This prospective observational study was carried out in the Department of Pharmacology in a tertiary care institute over a period of one year after approval from the Institutional Ethics Committee (All India Institute of Medical Sciences (AIIMS), Rishikesh) (approval number AIIMS/IEC/18/160). Our study followed the principles of the Declaration of Helsinki. Subjects were recruited from patients presenting to the Rheumatology Outpatient Department (OPD) with a primary diagnosis of RA after obtaining written informed consent. Inclusion criteria were all new and previously diagnosed patients with rheumatoid arthritis based on the American College of Rheumatology (ACR) 2010 diagnostic criteria of either sex. Patients excluded from this study included those affected with arthritis due to reasons other than RA, such as vasculitis, polymyalgia rheumatica, spondyloarthropathies (reactive arthritis, ankylosing spondylitis, and psoriatic arthritis), bacterial arthritis, and fibromyalgia.
On the basis of DMARD therapy being received by the patients, they were divided into different groups: Regimen 1, monotherapy with one DMARD (methotrexate (MTX)); Regimen 2, double DMARD therapy or two DMARD therapy (methotrexate + hydroxychloroquine (MTX + HCQ)); Regimen 3, triple DMARD therapy or three DMARD therapy (methotrexate + hydroxychloroquine + leflunomide (MTX + HCQ + Lef)); and Regimen 4, >3 DMARD therapy (MTX + HCQ + Lef + bDMARD adalimumab). Patients were assessed at baseline and after the follow-up visit as per the clinician’s discretion (varying from 7 to 12 weeks). Treatment response was recorded at the baseline and follow-up visit based on the Disease Activity Score (DAS28) criteria, which comprises a number of tender joints, swollen joints, erythrocyte sedimentation rate (ESR), and “patient global health” score [10 (link)].
The medication cost of DMARD therapy was analyzed by calculating the cost of therapy per month for each patient by taking the prices from the Bureau of Pharma Public Sector Undertakings of India (BPPI), Department of Pharmaceuticals, Government of India, for all the DMARDs, except the biological drug for which the price from Cadila Healthcare Ltd. (Zydus Cadila, Ahmedabad, India) was taken. Cost-effectiveness was calculated by dividing the cost of therapy by the change in DAS in a month. Adherence was assessed using the Morisky-Green-Levine Scale (MGLS) [11 (link)]. Patients were interviewed and asked to answer four questions listed in the questionnaire on their second visit. High adherence was denoted by a score of 0, medium adherence was denoted by a score of 1 or 2, and low adherence was denoted by a score of 3 or 4. The p value was taken to be 0.05. For the cost-effective analysis, the mean was applied to the DAS28 values and the cost of treatment. Statistical analysis was performed using the Statistical Package for the Social Sciences (SPSS) software (IBM SPSS Statistics, Armonk, NY, USA).
On the basis of DMARD therapy being received by the patients, they were divided into different groups: Regimen 1, monotherapy with one DMARD (methotrexate (MTX)); Regimen 2, double DMARD therapy or two DMARD therapy (methotrexate + hydroxychloroquine (MTX + HCQ)); Regimen 3, triple DMARD therapy or three DMARD therapy (methotrexate + hydroxychloroquine + leflunomide (MTX + HCQ + Lef)); and Regimen 4, >3 DMARD therapy (MTX + HCQ + Lef + bDMARD adalimumab). Patients were assessed at baseline and after the follow-up visit as per the clinician’s discretion (varying from 7 to 12 weeks). Treatment response was recorded at the baseline and follow-up visit based on the Disease Activity Score (DAS28) criteria, which comprises a number of tender joints, swollen joints, erythrocyte sedimentation rate (ESR), and “patient global health” score [10 (link)].
The medication cost of DMARD therapy was analyzed by calculating the cost of therapy per month for each patient by taking the prices from the Bureau of Pharma Public Sector Undertakings of India (BPPI), Department of Pharmaceuticals, Government of India, for all the DMARDs, except the biological drug for which the price from Cadila Healthcare Ltd. (Zydus Cadila, Ahmedabad, India) was taken. Cost-effectiveness was calculated by dividing the cost of therapy by the change in DAS in a month. Adherence was assessed using the Morisky-Green-Levine Scale (MGLS) [11 (link)]. Patients were interviewed and asked to answer four questions listed in the questionnaire on their second visit. High adherence was denoted by a score of 0, medium adherence was denoted by a score of 1 or 2, and low adherence was denoted by a score of 3 or 4. The p value was taken to be 0.05. For the cost-effective analysis, the mean was applied to the DAS28 values and the cost of treatment. Statistical analysis was performed using the Statistical Package for the Social Sciences (SPSS) software (IBM SPSS Statistics, Armonk, NY, USA).
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