Ahmed, S. K. Shahriar

Atopic dermatitis (AD) is a chronic inflammatory skin disease characterized by pruritus and eczematous lesions. Abrocitinib, a selective Janus kinase 1 (JAK1) inhibitor, has recently been approved in India for moderate-to-severe AD in adults. This prospective real-world case series evaluated the effectiveness and safety of abrocitinib in patients with moderate-to-severe AD who showed an inadequate response to cyclosporine. Nine patients (five females, four males; mean age 19.44 ± 7.68 years, range 10–34 years) were included. Three were adolescents or children in whom abrocitinib was used off-label. The mean disease duration was 13.33 ± 8.06 years, and eight patients had a positive family history of AD. Prior treatments included cyclosporine, methotrexate, and systemic corticosteroids. Abrocitinib was prescribed at a mean dose of 177.77 ± 44.09 mg daily (seven patients received 200 mg, two received 100 mg). Effectiveness was assessed at baseline and weeks 2, 4, 8, and 12 using the Eczema Area and Severity Index (EASI), Investigator’s Global Assessment (IGA), and Peak Pruritus Numerical Rating Scale (PP-NRS). Significant and progressive reductions were observed in all scores. Mean EASI decreased from 48.22 ± 7.88 at baseline to 6.33 ± 3.35 at week 12 ( P < 0.0001). IGA scores improved from 4 to 1.22 ± 0.44, while PP-NRS declined from 8.44 ± 0.52 to 2 ± 0.86 by week 12, with significance evident early in treatment. Most patients demonstrated good adherence, and dose adjustments were required in some cases. One patient developed mild thrombocytopenia. Abrocitinib demonstrated rapid, significant clinical improvement and was generally well-tolerated, supporting its role as an effective option for moderate-to-severe AD, particularly in patients with inadequate response to cyclosporine.

Omalizumab, an anti-IgE monoclonal antibody, is a standard treatment for chronic spontaneous urticaria (CSU). In India, an ‘intended-copy biosimilar’ (ICB) was introduced in 2020, based on structural similarity, without clinical trials. This case series compares the efficacy and safety of ICBs with the original biologic. A retrospective review of nine patients with CSU (mean age 37.1 years) who switched from omalizumab to an ICB due to the unavailability of omalizumab. Disease control was assessed using the Urticaria Activity Score and the Urticaria Control Test. Findings highlight the need for rigorous biosimilar testing and standardized nomenclature to distinguish biosimilar types.