Background Biologic therapies have dawned a new era in the management of patients with chronic inflammatory arthritis by nudging the goal post from control to induction of remission. Adalimumab, a TNF-α inhibitor, has proven to be safe and effective in improving the disease activity and quality of life in patients with conditions like rheumatoid arthritis (RA) and ankylosing spondylitis (AS).1,2 A biosimilar adalimumab (developed by Cadila Healthcare Ltd., India) has been approved for clinical use in 2014 in India. While the initial biosimilarity has been established for physicochemical, functional as well as clinical efficacy and safety aspects;3,4 ongoing evaluation of safety in real-life patients is crucial for such biosimilar therapies.
Objectives We share our experience on the real-life safety profile of biosimilar adalimumab following its clinical use in patients with RA and AS.
Methods Patients with RA or AS treated with biosimilar adalimumab in our outpatient clinic at Arthritis and Rheumatism Centre during the period of 17 Dec 2014 to 30 Mar 2016 were considered for this analysis. The patients were prescribed biosimilar adalimumab 40 mg subcutaneously every fortnight for a minimum of 6 months. The patients were followed up till the end of the treatment, and any safety signals or adverse events reported were collected and analysed.
Results A total of 200 patients - 119 patients with AS and 81 patients with RA - who received biosimilar adalimumab therapy for a period of 6 months were included. The median age for the group was 36 (17–68 years); and 138 patients were males. The mean BMI was 25.74±3.83; and the median duration of disease for the entire group was 4.54 (0.5–13.5) years - 4.54 (0.5–9.58) years for the patients with AS, and 4.58 (2.5–13.5) years for the patients with RA. About 90% (181 out of 200 patients) received concomitant therapy with methotrexate. Biosimilar adalimumab therapy was well tolerated by all patients, with no serious adverse events. Adverse events were noted in only 2 patients - one patient had developed pulmonary tuberculosis in the 4th month of treatment, biosimilar adalimumab was discontinued and AKT treatment was started; while another patient experienced rise in transaminases for which, the dose of methotrexate was reduced. Overall assessment of tolerability as “Excellent” was 65.5% by the treating physician and 82% by patients.
Conclusions To the best of our knowledge, this is the first report on “real-life” use of biosimilar adalimumab in such a large number of patients. The analysis reveals a safety and tolerability profile of biosimilar adalimumab comparable to that of the innovator product.
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Disclosure of Interest None declared