AB0641 MANAGING ANKYLOSING SPONDYLITIS (AS) WITH SHORT TERM BIOSIMILAR ADALIMUMAB REGIMEN IN A RESOURCE STRAPPED SETTING: A PROTOCOL DRIVEN COMMUNITY CLINIC ORIENTED STUDY
Authors: A. Chopra, N. Khadke, M. Saluja, T. Kianifard, A. Venugopalan
Journal: Annals of the Rheumatic Diseases (2020)

Background: We were handicapped by the exorbitant cost of innovator anti-Tumour Necrosis Factor (TNF) drugs. Despite limited use, we sometimes observed long-term benefits following short term induction like use. Emboldened by advent of biosimilars, we carried out an investigational study. Objectives: To evaluate the effectiveness of a short regimen of biosimilar (Bs) Adalimumab in AS Methods: 50 consenting patients (86% B27+) naïve for biologics and negative for latent TB screen were enrolled into an observational design study of one year; Baseline mean values for age, duration, ASDAS and CRP was 31 years, 98.8 months, 4.6 and 64 mg per dl respectively. During the first year, patients were begun with 40 mg Bs Adalimumab (Bs-ADL) (Exemptia™), injected fortnight, for 12-16 weeks. No patient received DMARD or steroid in the first year of study. Patients continued standard of care follow up program in the clinic. The ASAS (Assessment Spondyloarthritis International Society) improvement indices were used. Standard intention-to-treat analysis was performed; significant p &lt;0.05. Results: Optimum ASAS 40 improvement was observed at week 12 (68%); substantial improvement lasted till week 36. At one year, the ASAS 40 was 38%; ASAS partial remission 22% patients. Pro-inflammatory cytokines (IL-6, TNF α and IL-17) showed conspicuous reduction; maximum drop in IL-6 at week 24 (See Figure). 11 patients withdrew in the first year. 30 patients completed two years and 22 patients completed 3 year follow up. Over time, there was substantial loss in the ASAS 20 and 40 responses but patients seemed satisfied with the on-going symptomatic relief and improved function. Admittedly, patients showed more adherences to advice on physical exercise and stress reduction. Flares were more frequent after 1 year requiring short term round the clock NSAID; only 5 patients could afford to repeat a short term Bs-ADL regimen and one patient underwent hip arthroplasty. None received steroids and 5 patients were begun on Sulfasalazine in the second year and monitored. We could not evaluate structural modification (AS). Selected outcomes over 2 and 3 years from the current study will be compared to matched control (derived from the clinic database). None developed TB or any serious drug related toxicity. 2 patients developed recurrent uveitis. Conclusion: This real life documented experience unravelled impressive long term benefits following a kick start short term induction regimen of Biosimilar Adalimumab in AS. Though contrary to standard practice, this seemed a practical solution in our setting. We speculate a psychological and motivational boost rather than a prolonged real time biological effect (Bs-ADL) for this phenomenon. Our study has important socioeconomic bearing and merits validation. Acknowledgement: This was essentially a non-commercial investigator-initiated study. Zydus Cedilla India provided a generous research grant with free of cost Bs_ADL to several patients and a large concession in the cost to the rest. Disclosure of Interests: Arvind Chopra Grant/research support from: Zydus Pharamceutical Ltd India, Nagnath Khadke: None declared, Manjit Saluja: None declared, Toktam Kianifard: None declared, Anuradha Venugopalan: None declared