An Observational Study on the Use of Etanercept in Indian Rheumatoid Arthritis Patients

Gautam Mullick; Darshan S. Bhakuni; Krishnan Shanumganandan; K. Narayanan; Vivek Vasdev; Sivasami Kartik; Amar T. Atal

Volume : VI, Issue : IX, September - 2016

An Observational Study on the Use of Etanercept in Indian Rheumatoid Arthritis Patients

Gautam Mullick, Darshan S. Bhakuni, Krishnan Shanumganandan, K. Narayanan, Vivek Vasdev, Sivasami Kartik, Amar T. Atal

Abstract :

Objective: To determine the effectiveness and safety of Etanercept (ETN) in Indian patients of rheumatoid arthritis (RA) who are inadequately controlled with combination therapy of two or more disease modifying anti–rheumatic drugs (DMARDs) and oral low dose glucocorticoids (GC). Method: This is a 52–weeks observational study of 35 RA patients with inadequate response to combination DMARDs, who were shifted to subcutaneous ETN 50 mg weekly along with MTX. The clinical response of therapy was measured through the American College of Rheumatology criteria (ACR) for ACR20 & ACR50 improvement and Disease Activity Score (DAS–28). The other response assessment criteria were Health Assessment Questionnaire Disability Index (HAQDI), visual analogue scale (VAS) and erythrocytic sedimentation rate (ESR). Safety of ETN treatment was assessed by recording any adverse event that occurred during the 52 weeks of study duration. Results: ETN in combination with MTX resulted in achievement of ACR20 response in 68.5% and ACR50 response in 45.7% patients at 24 weeks. At 52 weeks, 51% of the patients attained both the DAS–28 remission (DAS–28 score less than 2.6) as well as ACR50 response. Significant outcomes (p<0.001) of VAS score, HAQ–DI and ESR values were achieved after 24 weeks. Five patients (14.2%) had no improvement in disease activity and were withdrawn from the treatment. Two patients were discontinued due to development of injection site reaction after 4 weeks of initiation of ETN. One patient reported transient cough during the course of study which spontaneously resolved in a week without any treatment and one patient developed herpes zoster during ETN treatment. Conclusion: RA patients, who were inadequate responders to two or more combination DMARDs including MTX and oral GC therapy, responded well when switched to ETN with continued MTX therapy. Significant clinical improvement was seen as early as 4th week of treatment and there was further improvement at 12 and 24 weeks of treatment. Beneficial response to ETN was sustained during the 1–year duration of study. This study supports the therapeutic benefits of switching over to ETN therapy while continuing MTX in RA patients who were partial responders to combination DMARD therapy