Objective: To determine the effectiveness and the incidence of severe adverse events in a cohort of Costa Rican patients with Rheumatoid Arthritis (RA) treated with intravenous (IV) tocilizumab (TCZ). Patients and methods: A retrospective analysis was carried out in 45 patients that were unresponsive to disease-modifying antirheumatic drugs (DMARDs). The study included patients who received IV TCZ every 4 weeks (4 mg/kg) along with methotrexate or leflunomide. Effectiveness was measured through the incidence of clinical remission according to a disease activity score - erythrocyte sedimentation rate (DAS28-ESR) less than 2.6. Safety was assessed by the incidence rate of serious adverse events. An univariate and multivariate logistic regression analysis was performed to assess the association of potential variables with the probability of achieving remission during the first 3 months of TCZ therapy. Results: During the 3rd month of TCZ therapy, a total of 22 patients (48.9%; 95% Confidence Interval (CI) 34.3-63.5%) achieved remission. The cumulative incidence of patients with remission at month 12 was 75.0% (n = 34) (95% CI: 62.3-87.6%). A total of 18 patients (40%; 95% CI: 25.7-54.3%) were switched to a 8 mg/kg dose due to the absence of remission. The incidence rate of serious adverse events was .98 per 100 patients/year, all of them due to infectious diseases with no fatal events reported. Only basal DAS28-ESR was associated with the probability of achieving remission at month 3. Conclusions: IV TCZ (4 mg/kg) is an effective and safe treatment for RA patients in a clinical setting in Costa Rica. (C) 2019 Elsevier Espana, S.L.U. and Sociedad Espanola de Reumatologia y Colegio Mexicano de Reumatologia. All rights reserved.
机构:
Hokkaido Univ, Grad Sch Med, Div Rheumatol Endocrinol & Nephrol, Sapporo, Hokkaido, JapanHokkaido Univ, Grad Sch Med, Div Rheumatol Endocrinol & Nephrol, Sapporo, Hokkaido, Japan
Atsumi, Tatsuya
Fujio, Keishi
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Univ Tokyo, Grad Sch Med, Dept Allergy & Rheumatol, Tokyo, JapanHokkaido Univ, Grad Sch Med, Div Rheumatol Endocrinol & Nephrol, Sapporo, Hokkaido, Japan
Fujio, Keishi
Yamaoka, Kunihiro
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Keio Univ, Dept Internal Med, Sch Med, Div Rheumatol, Tokyo, JapanHokkaido Univ, Grad Sch Med, Div Rheumatol Endocrinol & Nephrol, Sapporo, Hokkaido, Japan
Yamaoka, Kunihiro
Tomobe, Minako
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Chugai Pharmaceut Co Ltd, Tokyo, JapanHokkaido Univ, Grad Sch Med, Div Rheumatol Endocrinol & Nephrol, Sapporo, Hokkaido, Japan
Tomobe, Minako
Kuroyanagi, Kazuyuki
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Chugai Pharmaceut Co Ltd, Tokyo, JapanHokkaido Univ, Grad Sch Med, Div Rheumatol Endocrinol & Nephrol, Sapporo, Hokkaido, Japan
机构:
Univ Calif San Diego, Ctr Innovat Therapy, Div Rheumatol, La Jolla, CA 92093 USAUniv Calif San Diego, Ctr Innovat Therapy, Div Rheumatol, La Jolla, CA 92093 USA
Mircic, Maja
Kavanaugh, Arthur
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Univ Calif San Diego, Ctr Innovat Therapy, Div Rheumatol, La Jolla, CA 92093 USAUniv Calif San Diego, Ctr Innovat Therapy, Div Rheumatol, La Jolla, CA 92093 USA