Satyendra Kumar Singh1, Tulika Rai. 1. Department of Dermatology and Venereology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India.
Abstract
UNLABELLED: Background : Systemic therapy with methotrexate is a very useful modality in psoriasis, but relapses can occur soon after stopping it. Aim : To compare the relapse rates in psoriasis with two different tapering regimens of methotrexate after control is achieved. Methods : This was a randomized open-label controlled study, and patients of chronic plaque psoriasis with psoriasis area and severity index (PASI) >10 were included.Methotrexate 0.3 mg/kg weekly was given and the PASI calculated every 2 weeks. After achieving a 75% reduction in the PASI (PASI-75), patients were assigned randomly in to one of three groups. In the half-dose group, the dose of methotrexate was reduced to half and given weekly; in the 2-weekly group, the same dose was given at 2-week intervals; in the control group,methotrexate was stopped. Patients were followed up for 12 weeks. Results : Out of 141 registered patients, 81 were included: 27 in the half-dose group, 28 in the 2-weekly group, and 26 in the control group. After further exclusions due to adverse effects and loss to follow-up, the results were analysed for 16, 17 and 19 patients respectively in the 3 groups. There was statistically a highly significant difference in relapse rates between the half-dose and control groups (P < 0.001), and a significant difference between the 2-weekly and control groups (P = 0.001).Relapse rates in the half-dose and 2-weekly groups did not show a significant difference (P = 0.680). LIMITATION: Many (35.8%)patients were excluded and only 52 (64.2%) completed the study. CONCLUSION: There appears to be no significant difference in the frequency of relapse in psoriasis whether methotrexate is tapered by halving the weekly dose or by doubling the interval between two doses, and both methods led to fewer relapses than abrupt cessation of the drug.
RCT Entities:
UNLABELLED: Background : Systemic therapy with methotrexate is a very useful modality in psoriasis, but relapses can occur soon after stopping it. Aim : To compare the relapse rates in psoriasis with two different tapering regimens of methotrexate after control is achieved. Methods : This was a randomized open-label controlled study, and patients of chronic plaque psoriasis with psoriasis area and severity index (PASI) >10 were included. Methotrexate 0.3 mg/kg weekly was given and the PASI calculated every 2 weeks. After achieving a 75% reduction in the PASI (PASI-75), patients were assigned randomly in to one of three groups. In the half-dose group, the dose of methotrexate was reduced to half and given weekly; in the 2-weekly group, the same dose was given at 2-week intervals; in the control group, methotrexate was stopped. Patients were followed up for 12 weeks. Results : Out of 141 registered patients, 81 were included: 27 in the half-dose group, 28 in the 2-weekly group, and 26 in the control group. After further exclusions due to adverse effects and loss to follow-up, the results were analysed for 16, 17 and 19 patients respectively in the 3 groups. There was statistically a highly significant difference in relapse rates between the half-dose and control groups (P < 0.001), and a significant difference between the 2-weekly and control groups (P = 0.001). Relapse rates in the half-dose and 2-weekly groups did not show a significant difference (P = 0.680). LIMITATION: Many (35.8%) patients were excluded and only 52 (64.2%) completed the study. CONCLUSION: There appears to be no significant difference in the frequency of relapse in psoriasis whether methotrexate is tapered by halving the weekly dose or by doubling the interval between two doses, and both methods led to fewer relapses than abrupt cessation of the drug.