AIM: To compare clinical efficacy of methotrexate monotherapy and methotrexate combination with prospidin in patients with psoriatic arthritis (PA). MATERIAL AND METHODS: Sixty three patients (42 females and 21 males) with documented PA, generalized articular syndrome of the second-third degree of activity were divided into two groups. Patients of group 1 (n = 30) received combined therapy (i.v. prospidin 200-300 mg/week + i.m. methotrexate 10 mg/week). Maintenance consisted of prospidin in a dose 100-200 mg/week i.m., methotrexate dose was the same. Patients of group 2 (n = 33) were given methotrexate monotherapy in a dose 10 mg/ week i.m. RESULTS: In the first three months of the study and in maintenance therapy, combined treatment was more effective. By ACR criteria, 50-70% response was achieved after 12 months of treatment in 44 and 27.3% patients of groups 1 and 2, respectively. The number of side effects and drug-related withdrawals was 23.3 and 36.4%, 10 and 15.1% in groups 1 and 2, respectively. CONCLUSION: Combination of methotrexate with prospidin produced an earlier and more potent positive clinical effect than methotrexate alone in PA patients.
RCT Entities:
AIM: To compare clinical efficacy of methotrexate monotherapy and methotrexate combination with prospidin in patients with psoriatic arthritis (PA). MATERIAL AND METHODS: Sixty three patients (42 females and 21 males) with documented PA, generalized articular syndrome of the second-third degree of activity were divided into two groups. Patients of group 1 (n = 30) received combined therapy (i.v. prospidin 200-300 mg/week + i.m. methotrexate 10 mg/week). Maintenance consisted of prospidin in a dose 100-200 mg/week i.m., methotrexate dose was the same. Patients of group 2 (n = 33) were given methotrexate monotherapy in a dose 10 mg/ week i.m. RESULTS: In the first three months of the study and in maintenance therapy, combined treatment was more effective. By ACR criteria, 50-70% response was achieved after 12 months of treatment in 44 and 27.3% patients of groups 1 and 2, respectively. The number of side effects and drug-related withdrawals was 23.3 and 36.4%, 10 and 15.1% in groups 1 and 2, respectively. CONCLUSION: Combination of methotrexate with prospidin produced an earlier and more potent positive clinical effect than methotrexate alone in PA patients.