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Presentation
Safety and Efficacy of Tofacitinib, an Oral Janus Kinase Inhibitor, up to 36 Months in Patients with Active Psoriatic Arthritis: Data from the Third Interim Analysis of OPAL Balance, an Open Label, Long-Term Extension Study. Australian Rheumatology Association (ARA) 59th Annual Scientific Meeting, Melbourne Australia, May 2018.
Australian Rheumatology Association (ARA) 59th Annual Scientific Meeting (2018)
  • Peter Nash
  • LC Coates
  • Alan Kivitz
  • Philip Mease, Providence St. Joseph Health
  • Dafna D. Gladman, University of Toronto
  • JA Covarrubias-Cobos
  • Dona Fleishaker
  • C Wang
  • Elizabeth Kudlacz, Pfizer
  • Sujatha Menon
  • Thijs Hendrikx
  • KS Kanik
Abstract
Aim. Tofacitinib is an oral Janus kinase inhibitor for the treatment of pso-
riatic arthritis (PsA). We report tofacitinib safety, tolerability and efficacy in active PsA 
patients from an open-label extension (LTE) study (OPAL Balance; NCT01976364; November 2017 
data-cut; database not locked).

Method. Eligible patients from 2 Phase (P)3 tofacitinib PsA studies (OPAL Broaden; OPAL Beyond) 
entered a 3-year LTE. Patients received tofacitinib 5 mg BID to Month (M)1, after which dose 
adjustments between 5 and 10 mg BID were permitted to improve efficacy, or for safety reasons. 
Patients receiving a csDMARD at P3 study entry continued the same csDMARD in the LTE. Primary 
endpoints: incidence and severity of adverse events (AEs) through M36; change from baseline (Δ) in 
labora- tory values. Efficacy was evaluated through M30 (when N>50).

Result. 686 patients were treated in OPAL Balance; 468 (68.2%) remained in the study at data 
cut-off. Mean (range) LTE tofacitinib expo- sure was 614 (1–1032) days. To  M36,  2189  AEs  were  
reported  in 546 patients (79.6%); 95 (13.8%) had serious AEs; 59 (8.6%) discontin- ued due to AEs. 
Serious infections occurred in 12 patients (1.7%), herpes zoster  in  20  (2.9%),  major  adverse  
cardiovascular  events  in  5  (0.7%),malignancies in 24 (3.5%; including 12 NMSC) and uveitis in 2 (0.3%). No gastrointestinal perforations or inflammatory bowel disease were reported. There were 5 deaths, all unrelated to 
study drug (investigator- determined). ALT ≥3x ULN occurred in 27 patients  (4.0%);  AST  ≥3x ULN 
in 15 (2.2%). Eight patients (1.2%) discontinued (protocol-man- dated) due to laboratory changes. 
ACR responses, ΔHAQ-DI, PASI75 response, ΔLEI, ΔDSS and ΔPain were maintained through M30.

Conclusions. Over 36 months in the LTE, the safety profile of tofacitinib in active PsA patients was 
generally similar to that of P3 studies. No new safety risks were identified. Efficacy was maintained 
over time across various PsA disease domains.

Disciplines
Publication Date
May, 2018
Location
Melbourne
Citation Information
Peter Nash, LC Coates, Alan Kivitz, Philip Mease, et al.. "Safety and Efficacy of Tofacitinib, an Oral Janus Kinase Inhibitor, up to 36 Months in Patients with Active Psoriatic Arthritis: Data from the Third Interim Analysis of OPAL Balance, an Open Label, Long-Term Extension Study. Australian Rheumatology Association (ARA) 59th Annual Scientific Meeting, Melbourne Australia, May 2018." Australian Rheumatology Association (ARA) 59th Annual Scientific Meeting (2018)
Available at: http://works.bepress.com/philip-mease/133/