TY - JOUR
T1 - Impact of Concomitant Thiopurine on the Efficacy and Safety of Filgotinib in Patients with Ulcerative Colitis
T2 - Post Hoc Analysis of the Phase 2b/3 SELECTION Study
AU - Watanabe, Kenji
AU - Peyrin-Biroulet, Laurent
AU - Danese, Silvio
AU - Fujitani, Yasushi
AU - Faes, Margaux
AU - Oortwijn, Alessandra
AU - Lindsay, James O.
AU - Rogler, Gerhard
AU - Hibi, Toshifumi
N1 - Publisher Copyright:
© 2023 The Author(s). Published by Oxford University Press on behalf of European Crohn's and Colitis Organisation.
PY - 2024/6/1
Y1 - 2024/6/1
N2 - Background and Aims: SELECTION is the first study to assess the impact of concomitant thiopurine and other immunomodulator [IM] use on the efficacy and safety of a Janus kinase inhibitor, filgotinib, in patients with ulcerative colitis. Methods: Data from the phase 2b/3 SELECTION study were used for this post hoc analysis. Patients were randomised [2:2:1] to two induction studies [biologic-naive, biologic-experienced] to filgotinib 200 mg, 100 mg, or placebo. At Week 10, patients receiving filgotinib were re-randomised [2:1] to continue filgotinib or to switch to placebo until Week 58 [maintenance]. Outcomes were compared between subgroups with and without concomitant IM use. Results: At Week 10, similar proportions of patients in the +IM and -IM groups treated with filgotinib 200 mg achieved Mayo Clinic Score [MCS] response [biologic-naive: 65.8% vs 66.9%; biologic-experienced: 61.3% vs 50.5%] and clinical remission [biologic-naive: 26.0% vs 26.2%; biologic-experienced: 11.3% vs 11.5%]. At Week 58, similar proportion of patients in the +IM and -IM groups treated with filgotinib 200 mg achieved MCS response [biologic-naive: 74.2% vs 75.0%; biologic-experienced: 45.5% vs 61.4%] and clinical remission [biologic-naive: 51.6% vs 47.4%; biologic-experienced: 22.7% vs 24.3%]. The probability of protocol-specified disease worsening during the maintenance study in patients treated with filgotinib 200 mg did not differ between +IM and -IM groups [p=0.6700]. No differences were observed in the incidences of adverse events between +IM and -IM groups in the induction/maintenance studies. Conclusions: The efficacy and safety profiles of filgotinib treatment in SELECTION did not differ with or without concomitant IM use.
AB - Background and Aims: SELECTION is the first study to assess the impact of concomitant thiopurine and other immunomodulator [IM] use on the efficacy and safety of a Janus kinase inhibitor, filgotinib, in patients with ulcerative colitis. Methods: Data from the phase 2b/3 SELECTION study were used for this post hoc analysis. Patients were randomised [2:2:1] to two induction studies [biologic-naive, biologic-experienced] to filgotinib 200 mg, 100 mg, or placebo. At Week 10, patients receiving filgotinib were re-randomised [2:1] to continue filgotinib or to switch to placebo until Week 58 [maintenance]. Outcomes were compared between subgroups with and without concomitant IM use. Results: At Week 10, similar proportions of patients in the +IM and -IM groups treated with filgotinib 200 mg achieved Mayo Clinic Score [MCS] response [biologic-naive: 65.8% vs 66.9%; biologic-experienced: 61.3% vs 50.5%] and clinical remission [biologic-naive: 26.0% vs 26.2%; biologic-experienced: 11.3% vs 11.5%]. At Week 58, similar proportion of patients in the +IM and -IM groups treated with filgotinib 200 mg achieved MCS response [biologic-naive: 74.2% vs 75.0%; biologic-experienced: 45.5% vs 61.4%] and clinical remission [biologic-naive: 51.6% vs 47.4%; biologic-experienced: 22.7% vs 24.3%]. The probability of protocol-specified disease worsening during the maintenance study in patients treated with filgotinib 200 mg did not differ between +IM and -IM groups [p=0.6700]. No differences were observed in the incidences of adverse events between +IM and -IM groups in the induction/maintenance studies. Conclusions: The efficacy and safety profiles of filgotinib treatment in SELECTION did not differ with or without concomitant IM use.
KW - Ulcerative colitis
KW - filgotinib
KW - thiopurine
UR - http://www.scopus.com/inward/record.url?scp=85195225575&partnerID=8YFLogxK
U2 - 10.1093/ecco-jcc/jjad201
DO - 10.1093/ecco-jcc/jjad201
M3 - 学術論文
C2 - 38019901
AN - SCOPUS:85195225575
SN - 1873-9946
VL - 18
SP - 801
EP - 811
JO - Journal of Crohn's and Colitis
JF - Journal of Crohn's and Colitis
IS - 6
ER -