Abstract | 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.
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Authors | Ajay Chopra, Debdeep Mitra, Reetu Agarwal, Neerja Saraswat, Pooja Chemburkar, Loknandini Sharma |
Journal | Indian dermatology online journal
(Indian Dermatol Online J)
2020 Mar-Apr
Vol. 11
Issue 2
Pg. 182-186
ISSN: 2229-5178 [Print] India |
PMID | 32477976
(Publication Type: Journal Article)
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Copyright | Copyright: © 2020 Indian Dermatology Online Journal. |