Characteristics and 6-Month Outcomes in Patients with Rheumatoid Arthritis Initiating Infliximab Biosimilar IFX-dyyb in a Real-World Setting

被引：2

作者：

Baker, Joshua F. ^{[1
]}

Bakewell, Catherine ^{[2
]}

Dikranian, Ara ^{[3
]}

Lam, Gordon ^{[4
,5
]}

O'Brien, Jacqueline ^{[6
]}

Moore, Page C. ^{[6
]}

Yu, Miao ^{[6
]}

Hur, Peter ^{[7
]}

Masri, Karim R. ^{[8
]}

机构：

[1] Hosp Univ Penn, Philadelphia, PA USA

[2] Intermt Healthcare, Salt Lake City, UT USA

[3] Cabrillo Ctr Rheumat Dis, San Diego, CA USA

[4] Arthrit & Osteoporosis Consultants Carolinas, Charlotte, NC USA

[5] Atrium Hlth Wake Forest Baptist, Charlotte, NC USA

[6] CorEvitas LLC, Waltham, MA USA

[7] Pfizer Inc, New York, NY USA

[8] Pfizer Inc, Collegeville, PA 19426 USA

来源：

RHEUMATOLOGY AND THERAPY | 2024年 / 11卷 / 03期

关键词：

Biologic; Biosimilar; CorEvitas Registry; IFX-dyyb; DMARD; Effectiveness; Infliximab; Real-world evidence; Rheumatoid arthritis; TNF alpha inhibition; DOUBLE-BLIND; CT-P13; CORRONA; SAFETY;

D O I：

10.1007/s40744-024-00653-6

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Introduction Real-world studies describing biosimilar initiation or switching in patients with rheumatoid arthritis (RA) are limited. The aim of this study was to assess treatment patterns and effectiveness of real-world patients with RA initiating infliximab biosimilar IFX-dyyb (CT-P13; Inflectra (R)) in the USA. Methods This observational study evaluated patients with RA from the CorEvitas RA Registry who initiated IFX-dyyb and had Clinical Disease Activity Index (CDAI) recorded at baseline and 6 months. The primary outcome was reaching low disease activity (LDA; CDAI <= 10) at 6 months in patients with moderate or high disease activity (CDAI > 10) at baseline. Secondary outcomes were change at 6 months in CDAI and certain patient-reported outcomes (PROs). Patient data were stratified by prior treatment: biologic/targeted synthetic disease-modifying antirheumatic drug (tsDMARD)-na & iuml;ve, reference infliximab (IFX-REF) or IFX biosimilar, or a non-IFX biologic or tsDMARD. Results Of 318 patients initiating IFX-dyyb, 176 had baseline and 6-month CDAI scores; 73 (41%) switched from IFX, 61 (35%) switched from another non-IFX/biologic/tsDMARD, 32 (18%) were na & iuml;ve to biologics/tsDMARDs, and 10 (6%) switched from an IFX biosimilar. Among patients with moderate or high disease activity at baseline, 32.9% (95% CI 22.9, 42.9) achieved LDA at 6 months. Mean 6-month change from baseline in CDAI was - 1.8 (95% CI - 3.3, - 0.3) overall; - 4.7 (- 7.6, - 1.7) in patients who switched from a non-IFX biologic/tsDMARD, - 4.1 (- 7.8, - 0.3) in biologic/tsDMARD-na & iuml;ve patients, and 1.1 (- 0.4, 2.6) in patients who switched from IFX-REF/IFX biosimilar. Other clinical outcomes/PROs improved at 6 months. Of the IFX-dyyb initiators, 68% remained on IFX-dyyb at 6 months. Conclusion In this real-world population of patients with RA initiating IFX-dyyb, the majority switched from IFX-REF or a non-IFX biologic/tsDMARD. CDAI remained stable in patients switching from IFX-REF/IFX biosimilar and improved in patients switching from a non-IFX biologic/tsDMARD and in biologic/tsDMARD-na & iuml;ve patients.

引用

页码：841 / 853

页数：13

共 28 条

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