AB0396 Safety of Tofacitinib for The Treatment of Rheumatoid Arthritis in Patients from Latin America and The Rest of The World

Background Tofacitinib is an oral JAK inhibitor for the treatment of rheumatoid arthritis (RA). Objectives To assess the safety of tofacitinib in patients from Latin America (LA) and the rest of the world (ROW). Methods Data were pooled from patients who received tofacitinib 5 or 10 mg twice daily ± conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) from two Phase 1, nine Phase 2, six Phase 3 and two long-term extension (LTE) studies (one LTE was ongoing at time of analysis, data as of March 2015). Incidence rates (IR; patients with events/100 patient-years) and 95% confidence intervals (CI) for safety events of special interest pooled for both tofacitinib doses were calculated and compared between LA and ROW patient populations. LA countries that enrolled patients were: Argentina, Brazil, Chile, Colombia, Costa Rica, the Dominican Republic, Mexico, Peru and Venezuela. Results The analysis included 1037 LA patients (91.2% female; mean age 49.5 years; 7.5 years mean RA duration; 67.1 kg mean weight; 6.5 mean baseline Disease Activity Score for 28-joint counts based on erythrocyte sedimentation rate [DAS28-4(ESR)]; 71.3% baseline concomitant steroid use) and 5157 ROW patients (81.0% female; mean age 53.7 years; 8.1 years mean RA duration; 71.9 kg mean weight; 6.3 mean baseline DAS28-4 [ESR]; 63.8% baseline concomitant steroid use). IRs for safety events of special interest were generally similar for LA and ROW populations with overlapping 95% CIs (Table). Conclusions In this analysis of pooled data from tofacitinib RA trials, the safety profile of tofacitinib in the LA and ROW populations was similar. Acknowledgement This analysis was sponsored by Pfizer Inc. Medical writing support under the guidance of the authors was provided by Dan Binks, PhD, of Complete Medical Communications and funded by Pfizer Inc. Disclosure of Interest O. Castaneda Grant/research support from: AbbVie, Bristol-Myers Squibb, GlaxoSmithKline, IQfarma, Janssen, MSD, Novartis, Perinan, Pfizer Inc, Roche, Roemmers, UCB, Consultant for: AbbVie, Bristol-Myers Squibb, GlaxoSmithKline, IQfarma, Janssen, MSD, Novartis, Perinan, Pfizer Inc, Roche, Roemmers, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, GlaxoSmithKline, IQfarma, Janssen, MSD, Novartis, Perinan, Pfizer Inc, Roche, Roemmers, UCB, J. Jaller Consultant for: Amgen, Bristol-Myers Squibb, GlaxoSmithKline, Janssen, MSD, Novartis, Pfizer Inc, Roche, UCB, Speakers bureau: Amgen, Bristol-Myers Squibb, GlaxoSmithKline, Janssen, MSD, Novartis, Pfizer Inc, Roche, UCB, G. Citera Grant/research support from: AbbVie, Bristol Myers Squibb, Pfizer Inc, Consultant for: AbbVie, Bristol Myers Squibb, Pfizer Inc, Speakers bureau: AbbVie, Bristol Myers Squibb, Pfizer Inc, S. Radominski Grant/research support from: Pfizer Inc, Consultant for: Pfizer Inc, Speakers bureau: Pfizer Inc, M. Cardiel Grant/research support from: Pfizer Inc, Roche, Amgen, Bristol-Myers Squibb, Astellas, Janssen, Eli Lilly, Anthera, Consultant for: Pfizer Inc, Roche, AbbVie, Merck, Eli Lilly, Bristol-Myers Squibb, Speakers bureau: Pfizer Inc, Bristol-Myers Squibb, Roche, C. A. Zerbini Grant/research support from: Pfizer Inc, Consultant for: Pfizer Inc, Speakers bureau: Pfizer Inc, R. Guzman Consultant for: MSD, Pfizer Inc, Roche, Novartis, UCB, Speakers bureau: Pfizer Inc, UCB, G. Solano Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, M. Belini Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, A. Maniccia Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, K. Kwok Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, R. Rojo Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, D. Ponce de Leon Shareholder of: Pfizer Inc, Employee of: Pfizer Inc