Improvements in Patient-Reported Outcomes Through Six Months of Guselkumab Treatment in Patients With Active Psoriatic Arthritis: Real-World Data From the CorEvitas Psoriatic Arthritis/Spondyloarthritis Registry

被引:2
作者
Mease, Philip J. [1 ,2 ]
Ogdie, Alexis [3 ]
Tesser, John [4 ]
Shiff, Natalie J. [5 ,6 ]
Zhao, Ruizhi Sophia [5 ]
Chakravarty, Soumya D. [5 ,7 ]
Kelleman, Michael [8 ]
Dodge, Rhiannon [8 ]
McLean, Robert R. [8 ]
Broadwell, Aaron [9 ]
Kavanaugh, Arthur [10 ]
Merola, Joseph F. [11 ,12 ]
机构
[1] Providence Swedish Med Ctr Seattle, Rheumatol Res, Seattle, WA 98122 USA
[2] Univ Washington, Sch Med, Seattle, WA 98195 USA
[3] Univ Penn, Philadelphia, PA USA
[4] Arizona Arthrit & Rheumatol Associates PC, Phoenix, AZ USA
[5] Janssen Sci Affairs LLC, Horsham, PA USA
[6] Univ Saskatchewan, Saskatoon, SK, Canada
[7] Janssen Sci Affairs LLC, Philadelphia, PA USA
[8] CorEvitas LLC, Waltham, MA USA
[9] Rheumatol & Osteoporosis Specialists, Shreveport, LA USA
[10] Univ Calif San Diego, La Jolla, CA USA
[11] UT Southwestern Med Ctr, Dept Dermatol, Dept Med, Dallas, TX USA
[12] Brigham & Womens Hosp, Harvard Med Sch, Div Rheumatol & Immunol, Boston, MA USA
关键词
AMERICAN-COLLEGE; BIOLOGIC-NAIVE; DOUBLE-BLIND; QUESTIONNAIRE; IMPACT;
D O I
10.1002/acr2.11657
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Objective. Evaluate patient-reported outcomes after 6 months of on-label guselkumab use in patients with rheumatologist-diagnosed active psoriatic arthritis (PsA) enrolled in the CorEvitas PsA/Spondyloarthritis Registry. Methods. This analysis includes registry participants who initiated and persisted with on-label guselkumab (after US Food and Drug Administration approval for PsA; 100 mg at weeks 0, 4, and every 8 weeks) at their 6-month follow-up visit (On-Label Persisters). Among patients not meeting response criteria at baseline, responses at 6 months were determined for patient-reported outcomes, including patient-reported pain (0-100 mm visual analog scale), patient global assessment of arthritis + psoriasis (PtGA; 0-100 visual analog scale), and Health Assessment Questionnaire-Disability Index (HAQ-DI; 0-3). Unadjusted, nominal P values were calculated via single-proportion, one-sided test (H-0 = 0%; alpha = 0.05). Results. Of 90 On-Label Persisters, most had treatment-resistant PsA (92.2% and 73.3% previously received >= 1 and >= 2 biologic/targeted synthetic disease-modifying antirheumatic drugs, respectively), with mean (SD) baseline patient-reported pain, PtGA, and HAQ-DI scores of 57.0 (24.6), 50.3 (24.4), and 0.9 (0.6), respectively. Among those with patient-reported pain and PtGA scores of at least 15 at baseline, 40.2% (33/82) and 46.8% (36/77), respectively, achieved at least 15-mm reductions at 6 months; among those with HAQ-DI scores of at least 0.35 and more than 0.5 at baseline, respectively, 30.4% (21/69) achieved improvements of at least 0.35 and 10.3% (6/58) achieved scores of 0.5 or lower at 6 months (all nominal P < 0.001). Conclusion. Pain and physical function are important contributors to health-related quality of life. In this real-world population of patients with treatment-resistant PsA and 6 months of persistent guselkumab treatment, clinically meaningful improvements in pain and physical function were achieved by approximately 40% and 30% of patients, respectively.
引用
收藏
页码:304 / 311
页数:8
相关论文
共 32 条
[1]  
[Anonymous], 2020, TREMFYA GUSELKUMAB I
[2]   Efficacy and safety of guselkumab in patients with active psoriatic arthritis who are inadequate responders to tumour necrosis factor inhibitors: results through one year of a phase IIIb, randomised, controlled study (COSMOS) [J].
Coates, Laura C. ;
Gossec, Laure ;
Theander, Elke ;
Bergmans, Paul ;
Neuhold, Marlies ;
Karyekar, Chetan S. ;
Shawi, May ;
Noel, Wim ;
Schett, Georg ;
McInnes, Iain B. .
ANNALS OF THE RHEUMATIC DISEASES, 2022, 81 (03) :359-369
[3]  
CorEvitas®, US
[4]   The Effect of Guselkumab on General Health State in Biologic-Naive Patients with Active Psoriatic Arthritis Through Week 52 of the Phase 3, Randomized, Placebo-Controlled DISCOVER-2 Trial [J].
Curtis, Jeffrey R. ;
McInnes, Iain B. ;
Rahman, Proton ;
Gladman, Dafna D. ;
Yang, Feifei ;
Peterson, Steven ;
Agarwal, Prasheen ;
Kollmeier, Alexa P. ;
Hsia, Elizabeth C. ;
Han, Chenglong ;
Shiff, Natalie J. ;
Shawi, May ;
Tillett, William ;
Mease, Philip J. .
ADVANCES IN THERAPY, 2022, 39 (10) :4632-4644
[5]   Guselkumab in patients with active psoriatic arthritis who were biologic-naive or had previously received TNFα inhibitor treatment (DISCOVER-1): a double-blind, randomised, placebo-controlled phase 3 trial [J].
Deodhar, Atul ;
Helliwell, Philip S. ;
Boehncke, Wolf-Henning ;
Kollmeier, Alexa P. ;
Hsia, Elizabeth C. ;
Subramanian, Ramanand A. ;
Xu, Xie L. ;
Sheng, Shihong ;
Agarwal, Prasheen ;
Zhou, Bei ;
Zhuang, Yanli ;
Ritchlin, Christopher T. .
LANCET, 2020, 395 (10230) :1115-1125
[6]   American College of Rheumatology/European League Against Rheumatism Provisional Definition of Remission in Rheumatoid Arthritis for Clinical Trials [J].
Felson, David T. ;
Smolen, Josef S. ;
Wells, George ;
Zhang, Bin ;
van Tuyl, Lilian H. D. ;
Funovits, Julia ;
Aletaha, Daniel ;
Allaart, Cornelia F. ;
Bathon, Joan ;
Bombardieri, Stefano ;
Brooks, Peter ;
Brown, Andrew ;
Matucci-Cerinic, Marco ;
Choi, Hyon ;
Combe, Bernard ;
de Wit, Maarten ;
Dougados, Maxime ;
Emery, Paul ;
Furst, Daniel ;
Gomez-Reino, Juan ;
Hawker, Gillian ;
Keystone, Edward ;
Khanna, Dinesh ;
Kirwan, John ;
Kvien, Tore K. ;
Landewe, Robert ;
Listing, Joachim ;
Michaud, Kaleb ;
Martin-Mola, Emilio ;
Montie, Pamela ;
Pincus, Theodore ;
Richards, Pamela ;
Siegel, Jeffrey N. ;
Simon, Lee S. ;
Sokka, Tuulikki ;
Strand, Vibeke ;
Tugwell, Peter ;
Tyndall, Alan ;
van der Heijde, Desiree ;
Verstappen, Suzan ;
White, Barbara ;
Wolfe, Frederick ;
Zink, Angela ;
Boers, Maarten .
ARTHRITIS AND RHEUMATISM, 2011, 63 (03) :573-586
[7]  
Fitzgerald T., 2023, AM AC DERM ANN M MAR
[8]   MEASUREMENT OF PATIENT OUTCOME IN ARTHRITIS [J].
FRIES, JF ;
SPITZ, P ;
KRAINES, RG ;
HOLMAN, HR .
ARTHRITIS AND RHEUMATISM, 1980, 23 (02) :137-145
[9]  
GARRETT S, 1994, J RHEUMATOL, V21, P2286
[10]  
Gladman DD, 2009, DERMATOL THER, V22, P40, DOI [10.1056/nejmc1704342, 10.1111/j.1529-8019.2008.01215.x]