Comparison of the efficacy and safety of biosimilar adalimumab injection with innovator adalimumab in subjects with active ankylosing spondylitis

Abstract

Abstract Objectives To compare the efficacy and safety of biosimilar adalimumab injection manufactured by Enzene Biosciences Ltd. with innovator adalimumab (iADA, HUMIRA®) in subjects with active ankylosing spondylitis (AS). Methods The prospective, multicenter, randomized, double-blind, phase III study involved 192 subjects with active AS recruited at 20 centers across India. The subjects who fulfilled the eligibility criteria were randomized in a ratio of 2:1 (i.e.,125 subjects in biosimilar adalimumab arm and 67 subjects in the iADA arm). The selected subjects received both the investigational products at a dose of 40 mg subcutaneously (pre-filled syringe contained 40 mg adalimumab in 0.4 ml as the active ingredient) every other week for a total of 12 weeks. Efficacy assessment was done based on ASAS response criteria. Safety assessment was based on complete physical examination, adverse event (AE) monitoring, vital signs, ECG, anti-adalimumab antibody (ADA) assessment, and laboratory tests. Results At 12 weeks, the ASAS 20/40/70 responses were achieved by 97.5%, 94.1%, and 68.9% patients who received biosimilar injection as compared to 98.4%, 96.7%, and 77% patients in iADA arm. Safety assessment showed that 19 (15.2%) subjects reported 33 AEs in the biosimilar adalimumab arm and 8 (11.9%) subjects reported 11 AEs in iADA arm. ADA for positive and negative subjects was statistically non-significant (P 0.3516) between the two arms. Conclusion The ASAS 20/40/70 response rates at week 12 were equivalent between patients treated with biosimilar adalimumab injection manufactured by Enzene Biosciences Ltd and those treated with iADA. Both the drugs had comparable safety and tolerability profiles. Trial registry name: The Clinical Trials Registry- India (CTRI), URL: http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=42640&EncHid=&userName=enzene Trial registration no: no. CTRI/2020/09/028070