Results from a prospective, multicentre study have answered the unmet medical need for a cost‑effective biosimilar alternative for managing active Rheumatoid Arthritis (RA) by evaluating the clinical comparability between biosimilar adalimumab and innovator product among Indian patients with active Rheumatoid arthritis.

In the management of rheumatoid arthritis (RA), the efficacy of adalimumab has been well established. It improves disease activity, quality of life, and prevents structural deterioration and disability. Combination of methotrexate (MTX) and adalimumab also has been extensively evaluated and the combination improves the symptoms compared in patients with RA who had a partial response to MTX.

Biosimilar adalimumab products are developed, which are similar to licensed reference product. Biosimilar adalimumab has similar safety, purity, and potency and no clinically significant differences exist compared with the reference product.

However, a prospective, multicentre, randomised, double‑blind, two‑arm, parallel group, active‑control, comparative clinical study was conducted to validate the clinical efficacy and safety of the biosimilar adalimumab with the reference (innovator) adalimumab in patients with moderate‑to‑severe RA who were on stable dose of MTX.

The study included 104 patients, who were randomised to biosimilar adalimumab (study arm) or reference innovator adalimumab (reference arm), 40 mg every 2 weeks.

Key findings of the study were:

• At week 16 an ACR20 response was achieved by 90.48% subjects in the study arm compared with 90% in the reference arm.
• ACR70 response at week 16 was observed in 13.1% and 15% subjects in the study arm and the reference arm, respectively.
• Statistically, no significant difference was observed in the number of responders at week 16 among two treatment arms (P > 0.05).
• Similarly, DAS28, HAQ‑DI scores, RF, and CRP changes from baseline were comparable in both groups. In the study arm 38.1% patients and 50% patients in the reference arm suffered from at least one adverse event in the study. But no clinically significant differences were seen in adverse events. In the study arm, the mean RF titres change was −255.74 and −270.51 in the reference arm at week 16.

Conclusion

The study validates that biosimilar adalimumab and the reference product have comparable efficacy and safety in RA patients who were on stable dose of MTX. Moreover, the study also answers the medical need to offer a cost-effective biosimilar alternative for managing patients with active RA.

Source: Apsangikar P, et al. A Prospective, Randomized, Double‑blind, Comparative Clinical Study of Efficacy and Safety of a Biosimilar Adalimumab with Innovator Product in Patients with Active Rheumatoid Arthritis on a Stable Dose of Methotrexate. Indian J Rheumatol. 2018;13:84-9.