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

Area of Science:

• Rheumatology
• Immunology
• Pharmacology

Background:

• Adalimumab, a TNF-α blocker, is an established therapy for rheumatoid arthritis (RA).
• A biosimilar adalimumab (bADA), a 'fingerprint match' to reference adalimumab, has been available in India since 2014.
• The Adalimumab Biosimilar Patient Registry (ASPIRE) collects real-world data on bADA in Indian RA patients.

Purpose of the Study:

• To evaluate the real-world effectiveness and tolerability of biosimilar adalimumab (bADA) in Indian patients with rheumatoid arthritis (RA).
• To analyze clinical outcomes and safety data from a post-marketing observational registry (ASPIRE).
• To understand treatment strategies and prescription patterns for bADA in Indian clinical practice.

Main Methods:

• ASPIRE is a multi-center, post-marketing, observational registry study in India.
• Patients with moderate to severe RA prescribed bADA 40 mg subcutaneously every fortnight were enrolled.
• Data from 73 patients with complete 24-week treatment records were analyzed for disease activity and adverse events.

Main Results:

• Significant decreases in ESR, DAS-ESR, and VAS-pain scores were observed after 24 weeks of bADA therapy (p < 0.0001).
• ACR20, ACR50, and ACR70 responses were achieved by 48%, 48%, and 34% of patients, respectively.
• Physician and patient global assessments of efficacy and tolerability were rated 'good' to 'excellent' by ≥96% of patients, with no new safety signals.

Conclusions:

• Real-world data from the ASPIRE registry demonstrate the clinical effectiveness and tolerability of 24-week bADA therapy in Indian RA patients.
• The findings support the use of bADA as a viable treatment option for RA in the Indian population.
• This analysis provides insights into current treatment strategies and prescription patterns for biosimilar therapies in India.