Tofacitinib, an oral Janus kinase inhibitor, in patients from Mexico with rheumatoid arthritis: Pooled efficacy and safety analyses from Phase 3 and LTE studies
| Autor: | Ruben Burgos-Vargas, Karina Santana, Haiyun Fan, Virginia Pascual-Ramos, Mario H. Cardiel, Erika G. García, Ehab Mahgoub, Carlos Abud-Mendoza, Ricardo Rojo, Daniel Xibille, Mahboob Rahman, César Pacheco-Tena |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
Adult
Male medicine.medical_specialty Administration Oral Phases of clinical research Placebo Drug Administration Schedule Arthritis Rheumatoid 03 medical and health sciences 0302 clinical medicine Piperidines Rheumatology Internal medicine Adalimumab medicine Humans Janus Kinase Inhibitors Pyrroles Longitudinal Studies 030212 general & internal medicine Adverse effect Mexico Aged Randomized Controlled Trials as Topic Janus kinase inhibitor Aged 80 and over 030203 arthritis & rheumatology Tofacitinib business.industry General Medicine Middle Aged medicine.disease Pyrimidines Treatment Outcome Clinical Trials Phase III as Topic Antirheumatic Agents Rheumatoid arthritis Physical therapy Drug Therapy Combination Female business medicine.drug |
| Zdroj: | Reumatología Clínica (English Edition). 15:43-53 |
| ISSN: | 2173-5743 |
| Popis: | Objectives Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We characterized efficacy and safety of tofacitinib in Mexican patients from RA Phase 3 and long-term extension (LTE) studies. Methods Data from Mexican patients with RA and an inadequate response to disease-modifying antirheumatic drugs (DMARDs) were taken from four Phase 3 studies (pooled across studies) and one open-label LTE study of tofacitinib. Patients received tofacitinib 5 or 10 mg twice daily, adalimumab (one Phase 3 study) or placebo (four Phase 3 studies) as monotherapy or in combination with conventional synthetic DMARDs. Efficacy up to Month 12 (Phase 3) and Month 36 (LTE) was assessed by American College of Rheumatology 20/50/70 response rates, Disease Activity Score (erythrocyte sedimentation rate), and Health Assessment Questionnaire-Disability Index. Safety, including incidence rates (IRs; patients with events/100 patient-years) for adverse events (AEs) of special interest, was assessed throughout the studies. Results 119 and 212 Mexican patients were included in the Phase 3 and LTE analyses, respectively. Tofacitinib-treated patients in Phase 3 had numerically greater improvements in efficacy responses versus placebo at Month 3. Efficacy was sustained in Phase 3 and LTE studies. IRs for AEs of special interest were similar to those with tofacitinib in the global and Latin American RA populations. Conclusions In Mexican patients from the tofacitinib global RA program, tofacitinib efficacy was demonstrated up to Month 12 in Phase 3 studies and Month 36 in the LTE study, with a safety profile consistent with tofacitinib global population. |
| Databáze: | OpenAIRE |
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