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OBJECTIVE: Adalimumab is a well-established anti-tumor necrosis factor therapy for patients with ankylosing spondylitis (AS). An indigenously developed biosimilar adalimumab (bADA) (ZRC-3197; Exemptia) is approved for prescribing in India. In this article, we present the effectiveness and tolerability of this bADA in real-life Indian patients with AS from the Adalimumab Biosimilar Patient Registry (ASPIRE) (ISRCTN: 16838474). METHODS: ASPIRE is a postmarketing observational registry for evaluating the real-world experiences of patients with autoimmune inflammatory disorders across multiple centers in India who were prescribed 40 mg of Exemptia subcutaneously every fortnight. For this report, data available until 24 weeks of bADA treatment for patients with AS who were included in the registry were evaluated. RESULTS: Data from 308 patients with AS from the registry (median age of 35.0 [range 17-68] years, 19% women) were analyzed. In analyzable patients with complete data, there was a gradual and significant decrease (P < 0.001) in the primary disease outcome scores (the mean Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] score [n = 107] improved from 6.2 ± 1.54 to 2.1 ± 0.64, and the median visual analogue scale [VAS] score [n = 101] improved from 8 to 2) after 24 weeks of bADA therapy. BASDAI score was lower than 4 in about 94% of patients after 24 weeks of therapy, and 95% of patients achieved BASDAI50 response. The overall global assessment for efficacy and tolerability was 'good' to 'excellent' for a majority of the patients (≥98%), as rated by physicians as well as patients. The therapy was tolerated well, and there were no new unexpected adverse reactions with the biosimilar's use during this study. CONCLUSION: This report demonstrates the tolerability and effectiveness of bADA (Exemptia) after its clinical use for 24 weeks in real-world patients with AS from Indian clinical practice.
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INTRODUCTION: The TNF-α blocker adalimumab is a well-proven therapy for rheumatoid arthritis (RA). A biosimilar adalimumab (ZRC-3197; Exemptia™), a 'fingerprint match' to reference adalimumab, has been approved for prescription in India since 2014. Here, we report on the effectiveness and tolerability of this biosimilar adalimumab (bADA) from the Adalimumab Biosimilar Patient Registry [ASPIRE; ISRCTN16838474], which contains data from real-life RA patients from India. METHODS: ASPIRE is a post-marketing, observational registry that evaluates real-world experience across multiple centres in India. Patients with moderate to severe RA who were prescribed bADA 40 mg subcutaneously every fortnight were enrolled. Patients with complete data available until 24 weeks of bADA treatment were extracted and analyzed for standard disease activity measures and reported adverse events. RESULTS: The registry included 149 patients with RA who had a median age of 41 (22-67) years; 65% of the patients were female. Disease outcome measures, i.e. ESR, DAS-ESR and VAS-pain scores, showed gradual and significant decreases (p < 0.0001 for all) in 73 analyzable patients who received 24 weeks of bADA therapy. ACR20, ACR50 and ACR70 responses were achieved in 48%, 48% and 34% of patients after 24 weeks of therapy, respectively, and about 58% and 15% of patients were moderate and good EULAR responders, respectively. Physician and patient ratings for the overall global assessment of efficacy and tolerability were 'good' to 'excellent' for the majority of the patients (≥ 96%). No new safety signals were observed when analyzing this registry data. CONCLUSION: Real-life data from this post-marketing observational analysis demonstrate the clinical effectiveness and tolerability of 24 weeks of adalimumab biosimilar therapy in Indian patients with RA. This report also reflects upon the treatment strategies and prescription patterns for such therapies in Indian clinical practice. TRIAL REGISTRATION: ISRCTN16838474. FUNDING: Cadila Healthcare Limited, India.
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The current literature states the prevalence of methotrexate pneumonitis (MTX-P) to be 3.5-7.6%. This is based on retrospective data. Consequently, clinicians remain cautious in using methotrexate especially in patients with pre-existing lung disease. To get a true idea of the incidence of MTX-P we designed an ongoing prospective study, which is the largest to date. We recruited all patients starting low-dose methotrexate in our department, and followed them up for 2 years or until development of MTX-P. All patients had their pulmonary spirometry checked at baseline. Patients were excluded if they did not give consent for methotrexate therapy, or had a forced expiratory volume in 1 s (fev1) or full vital capacity (FVC) of less than 1 l. So far, 223 patients have been recruited of whom 223 have completed 6 months and 185 have finished 2 years of follow-up from commencing methotrexate. Only two patients developed MTX-P. This gave an incidence of one case every 192 patient years of MTX-P. The results of this ongoing prospective study suggest that MTX-P when diagnosed using Carson's criteria and Chest HRCT scanning, does not occur as often as previously thought. Also it would appear from our data that baseline spirometry rather than full pulmonary function tests can be used routinely as an immediate screening of lung function prior to commencement of methotrexate. Interestingly the patients who developed MTX-P did not have any specific abnormalities at baseline.
