Efficacy and safety of tofacitinib in US and non-US rheumatoid arthritis patients: pooled analyses of phase II and III.

Autor:	Cohen SB; Metroplex Clinical Research Center, Dallas, TX, USA., Koenig A; Pfizer Inc., Collegeville, PA, USA., Wang L; Pfizer Inc., Groton, CT, USA., Kwok K; Pfizer Inc., New York, NY, USA., Mebus CA; Pfizer Inc., Groton, CT, USA., Riese R; Pfizer Inc., Groton, CT, USA., Fleischmann R; Metroplex Clinical Research Center, Dallas, TX, USA. rfleischmann@arthdocs.com.
Jazyk:	angličtina
Zdroj:	Clinical and experimental rheumatology [Clin Exp Rheumatol] 2016 Jan-Feb; Vol. 34 (1), pp. 32-6. Date of Electronic Publication: 2015 Nov 17.
Abstrakt:	Objectives: Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis. This post-hoc pooled analysis assessed commonalities and differences in tofacitinib efficacy and safety for US versus rest of the world (ROW) populations. Methods: Pooled phase (P) III data from patients receiving tofacitinib 5 or 10 mg twice daily (BID) or placebo were assessed for efficacy at Month 3 and for safety outcomes over 12 months. For adverse events of special interest, data on tofacitinib 5 or 10 mg BID or placebo were pooled from six PII and five PIII randomised studies. Results: PIII data were available for 664 vs. 2447 and PII/PIII data for 943 vs. 3567 US vs. ROW patients, respectively. The US population had a higher proportion of Caucasians (81.5% vs. 54.4%), lower proportion of Asians (1.0% vs. 34.6%), and higher mean body weight (85.7 vs. 66.2 kg) and body mass index (31.5 vs. 25.6 kg/m2) compared with ROW. At Month 3, PIII efficacy was similar between US and ROW as assessed by ACR 20/50/70 response rates, remission rates (DAS 28-4[ESR]<2.6), and HAQ-DI scores. Diarrhoea, peripheral oedema, and upper respiratory tract infection occurred in >5% of PIII patients in the US population. Incidence rates for adverse events of special interest were similar between the US and ROW PII/PIII populations. Conclusions: Patients in the US achieved similar efficacy and safety with tofacitinib 5 and 10 mg BID compared with patients in ROW.
Databáze:	MEDLINE
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