Background Biologic disease modifying anti-rheumatic drugs (DMARD) have revolutionized the management of several rheumatic disorders. A decade of experience in the west has gained insights in to the safety and efficacy of these cytokine inhibitors in inflammatory rheumatological disorders. However, the access to biologics has been restricted by the cost, in the developing world.
Bio-similars (1) have been developed in the Far East including India and the efficacy and safety have been comparable to their reference products, with affordable cost, with huge benefit to the patients.
Objectives To review the use of synthetic DMARDs- Biosimilars in two centres of Rheumatology in south India and assess the efficacy/safety profile among the patients.
Methods All Biologic users for a period of one year in the Rheumatology centre in Velammal Medical College Hospital, Madurai and Aruna Hospitals, Tirunelveli were reviewed (Oct 14-Oct 15). All patients should satisfy ACR criteria for diagnosis and would have failed classic DMARDs. They were all screened for TB, Hepatitis as per UK-NICE guidelines. All had 3 months review and are under regular follow up.
Results Data from 15 patients were collected in this retrospective review. (Indications below)
All 7 patients with RA were Bio-naive, received the biosynthetic DMARDS and achieved remission in 3 months. Pre treatment average DAS score was 5.65 and 3 months following treatment, the average DAS 28 score was 2.01, which shows significant improvement. The girl with SLE has responded dramatically following Mabtas therapy. In the Spondyloarthropathy group, all but one had spinal disease only. Pre treatment average BASDAI was 6.64 and 3 months following biosimilars BASDAI was 2.6. To date no infective complications were reported. All are maintained on oral DMARDS either Methotrexate or Leflunomide without steroids.
Conclusions Biosimilars have been developed in the developing world with affordable cost. They are increasingly being used in different complex inflammatory rheumatologic diseases. It has gained reasonable acceptance. The rheumatologist should be aware of safety and use in a diligent manner.
Thomas Dorner and Jonathan Kay. Biosimilars in rheumatology: current perspectives and lessons learnt. Nature Reviews Rheumatology 2015. Pages 713–724.
Acknowledgement Special thanks to all the patients and The Velammal hospital rheumatology and medicine team.
Disclosure of Interest None declared