Real-world treatment patterns for repository corticotropin injection in patients with rheumatoid arthritis

被引:1
作者
Busch, Howard [1 ]
Wan, George J. [2 ]
Niewoehner, John [2 ]
Houston, Parul [3 ]
Su, Yujie [4 ]
Clinton, Cassie [4 ]
Panaccio, Mary P. [2 ]
机构
[1] Amer Arthrit & Rheumatol Associates LLC, Loxahatchee, FL USA
[2] Mallinckrodt Pharmaceut, Hampton, NJ USA
[3] SSI Strategy, Parsippany, NJ USA
[4] Univ Alabama Birmingham, Birmingham, AL USA
关键词
Acthar Gel; disease-modifying antirheumatic drugs; DMARDs; glucocorticoids; real-world evidence; repository corticotropin injection; rheumatoid arthritis; DISEASE-ACTIVITY INDEX; SYSTEMIC-LUPUS-ERYTHEMATOSUS; RAPID3 ROUTINE ASSESSMENT; FORMAL JOINT COUNTS; ACTIVITY SCORE; SEVERITY CATEGORIES; CDAI; DIFFERENCE; RECEPTORS; THERAPIES;
D O I
10.7573/dic.2021-10-4
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Introduction: Repository corticotropin injection (RCI, Acthar (R) Gel) is a naturally sourced mixture of adrenocorticotropic hormone analogues and other pituitary peptides with anti-inflammatory and immunomodulatory effects. In a recent clinical trial, RCI was safe and effective for the treatment of refractory rheumatoid arthritis (RA). This study aims to describe real-world use and outcomes of patients with RA who were prescribed RCI in clinical practice through retrospective analysis of an electronic medical record database. Methods: Patients with RA who were prescribed RCI were identified through the ColumbusTM TM electronic medical record repository, representing approximately 100 rheumatology practices. Demographics, medications, comorbidities, disease histories, laboratory evaluations, clinical outcomes and patient-reported outcomes were evaluated from 12 months pre-RCI to 12 months post-RCI initiation. Results: The RCI cohort (n=63) n =63) comprised predominantly white women, aged 54 years on average, at 6 years from RA diagnosis, with high disease activity at baseline according to Clinical Disease Activity Index (CDAI) and Routine Assessment of Patient Index Data 3 (RAPID3) scores. Within the 12 months pre-RCI initiation, 87% of patients were prescribed disease-modifying antirheumatic drugs and 67% were prescribed glucocorticoids. Twelve months postRCI initiation, glucocorticoid, opioid and non-steroidal antiinflammatory drug prescriptions decreased; disease-modifying antirheumatic drug prescriptions remained stable. Reductions in CDAI, RAPID3, physician global assessment, tender joint count, swollen joint count, and pain visual analogue scale scores were observed 12 months post-RCI initiation. Few discontinuations were due to side effects. Study limitations included small sample size and incomplete electronic medical record data. Conclusion: These findings support the safety and effectiveness of RCI for short-term adjunctive treatment of refractory RA and provide patient-management insights from routine clinical practice.
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页数:12
相关论文
共 48 条
[1]   Curbing Inflammation through Endogenous Pathways: Focus on Melanocortin Peptides [J].
Ahmed, Tazeen J. ;
Montero-Melendez, Trinidad ;
Perretti, Mauro ;
Pitzalis, Costantino .
INTERNATIONAL JOURNAL OF INFLAMMATION, 2013, 2013
[2]  
Aletaha D, 2005, CLIN EXP RHEUMATOL, V23, pS100
[3]   2019 American College of Rheumatology Recommended Patient-Reported Functional Status Assessment Measures in Rheumatoid Arthritis [J].
Barber, Claire E. H. ;
Zell, JoAnn ;
Yazdany, Jinoos ;
Davis, Aileen M. ;
Cappelli, Laura ;
Ehrlich-Jones, Linda ;
Everix, Donna ;
Thorne, J. Carter ;
Bohm, Victoria ;
Suter, Lisa ;
Limanni, Alex ;
Michaud, Kaleb .
ARTHRITIS CARE & RESEARCH, 2019, 71 (12) :1531-1539
[4]   Cut-off points for mild, moderate, and severe pain on the visual analogue scale for pain in patients with chronic musculoskeletal pain [J].
Boonstra, Anne M. ;
Preuper, Henrica R. Schiphorst ;
Balk, Gerlof A. ;
Stewart, Roy E. .
PAIN, 2014, 155 (12) :2545-2550
[5]   The Melanocortin System in Control of Inflammation [J].
Catania, Anna ;
Lonati, Caterina ;
Sordi, Andrea ;
Carlin, Andrea ;
Leonardi, Patrizia ;
Gatti, Stefano .
THESCIENTIFICWORLDJOURNAL, 2010, 10 :1840-1853
[6]   Repository corticotropin injection in patients with advanced symptomatic sarcoidosis: retrospective analysis of medical records [J].
Chopra, Ishveen ;
Qin, Yimin ;
Kranyak, John ;
Gallagher, Jack R. ;
Heap, Kylee ;
Carroll, Susan ;
Wan, George J. .
THERAPEUTIC ADVANCES IN RESPIRATORY DISEASE, 2019, 13
[7]   Melanocortin receptors and their accessory proteins [J].
Cooray, Sadani N. ;
Clark, Adrian J. L. .
MOLECULAR AND CELLULAR ENDOCRINOLOGY, 2011, 331 (02) :215-221
[8]   Real-World Evidence and Real-World Data for Evaluating Drug Safety and Effectiveness [J].
Corrigan-Curay, Jacqueline ;
Sacks, Leonard ;
Woodcock, Janet .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2018, 320 (09) :867-868
[9]   Use of NSAIDs in treating patients with arthritis [J].
Crofford, Leslie J. .
ARTHRITIS RESEARCH & THERAPY, 2013, 15
[10]   Determining the Minimally Important Difference in the Clinical Disease Activity Index for Improvement and Worsening in Early Rheumatoid Arthritis Patients [J].
Curtis, J. R. ;
Yang, S. ;
Chen, L. ;
Pope, J. E. ;
Keystone, E. C. ;
Haraoui, B. ;
Boire, G. ;
Thorne, J. C. ;
Tin, D. ;
Hitchon, C. A. ;
Bingham, C. O. ;
Bykerk, V. P. .
ARTHRITIS CARE & RESEARCH, 2015, 67 (10) :1345-1353