Comparative evaluation of efficacy and safety of methotrexate either alone or in combination with hydroxychloroquine in patients suffering from rheumatoid arthritis

Background: Rheumatoid arthritis (RA) a chronic autoimmune inflammatory disease and Methotrexate being widely used as monotherapy and in combination for the treatment of RA. Combination therapy provides additional or even more potentiating effects, therefore have been widely used. This study is aimed at comparing the efficacy and safety of Methotrexate either alone or in combination.Methods: This study was conducted for one year from 1st January to 31st December 2015. 52 patients diagnosed with RA were included in this study and were divided in two groups, Group-1 (n=29) patients received methotrexate (MTX) 7.5-15mg/week and Group-2 (n=23) patients received methotrexate 7.5mg once a week + Hydroxychloroquine (HCQ) 200mg twice daily. The patients were followed up for a period of 16 weeks. Statistical analysis was done by using graph pad insta and p value of <0.05 was considered significant.Results: A total of 52 patients were included in the study. The mean age of patients was 50.53±14.81 years. 43 (82.69%) patients were females and 9 (17.30%) were males. 23 (44.23%) patients had positive family history of the disease. The Rheumatoid factor was positive in 42 (80.70%) and anti-CCP was raised in 50 (96.15%) patients. The RAPID-3 and DAS-28 scores on intragroup comparison was highly significant (p <0.0001) and the intergroup comparison was significant (p <0.01) between baseline and 16 weeks in both the groups. The improvement in inflammatory marker CRP was highly significant on intragroup (p <0.0001) and intergroup (p<0.001) comparison between baseline and 16 weeks in both the groups. The mean changes in Vitamin-D3 between baseline and at 16 weeks were insignificant (p >0.05) in both the groups. Total of Adverse drug reactions reported were 42 (50.60%) in group-1 and 41 (49.40%) in group-2.Conclusions: The combination therapy was found to be more efficacious than MTX monotherapy in improving symptoms and quality of life. The adverse drug reactions were mild, more in combination therapy and none of the patients required withdrawal of treatment