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. 2023 Jan 1;118(1):138-147.
doi: 10.14309/ajg.0000000000001979. Epub 2022 Aug 23.

Rapid and Sustained Symptom Relief in Patients With Ulcerative Colitis Treated With Filgotinib: Data From the Phase 2b/3 SELECTION Trial

Silvio Danese  1   2 , Marc Ferrante  3 , Brian G Feagan  4   5 , Laurent Peyrin-Biroulet  6   7 , Toshifumi Hibi  8 , William J Sandborn  9 , Stefan Schreiber  10 , Timothy Ritter  11 , Edward V Loftus Jr  12 , Gerhard Rogler  13 , Alessandra Oortwijn  14 , Chohee Yun  15 , Franck-Olivier Le Brun  16 , Jason Dinoso  15 , Jeremy Hsieh  15 , Séverine Vermeire  3
Affiliations

Rapid and Sustained Symptom Relief in Patients With Ulcerative Colitis Treated With Filgotinib: Data From the Phase 2b/3 SELECTION Trial

Silvio Danese et al. Am J Gastroenterol. .

Abstract

Introduction: Patients with ulcerative colitis (UC) regard rapid onset of action among the most important aspects of their treatment. We used the partial Mayo Clinic Score (pMCS) and component patient-reported subscores to assess the rapidity and sustainability of response to filgotinib, a once-daily, oral Janus kinase 1 preferential inhibitor, in adults with moderately to severely active UC in the phase 2b/3 SELECTION trial. The association between early symptomatic improvements and health-related quality of life (HRQoL) outcomes was also assessed.

Methods: In these post hoc analyses of the double-blinded, randomized, placebo-controlled 58-week SELECTION trial (NCT02914522), rectal bleeding and stool frequency diary data on days 1-15 and pMCS remission and response at multiple time points including weeks 10 and 58 were evaluated. HRQoL was assessed using the Inflammatory Bowel Disease Questionnaire at weeks 10 and 58.

Results: Filgotinib 200 mg relative to placebo improved rectal bleeding and stool frequency within 7 days ( P < 0.05). By week 2, greater proportions of filgotinib 200 mg-treated patients than placebo-treated patients achieved pMCS remission (biologic-naive, 15.1% vs 8.0%, P = 0.0410; biologic-experienced, 10.3% vs 4.2%, P = 0.0274). A similar treatment effect was observed at week 58 ( P < 0.0001). Day 7 rectal bleeding and stool frequency subscores were associated with the Mayo Clinic Score response at weeks 10 and 58. Patients in pMCS remission at weeks 10 and 58 had greater improvements in the Inflammatory Bowel Disease Questionnaire score than those not in pMCS remission.

Discussion: Filgotinib 200 mg daily resulted in rapid and sustained improvements in both UC symptoms and HRQoL.

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Conflict of interest statement

Guarantor of the article: Alessandra Oortwijn, MD, PhD.

Specific author contributions: A.O., C.Y., F.-O.L.B., J.D., and J.H. contributed to the study design. S.D., M.F., B.G.F., L.P.-B., T.H., W.J.S., S.S., T.R., E.V.L., G.R., and S.V. contributed to data collection. C.Y., F.-O.L.B., J.D., and J.H. contributed to data analysis. All authors contributed to data interpretation. All authors contributed to the development of the manuscript, and all authors approved the final version. All authors agree to be accountable for all aspects of the work.

Financial support: The SELECTION trial was sponsored by Gilead Sciences Inc. Galapagos NV was a collaborator for the SELECTION trial and funded this analysis.

Potential competing interests: S.D. has received personal fees from AbbVie, Allergan, Amgen, AstraZeneca, Athos Therapeutics, Biogen, Boehringer Ingelheim, Celgene, Celltrion, Eli Lilly, Enthera, Ferring Pharmaceuticals, Gilead, Hospira, Inotrem, Janssen, Johnson & Johnson, MSD, Mundipharma, Mylan, Pfizer, Roche, Sandoz, Sublimity Therapeutics, Takeda, TiGenix, UCB, and Vifor. M.F. has received consultancy fees from AbbVie, Boehringer Ingelheim, Celltrion, Janssen, Lilly, Medtronic, MSD, Pfizer, Sandoz, Takeda, and Thermo Fisher; speaker's fees from AbbVie, Amgen, Biogen, Boehringer Ingelheim, Celltrion, Falk, Ferring, Janssen, Lamepro, MSD, Mylan, Pfizer, Sandoz, Takeda, and Truvion Healthcare; and grants from AbbVie, Amgen, Biogen, Janssen, Pfizer, Takeda, and Viatris. B.G.F. has received grants and personal fees from AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb (BMS), Janssen Biotech/Centocor, JnJ/Janssen, Pfizer, Receptos, and Takeda; personal fees from Ablynx, ActoGeniX, AdMIRx, Akebia Therapeutics, Allergan, Atlantic Pharma, Avaxia Biologics, Avir Pharma, Baxter Healthcare Corporation, Biogen Idec, BiomX Israel, Boehringer Ingelheim, Boston Pharmaceuticals, Calypso Biotech, Celgene, Elan/Biogen, enGene, Ferring, Galapagos, Genentech/Roche, gICare Pharma, Gilead, Given Imaging, Gossamer Pharma, GSK, Inception IBD, Ironwood, Japan Tobacco, Kyowa Hakko Kirin, Lexicon, Lilly, Lycera Biotech, Merck, Mesoblast Pharma, Millennium, Nestlé, Nextbiotix, Novartis, Novo Nordisk, Par'Immune, Progenity, Prometheus Therapeutics and Diagnostics, Protagonist, Qu Biologics, Salix, Shire, Sienna Biologics, Sigmoid Pharma, Synergy Pharma, Teva Pharma, TiGenix, Tillotts, UCB, Vertex, VHsquared, Vivelix Pharma, Wyeth, Zealand, and Zyngenia; and is the Senior Scientific Director at Alimentiv and a Professor of Medicine at Western University. L.P.-B. has received personal fees from AbbVie, Allergan, Amgen, Arena, Biogen, BMS, Celgene, Celltrion, Enthera, Ferring, Fresenius Kabi, Galapagos, Genentech, Gilead, Gossamer Bio, InDex Pharmaceuticals, Inotrem, Janssen, Lilly, MSD, Mylan, Norgine, OSE Immunotherapeutics, Pandion Therapeutics, Pfizer, Roche, Samsung Bioepis, Sandoz, Takeda, Theravance, Thermo Fisher, Tillotts, Viatris, and Vifor; grants from AbbVie, Fresenius Kabi, MSD, and Takeda; and stock options from CTMA. T.H. has received grants from Otsuka Holdings; grants and personal fees from AbbVie GK, IMRO, Kyorin, Mitsubishi Tanabe Pharma, Mochida Pharmaceutical, Takeda Pharmaceutical, and Zeria Pharmaceutical; and personal fees from Aspen Japan K.K., BMS, Celltrion, EA Pharma, Eli Lilly, Ferring, Gilead Sciences, Janssen, Kissei Pharmaceutical, Nichi-Iko Pharmaceutical, Nippon Kayaku, and Pfizer. W.J.S. has received research grants from AbbVie, Abivax, Arena Pharmaceuticals, Boehringer Ingelheim, Bristol Meyers Squibb, Genentech, Gilead Sciences, Glaxo Smith Kline, Janssen, Lilly, Pfizer, Prometheus Biosciences, Seres Therapeutics, Shire, Takeda, and Theravance Biopharma; consulting fees from AbbVie, Abivax, Alfasigma, Alimentiv (previously Robarts Clinical Trials, owned by Alimentiv Health Trust), Allakos, Amgen, Arena Pharmaceuticals, AstraZeneca, Atlantic Pharmaceuticals, Beigene, Boehringer Ingelheim, Bristol Meyers Squibb, Celltrion, Clostrabio, Forbion, Galapagos, Genentech (Roche), GlaxoSmithKline, Gossamer Bio, Index Pharmaceuticals, Iota Biosciences, Janssen, Lilly, Morphic Therapeutics, Novartis, Oppilan Pharma (now Ventyx Biosciences), Pfizer, Pharm Olam, Polpharm, Progenity, Prometheus Biosciences, Protagonist Therapeutics, PTM Therapeutics, Seres Therapeutics, Shoreline Biosciences, Sublimity Therapeutics, Surrozen, Takeda, Theravance Biopharma, Vedanta Biosciences, Ventyx Biosciences, Vimalan Biosciences, Vivreon Gastrosciences, Xencor, and Zealand Pharmaceuticals; stock or stock options from Allakos, BeiGene, Gossamer Bio, Oppilan Pharma (now Ventyx Biosciences), Progenity, Prometheus Biosciences, Prometheus Laboratories, Protagonists Therapeutics, Shoreline Biosciences, Ventyx Biosciences, Vimalan Biosciences, and Vivreon Gastrosciences; and is an employee at Shoreline Biosciences. W.J.S.'s spouse has received consulting fees from Iveric Bio and Prometheus Laboratories; stock or stock options from Iveric Bio, Progenity, Oppilan Pharma (now Ventyx Biosciences), Prometheus Biosciences, Prometheus Laboratories, Ventyx Biosciences, and Vimalan Biosciences; and is an employee at Prometheus Biosciences. S.S. has received personal fees from AbbVie, Arena, Biogen, BMS, Celgene, Celltrion, Dr. Falk Pharma, Fresenius, Galapagos/Gilead, I-Mab, Janssen, MSD, Mylan, Pfizer, Protagonist, ProventionBio, Takeda, and Theravance. T.R. has received personal fees from Gilead during the conduct of the study; and personal fees from AbbVie, Arena Pharmaceuticals, Ferring Pharmaceuticals, Genentech, Gossamer, Intercept, Janssen, Eli Lilly, Pfizer, Prometheus, and Takeda. E.V.L. has received grants and personal fees from Gilead during the conduct of the study; grants from Receptos, Robarts Clinical Trials, and Theravance; grants and personal fees from AbbVie, Amgen, BMS, Celgene, Genentech, Gilead, Gossamer Bio, Janssen, Pfizer, and Takeda; and personal fees from Arena, Boehringer Ingelheim, CALIBR, Eli Lilly, Iterative Scopes, Morphic, Ono Pharma, Protagonist, Scipher Medicine, Sun Pharma, and Surrozen. G.R. has received personal fees from AbbVie, AstraZeneca, Augurix, BMS, Boehringer, Calypso, Celgene, Dr. Falk Pharma, Ferring, Fisher, Genentech, Gilead, Janssen, MSD, Novartis, Pfizer, Phadia, Roche, Takeda, Tillotts, UCB, Vifor, Vital Solutions, and Zeller; and grants from AbbVie, Ardeypharm, Augurix, Calypso, Dr. Falk Pharma, Flamentera, MSD, Novartis, Pfizer, Roche, Takeda, Tillotts, UCB, and Zeller. A.O. is an employee and shareholder of Galapagos NV. C.Y. is an employee and shareholder of Gilead Sciences. F.-O.L.B. is an employee and shareholder of Galapagos NV. J.D. is an employee and shareholder of Gilead Sciences. J.H. is an employee and shareholder of Gilead Sciences. S.V. has received grants from AbbVie, J&J, Pfizer, and Takeda; and consultancy fees from AbbVie, Arena Pharmaceuticals, Avaxia, Boehringer Ingelheim, Celgene, Dr. Falk Pharma, Ferring, Galapagos, Genentech/Roche, Gilead, Hospira, Janssen, Mundipharma, MSD, Pfizer, ProDigest, Progenity, Prometheus, Robarts Clinical Trials, Second Genome, Shire, Takeda, Theravance, and Tillotts Pharma AG.

ClinicalTrials.gov identifier: NCT02914522

Data availability statement: Anonymized individual patient data will be shared upon request for research purposes dependent upon the nature of the request, the merit of the proposed research, the availability of the data, and its intended use. The full data sharing policy for Gilead Sciences Inc. can be found at https://www.gilead.com/about/ethics-and-code-of-conduct/policies.

Figures

Figure 1.
Figure 1.
Proportions of patients in Induction Studies A (biologic-naive) and B (biologic-experienced) who achieved (a, b) a rectal bleeding subscore of 0, (c, d) a stool frequency subscore ≤1, and (e, f) a combined rectal bleeding subscore of 0 and stool frequency subscore ≤1 during days 1–15 of treatment. *P < 0.05, **P < 0.01, ***P < 0.001, ****P < 0.0001 filgotinib 200 mg vs placebo.
Figure 2.
Figure 2.
Proportions of patients in Induction Studies A (biologic-naive) and B (biologic-experienced) who achieved (a, b) pMCS remission and (c, d) pMCS response over time. Error bars represent 95% confidence intervals. Baseline values for pMCS response are not available because pMCS response was calculated based on changes in pMCS from baseline. pMCS remission was defined as pMCS ≤2 and no individual rectal bleeding, stool frequency, or physician's global assessment subscore >1. pMCS response was defined as a reduction in pMCS of ≥2 and ≥30% from induction baseline with a decrease in rectal bleeding score of ≥1 or an absolute rectal bleeding subscore of 0 or 1. pMCS, partial Mayo Clinic Score.
Figure 3.
Figure 3.
Proportions of patients treated with filgotinib 200 mg vs placebo in (a) pMCS remission and (b) pMCS response over time in the Maintenance Study. Error bars represent 95% confidence intervals. pMCS remission was defined as pMCS ≤2 and no individual rectal bleeding, stool frequency, or physician's global assessment subscore >1. pMCS response was defined as a reduction in pMCS of ≥2 and ≥30% from induction baseline with an accompanying decrease in rectal bleeding subscore of ≥1 or an absolute rectal bleeding subscore of 0 or 1. pMCS, partial Mayo Clinic Score.
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