関節リウマチ患者における，MTX併用または非併用での 選択的JAK1阻害薬であるフィルゴチニブの有効性: 患者立脚型評価
Patient-reported outcomes (PROs) from two, Phase 2b, filgotinib (FIL) studies, DARWIN 1 and 2, revealed that patients receiving FIL had improved and sustained PRO responses compared with placebo.
With suboptimal RA treatment, patients lose joint functional ability, which heavily influences patient quality of life. The previously reported data from the DARWIN studies, concluded that patients given FIL achieved clinically relevant dose-dependent improvements compared with patients given placebo¹,². To assess the effect of FIL on patient quality of life, this paper analysed the PRO data from both DARWIN studies.
DARWIN 1 was an add-on therapy study, with FIL given in addition to methotrexate, whereas, in DARWIN 2 FIL was given as a monotherapy. In both studies, patients were randomised to receive placebo or FIL (doses ranged from 25 mg BID to 200 mg QD). Patient Pain, Patient Global, FACIT-Fatigue and SF-36 mental and physical component scores were measured over the 24-weeks.
In each study, improvements in PROs were observed in all groups, with an overall dose effect noted. In DARWIN 1, patients given FIL 100 mg QD presented greater improvements in PROs compared with patients given FIL 50 mg BID; similar trends were observed in DARWIN 2, between FIL 100 mg BID and 200 mg QD patients. Both studies appeared to favour FIL 100 mg doses, however differences were not considered significant.
The authors concluded that patients presented rapid and sustained improvements in PROs when given FIL compared with placebo, further suggesting that FIL can improve health-related quality of life. In 2016, the FINCH FIL Phase 3 trials were initiated – to assess FIL combination and monotherapy for both 100- and 200 mg QD doses³.
1. Westhovens R, et al. Ann Rheum Dis 2017;76:998–1008.
2. Kavanaugh A, et al. Ann Rheum Dis 2017;76:1009–19.
3. Galapagos Press Release, 22 August 2016. Available at: http://www.glpg.com/docs/view/57bb579f12ea6-en