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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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4. The Effect of Benralizumab Versus Mepolizumab on the Depletion of Eosinophils in the Treatment of Eosinophilic Granulomatosis With Polyangiitis During the Phase 3 MANDARA Study

Author

Wechsler, M.E., primary, Jackson, D.J., additional, Specks, U., additional, Pagnoux, C., additional, Lugogo, N.L., additional, Akuthota, P., additional, Baudy, P., additional, Börjesson Sjö, L., additional, McCrae, C., additional, Necander, S., additional, Shavit, A., additional, Walton, C., additional, and Rodríguez-Suárez, E., additional

Published
2024
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6. 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

10. A Transcriptomic Signature of Mepolizumab Response in Eosinophilic Granulomatosis With Polyangiitis (EGPA)

Author

Baek, S.H., primary, Khoury, P., additional, Maiorino, E., additional, Glass, K., additional, Carey, V., additional, Chase, R., additional, Stankiewicz, S., additional, Weller, P.F., additional, Langford, C.A., additional, Dyer, A.-M., additional, Merkel, P.A., additional, Specks, U., additional, Klion, A., additional, Gleich, G.J., additional, Akuthota, P., additional, Calyton, F., additional, Wechsler, M.E., additional, and Raby, B.A., additional

Published
2023
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11. Rituximab versus azathioprine for maintenance of remission for patients with ANCA- associated vasculitis and relapsing disease: an international randomised controlled trial.

Author

Smith, R. M., Jones, R. B., Specks, U., Nodale, S. Bond M., Al-jayyousi, R., Andrews, J., Bruchfeld, A., Camilleri, B., Derebail, S. Carette C. K. Cheung V., Doulton, T., Forbess, A. Ferraro L., Fujimoto, S., Furuta, S., Harper, O. Gewurz-Singer L., Ito-Ihara, T., Khalidi, N., Klocke, R., Koening, C., Langford, Y. Komagata C., and Lanyon, P.

Published
2023
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12. POS0244 ASSOCIATION OF PROTEINASE 3 GENE (PRTN3) Val119Ile POLYMORPHISM (SNP rs351111) WITH RISK OF RELAPSE AMONG HOMOZYGOUS PATIENTS WITH PR3 ANCA-ASSOCIATED VASCULITIS

Author

Casal Moura, M., primary, Deng, Z., additional, Brooks, S., additional, Tew, W., additional, Hummel, A., additional, Fervenza, F., additional, Kallenberg, C., additional, Langford, C., additional, Merkel, P. A., additional, Monach, P. A., additional, Seo, P., additional, Spiera, R., additional, St. Clair, W., additional, Stone, J. H., additional, Prunotto, M., additional, Grayson, P., additional, and Specks, U., additional

Published
2022
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16. Eosinophilic Granulomatosis With Polyangiitis: Clinical Predictors of Long-term Asthma Severity

Author

Berti A., Cornec D., Casal Moura M., Smyth R. J., Dagna L., Specks U., Keogh K. A., Berti, A., Cornec, D., Casal Moura, M., Smyth, R. J., Dagna, L., Specks, U., and Keogh, K. A.

Subjects
severe/uncontrolled asthma, Churg-Strauss, asthma, ANCA-associated vasculitis, EGPA, eosinophilic granulomatosis with polyangiitis
Abstract

Background: The long-term clinical course of asthma in patients with eosinophilic granulomatosis with polyangiitis (EGPA) remains unclear. We aimed to characterize long-term asthma in EGPA and to identify baseline predictors of long-term asthma severity. Methods: This retrospective cohort study included patients who fulfilled standardized criteria for EGPA who were followed up in a single referral center between 1990 and 2017. Baseline and 3 (± 1) years of follow-up clinical, laboratory, and pulmonary function data were analyzed. Results: Eighty-nine patients with EGPA and a documented asthma assessment at baseline and at 3 years from diagnosis were included. Severe/uncontrolled asthma was observed in 42.7% of patients at diagnosis and was associated with previous history of respiratory allergy (P < .01), elevated serum total IgE levels (P < .05), and increased use of high-dose inhaled corticosteroids (ICSs; P < .05) and oral corticosteroids (OCSs; P < .001) for respiratory symptoms the year before the EGPA diagnosis. During follow-up, an improvement or worsening in asthma severity was noted in 12.3% and 10.1% of patients, respectively. Severe/uncontrolled asthma was present in 40.5% of patients at 3 years and was associated with increased airway resistance on pulmonary function tests (PFTs; P < .05). Long-term PFTs did not improve during long-term follow-up regardless of ICS or OCS therapy. Multivariate binary logistic regression results indicated that severe rhinosinusitis (P = .038), pulmonary infiltrates (P = .011), overweight (BMI ≥ 25 kg/m2; P = .041), and severe/uncontrolled asthma at vasculitis diagnosis (P < .001) independently predicted severe/uncontrolled asthma at the 3-year end point. Conclusions: In patients with asthma with EGPA, long-term severe/uncontrolled asthma is associated with baseline pulmonary and ear, nose, and throat manifestations but not with clear-cut vasculitic features.

Published
2020

18. 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

19. Rituximab for the Treatment of Relapses in Antineutrophil Cytoplasmic Antibody–Associated Vasculitis

Author

Miloslavsky, E. M., Specks, U., Merkel, P. A., Seo, P., Spiera, R., Langford, C. A., Hoffman, G. S., Kallenberg, C. G. M., St. Clair, E. W., Tchao, N. K., Viviano, L., Ding, L., Iklé, D., Villarreal, M., Jepson, B., Brunetta, P., Allen, N. B., Fervenza, F. C., Geetha, D., Keogh, K., Kissin, E. Y., Monach, P. A., Peikert, T., Stegeman, C., Ytterberg, S. R., and Stone, J. H.

Published
2014
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23. AB0501 Three cases of vertebral arteritis identified on FDG-PET in patients with suspected GCA at University of College London Hospital (UCLH)

Author

Moiseev, S, Tervaert, JWC, Arimura, Y, Bogdanos, D, Elena, C, Damoiseaux, J, Ferrante, M, Flores-Suarez, LF, Fritzler, M, Invernizzi, P, Jayne, D, Jennette, JC, Little, M, Mcadoo, SP, Novikov, P, Pusey, CD, Radice, A, Salama, AD, Savige, J, Segelmark, M, Shoenfeld, Y, Sinico, RA, De Sousa, MJR, Specks, U, Terrier, B, Tzioufas, A, Vermeire, S, Zhao, MH, and Bossuyt, X

Subjects
Science & Technology, Rheumatology, 1107 Immunology, cardiovascular system, 1103 Clinical Sciences, skin and connective tissue diseases, Life Sciences & Biomedicine, 1117 Public Health and Health Services, Arthritis & Rheumatology
Abstract

Background: Giant cell arteritis (GCA) may affect both cranial and extra-cranial vessels; where the latter occurs, it can be termed large-vessel GCA (LV-GCA). Large vessel involvement is common: histological evidence has been seen in 80% of autopsies of patients with known GCA, and imaging studies suggest large vessel involvement in over 80%1. LV-GCA is important to diagnose due to the risks of vascular complications such as occlusion and ischaemic stroke. The clinical diagnosis can be challenging, and the American College of Rheumatology (ACR) GCA classification criteria often underperform in cases of LV-GCA1. F-fluorodeoxyglucose positron emission tomography (FDG-PET) has been found to be useful in the detection of extra-cranial involvement to support the diagnosis of LV-GCA.2 Objectives: To appreciate the variability in presentation of cases of LV-GCA, and to further characterise a subgroup of patients with vertebral arteritis. To explore the use of FDG-PET imaging in GCA patients in addition to or in place of traditional diagnostic tools (temporal artery ultrasound / biopsy). Methods: Through evaluation of the new GCA fast-track pathway implemented at UCLH, a subgroup of patients diagnosed with vertebral arteritis was identified. The history and presentation of these patients were analysed. Results: Three patients were diagnosed with vertebral arteritis. All three were male, Caucasian and aged over 70. All were investigated for GCA due to a history of severe headache (frontal in one, occipital in one, bi-temporal in one) with associated red flag symptoms. Two had a history of jaw claudication and visual disturbances (unilateral visual loss in one, transient diplopia in the other). Both of these patients had positive temporal artery biopsies. The third patient had no ischaemic symptoms but a strong history of prominent polymyalgic features and a positive temporal artery ultrasound. Inflammatory markers were raised in two, and normal in one, of the patients. Only one had systemic symptoms (weight loss). All three proceeded to FDG-PET scans which showed vertebral arteritis and were commenced on immunosuppressive treatment. Conclusion: The cases discussed illustrate the heterogeneity of the presentation of LV-GCA, and the diagnostic challenge this poses. FDG-PET imaging is useful in confirming extra-cranial involvement and therefore guiding treatment.

Published
2020

24. Metalloenzymes

Author

Pollard, J. W., Danilkovitch-Miagkova, A., Minaguchi, T., Waite, K. A., Buys, T. P. H., Lam, W. L., Müller-Hermelink, H. K., Ott, G., Robb, V. A., Henske, E. P., Lynge, E., Boyd, N., Geisler, C., Seger, R., De Wolf-Peeters, C., Sagaert, X., Sheng, S., Ribatti, D., Verstovsek, S., Akin, C., Stack, M. S., Kitada, S., Gartenhaus, R., Moretti, F., Frühwald, Michael C., Mooi, W. J., Krausz, T., Kefford, R., Peikert, T., Specks, U., Tueting, T., Pföhler, C., Blask, D. E., Stevens, R. G., Nies, A. T., Gotoh, N., Tsuchida, N., Escriba, P., Singh, V., Hickey, M., Saunders, C., Xiao, G.-H., Testa, J. R., Furtwängler, R., Scholler, N., Carbone, M., Furge, K., Woude, G. F. V., Roland, W. C., Muschel, R., Hunter, K., Welch, D. R., Vaidya, K. S., Hurst, D. R., Silveira, A. C., Zang, X. A., Bari, R., Silveira, A., Szmulewitz, R., Taylor, J., Rinker-Schaffer, C., Shim, H., Plass, C., Lindsey, J. C., Clifford, S. C., Holdenrieder, S., Steinle, A., Salih, H., Brown, D. A., Breit, S. N., Bauskin, A. R., Mousses, S., Lung, M. L., Alix-Panabieres, C., Pantel, K., Djuzenova, C. S., Dalmay, T., Ahlquist, T., Lothe, R. A., Bhat, K., Setaluri, V., Rutka, J. T., Salhia, B., Cockell, K. A., Radich, J. P., Yamagishi, S.-I., Bignami, M., Verma, M., Kumar, D., Brenner, C., Zhang, Y.-W., Jamieson, D., Chi, Y.-H., Jeang, K.-T., Roninson, I., Dragani, T., Sobolev, A. S., Powers, M. V., Workmann, P., Evans, M. F., Cooper, K., Kausch, I., Doehn, C., Janz, S., Huang, C.-L., Toland, A. E., Osinaga, E., Kaye, F., Lemos, M. C., Thakker, R. V., Teh, B. T., Ponder, B. A. J., Mulligan, L. M., Gullo, C., Klein, G., Wu, X., Araten, D. J., Loeb, L. A., Cheadle, J. P., Lipsick, J., Albihn, A., Henriksson, M., Kremens, B., Germing, U., Zangemeister-Wittke, U., Simon, H.-U., Yu, Y. P., Luo, J., and Aman, P.

Published
2020

25. Metallothionein enzymes

Author

Pollard, J. W., Danilkovitch-Miagkova, A., Minaguchi, T., Waite, K. A., Buys, T. P. H., Lam, W. L., Müller-Hermelink, H. K., Ott, G., Robb, V. A., Henske, E. P., Lynge, E., Boyd, N., Geisler, C., Seger, R., De Wolf-Peeters, C., Sagaert, X., Sheng, S., Ribatti, D., Verstovsek, S., Akin, C., Stack, M. S., Kitada, S., Gartenhaus, R., Moretti, F., Frühwald, Michael C., Mooi, W. J., Krausz, T., Kefford, R., Peikert, T., Specks, U., Tueting, T., Pföhler, C., Blask, D. E., Stevens, R. G., Nies, A. T., Gotoh, N., Tsuchida, N., Escriba, P., Singh, V., Hickey, M., Saunders, C., Xiao, G.-H., Testa, J. R., Furtwängler, R., Scholler, N., Carbone, M., Furge, K., Woude, G. F. V., Roland, W. C., Muschel, R., Hunter, K., Welch, D. R., Vaidya, K. S., Hurst, D. R., Silveira, A. C., Zang, X. A., Bari, R., Silveira, A., Szmulewitz, R., Taylor, J., Rinker-Schaffer, C., Shim, H., Plass, C., Lindsey, J. C., Clifford, S. C., Holdenrieder, S., Steinle, A., Salih, H., Brown, D. A., Breit, S. N., Bauskin, A. R., Mousses, S., Lung, M. L., Alix-Panabieres, C., Pantel, K., Djuzenova, C. S., Dalmay, T., Ahlquist, T., Lothe, R. A., Bhat, K., Setaluri, V., Rutka, J. T., Salhia, B., Cockell, K. A., Radich, J. P., Yamagishi, S.-I., Bignami, M., Verma, M., Kumar, D., Brenner, C., Zhang, Y.-W., Jamieson, D., Chi, Y.-H., Jeang, K.-T., Roninson, I., Dragani, T., Sobolev, A. S., Powers, M. V., Workmann, P., Evans, M. F., Cooper, K., Kausch, I., Doehn, C., Janz, S., Huang, C.-L., Toland, A. E., Osinaga, E., Kaye, F., Lemos, M. C., Thakker, R. V., Teh, B. T., Ponder, B. A. J., Mulligan, L. M., Gullo, C., Klein, G., Wu, X., Araten, D. J., Loeb, L. A., Cheadle, J. P., Lipsick, J., Albihn, A., Henriksson, M., Kremens, B., Germing, U., Zangemeister-Wittke, U., Simon, H.-U., Yu, Y. P., Luo, J., and Aman, P.

Published
2020

26. International consensus on antineutrophil cytoplasm antibodies testing in eosinophilic granulomatosis with polyangiitis

Author

Moiseev, S. Bossuyt, X. Arimura, Y. Blockmans, D. Csernok, E. Damoiseaux, J. Emmi, G. Flores-Suarez, L.F. Hellmich, B. Jayne, D. Charles Jennette, J. Little, M.A. Mohammad, A.J. Moosig, F. Novikov, P. Pagnoux, C. Radice, A. Sada, K.-e. Segelmark, M. Shoenfeld, Y. Sinico, R.A. Specks, U. Terrier, B. Tzioufas, A.G. Vaglio, A. Zhao, M.-H. Tervaert, J.C.

Subjects
immune system diseases, cardiovascular diseases, urologic and male genital diseases, skin and connective tissue diseases, respiratory tract diseases
Abstract

An international consensus on antineutrophil cytoplasm antibodies (ANCA) testing in eosinophilic granulomatosiswith polyangiitis (EGPA) is presented.ANCA, specific formyeloperoxidase (MPO), can be detected in 30-35% of patients with EGPA. MPO-ANCA should be tested with antigen-specific immunoassays in any patient with eosinophilic asthma and clinical features suggesting EGPA, including constitutional symptoms; purpura; polyneuropathy; unexplained heart, gastrointestinal, or kidney disease; and/or pulmonary infiltrates or hemorrhage.Apositive MPO-ANCA result contributes to the diagnostic workup for EGPA. Patients with MPO-ANCA-associated EGPA have vasculitis features, such as glomerulonephritis, neuropathy, and skin manifestations, more frequently than patients with ANCA-negative EGPA. However, the presence of MPO-ANCA is neither sensitive nor specific enough to identifywhether a patient should be subclassified as having "vasculitic"or "eosinophilic"EGPA. At present, ANCA status cannot guide treatment decisions, that is,whether cyclophosphamide, rituximab, ormepolizumab should be added to conventional glucocorticoid treatment. In EGPA, monitoring of ANCA is only useful when MPO-ANCA was tested positive at disease onset. © 2020 by the American Thoracic Society.

Published
2020

27. 2020 international consensus on ANCA testing beyond systemic vasculitis

Author

Moiseev, S. Cohen Tervaert, J.W. Arimura, Y. Bogdanos, D.P. Csernok, E. Damoiseaux, J. Ferrante, M. Flores-Suárez, L.F. Fritzler, M.J. Invernizzi, P. Jayne, D. Jennette, J.C. Little, M.A. McAdoo, S.P. Novikov, P. Pusey, C.D. Radice, A. Salama, A.D. Savige, J.A. Segelmark, M. Shoenfeld, Y. Sinico, R.A. Sousa, M.-J. Specks, U. Terrier, B. Tzioufas, A.G. Vermeire, S. Zhao, M.-H. Bossuyt, X.

Subjects
immune system diseases, cardiovascular diseases, skin and connective tissue diseases, urologic and male genital diseases, respiratory tract diseases
Abstract

This document follows up on a 2017 revised international consensus on anti-neutrophil cytoplasm antibodies (ANCA) testing in granulomatosis with polyangiitis and microscopic polyangiitis and focuses on the clinical and diagnostic value of ANCA detection in patients with connective tissue diseases, idiopathic interstitial pneumonia, autoimmune liver diseases, inflammatory bowel diseases, anti-glomerular basement membrane (GBM) disease, infections, malignancy, and during drug treatment. Current evidence suggests that in certain settings beyond systemic vasculitis, ANCA may have clinical, pathogenic and/or diagnostic relevance. Antigen-specific ANCA targeting proteinase-3 and myeloperoxidase should be tested by solid phase immunoassays in any patient with clinical features suggesting ANCA-associated vasculitis and in all patients with anti-GBM disease, idiopathic interstitial pneumonia, and infective endocarditis associated with nephritis, whereas in patients with other aforementioned disorders routine ANCA testing is not recommended. Among patients with autoimmune liver diseases or inflammatory bowel diseases, ANCA testing may be justified in patients with suspected autoimmune hepatitis type 1 who do not have conventional autoantibodies or in case of diagnostic uncertainty to discriminate ulcerative colitis from Crohn's disease. In these cases, ANCA should be tested by indirect immunofluorescence as the target antigens are not yet well characterized. Many questions concerning the optimal use of ANCA testing in patients without ANCA-associated vasculitis remain to be answered. © 2020 Elsevier B.V.

Published
2020

28. INTERNATIONAL CONSENSUS ON ANCA TESTING AND INTERPRETATION BEYOND SYSTEMIC VASCULITIS

Author

Moiseev, S. Tervaert, J. W. Cohen Arimura, Y. Bogdanos, D. and Elena, C. Damoiseaux, J. Ferrante, M. Flores-Suarez, L. F. Fritzler, M. Invernizzi, P. Jayne, D. Jennette, J. C. and Little, M. Mcadoo, S. P. Novikov, P. Pusey, C. D. and Radice, A. Salama, A. D. Savige, J. Segelmark, M. and Shoenfeld, Y. Sinico, R. A. De Sousa, M. J. R. Specks, U. and Terrier, B. Tzioufas, A. Vermeire, S. Zhao, M. H. and Bossuyt, X.

Published
2020

29. Clinical Outcomes of Remission Induction Therapy for Severe Antineutrophil Cytoplasmic Antibody–Associated Vasculitis

Author

Miloslavsky, E. M., Specks, U., Merkel, P. A., Seo, P., Spiera, R., Langford, C. A., Hoffman, G. S., Kallenberg, C. G. M., St. Clair, E. W., Tchao, N. K., Viviano, L., Ding, L., Sejismundo, L. P., Mieras, K., Iklé, D., Jepson, B., Mueller, M., Brunetta, P., Allen, N. B., Fervenza, F. C., Geetha, D., Keogh, K., Kissin, E. Y., Monach, P. A., Peikert, T., Stegeman, C., Ytterberg, S. R., and Stone, J. H.

Published
2013
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30. 2012 Revised International Chapel Hill Consensus Conference Nomenclature of Vasculitides

Author

Jennette, J. C., Falk, R. J., Bacon, P. A., Basu, N., Cid, M. C., Ferrario, F., Flores-Suarez, L. F., Gross, W. L., Guillevin, L., Hagen, E. C., Hoffman, G. S., Jayne, D. R., Kallenberg, C. G. M., Lamprecht, P., Langford, C. A., Luqmani, R. A., Mahr, A. D., Matteson, E. L., Merkel, P. A., Ozen, S., Pusey, C. D., Rasmussen, N., Rees, A. J., Scott, D. G. I., Specks, U., Stone, J. H., Takahashi, K., and Watts, R. A.

Published
2013
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33. THU0040 PROTEINASE 3-REACTIVE B CELL RECONSTITUTION AFTER TREATMENT WITH RITUXIMAB FOR ANCA-ASSOCIATED VASCULITIS

Author

Berti, A., primary, Hillion, S., additional, Hummel, A., additional, Carmona, E., additional, Peikert, T., additional, Langford, C., additional, Merkel, P. A., additional, Monach, P., additional, Seo, P., additional, Spiera, R., additional, St Clair, E. W., additional, Fervenza, F., additional, Harris, K., additional, Stone, J. H., additional, Pers, J. O., additional, Specks, U., additional, and Cornec, D., additional

Published
2020
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34. AB0511 INTERNATIONAL CONSENSUS ON ANCA TESTING AND INTERPRETATION BEYOND SYSTEMIC VASCULITIS

Author

Moiseev, S., primary, Cohen Tervaert, J. W., additional, Arimura, Y., additional, Bogdanos, D., additional, Elena, C., additional, Damoiseaux, J., additional, Ferrante, M., additional, Flores-Suárez, L. F., additional, Fritzler, M., additional, Invernizzi, P., additional, Jayne, D., additional, Jennette, J. C., additional, Little, M., additional, Mcadoo, S. P., additional, Novikov, P., additional, Pusey, C. D., additional, Radice, A., additional, Salama, A. D., additional, Savige, J., additional, Segelmark, M., additional, Shoenfeld, Y., additional, Sinico, R. A., additional, De Sousa, M. J. R., additional, Specks, U., additional, Terrier, B., additional, Tzioufas, A., additional, Vermeire, S., additional, Zhao, M. H., additional, and Bossuyt, X., additional

Published
2020
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35. THU0310 CASE–CONTROL SEROPREVALENCE STUDY ON THE ASSOCIATION BETWEEN BARTONELLA INFECTION AND ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY-ASSOCIATED VASCULITIS

Author

Mahr, A., primary, Edouard, S., additional, Cornec, D., additional, Gonzalez-Chiappe, S., additional, Goronzy, J., additional, Guilpain, P., additional, Langford, C., additional, Lévy, P. Y., additional, Merkel, P. A., additional, Monach, P., additional, St Clair, E. W., additional, Seo, P., additional, Spiera, R., additional, Weyand, C., additional, Stone, J. H., additional, Rauolt, D., additional, and Specks, U., additional

Published
2020
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38. MEPOLIZUMAB FOR THE TREATMENT OF PATIENTS WITH EOSINOPHILIC GRANULOMATOSIS WITH POLYANGIITIS: A PHASE III RANDOMISED, PLACEBO-CONTROLLED TRIAL

Author

Wechsler, ME, Akuthota, P, Jayne, D, Khoury, P, Klion, A, Langford, C, Merkel, PA, Moosig, F, Specks, U, Cid, MC, Luqmani, R, Brown, J, Mallett, S, Philipson, R, Yancey, SW, Steinfeld, J, Weller, PF, and Gleich, G

Subjects
Clinical Research, 6.1 Pharmaceuticals, Clinical Trials and Supportive Activities, 32 Biomedical and Clinical Sciences, 3202 Clinical Sciences, 6 Evaluation of treatments and therapeutic interventions
Abstract

MEPOLIZUMAB FOR THE TREATMENT OF PATIENTS WITH EOSINOPHILIC GRANULOMATOSIS WITH POLYANGIITIS: A PHASE III RANDOMISED, PLACEBO-CONTROLLED TRIAL

Published
2019
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39. Relationship between rituximab concentration and autoantibody levels in anti-neutrophil cytoplasmic antibody associated vasculitis

Author

Bensalem, A, Ternant, D, Azzopardi, N., Paintaud, G., Gouilleux-Gruart, V, Cornec, D., Specks, U, Mulleman, D., Groupe innovation et ciblage cellulaire (GICC), EA 7501 [2018-...] (GICC EA 7501), Université de Tours (UT), Laboratoire de Pharmacologie-Toxicologie [CHRU Tours], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Université François-Rabelais de Tours, CNRS, LI EA 6300, OC ERL CNRS 6305, Tours, France, Laboratoire d'Immunologie Tours, Lymphocyte B et Auto-immunité (LBAI), Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHRU Brest - Service de Rhumatologie (CHU - BREST - Rhumato), Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Mayo Clinic [Rochester], Université de Tours, Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Brestois Santé Agro Matière (IBSAM), and Université de Brest (UBO)

Subjects
[SDV.IMM]Life Sciences [q-bio]/Immunology, ComputingMilieux_MISCELLANEOUS
Abstract

International audience

Published
2019

40. Feasibility and construct validation of the patient reported outcomes measurement information system in systemic vasculitis

Author

Tomasson, G, Farrar, JT, Cuthbertson, D, McAlear, CA, Ashdown, S, Cronholm, PF, Dawson, J, Gebhart, D, Lanier, G, Luqmani, RA, Milman, N, Peck, J, Robson, JC, Shea, JA, Carette, S, Khalidi, N, Koening, CL, Langford, CA, Monach, PA, Moreland, L, Pagnoux, C, Specks, U, Sreih, AG, Ytterberg, SR, Merkel, PA, and Consortium, Vasculitis Clinical Research

Subjects
Adult, Male, Patient-Reported Outcomes Measurement Information System, medicine.medical_specialty, Immunology, Anti-Inflammatory Agents, Pain, Physical function, Article, Disease activity, Disability Evaluation, 03 medical and health sciences, Cognition, 0302 clinical medicine, Rheumatology, Humans, Immunology and Allergy, Medicine, Longitudinal Studies, Patient Reported Outcome Measures, 030212 general & internal medicine, Longitudinal cohort, Fatigue, Aged, 030203 arthritis & rheumatology, business.industry, Systemic Vasculitis, Construct validity, Middle Aged, Social Participation, medicine.disease, Cross-Sectional Studies, Quality of Life, Physical therapy, Feasibility Studies, Female, Patient-reported outcome, Computerized adaptive testing, business, Systemic vasculitis
Abstract

Objective.The Patient Reported Outcome Measurement Information System (PROMIS) is a collection of item banks of self-reported health. This study assessed the feasibility and construct validity of using PROMIS instruments in vasculitis.Methods.Data from a multicenter longitudinal cohort of subjects with systemic vasculitis were used. Instruments from 10 PROMIS item banks were selected with direct involvement of patients. Subjects completed PROMIS instruments using computer adaptive testing (CAT). The Medical Outcomes Study Short Form-36 (SF-36) was also administered. Cross-sectional construct validity was assessed by calculating correlations of PROMIS scores with SF-36 measures and physician and patient global scores for disease activity. Longitudinal construct validity was assessed by correlations of between-visit differences in PROMIS scores with differences in other measures.Results.During the study period, 973 subjects came for 2306 study visits and the PROMIS collection was completed at 2276 (99%) of visits. The median time needed to complete each PROMIS instrument ranged from 40 to 55 s. PROMIS instruments correlated cross-sectionally with individual scales of the SF-36, most strongly with subscales of the SF-36 addressing the same domain as the PROMIS instrument. For example, PROMIS fatigue correlated with both the physical component score (PCS; r = −0.65) and with the mental component score (MCS; r = −0.54). PROMIS physical function correlated strongly with PCS (r = 0.81) but weakly with MCS (r = 0.29). Weaker correlations were observed longitudinally between change in PROMIS scores with change in PCS and MCS.Conclusion.Collection of data using CAT PROMIS instruments is feasible among patients with vasculitis and has some cross-sectional and longitudinal construct validity.

Published
2019

41. Mepolizumab For The Treatment Of Patients With Eosinophilic Granulomatosis With Polyangiitis: A Phase Iii Randomized, Placebo-Controlled Trial

Author

Wechsler, M, Akuthota, P, Jayne, D, Khoury, P, Klion, A, Langford, C, Merkel, P, Moosig, F, Specks, U, Cid, M, Luqmani, R, Brown, J, Mallett, S, Philipson, R, Yancey, S, Steinfeld, J, Weller, P, and Gleich, G

Abstract

Mepolizumab For The Treatment Of Patients With Eosinophilic Granulomatosis With Polyangiitis: A Phase Iii Randomized, Placebo-Controlled Trial

Published
2019

46. Revised 2017 international consensus on testing of ANCAs in granulomatosis with polyangiitis and microscopic polyangiitis [Position paper]

Author

Bossuyt, X, Cohen Tervaert, J, Arimura, Y, Blockmans, D, Flores Suárez, L, Guillevin, L, Hellmich, B, Jayne, D, Jennette, J, Kallenberg, C, Moiseev, S, Novikov, P, Radice, A, Savige, J, SINICO, RENATO ALBERTO, Specks, U, van Paassen, P, Zhao, M, Rasmussen, N, Damoiseaux, J, Csernok, E., Bossuyt, X, Cohen Tervaert, J, Arimura, Y, Blockmans, D, Flores Suárez, L, Guillevin, L, Hellmich, B, Jayne, D, Jennette, J, Kallenberg, C, Moiseev, S, Novikov, P, Radice, A, Savige, J, Sinico, R, Specks, U, van Paassen, P, Zhao, M, Rasmussen, N, Damoiseaux, J, and Csernok, E

Subjects
ANCA, vasculitis, assay. diagnostic performance
Abstract

Anti-neutrophil cytoplasmic antibodies (ANCAs) are valuable laboratory markers used for the diagnosis of well-defined types of small-vessel vasculitis, including granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA). According to the 1999 international consensus on ANCA testing, indirect immunofluorescence (IIF) should be used to screen for ANCAs, and samples containing ANCAs should then be tested by immunoassays for proteinase 3 (PR3)-ANCAs and myeloperoxidase (MPO)-ANCAs. The distinction between PR3-ANCAs and MPO-ANCAs has important clinical and pathogenic implications. As dependable immunoassays for PR3-ANCAs and MPO-ANCAs have become broadly available, there is increasing international agreement that high-quality immunoassays are the preferred screening method for the diagnosis of ANCA-associated vasculitis. The present Consensus Statement proposes that high-quality immunoassays can be used as the primary screening method for patients suspected of having the ANCA-associated vaculitides GPA and MPA without the categorical need for IIF, and presents and discusses evidence to support this recommendation.

Published
2017

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