Eduardo Mysler1, Mario H Cardiel2, Ricardo M Xavier3, Alejandra López4, Allan Ramos-Esquivel5. 1. From the Organización Medica de Investigación, Buenos Aires, Argentina. 2. Centro de Investigación Clínica de Morelia, SC, Morelia, Michoacán, México. 3. Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil. 4. Roche Servicios S.A. 5. Department of Pharmacology, School of Medicine, University of Costa Rica, San José, Costa Rica.
Abstract
OBJECTIVE: To assess the efficacy and safety of subcutaneous tocilizumab (TCZ) in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) in Latin American patients with rheumatoid arthritis (RA) and inadequate response to previous csDMARDs. METHODS:ML28700 was a multicenter, open-label, single-arm trial. Previously treated RA patients who had not received treatment with TCZ or any biological agent (n = 284) and with a baseline Disease Activity Score in 28 joints based on erythrocyte sedimentation rate (DAS28-ESR) of 3.2 or greater were assigned to receive subcutaneous TCZ (162 mg/wk) in association with csDMARD for 24 weeks. Patients who achieved remission (DAS28-ESR <2.6) at week 24 continued withTCZ as monotherapy until week 52; otherwise, they continued with their assigned treatment. The primary efficacy end point was remission rate (DAS28-ESR <2.6) at weeks 24 and 52. Secondary objectives included disease activity scores, safety, and quality of life. RESULTS: At week 24, a total of 169 patients (59.5%; 95% confidence interval, 53.5%-65.3%) achieved remission, 91 patients (32.0%) had low disease activity, and 46 patients (8.4%) were not responders. Sustained remission at week 52 was achieved by 80.8% (n = 126) of patients who continued with TCZ monotherapy versus 44.6% (n = 37) of those on combination therapy. A total of 241 patients (84.9%; 95% confidence interval, 80.2%-88.8%) had at least 1 adverse event during follow-up. Adverse events led to drug modification in 32 patients (11.3%) or discontinuation in 21 patients (7.4%). CONCLUSIONS:Subcutaneous TCZ is an efficacious therapy with long-lasting results and tolerable adverse events in Latin American patients with RA.Trial registration no.: NCT02011334 Tozura Study Program.
RCT Entities:
OBJECTIVE: To assess the efficacy and safety of subcutaneous tocilizumab (TCZ) in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) in Latin American patients with rheumatoid arthritis (RA) and inadequate response to previous csDMARDs. METHODS: ML28700 was a multicenter, open-label, single-arm trial. Previously treated RApatients who had not received treatment with TCZ or any biological agent (n = 284) and with a baseline Disease Activity Score in 28 joints based on erythrocyte sedimentation rate (DAS28-ESR) of 3.2 or greater were assigned to receive subcutaneous TCZ (162 mg/wk) in association with csDMARD for 24 weeks. Patients who achieved remission (DAS28-ESR <2.6) at week 24 continued with TCZ as monotherapy until week 52; otherwise, they continued with their assigned treatment. The primary efficacy end point was remission rate (DAS28-ESR <2.6) at weeks 24 and 52. Secondary objectives included disease activity scores, safety, and quality of life. RESULTS: At week 24, a total of 169 patients (59.5%; 95% confidence interval, 53.5%-65.3%) achieved remission, 91 patients (32.0%) had low disease activity, and 46 patients (8.4%) were not responders. Sustained remission at week 52 was achieved by 80.8% (n = 126) of patients who continued with TCZ monotherapy versus 44.6% (n = 37) of those on combination therapy. A total of 241 patients (84.9%; 95% confidence interval, 80.2%-88.8%) had at least 1 adverse event during follow-up. Adverse events led to drug modification in 32 patients (11.3%) or discontinuation in 21 patients (7.4%). CONCLUSIONS: Subcutaneous TCZ is an efficacious therapy with long-lasting results and tolerable adverse events in Latin American patients with RA.Trial registration no.: NCT02011334 Tozura Study Program.
Authors: György Nagy; Pál Géher; László Tamási; Edit Drescher; Péter Keszthelyi; Judit Pulai; László Czirják; Zoltán Szekanecz; Gergely Kiss; László Kovács Journal: Rheumatol Adv Pract Date: 2022-05-16