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1. Breakthrough SARS-CoV-2 infection in fully vaccinated patients with systemic lupus erythematosus: results from the COVID-19 Vaccination in Autoimmune Disease (COVAD) study

Author

Palazzo, Leonardo, Lindblom, Julius, Kihlgren Olsson, Emelie, Nikiphorou, Elena, Wincup, Chris, Saha, Sreoshy, Shaharir, Syahrul Sazliyana, Katchamart, Wanruchada, Akarawatcharangura Goo, Phonpen, Traboco, Lisa, Chen, Yi-Ming, Lilleker, James B., Nune, Arvind, Pauling, John D., Agarwal, Vishwesh, Dzifa, Dey, Toro Gutiérrez, Carlos Enrique, Caballero-Uribe, Carlo V., Chinoy, Hector, Agarwal, Vikas, Gupta, Latika, and Parodis, Ioannis

Published
2024
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2. Flares of autoimmune rheumatic disease following COVID‐19 infection: Observations from the COVAD study

Author

Sandhu, Nimrat Kaur, Ravichandraan, Naveen, Nune, Arvind, Day, Jessica, Sen, Parikshit, Nikiphorou, Elena, Tan, Ai Lyn, Joshi, Mrudula, Saha, Sreoshy, Shinjo, Samuel Katsuyuki, Jagtap, Kshitij, Agarwal, Vishwesh, Ziade, Nelly, Velikova, Tsvetelina, Milchert, Marcin, Parodis, Ioannis, Gracia‐Ramos, Abraham Edgar, Cavagna, Lorenzo, Kuwana, Masataka, Knitza, Johannes, Makol, Ashima, Patel, Aarat, Pauling, John D, Wincup, Chris, Barman, Bhupen, Tehozol, Erick Adrian Zamora, Serrano, Jorge Rojas, La Torre, Ignacio García‐De, Colunga‐Pedraza, Iris J, Merayo‐Chalico, Javier, Okwara, Celestine Chibuzo, Katchamart, Wanruchada, Goo, Phonpen Akawatcharangura, Shumnalieva, Russka, Chen, Yi‐Ming, Hoff, Leonardo Santos, Kibbi, Lina El, Halabi, Hussein, Vaidya, Binit, Shaharir, Syahrul Sazliyana, Hasan, ATM Tanveer, Dey, Dzifa, Gutiérrez, Carlos Enrique Toro, Caballero‐Uribe, Carlo Vinicio, Lilleker, James B, Salim, Babur, Gheita, Tamer, Saavedra, Miguel A, Chatterjee, Tulika, Distler, Oliver, Group, COVAD Study, Chinoy, Hector, Agarwal, Vikas, Aggarwal, Rohit, and Gupta, Latika

Subjects
Biomedical and Clinical Sciences, Immunology, Autoimmune Disease, Emerging Infectious Diseases, Infectious Diseases, Arthritis, Coronaviruses, Humans, COVID-19, Rheumatic Diseases, Autoimmune Diseases, COVAD Study Group, Arthritis & Rheumatology
Published
2024

5. Managing Complicated Digital Ulcers

Author

Pauling, John D., Matucci-Cerinic, Marco, Allanore, Yannick, editor, Varga, John, editor, Denton, Christopher P., editor, Kuwana, Masataka, editor, Chung, Lorinda, editor, and Shah, Ami A., editor

Published
2024
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7. Correlates of breakthrough COVID-19 in vaccinated patients with systemic sclerosis: survival analysis from a multicentre international patient-reported survey

Author

Ahmed, Sakir, Gupta, Latika, Kuwana, Masataka, Pauling, John D., Day, Jessica, Ravichandran, Naveen, Joshi, Mrudula, Parodis, Ioannis, Sen, Parikshit, Jagtap, Kshitij, Nikiphorou, Elena, Saha, Sreoshy, Agarwal, Vishwesh, Chatterjee, Tulika, Lilleker, James B., Kardes, Sinan, Milchert, Marcin, Gheita, Tamer, Salim, Babur, Velikova, Tsvetelina, Gracia-Ramos, Abraham Edgar, Tan, Ai Lyn, Nune, Arvind, Cavagna, Lorenzo, Saavedra, Miguel A., Shinjo, Samuel Katsuyuki, Ziade, Nelly, Knitza, Johannes, Distler, Oliver, Wibowo, Suryo Anggoro Kusumo, Chinoy, Hector, Aggarwal, Rohit, Agarwal, Vikas, and Makol, Ashima

Published
2024
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8. Delayed adverse events following COVID-19 vaccination in patients with systemic sclerosis and other autoimmune diseases: a substudy of the COVAD-2 cohort

Author

Panchawagh, Suhrud, Bohdana, Doskaliuk, Kuwana, Masataka, Yoshida, Akira, Yomono, Keina, Pauling, John D., Makol, Ashima, Kadam, Esha, Day, Jessica, Chatterjee, Tulika, Katchamart, Wanruchada, Goo, Phonpen Akarawatcharangura, Nikiphorou, Elena, Sen, Parikshit, Dey, Dzifa, Cavagna, Lorenzo, Gutiérrez, Carlos Enrique Toro, Agarwal, Vishwesh, Milchert, Marcin, Ziade, Nelly, Distler, Oliver, Group, COVAD Study, Chinoy, Hector, Aggarwal, Rohit, Gupta, Latika, and Agarwal, Vikas

Published
2023
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9. The association of outdoor temperature and self-reported Raynaud's phenomenon severity among people with systemic sclerosis: a Scleroderma Patient-centered Intervention Network Cohort study

Author

Fortuné, Catherine, Adams, Claire E., Henry, Richard S., El-Baalbaki, Ghassan, Fligelstone, Kim, Frech, Tracy, Harel, Daphna, Hinchcliff, Monique, Johnson, Sindhu R., Larche, Maggie, Leite, Catarina, Nguyen, Christelle, Nielsen, Karen, Pope, Janet, Rannou, François, Rodriguez-Reyna, Tatiana Sofía, Shouffoer, Anne A., Suarez-Almazor, Maria E., Agard, Christian, Alric, Laurent, André, Marc, Beaslay, Floryan, Bernstein, Elana J., Berthier, Sabine, Bissonnette, Lyne, Blaise, Sophie, Bories, Eva, Bruns, Alessandra, Cacciatore, Carlotta, Carreira, Patricia, Casadevall, Marion, Chaigne, Benjamin, Chung, Lorinda, Crichi, Benjamin, Deltombe, Thylbert, Denton, Christopher, Desroche, Tannvir, Domsic, Robyn, Dunne, James V., Dunogue, Bertrand, Fare, Regina, Farge-Bancel, Dominique, Fortin, Paul R., Gauzère, Loraine, Gerber, Anne, Gordon, Jessica, Granel-Rey, Brigitte, Guffroy, Aurélien, Gyger, Geneviève, Hachulla, Erica, Hoa, Sabrina, Hughes, Michael, Ikic, Alena, Khalidi, Nader, Lakin, Kimberly, Lambert, Marc, Launay, David, Lee, Yvonne C., Legendre, Paul, Maillard, Hélène, Maltez, Nancy, Manning, Joanne, Marie, Isabelle, Martin Lopez, Maria, Martin, Thierry, Masetto, Ariel, Mekinian, Arsène, Melchor Díaz, Sheila, Mourguet, Morgane, Nikpour, Mandana, Olgane, Louis, Poindron, Vincent, Proudman, Susanna, Pugnet, Grégory, Raffray, Loïc, Régent, Alexis, Renou, Frederic, Rivière, Sébastien, Robinson, David, Rodríguez Almazar, Esther, Roux, Sophie, Smets, Perrine, Sobanski, Vincent, Spiera, Robert, Steen, Virginia, Sutton, Evelyn, Thorne, Carter, Vagner, Damien, Varga, John, Wilcox, Pearce, Cañedo Ayala, Mara, Cook, Vanessa, Dal Santo, Cassidy, Dal Santo, Tiffany, D'Onofrio, Monica, Hu, Sophie, Neyer, Marieke Alexandra, Provencher, Sabrina, Virgili-Gervais, Gabrielle, Matthews, Bianca, Nassar, Elsa-Lynn, Carrier, Marie-Eve, Kwakkenbos, Linda, Pauling, John D, Bartlett, Susan J, Gietzen, Amy, Gottesman, Karen, Guillot, Geneviève, Hudson, Marie, Hummers, Laura K, Lawrie-Jones, Amanda, Malcarne, Vanessa L, Mayes, Maureen D, Richard, Michelle, Sauvé, Maureen, Wojeck, Robyn K, Mouthon, Luc, Benedetti, Andrea, and Thombs, Brett D

Published
2024
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11. Long-term safety of COVID vaccination in individuals with idiopathic inflammatory myopathies: results from the COVAD study

Author

Doskaliuk, Bohdana, Ravichandran, Naveen, Sen, Parikshit, Day, Jessica, Joshi, Mrudula, Nune, Arvind, Nikiphorou, Elena, Saha, Sreoshy, Tan, Ai Lyn, Shinjo, Samuel Katsuyuki, Ziade, Nelly, Velikova, Tsvetelina, Milchert, Marcin, Jagtap, Kshitij, Parodis, Ioannis, Gracia-Ramos, Abraham Edgar, Cavagna, Lorenzo, Kuwana, Masataka, Knitza, Johannes, Chen, Yi Ming, Makol, Ashima, Agarwal, Vishwesh, Patel, Aarat, Pauling, John D., Wincup, Chris, Barman, Bhupen, Tehozol, Erick Adrian Zamora, Serrano, Jorge Rojas, La Torre, Ignacio García-De, Colunga-Pedraza, Iris J., Merayo-Chalico, Javier, Chibuzo, Okwara Celestine, Katchamart, Wanruchada, Goo, Phonpen Akarawatcharangura, Shumnalieva, Russka, Hoff, Leonardo Santos, Kibbi, Lina El, Halabi, Hussein, Vaidya, Binit, Shaharir, Syahrul Sazliyana, Hasan, A. T. M. Tanveer, Dey, Dzifa, Gutiérrez, Carlos Enrique Toro, Caballero-Uribe, Carlo V., Lilleker, James B., Salim, Babur, Gheita, Tamer, Chatterjee, Tulika, Distler, Oliver, Saavedra, Miguel A., Chinoy, Hector, Agarwal, Vikas, Aggarwal, Rohit, and Gupta, Latika

Published
2023
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12. Systemic sclerosis and COVID-19 vaccine safety: short-term insights from the global COVID-19 vaccination in autoimmune disease (COVAD) survey

Author

Naveen, R., Thakare, Darpan R., Kuwana, Masataka, Pauling, John D., Day, Jessica, Joshi, Mrudula, Parodis, Ioannis, Sen, Parikshit, Jagtap, Kshitij, Nikiphorou, Elena, Saha, Sreoshy, Agarwal, Vishwesh, Chatterjee, Tulika, Lilleker, James B., Kardes, Sinan, Milchert, Marcin, Gheita, Tamer, Salim, Babur, Velikova, Tsvetelina, Gracia-Ramos, Abraham Edgar, Tan, Ai Lyn, Nune, Arvind, Cavagna, Lorenzo, Saavedra, Miguel A., Shinjo, Samuel Katsuyuki, Ziade, Nelly, Knitza, Johannes, Distler, Oliver, Chinoy, Hector, Aggarwal, Rohit, Gupta, Latika, Agarwal, Vikas, and Makol, Ashima

Published
2023
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13. Patients’ perspectives on systemic sclerosis-related Raynaud's phenomenon in the feet: A qualitative study from the OMERACT Foot and Ankle Working Group

Author

Chapman, Lara S., Alcacer-Pitarch, Begonya, Pauling, John D., Flurey, Caroline A., Redmond, Anthony C., Richards, Pamela, Herrick, Ariane L., Merkel, Peter A., Proudman, Susanna, Menz, Hylton B., Helliwell, Philip S., Hannan, Marian T., Domsic, Robyn T., Saketkoo, Lesley A., Shea, Beverley, and Siddle, Heidi J.

Published
2024
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14. COVID-19 severity and vaccine breakthrough infections in idiopathic inflammatory myopathies, other systemic autoimmune and inflammatory diseases, and healthy controls: a multicenter cross-sectional study from the COVID-19 Vaccination in Autoimmune Diseases (COVAD) survey

Author

Hoff, Leonardo Santos, Ravichandran, Naveen, Shinjo, Samuel Katsuyuki, Day, Jessica, Sen, Parikshit, Junior, Jucier Gonçalves, Lilleker, James B., Joshi, Mrudula, Agarwal, Vishwesh, Kardes, Sinan, Kim, Minchul, Milchert, Marcin, Makol, Ashima, Gheita, Tamer, Salim, Babur, Velikova, Tsvetelina, Gracia-Ramos, Abraham Edgar, Parodis, Ioannis, O’Callaghan, Albert Selva, Nikiphorou, Elena, Tan, Ai Lyn, Chatterjee, Tulika, Cavagna, Lorenzo, Saavedra, Miguel A., Ziade, Nelly, Knitza, Johannes, Kuwana, Masataka, Nune, Arvind, Distler, Oliver, Cansu, Döndü Üsküdar, Traboco, Lisa, Wibowo, Suryo Angorro Kusumo, Tehozol, Erick Adrian Zamora, Serrano, Jorge Rojas, La Torre, Ignacio García-De, Wincup, Chris, Pauling, John D., Chinoy, Hector, Agarwal, Vikas, Aggarwal, Rohit, and Gupta, Latika

Published
2023
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19. IMproving PULmonary hypertension Screening by Echocardiography: IMPULSE

Author

Slegg, Oliver Graham, Willis, James Alexander, Wilkinson, Fiona, Sparey, Joseph, Wild, Christopher Basil, Rossdale, Jennifer, Ross, Robert Mackenzie, Pauling, John D., Carson, Kevin, Kandan, Sri Raveen, Oxborough, David, Knight, Daniel, Peacock, Oliver James, Suntharalingam, Jay, Coghlan, John Gerard, and Augustine, Daniel Xavier

Published
2022
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21. COVID-19 severity, breakthrough infections and vaccine safety in young individuals with autoimmune diseases: insights from the COVAD study.

Author

Alunno, Alessia, Carubbi, Francesco, Tan, Ai Lyn, Sen, Parikshit, Cavagna, Lorenzo, Joshi, Mrudula, Day, Jessica, Saha, Sreoshy, Gutiérrez, Carlos Enrique Toro, Caballero-Uribe, Carlo Vinicio, Distler, Oliver, Chinoy, Hector, Aggarwal, Rohit, Agarwal, Vikas, Gupta, Latika, COVAD Study Group, Nikiphorou, Elena, Nune, Arvind, Lilleker, James B., and Pauling, John D.

Subjects
BREAKTHROUGH infections, YOUNG adults, COVID-19, VACCINE safety, COVID-19 vaccines
Abstract

Notwithstanding the wealth of literature on COVID-19, studies focusing on young adults with autoimmune diseases (AD) are lacking. To determine early (within 7 days) and late (after 7 days) anti-SARS-CoV-2 vaccine-related adverse events (AEs), post-vaccine disease flares, COVID-19 severity and breakthrough infections (B-INFs) in young people with rheumatic diseases (RMDs) and non-rheumatic autoimmune diseases (nr-ADs) compared to healthy controls (HC). Data were captured through the international COVID-19 vaccination in autoimmune diseases (COVAD) 1 and 2 questionnaires. Of 20,685 complete responses, we identified 6010 from patients aged 18–35 years (1692 RMD, 400 nrADs, 3918 HC) who received up to 4 vaccine doses. BNT162b2 was the most frequently administered vaccine and prior to vaccination, 7% of people with nrAD were taking immunosuppressants (IS) versus 80% in RMDs. Early mild AEs were more frequent in RMDs (93%) and nr-ADs (92%) compared to HC (85%). The frequency of late mild AEs was < 20% in all groups. Severe AEs were rare. SARS-CoV-2 infection rates were similar across all groups, however, RMD patients reported a single episode of infection more frequently than nrADs and HC, while nrADs reported multiple infections more frequently than RMD. Self-reported disease flares were reported by 10% or RMD and 7% of nrAD patients. Our study reinforces the safety of anti-SARS-CoV-2 vaccine also in young people with ADs, but it also highlights that among young individuals the number and clinical picture of SARS-CoV-2 infections is affected more by the type of AD rather than by coexisting IS therapy. [ABSTRACT FROM AUTHOR]

Published
2024
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24. Attitudes and barriers to pulmonary arterial hypertension screening in systemic sclerosis patients: A survey of UK-based rheumatologists

Author

Álvarez-Hernández, María Paula, primary, Allanore, Yannick, additional, Andrade, Ivo, additional, Buch, Maya H, additional, Coghlan, Gerry, additional, Del Galdo, Francesco, additional, Denton, Christopher P, additional, Khanna, Dinesh, additional, Kiely, David G, additional, Pauling, John D, additional, Ramjug, Sheila, additional, and Hughes, Michael, additional

Published
2024
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26. Development of a measuring app for systemic sclerosis-related digital ulceration (SALVE: Scleroderma App for Lesion VErification)

Author

Davison, Adrian K, Krishan, Ashma, New, Robert P, Murray, Andrea, Dinsdale, Graham, Manning, Joanne, Hall, Frances, Pauling, John D, Vail, Andy, Kearney, Kathryn, Patrick, Helen, Hughes, Michael, Dixon, William, Dickinson, Mark, Taylor, Chris, Herrick, Ariane L, Davison, Adrian K, Krishan, Ashma, New, Robert P, Murray, Andrea, Dinsdale, Graham, Manning, Joanne, Hall, Frances, Pauling, John D, Vail, Andy, Kearney, Kathryn, Patrick, Helen, Hughes, Michael, Dixon, William, Dickinson, Mark, Taylor, Chris, and Herrick, Ariane L

Abstract

Objectives To test the hypothesis that photographs (in addition to self-reported data) can be collected daily by patients with SSc using a smartphone app designed specifically for digital lesions, and could provide an objective outcome measure for use in clinical trials. Methods An app was developed to collect images and patient-reported outcome measures including Pain score and the Hand Disability in Systemic Sclerosis-Digital Ulcers (HDISS-DU) questionnaire. Participants photographed their lesion(s) each day for 30 days and uploaded images to a secure repository. Lesions were analysed both manually and automatically, using a machine learning approach. Results Twenty-five patients with SSc-related digital lesions consented, of whom 19 completed the 30-day study, with evaluable data from 27 lesions. Mean (s.d.) baseline Pain score was 5.7 (2.4) and HDISS-DU 2.2 (0.9), indicating high lesion- and disease-related morbidity. A total of 506 images were used in the analysis [mean number of used images per lesion 18.7 (s.d. 8.3)]. Mean (s.d.) manual and automated lesion areas at day 1 were 11.6 (16.0) and 13.9 (16.7) mm2, respectively. Manual area decreased by 0.08 mm2 per day (2.4 mm2 over 30 days) and automated area by 0.1 mm2 (3.0 mm2 over 30 days). Average gradients of manual and automated measurements over 30 days correlated strongly (r = 0.81). Manual measurements were on average 40% lower than automated ones, with wide limits of agreement. Conclusion Even patients with significant hand disability were able to use the app. Automated measurement of finger lesions could be valuable as an outcome measure in clinical trials.

Published
2024

27. A phase 2 trial investigating the efficacy and safety of the mPGES-1 inhibitor vipoglanstat in systemic sclerosis-related Raynaud's

Author

Tornling, Göran, Edenius, Charlotte, Pauling, John D, Denton, Christopher P, Olsson, Anna, Kowalski, Jan, Murray, Andrea, Anderson, Marina, Bhat, Smita, Del Galdo, Francesco, Hall, Frances, Korkosz, Mariusz, Krasowska, Dorota, Olas, Jacek, Smith, Vanessa, van Laar, Jacob M, Vonk, Madelon C, Wojteczek, Anna, Herrick, Ariane L, Tornling, Göran, Edenius, Charlotte, Pauling, John D, Denton, Christopher P, Olsson, Anna, Kowalski, Jan, Murray, Andrea, Anderson, Marina, Bhat, Smita, Del Galdo, Francesco, Hall, Frances, Korkosz, Mariusz, Krasowska, Dorota, Olas, Jacek, Smith, Vanessa, van Laar, Jacob M, Vonk, Madelon C, Wojteczek, Anna, and Herrick, Ariane L

Abstract

OBJECTIVE Our objective was to test the hypothesis, in a double-blind, placebo-controlled study that vipoglanstat, an inhibitor of microsomal prostaglandin E synthase-1 (mPGES-1) which decreases prostaglandin E2 (PGE2) and increases prostacyclin biosynthesis, improves RP. METHODS Patients with systemic sclerosis (SSc) and ≥7 RP attacks during the last screening week prior to a baseline visit were randomised to four weeks treatment with vipoglanstat 120 mg or placebo. A daily electronic diary captured RP attacks (duration and pain) and Raynaud’s Condition Score, with change in RP attacks/week as primary end point. Cold challenge assessments were performed at baseline and end of treatment. Exploratory endpoints included patients’ and physicians’ global impression of change, Assessment of Scleroderma-associated Raynaud’s Phenomenon questionnaire, mPGES-1 activity, and urinary excretion of arachidonic acid metabolites. RESULTS Sixty-nine subjects received vipoglanstat (n = 33) or placebo (n = 36). Mean weekly number of RP attacks (baseline; vipoglanstat 14.4[SD 6.7], placebo 18.2[12.6]) decreased by 3.4[95% CI -5.8;-1.0] and 4.2[-6.5;-2.0] attacks per week (p= 0.628) respectively. All patient reported outcomes improved, with no difference between the groups. Mean change in recovery of peripheral blood flow after cold challenge did not differ between the study groups. Vipoglanstat fully inhibited mPGES-1, resulting in 57% reduction of PGE2 and 50% increase of prostacyclin metabolites in urine. Vipoglanstat was safe and well tolerated. CONCLUSION Although vipoglanstat was safe, and well tolerated in a dose achieving full inhibition of mPGES-1, it was ineffective in SSc-related RP. Further development and evaluation of vipoglanstat will therefore be in other diseases where mPGES-1 plays a pathogenetic role.

Published
2024

28. Characteristics and risk factors of COVID-19 breakthrough infections in Idiopathic Inflammatory Myopathies: Results from the COVAD study

Author

Hoff, Leonardo Santos; https://orcid.org/0000-0002-2083-4796, Naveen, Ravichandran; https://orcid.org/0000-0003-2014-3925, Sen, Parikshit; https://orcid.org/0000-0002-1630-6026, Day, Jessica; https://orcid.org/0000-0001-8528-4361, Joshi, Mrudula; https://orcid.org/0000-0001-7312-351X, Nune, Arvind; https://orcid.org/0000-0002-3849-614X, Nikiphorou, Elena; https://orcid.org/0000-0001-6847-3726, Saha, Sreoshy; https://orcid.org/0000-0001-6745-9770, Tan, Ai Lyn; https://orcid.org/0000-0002-9158-7243, Shinjo, Samuel Katsuyuki; https://orcid.org/0000-0002-3682-4517, Ziade, Nelly; https://orcid.org/0000-0002-4479-7678, Velikova, Tsvetelina; https://orcid.org/0000-0002-0593-1272, Milchert, Marcin; https://orcid.org/0000-0002-0943-8768, Jagtap, Kshitij; https://orcid.org/0000-0003-2729-737X, Parodis, Ioannis; https://orcid.org/0000-0002-4875-5395, Edgar Gracia-Ramos, Abraham; https://orcid.org/0000-0003-1842-2554, Cavagna, Lorenzo; https://orcid.org/0000-0003-3292-1528, Kuwana, Masataka; https://orcid.org/0000-0001-8352-6136, Knitza, Johannes; https://orcid.org/0000-0001-9695-0657, Chen, Yi Ming; https://orcid.org/0000-0001-7593-3065, Makol, Ashima; https://orcid.org/0000-0002-8748-898X, Agarwal, Vishwesh; https://orcid.org/0000-0002-0986-8354, Patel, Aarat, Pauling, John D; https://orcid.org/0000-0002-2793-2364, Wincup, Chris; https://orcid.org/0000-0002-8742-8311, Barman, Bhupen; https://orcid.org/0000-0002-5433-1310, Zamora Tehozol, Erick Adrian; https://orcid.org/0000-0002-7888-3961, Rojas Serrano, Jorge; https://orcid.org/0000-0001-6980-7898, García-De La Torre, Ignacio; https://orcid.org/0000-0002-9261-678X, Colunga-Pedraza, Iris J; https://orcid.org/0000-0002-2786-5843, Distler, Oliver; https://orcid.org/0000-0002-0546-8310, Saavedra, Miguel A; https://orcid.org/0000-0003-0687-9944, Chinoy, Hector; https://orcid.org/0000-0001-6492-1288, Agarwal, Vikas; https://orcid.org/0000-0002-4508-1233, Aggarwal, Rohit; https://orcid.org/0000-0001-7531-8038, Gupta, Latika; https://orcid.org/0000-0003-2753-2990, Hoff, Leonardo Santos; https://orcid.org/0000-0002-2083-4796, Naveen, Ravichandran; https://orcid.org/0000-0003-2014-3925, Sen, Parikshit; https://orcid.org/0000-0002-1630-6026, Day, Jessica; https://orcid.org/0000-0001-8528-4361, Joshi, Mrudula; https://orcid.org/0000-0001-7312-351X, Nune, Arvind; https://orcid.org/0000-0002-3849-614X, Nikiphorou, Elena; https://orcid.org/0000-0001-6847-3726, Saha, Sreoshy; https://orcid.org/0000-0001-6745-9770, Tan, Ai Lyn; https://orcid.org/0000-0002-9158-7243, Shinjo, Samuel Katsuyuki; https://orcid.org/0000-0002-3682-4517, Ziade, Nelly; https://orcid.org/0000-0002-4479-7678, Velikova, Tsvetelina; https://orcid.org/0000-0002-0593-1272, Milchert, Marcin; https://orcid.org/0000-0002-0943-8768, Jagtap, Kshitij; https://orcid.org/0000-0003-2729-737X, Parodis, Ioannis; https://orcid.org/0000-0002-4875-5395, Edgar Gracia-Ramos, Abraham; https://orcid.org/0000-0003-1842-2554, Cavagna, Lorenzo; https://orcid.org/0000-0003-3292-1528, Kuwana, Masataka; https://orcid.org/0000-0001-8352-6136, Knitza, Johannes; https://orcid.org/0000-0001-9695-0657, Chen, Yi Ming; https://orcid.org/0000-0001-7593-3065, Makol, Ashima; https://orcid.org/0000-0002-8748-898X, Agarwal, Vishwesh; https://orcid.org/0000-0002-0986-8354, Patel, Aarat, Pauling, John D; https://orcid.org/0000-0002-2793-2364, Wincup, Chris; https://orcid.org/0000-0002-8742-8311, Barman, Bhupen; https://orcid.org/0000-0002-5433-1310, Zamora Tehozol, Erick Adrian; https://orcid.org/0000-0002-7888-3961, Rojas Serrano, Jorge; https://orcid.org/0000-0001-6980-7898, García-De La Torre, Ignacio; https://orcid.org/0000-0002-9261-678X, Colunga-Pedraza, Iris J; https://orcid.org/0000-0002-2786-5843, Distler, Oliver; https://orcid.org/0000-0002-0546-8310, Saavedra, Miguel A; https://orcid.org/0000-0003-0687-9944, Chinoy, Hector; https://orcid.org/0000-0001-6492-1288, Agarwal, Vikas; https://orcid.org/0000-0002-4508-1233, Aggarwal, Rohit; https://orcid.org/0000-0001-7531-8038, and Gupta, Latika; https://orcid.org/0000-0003-2753-2990

Abstract

OBJECTIVES To explore prevalence, characteristics and risk factors of COVID-19 breakthrough infections (BIs) in idiopathic inflammatory myopathies (IIM) using data from the COVID-19 Vaccination in Autoimmune Diseases (COVAD) study. METHODS A validated patient self-reporting e-survey was circulated by the COVAD study group to collect data on COVID-19 infection and vaccination in 2022. BIs were defined as COVID-19 occurring ≥14 days after 2 vaccine doses. We compared BIs characteristics and severity among IIMs, other autoimmune rheumatic and non-rheumatic diseases (AIRD, nrAID), and healthy controls (HC). Multivariable Cox regression models assessed the risk factors for BI, severe BI and hospitalisations among IIMs. RESULTS Among 9449 included response, BIs occurred in 1447 (15.3%) respondents, median age 44 years (IQR 21), 77.4% female, and 182 BIs (12.9%) occurred among 1406 IIMs. Multivariable Cox regression among IIMs showed age as a protective factor for BIs [Hazard Ratio (HR)=0.98, 95%CI = 0.97-0.99], hydroxychloroquine and sulfasalazine use were risk factors (HR = 1.81, 95%CI = 1.24-2.64, and HR = 3.79, 95%CI = 1.69-8.42, respectively). Glucocorticoid use was a risk factor for severe BI (HR = 3.61, 95%CI = 1.09-11.8). Non-White ethnicity (HR = 2.61, 95%CI = 1.03-6.59) was a risk factor for hospitalisation. Compared with other groups, patients with IIMs required more supplemental oxygen therapy (IIM = 6.0% vs AIRD = 1.8%, nrAID = 2.2%, and HC = 0.9%), intensive care unit admission (IIM = 2.2% vs AIRD = 0.6%, nrAID, and HC = 0%), advanced treatment with antiviral or monoclonal antibodies (IIM = 34.1% vs AIRD = 25.8%, nrAID = 14.6%, and HC = 12.8%), and had more hospitalisation (IIM = 7.7% vs AIRD = 4.6%, nrAID = 1.1%, and HC = 1.5%). CONCLUSION Patients with IIMs are susceptible to severe COVID-19 BI. Age and immunosuppressive treatments were related to the risk of BIs.

Published
2024

31. IgG4-related disease presenting with gastric outlet obstruction.

Author

Masterman, Benjamin, Yve Zhang, Pauling, John D., and Zeino, Zeino

Abstract

A woman in her 20s presented with 6 weeks of fever, persistent vomiting and 28% loss of body weight. Symptoms were refractory to treatment with antiemetics and broad spectrum antibiotics. Further investigation via oesophageogastroduedenoscopy revealed a large gastric ulcer and pyloric stricture, causing gastric outlet obstruction (GOO). Biopsies of the stomach and duodenum showed plasma cell infiltration with a large proportion being IgG4 positive. Treatment with methylprednisolone, and later prednisolone, quickly improved inflammatory markers and symptoms. Balloon dilatation of the pyloric stricture also improved vomiting, allowing eventual re-establishment of oral nutrition. The patient made a full recovery with maintenance treatment on mycophenolate mofetil. IgG4-related disease (IgG4-RD) is a multisystem disorder with unpredictable presentation. The case highlights diagnostic challenges in IgG4-RD and identifies it as a rare differential in upper gastrointestinal symptoms. To our knowledge this is the first published case of IgG4-RD in the duodenum causing GOO. [ABSTRACT FROM AUTHOR]

Published
2024
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32. A phase 2 trial investigating the efficacy and safety of the mPGES-1 inhibitor vipoglanstat in systemic sclerosis-related Raynaud's

Author

Tornling, Göran, primary, Edenius, Charlotte, additional, Pauling, John D, additional, Denton, Christopher P, additional, Olsson, Anna, additional, Kowalski, Jan, additional, Murray, Andrea, additional, Anderson, Marina, additional, Bhat, Smita, additional, Del Galdo, Francesco, additional, Hall, Frances, additional, Korkosz, Mariusz, additional, Krasowska, Dorota, additional, Olas, Jacek, additional, Smith, Vanessa, additional, van Laar, Jacob M, additional, Vonk, Madelon C, additional, Wojteczek, Anna, additional, and Herrick, Ariane L, additional

Published
2024
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33. Best clinical practice in the treatment of juvenile systemic sclerosis: expert panel guidance - the result of the International Hamburg Consensus Meeting December 2022

Author

Foeldvari, Ivan, primary, Torok, Kathryn S., additional, Antón, Jordi, additional, Blakley, Michael, additional, Constantin, Tamás, additional, Cutolo, Maurizio, additional, Denton, Christopher P., additional, Fligelstone, Kim, additional, Hinrichs, Bernd, additional, Li, Suzanne C., additional, Maillard, Susan, additional, Marrani, Edoardo, additional, Moinzadeh, Pia, additional, Orteu, Catherine H., additional, Pain, Clare E., additional, Pauling, John D, additional, Pilkington, Clarissa, additional, Rosser, Franziska, additional, Smith, Vanessa, additional, and Furst, Daniel F, additional

Published
2023
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38. Construct validity and reliability of the Assessment of Systemic Sclerosis-Associated Raynaud's Phenomenon (ASRAP) questionnaire.

Author

Pauling, John D, Yu, Lan, Frech, Tracy M, Herrick, Ariane L, Hummers, Laura K, Shah, Ami A, Denton, Christopher P, Saketkoo, Lesley Ann, Withey, Jane, Khanna, Dinesh, and Domsic, Robyn T

Subjects
*MULTITRAIT multimethod techniques, *PAIN measurement, *RAYNAUD'S disease, *HEALTH status indicators, *RESEARCH funding, *QUESTIONNAIRES, *RESEARCH methodology evaluation, *VISUAL analog scale, *DISABILITY evaluation, *SEVERITY of illness index, *DESCRIPTIVE statistics, *CALCINOSIS, *SYSTEMIC scleroderma, *PSYCHOMETRICS, *RESEARCH methodology, *RESEARCH, *HEALTH outcome assessment, *CONFIDENCE intervals, *PHENOTYPES, *EVALUATION, *DISEASE complications
Abstract

Objectives Assessment of construct validity and reliability of a novel patient-reported outcome (PRO) instrument for assessing the severity and impact of RP in SSc. Methods An international multicentre study validation study of the 27-item Assessment of Systemic Sclerosis-Associated Raynaud's Phenomenon (ASRAP) and 10-item short-form (ASRAP-SF) questionnaires. The relationship between ASRAP questionnaires and demographics, clinical phenotype and legacy instruments for assessing SSc-RP severity, disability and pain was assessed. Repeatability was evaluated at 1 week. Anchor-based statements of health status facilitated assessment of ASRAP thresholds of meaning. Results A total of 420 SSc subjects were enrolled. There was good correlation between ASRAP (and ASRAP-SF) with RP visual analogue scale (VAS) and Scleroderma Health Assessment Questionnaire RP VAS (rho range 0.648–0.727, P  < 0.001). Correlation with diary-based assessment of SSc-RP attack frequency and duration was lower (rho range 0.258–0.504, P  < 0.001). ASRAP questionnaires had good correlation with instruments for assessing disability, hand function, pain and global health assessment (rho range 0.427–0.575, P  < 0.001). Significantly higher ASRAP scores were identified in smokers, patients with active digital ulceration (DU), previous history of DU and calcinosis (P  < 0.05 for all comparisons). There was excellent repeatability at 1 week among patients with stable SSc-RP symptoms (intra-class coefficients of 0.891 and 0.848, P  < 0.001). Patient-acceptable symptom state thresholds for ASRAP and ASRAP-SF were 45.34 and 45.77, respectively. A preliminary Minimally Important Clinical Difference threshold of 4.17 (95% CI 0.53, 7.81, P  = 0.029) was estimated. Conclusion ASRAP and ASRAP-SF questionnaires are valid and reliable novel PRO instruments for assessing the severity and impact of SSc-RP. [ABSTRACT FROM AUTHOR]

Published
2024
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39. Best clinical practice in the treatment of juvenile systemic sclerosis: expert panel guidance - the result of the International Hamburg Consensus Meeting December 2022.

Author

Foeldvari, Ivan, Torok, Kathryn S., Antón, Jordi, Blakley, Michael, Constantin, Tamás, Cutolo, Maurizio, Denton, Christopher P., Fligelstone, Kim, Hinrichs, Bernd, Li, Suzanne C., Maillard, Susan, Marrani, Edoardo, Moinzadeh, Pia, Orteu, Catherine H., Pain, Clare E., Pauling, John D., Pilkington, Clarissa, Rosser, Franziska, Smith, Vanessa, and Furst, Daniel F.

Subjects
SYSTEMIC scleroderma, BEST practices, PEDIATRIC rheumatology, RARE diseases, DISEASE prevalence
Abstract

Juvenile systemic sclerosis (jSSc) is an orphan disease with a prevalence of 3 in 1,000,000 children. Currently there is only one consensus treatment guideline concerning skin, pulmonary and vascular involvement for jSSc, the jSSc SHARE (Single Hub and Access point for pediatric Rheumatology in Europe) initiative, which was based on data procured up to 2014. Therefore, an update of these guidelines, with a more recent literature and expert experience, and extension of the guidance to more aspects of the disease is needed. Treatment options were reviewed, and opinions were provided for most facets of jSSc including general management, some of which differs from adult systemic sclerosis, such as the use of corticosteroids, and specific organ involvement, such as skin, musculoskeletal, pulmonary, and gastroenterology. We are suggesting the treat to target strategy to treat early to prevent cumulative disease damage in jSSc. Conclusions are derived from both expert opinion and available literature, which is mostly based on adult systemic sclerosis (aSSc), given shared pathophysiology, extrapolation of results from aSSc studies was judged reasonable. [ABSTRACT FROM AUTHOR]

Published
2024
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41. Evaluating digital vascular perfusion and platelet dysfunction in Raynaud's phenomenon and systemic sclerosis

Author

Pauling, John D. and McHugh, Neil

Subjects
612.1
Abstract

Raynaud’s phenomenon (RP) describes excessive vasoconstriction of the digital microvasculature in response to cold exposure and emotional stress. RP is typically the earliest clinical manifestation of systemic sclerosis (SSc); a complex multisystem disease of unknown aetiology characterized by vasculopathy, inflammation and fibrosis. Vasculopathy is considered an essential pre-requisite to tissue remodeling, characterized by excessive collagen synthesis and tissue fibrosis, which occurs in the skin and other organs of patients with SSc. There is mounting evidence associating platelets with important biological functions beyond primary haemostasis. Upon activation, platelets release a large array of mediators implicated in vasoconstriction, inflammation and fibrosis, which has led me to consider the contribution of platelets to the pathogenesis of both RP and SSc. The principal aim of this thesis is to explore the impact of targeted anti-thrombotic therapy on digital microvascular function, platelet activation, oxidative stress and eicosanoid biosynthesis in RP and SSc. It is not possible to examine the impact of anti-platelet therapy on microvascular function, without first identifying sensitive methods for assessing digital microvascular function in humans. I shall report the findings of work examining established (infrared thermography) and novel (laser speckle contrast imaging) methods for the objective assessment of digital microvascular function in RP and SSc. I shall critically appraise the application of these methods alongside subjective patient self-report assessment of digital vascular function. I shall examine associations between digital vascular function, platelet activation, oxidative stress and eicosanoid biosynthesis between primary RP and SSc. I shall also report the findings of an investigator-led early phase clinical trial of targeted anti-thrombotic medication in RP and SSc. The major findings of this study were highlighting the strengths and limitations of established and novel methods for objective microvascular assessment in RP and SSc, and the poor agreement that exists between objective and subjective methods for assessing RP severity. I have identified similarities and differences in platelet activation and eicosanoid biosynthesis in primary RP and SSc. I shall present evidence of apparent efficacy of asasantin retard therapy on subjective, but not objective, assessments of digital microvascular function; the relevance of which shall be discussed in detail.

Published
2013

43. COVID-19 Vaccination-Related Delayed Adverse Events among Patients with Systemic Lupus Erythematosus.

Author

Dey, Mrinalini, Doskaliuk, Bohdana, Lindblom, Julius, Nikiphorou, Elena, Wincup, Chris, Fathima, Madiha, Saha, Sreoshy, Shaharir, Syahrul Sazliyana, Katchamart, Wanruchada, Goo, Phonpen Akarawatcharangura, Traboco, Lisa, Chen, Yi-Ming, Kadam, Esha, Lilleker, James B., Nune, Arvind, Pauling, John D., Agarwal, Vishwesh, Dey, Dzifa, Toro Gutierrez, Carlos Enrique, and Caballero, Carlo Vinicio

Subjects
SYSTEMIC lupus erythematosus, COVID-19, COVID-19 vaccines, LOGISTIC regression analysis, AUTOIMMUNE diseases, RHEUMATISM
Abstract

Background: The safety profile of COVID-19 vaccination is well documented, but hesitancy among people with immune-mediated inflammatory diseases, often immunocompromised, remains high, partially due to a scarcity of data on safety over a longer term. We herein aimed to assess delayed adverse events (DAEs) occurring >7 days after COVID-19 vaccination in systemic lupus erythematosus (SLE) versus other rheumatic autoimmune diseases (rAIDs), non-rheumatic AIDs (nrAIDs), and healthy controls (HCs). Methods: Self-reported data were captured within the COVID-19 Vaccination in Autoimmune Diseases (COVAD)-2 online survey, which comprised >150 centres and responses from 106 countries, between February and June 2022. Logistic regression analysis adjusting for important confounders (age, sex, ethnicity) was used to compare groups. Results: Of 7203 eligible individuals, 882 (12.2%) patients had SLE, 3161 (43.9%) patients had rAIDs, 426 (5.9%) patients had nrAIDs, and 2734 (38.0%) were HCs. SLE patients had a median age of 39 years (IQR: 31–50); 93.7% were women. SLE patients reported, more frequently, major DAEs (OR: 1.6; 95% CI: 1.2–2.0; p = 0.001) and hospitalisation (OR: 2.2; 95% CI: 1.4–3.4; p < 0.001) compared to HCs, severe rashes (OR: 2.4; 95% CI: 1.3–4.2; p = 0.004) compared to people with rAIDS, and hospitalisation (OR: 2.3; 95% CI: 1.1–4.9; p = 0.029) as well as several minor DAEs compared to people with nrAIDs. Differences were observed between vaccines in terms of frequency of major DAEs and hospitalisations, with the latter seen more frequently in patients receiving the Moderna vaccine. People with SLE with no autoimmune multimorbidity less frequently reported overall minor DAEs compared to SLE patients with comorbid nrAIDs (OR: 0.5; 95% CI: 0.3–1.0; p = 0.036). Conclusion: Hospitalisations post-vaccination were more frequent in SLE patients than in HCs. Monitoring of SLE patients following COVID-19 vaccination can help in identifying DAEs early, informing patients about expected DAEs, and supporting patients, especially those with autoimmune multimorbidity. [ABSTRACT FROM AUTHOR]

Published
2023
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44. Systemic sclerosis and COVID-19 vaccine safety: short-term insights from the global COVID-19 vaccination in autoimmune disease (COVAD) survey

Author

Naveen, R, Thakare, Darpan R, Kuwana, Masataka, Pauling, John D, Day, Jessica, Joshi, Mrudula, Parodis, Ioannis, Sen, Parikshit, Jagtap, Kshitij, Nikiphorou, Elena, Saha, Sreoshy, Agarwal, Vishwesh, Chatterjee, Tulika, Lilleker, James B, Kardes, Sinan, Milchert, Marcin, Gheita, Tamer, Salim, Babur, Velikova, Tsvetelina, Gracia-Ramos, Abraham Edgar, Tan, Ai Lyn, Nune, Arvind, Cavagna, Lorenzo, Saavedra, Miguel A, Shinjo, Samuel Katsuyuki, Ziade, Nelly, Knitza, Johannes, Distler, Oliver, Chinoy, Hector, COVAD Study Group, et al, and University of Zurich

Subjects
10051 Rheumatology Clinic and Institute of Physical Medicine, 610 Medicine & health
Published
2023

50. A Phase II randomised controlled trial of oral prednisolone in early diffuse cutaneous systemic sclerosis (PRedSS)

Author

Griffiths-Jones, Deborah J, Garcia, Yvonne Sylvestre, Ryder, W David, Pauling, John D, Hall, Frances, Lanyon, Peter, Bhat, Smita, Douglas, Karen, Gunawardena, Harsha, Akil, Mohammed, Anderson, Marina, Griffiths, Bridget, Del Galdo, Francesco, Youssef, Hazem, Madhok, Rajan, Arthurs, Barbara, Buch, Maya, Fligelstone, Kim, Zubair, Mohammed, Mason, Justin C, Denton, Christopher P, Herrick, Ariane L, Griffiths-Jones, Deborah J, Garcia, Yvonne Sylvestre, Ryder, W David, Pauling, John D, Hall, Frances, Lanyon, Peter, Bhat, Smita, Douglas, Karen, Gunawardena, Harsha, Akil, Mohammed, Anderson, Marina, Griffiths, Bridget, Del Galdo, Francesco, Youssef, Hazem, Madhok, Rajan, Arthurs, Barbara, Buch, Maya, Fligelstone, Kim, Zubair, Mohammed, Mason, Justin C, Denton, Christopher P, and Herrick, Ariane L

Abstract

Objectives Although the painful and disabling features of early diffuse cutaneous systemic sclerosis (dcSSc) have an inflammatory basis and could respond to corticosteroids, corticosteroids are a risk factor for scleroderma renal crisis. Whether or not they should be prescribed is therefore highly contentious. Our aim was to examine safety and efficacy of moderate dose prednisolone in early dcSSc. Methods PRedSS set out as a Phase II, multicentre, double-blind randomised controlled trial, converted to open-label during the Covid-19 pandemic. Patients were randomised to receive either prednisolone (∼0.3 mg/kg) or matching placebo (or no treatment during open-label) for 6 months. Co-primary endpoints were the Health Assessment Questionnaire Disability Index (HAQ-DI) and modified Rodnan skin core (mRSS) at 3 months. Over 20 secondary endpoints included patient reported outcome measures reflecting pain, itch, fatigue, anxiety and depression, and helplessness. Target recruitment was 72 patients. Results Thirty-five patients were randomised (17 prednisolone, 18 placebo/control). The adjusted mean difference between treatment groups at 3 months in HAQ-DI score was -0.10 (97.5% CI -0.29–0.10), p= 0.254, and in mRSS -3.90 (97.5% CI -8.83–1.03), p= 0.070, both favouring prednisolone but not significantly. Patients in the prednisolone group experienced significantly less pain (p= 0.027), anxiety (p= 0.018) and helplessness (p= 0.040) than control patients at 3 months. There were no renal crises, but sample size was small. Conclusion PRedSS was terminated early primarily due to the Covid-19 pandemic, and so was underpowered. Therefore, interpretation must be cautious and results considered inconclusive, indicating the need for a further randomised trial. Trial registration ClinicalTrials.gov, https://clinicaltrials.gov, NCT03708718

Published
2023

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