pancreatic cancer (PC) is associated with a poor prognosis, with various modifiable risk factors affecting the survival of patients. Our aim was to evaluate the survival rate and the prognostic factors influencing survival in PC patients in northwestern Iran., Materials and Methods: All the PC patients admitted to the Imam Reza Hospital of Tabriz, Iran, from 2016 to 2020, were enrolled in this study. The survival rate and time were calculated, and the risk factors related to survival were evaluated by Cox regressions. The data were analyzed using the Cox proportional hazards model using STATA software., Results: Of 110 patients, 12-, 24-, 36-, and 48-month survival rates were 29.1%, 19.8%, 14.1%, and 8.5%, respectively, with the median survival time of seven months. The mean age was 65.5 years. The results showed that a higher age (hazard ratio [HR] [95% confidence interval (CI)] = 2.04 [1.20-3.46]), lower education (1.72 [1.03-2.89]), delayed diagnosis (1.03 [1.02-1.05]), hypertension (1.53 [1.01-2.31]), concomitant heart disorders (2.67 [1.50-4.74]), COPD (4.23 [1.01-17.69]), consanguineous marriage (1.59 [1.01-2.50]), and the presence of icterus complications (adjusted HR = 3.64 [1.56-8.49]) were directly associated with a worse survival. On the contrary, radiotherapy (0.10 [0.01-0.85]), chemotherapy (0.57 [0.36-0.89]), and surgical therapy (AHR = 0.48 [0.23-0.99]) were directly related to a good prognosis., Conclusion: Surgery, chemotherapy, and radiotherapy were the best predictors of survival in PC patients. Moreover, it seems that resolving jaundice can improve survival in these patients. It seems that increasing social awareness, treating underlying diseases, and employing an appropriate therapeutic method may promise a better outlook, improve the survival rate of patients, and reduce PC risk., Competing Interests: There are no conflicts of interest., (Copyright: © 2023 Journal of Research in Medical Sciences.)

Published
2023
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43. Disparities between US Hispanic and non-Hispanic women in obesity-related perinatal outcomes: a prospective cohort study.

Author

Stafford IA, Turrentine MA, Ostovar-Kermani T, Moustafa ASZ, Berra A, and Sangi-Haghpeykar H

Subjects
Pregnancy, Female, Infant, Newborn, Humans, Birth Weight, Prospective Studies, Obesity complications, Obesity epidemiology, Body Mass Index, Weight Gain, Pregnancy Outcome epidemiology, Retrospective Studies, Overweight complications, Pregnancy Complications epidemiology, Pregnancy Complications etiology
Abstract

Background: Mortality figures and national health surveillance data have demonstrated that Hispanics have a 24% lower risk of all-cause mortality compared to their non-Hispanic counterparts despite increased rates of obesity and related illnesses., Objective: The aim of this study is to evaluate if this paradox exists for obesity-related perinatal outcomes in otherwise low-risk Hispanic women., Materials and Methods: A prospective cohort study of low-risk women across all BMI classes with a singleton, non-anomalous term pregnancy admitted in active labor or undergoing induction of labor between May 2014 and April 2017. All demographic, obstetric, and neonatal outcomes were recorded, and the body mass index (BMI) closest to delivery was used for analysis. Data including composites of adverse maternal and neonatal outcomes were compared across BMI classes and between individuals of Hispanic and non-Hispanic ethnicity. Women with antenatal complications, prior cesarean delivery, and cesarean for non-reassuring fetal status were excluded., Results: Of the 11,369 women who met inclusion criteria, 6303 (55%) were Hispanic. Eight percent of Hispanic women were normal weight (BMI: 18.5-24.9), 34% were overweight (BMI: 25-29.9), and 58% were obese (BMI > 30). Fourteen percent of non-Hispanic women were normal weight, 42% were overweight, and 44% were obese. The majority (65%) of women were multiparous. Rate of induction and birthweight increased across BMI for Hispanic and non-Hispanic groups, however the route of delivery was not significantly different ( p  = .22, 0.16, respectively). Although the association between BMI and composite perinatal complications did not differ by BMI class and ethnicity, the newborns of non-Hispanic women were more likely to be admitted to the neonatal intensive care unit with increasing maternal weight class (<0.001), even after adjusting for age, parity, marital status, prenatal visits, current tobacco use, type of labor, mode of delivery, and birthweight., Conclusion: There were no demonstrable differences in composite adverse maternal or neonatal outcomes between Hispanic and non-Hispanic obese women. However, newborns of non-Hispanic obese women were more likely to be transferred to the neonatal intensive care unit with increasing maternal BMI.

Published
2022
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44. Standardization of Pediatric Noncardiac Operating Room to Intensive Care Unit Handoffs Improves Communication and Patient Care.

Author

Hebballi NB, Gupta VS, Sheppard K, Kubanda A, Salley D, Ostovar-Kermani T, Bryndzia C, Khan AM, Wadhwa N, Tsao K, Jain R, and Kawaguchi AL

Subjects
Child, Communication, Humans, Infant, Newborn, Intensive Care Units, Reference Standards, Operating Rooms, Patient Handoff
Abstract

Objectives: Handoffs are critical points in transitioning care between multidisciplinary teams, yet data regarding intensive care unit (ICU) handoffs in pediatric noncardiac surgical patients are lacking. We hypothesized that standardized handoffs from the pediatric operating room (OR) to the ICU would improve physician presence, communication, and patient care parameters., Methods: This quality improvement initiative was performed at a tertiary children's hospital. Stakeholders (anesthesiologists, nurses, intensivists, and surgeons) developed a standardized OR to pediatric and neonatal ICU handoff process based on common goals and outcomes of interest. Baseline data were collected before intervention. Implementation was carried out in 2 phases, phase 1 with a written handoff and Phase 2 with a scripted handoff process. Data collected by trained observers included handoff attendance, distractions, and transfer of essential patient information. As a surrogate for outcomes, patient care parameter data were collected for 6 hours after transfer., Results: After phase 1, surgery and ICU physician attendance increased significantly, distractions decreased, and communication of essential patient data improved. In phase 2 (scripted handoff), attendance continued to rise, distractions remained decreased, and transfer of essential information was still improved compared with baseline. Mean handoff duration did not significantly change throughout the study. Certain patient care parameters (escalation of respiratory support, additional laboratory studies, vasopressor administration, antibiotic administration and timing) remained unchanged compared with baseline. However, the need for resuscitative fluid bolus or blood products significantly decreased after implementation phase 2., Conclusions: Standardized handoffs for pediatric noncardiac surgical patients from the OR to the ICU can improve provider attendance and communication., Competing Interests: The authors disclose no conflict of interest., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Published
2022
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45. Drug-drug interactions with candidate medications used for COVID-19 treatment: An overview.

Author

Rezaee H, Pourkarim F, Pourtaghi-Anvarian S, Entezari-Maleki T, Asvadi-Kermani T, and Nouri-Vaskeh M

Subjects
Animals, Antibodies, Monoclonal, Humanized therapeutic use, Chloroquine therapeutic use, Drug Interactions, Humans, Lopinavir therapeutic use, Ribavirin therapeutic use, Ritonavir therapeutic use, Antiviral Agents therapeutic use, SARS-CoV-2, COVID-19 Drug Treatment
Abstract

Drug-drug interaction (DDI) is a common clinical problem that has occurred as a result of the concomitant use of multiple drugs. DDI may occur in patients under treatment with medications used for coronavirus disease 2019 (COVID-19; i.e., chloroquine, lopinavir/ritonavir, ribavirin, tocilizumab, and remdesivir) and increase the risk of serious adverse reactions such as QT-prolongation, retinopathy, increased risk of infection, and hepatotoxicity. This review focuses on summarizing DDIs for candidate medications used for COVID-19 in order to minimize the adverse reactions., (© 2021 The Authors. Pharmacology Research & Perspectives published by John Wiley & Sons Ltd, British Pharmacological Society and American Society for Pharmacology and Experimental Therapeutics.)

Published
2021
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46. Painful Sleep: Insomnia in Patients with Chronic Pain Syndrome and its Consequences.

Author

Ostovar-Kermani T, Arnaud D, Almaguer A, Garcia I, Gonzalez S, Mendez Martinez YH, and Surani S

Subjects
Chronic Pain epidemiology, Chronic Pain physiopathology, Global Health, Humans, Incidence, Sleep Initiation and Maintenance Disorders etiology, Sleep Initiation and Maintenance Disorders physiopathology, Syndrome, Chronic Pain complications, Quality of Life, Sleep physiology, Sleep Initiation and Maintenance Disorders epidemiology
Abstract

Insomnia is a chronic condition that occurs a minimum of three times per week over a period of three or more subsequent months. There are multiple causes of insomnia, and even though it is considered a symptom, it can be associated with chronic illnesses. Chronic pain syndrome, which is defined as pain that persists for a period longer than 3 months, is one of several etiologies of insomnia. The prevalence of insomnia among chronic pain patients is greater in comparison with the general population (percentage or ratio). Chronic pain is common in patients with rheumatoid arthritis, spinal pain (such as chronic back pain) and fibromyalgia. The prevalence of in-somnia is also higher in cancer patients when compared to the general population. When the clinical history indicates a straightforward diagnosis of chronic pain syndrome, patients will complain of insomnia as part of their symptomatology. It is imperative to manage their underlying illness to alleviate their sleep disorder. Various medications may be used to relieve and even improve pain symptoms. Other than pharmacological interventions, non-pharmacological alternatives such as yoga, meditation, acupuncture, and psychotherapy can help improve the quality of life of these patients. The purpose of this article is to review the diagnosis and management of insomnia in chronic pain syndrome and its impact on the quality of life., (This is an open access article distributed under the terms of the Creative Commons Attribution License (CC BY 4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Published
2020
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47. Ultrasound and multi-biomarker disease activity score for assessing and predicting clinical response to tofacitinib treatment in patients with rheumatoid arthritis.

Author

Razmjou AA, Brook J, Elashoff D, Kaeley G, Choi S, Kermani T, and Ranganath VK

Abstract

Background: Musculoskeletal ultrasound (MSUS) and the multi-biomarker disease activity (MBDA) score are outcome measures that may aid in the management of rheumatoid arthritis (RA) patients. This study evaluated tofacitinib response by MSUS/MBDA scores and assessed whether baseline MSUS/MBDA scores or their early changes predict later clinical response., Methods: Twenty-five RA patients treated with tofacitinib were assessed at baseline, 2, 6 and 12-weeks. Power doppler (PDUS) and gray scale (GSUS) ultrasound scores, MBDA score, clinical disease activity index (CDAI), and disease activity score (DAS28) were obtained. Pearson correlations and multiple linear regression models were used to evaluate associations and identify predictors of response to therapy., Results: MSUS, MBDA scores, CDAI, and DAS28 improved significantly over 12 weeks ( p  < 0.0001). Baseline MSUS and MBDA score correlated with each other, and with 12-week changes in CDAI/DAS28 (r = 0.45-0.62, p  < 0.05), except for GSUS with DAS28. Two-week change in MSUS correlated significantly with 12-week changes in CDAI/DAS28 (r = 0.42-0.57, p  < 0.05), except for early change in PDUS with 12-week change in CDAI. Regression analysis demonstrated significant independent associations between baseline PDUS/MBDA score and 6-week change in CDAI/DAS28, with adjustment for baseline CDAI/DAS28 (all p  < 0.05); and between baseline MBDA scores and 12-week change in DAS28 ( p  = 0.03)., Conclusions: RA patients treated with tofacitinib for 12 weeks demonstrated improvement by clinical, imaging, and biomarker end-points. Baseline PDUS and MBDA score were predictive of CDAI and DAS28 responses. This is the first study to evaluate early measurements of MSUS and MBDA score as predictors of clinical response in RA patients treated with tofacitinib., Trial Registration: ClinicalTrials.gov NCT02321930 (registered 12/22/2014)., Competing Interests: Competing interestsVK Ranganath, MD, MS- consultant BMS, DSMB Amgen, grants- Pfizer, BMS, Mallinckrodt, Genentech. All other authors have no competing interests to declare., (© The Author(s) 2020.)

Published
2020
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48. Takayasu Arteritis With Extensive Cardiovascular, Neurovascular, and Mesenteric Involvement.

Author

Custer A, Villano N, Ravi D, Shapiro H, Kermani T, and Honda HM

Abstract

Takayasu arteritis is a rare large vessel vasculitis with an incidence of 1 to 3 per million. This disease typically involves the aorta and its primary branches but has been found to involve the coronary arteries in 7% to 9% of cases. We highlight the need for prompt diagnosis and treatment. ( Level of Difficulty: Beginner. )., (© 2020 The Authors.)

Published
2020
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49. Intrathoracic Displacement of Fractured Right Humeral Head: A Case Report.

Author

Sadighi A, Asvadi Kermani T, Maroufi P, Tarvirdizade K, and Kermani AA

Abstract

Intrathoracic displacement of the humeral head is a very uncommon condition and can be life threatening due to lung or heart injuries. There is a report of this condition where intrathoracic bone fragment was missed. Because of rare incidence there is no guideline for approach and treatment of this condition. We hereby present a case of intrathoracic displacement of fractured humeral head in a man due to a car roll-over accident. This condition requires a concise team workup of trauma and orthopedic surgeons along with the physical therapists for the best possible decision making. Displaced fractured humoral head into the thorax is a rare condition that needs more punctuality for on time diagnosis and team approach.

Published
2020
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50. Effect of N-acetylcysteine on liver and kidney function tests after surgical bypass in obstructive jaundice: A randomized controlled trial.

Author

Kakaei F, Fasihi M, Hashemzadeh S, Zarrintan S, Beheshtirouy S, Asvadi-Kermani T, Tarvirdizadeh K, Rezaei S, and Sanei B

Subjects
Acetylcysteine administration & dosage, Aged, Female, Humans, Infusions, Intravenous, Length of Stay, Male, Middle Aged, Postoperative Care, Time Factors, Acetylcysteine pharmacology, Biliary Tract Surgical Procedures methods, Jaundice, Obstructive physiopathology, Jaundice, Obstructive surgery, Kidney physiopathology, Kidney Function Tests, Liver physiopathology, Liver Function Tests
Abstract

Background: It has been shown that N-acetylcysteine may be useful in correcting postoperative hepatic and renal function in many pathological conditions. The present study aimed to examine the effect of N-acetylcysteine on liver and kidney function tests after surgical bypass in patients with obstructive jaundice., Methods: & Materials: A total of 30 patients with obstructive jaundice who were candidates for bypass surgery were enrolled in this randomized clinical trial. In the case group, intravenous N-acetylcysteine (200 mg/kg per hour in the first 8 h, followed by 100 mg/kg per hour for another 16 h, the same dose for another 24 h) was administered postoperatively. Liver and renal function tests (serum AST, ALT, ALP, GGT, bilirubin, and creatinine) were compared between two groups, as well as duration of hospitalization and ICU stay., Results: Postoperatively, decrease in mean serum AST (p = 0.01), ALT (p = 0.02), ALP (p = 0.01), GGT (p = 0.04) and bilirubin (total, p = 0.02, direct, p = 0.01) levels compared to the preoperative values was significantly more among cases compared to those in controls. Changes in serum creatinine, however, did not differ significantly between two groups (p = 0.18). Hospital and ICU stays were also not different between two study groups (p = 0.27 and p = 0.94 respectively)., Conclusion: On the basis of our findings, intravenous N-acetylcysteine in patients with obstructive jaundice could significantly preserve liver function after bypass surgery. Effect of this medication on renal function; however, was not statistically significant., Trial Registration: Iranian Registry of Clinical Trial: IRCT2016041016473N7., (Copyright © 2019. Published by Elsevier Taiwan LLC.)

Published
2020
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