Tofacitinib, an oral janus kinase inhibitor: pooled efficacy and safety analyses in an Australian rheumatoid arthritis population

Hall, Stephen, Nash, Peter, Rischmueller, Maureen, Bossingham, David, Bird, Paul, Cook, Nicola, Witcombe, David, Soma, Koshika, Kwok, Kenneth, and Thirunavukkarasu, Krishan (2018) Tofacitinib, an oral janus kinase inhibitor: pooled efficacy and safety analyses in an Australian rheumatoid arthritis population. Rheumatology and Therapy, 5 (2). pp. 383-401.

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In Australia, there is an unmet need for improved treatments for rheumatoid arthritis (RA). Tofacitinib is an oral Janus kinase inhibitor for the treatment of RA. To provide an overview of key study outcomes for tofacitinib in Australian patients, we analyzed the efficacy and safety of tofacitinib in the Australian subpopulation of global RA phase III and long-term extension (LTE) studies.

Data were pooled from the Australian subpopulation of four phase III studies and one LTE study (database not locked at cut-off date: January 2016). Patients in the phase III studies received tofacitinib 5 or 10 mg twice daily (BID), placebo (advancing to tofacitinib at months 3 or 6), or adalimumab, with background methotrexate or conventional synthetic disease-modifying antirheumatic drugs. Patients in the LTE study received tofacitinib 5 or 10 mg BID. Efficacy endpoints were American College of Rheumatology (ACR) 20/50/70 response rates, and change from baseline in the Disease Activity Score in 28 joints, erythrocyte sedimentation rate [DAS28-4(ESR)] and Health Assessment Questionnaire-Disability Index (HAQ-DI) scores. Safety endpoints included incidence of adverse events (AEs), serious AEs, and discontinuations due to AEs. AEs of special interest and laboratory parameters were analyzed in the LTE study.

Across phase III studies (N = 100), ACR response rates and improvements in DAS28-4(ESR) and HAQ-DI scores were numerically greater with tofacitinib vs. placebo at month 3, and increased until month 12. The results were sustained in the LTE study (N = 99) after 60 months' observation. In general, the efficacy and safety profiles of tofacitinib were similar to those of the global RA population.

In Australian patients with RA, tofacitinib therapy demonstrated sustained efficacy and consistent safety over ae<yen> 60 months' treatment.

Pfizer Inc.

NCT00960440; NCT00847613; NCT00856544; NCT00853385; NCT00413699.

Item ID: 56654
Item Type: Article (Research - C1)
ISSN: 2198-6584
Keywords: Australia, Efficacy, Rheumatoid arthritis, Safety, Tofacitinib
Copyright Information: Copyright © The Author(s) 2018. This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (, which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
Funders: Pfizer Inc
Date Deposited: 19 Dec 2018 07:38
FoR Codes: 32 BIOMEDICAL AND CLINICAL SCIENCES > 3202 Clinical sciences > 320223 Rheumatology and arthritis @ 100%
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