Real-life Efficacy and Safety of Biosimilar Adalimumab (ZRC-3197) in Patients with Plaque Psoriasis: A Tertiary Care Center Experience.

BACKGROUND

Adalimumab is proven to be safe and effective in treating plaque psoriasis. A biosimilar adalimumab (ZRC-3197; Exemptia™) - approved by Indian Regulators in 2014 - is a 'fingerprint match' of the reference adalimumab in terms of purity, potency, safety, and clinical efficacy. While reference adalimumab remains unavailable, this biosimilar adalimumab (bADA) serves as an accessible, cost-effective option for Indian patients. This is a first-hand, prospective, real-life data on the clinical use of bADA in Indian patients with plaque psoriasis.

MATERIALS AND METHODS

Patients with moderate-to-severe plaque psoriasis were prospectively treated with bADA therapy for 16 weeks-80 mg subcutaneously initially, followed by 40 mg every other week from week 1 in real-life setting. Psoriasis Area and Severity Index (PASI) responses, Dermatology Life Quality Index (DLQI) outcomes, and Physician's Global Assessment (PGA) for psoriasis were analyzed. Safety and tolerability evaluations included reported adverse events.

RESULTS

A total of 29 patients (15 males) with median age of 38 (25-56) years were included. After 16 weeks of bADA treatment, 93% patients achieved ≥75% reduction in their baseline PASI scores including PASI75, PASI90, and PASI100 responses in 24%, 14%, and 55% patients, respectively. About 52% patients had a DLQI score of 0/1 and 93% patients had a PGA score of 'clear or minimal' at 16 weeks. Treatment was well tolerated with no severe or serious adverse reactions requiring therapy discontinuation.

CONCLUSIONS

This report serves as a real-life evidence for the efficacy and tolerability of biosimilar adalimumab administered for 16 weeks in patients with plaque psoriasis.