Real-Life Tolerability and Effectiveness of Adalimumab Biosimilar in Rheumatoid Arthritis: ASPIRE Registry Data

• DOI: 10.1007/s40744-019-0166-2
• Publication Date: 2019-06-28T14:02:43Z
• Authors: Sanjiv Kapoor; Viswanath V. Kaushik; Rahul Jain; Vijay Rao; Mihir Gharia
• Keywords: Tolerability; Biosimilar

The TNF-α blocker adalimumab is a well-proven therapy for rheumatoid arthritis (RA). A biosimilar (ZRC-3197; Exemptia™), 'fingerprint match' to reference adalimumab, has been approved prescription in India since 2014. Here, we report on the effectiveness and tolerability of this (bADA) from Adalimumab Biosimilar Patient Registry [ASPIRE; ISRCTN16838474], which contains data real-life RA patients India. ASPIRE post-marketing, observational registry that evaluates real-world experience across multiple centres Patients with moderate severe who were prescribed bADA 40 mg subcutaneously every fortnight enrolled. complete available until 24 weeks treatment extracted analyzed standard disease activity measures reported adverse events. included 149 had median age 41 (22–67) years; 65% female. Disease outcome measures, i.e. ESR, DAS-ESR VAS-pain scores, showed gradual significant decreases (p < 0.0001 all) 73 analyzable received therapy. ACR20, ACR50 ACR70 responses achieved 48%, 48% 34% after therapy, respectively, about 58% 15% good EULAR responders, respectively. Physician patient ratings overall global assessment efficacy 'good' 'excellent' majority (≥ 96%). No new safety signals observed when analyzing data. Real-life post-marketing analysis demonstrate clinical Indian RA. This also reflects upon strategies patterns such therapies practice. ISRCTN16838474. Cadila Healthcare Limited,