Clinical use of ZRC3197 (Adalimumab Biosimilar) in Patients with Inflammatory Arthritis: A Real-life Experience.

We present our real-life clinical experience of ZRC3197 (Adalimumab Biosimilar) in Indian patients with inflammatory arthritis [spondyloarthropathy (SPA) and rheumatoid arthritis (RA)]. Medical records of these patients were retrospectively retrieved and analysed at our single centre. All the patients had received biosimilar Adalimumab 40 mg every 15 days for initial 3 months. Post 3 months, an 'on-demand modified dosing approach' was followed, wherein BASDAI/DAS28-guided dose reduction or discontinuation of treatment was done. Dose reduction was primarily done by increasing the dosing interval for biosimilar Adalimumab. The 3, 6 and 12 months' follow-up data revealed a significant reduction in disease activity scores (BASDAI/DAS28). At 3 months, BASDAI50% was achieved in 91% and BASDAI 70% was achieved in 45% of SPA patients. At 3 months, 88% showed a reduction in DAS28 > 1.2 from baseline. At 12 months, 94% of the evaluable SPA patients and 58% of evaluable RA patients showed clinical remission or low disease activity. BASDAI/DAS28 score-guided dose reduction led to significantly lesser requirement of biosimilar Adalimumab doses. Biosimilar Adalimumab was well-tolerated with no serious or unexpected side effects. Our analysis suggests that disease activity-guided modified dosing may serve as an effective strategy for patients with inflammatory arthritis, leading to a lower dose requirement for the treatment. Despite the modified dosing, the clinical response following biosimilar Adalimumab was comparable to the published data for the standard Adalimumab treatment in such patients.