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Key clinical point: Filgotinib 200 mg once daily for up to 58 weeks effectively induced and maintained clinical remission (CR) and was well tolerated compared with placebo in both biologic-naive and biologic-experienced patients with moderately to severely active ulcerative colitis.
Major finding: CR was achieved by a greater proportion of patients treated with filgotinib 200 mg vs. placebo in both biologic-naïve (absolute difference [AD], 10.8%; P = .0157) and biologic-experienced (AD, 7.2%; P = .0103) patients at weeks 10 and 58 (AD, 26.0%; P less than .0001). Incidence of adverse events of interest and serious adverse events was similar across treatment arms.
Study details: Findings are from phase 2b/3 SELECTION trial involving 659 biologic-naive and 689 biologic-experienced patients with moderately to severely active ulcerative colitis randomly allocated to oral filgotinib 200 mg, filgotinib 100 mg, or placebo once daily.
Disclosures: The study was funded by Gilead Sciences. Some of the authors declared receiving grants, personal/consultancy fees, travel expense and/or non-financial support from; being an employee of; and/or holding stocks of various sources including Gilead Sciences.
Source: Feagan BG et al. Lancet. 2021 Jun 3. doi: 10.1016/S0140-6736(21)00666-8.
Key clinical point: Filgotinib 200 mg once daily for up to 58 weeks effectively induced and maintained clinical remission (CR) and was well tolerated compared with placebo in both biologic-naive and biologic-experienced patients with moderately to severely active ulcerative colitis.
Major finding: CR was achieved by a greater proportion of patients treated with filgotinib 200 mg vs. placebo in both biologic-naïve (absolute difference [AD], 10.8%; P = .0157) and biologic-experienced (AD, 7.2%; P = .0103) patients at weeks 10 and 58 (AD, 26.0%; P less than .0001). Incidence of adverse events of interest and serious adverse events was similar across treatment arms.
Study details: Findings are from phase 2b/3 SELECTION trial involving 659 biologic-naive and 689 biologic-experienced patients with moderately to severely active ulcerative colitis randomly allocated to oral filgotinib 200 mg, filgotinib 100 mg, or placebo once daily.
Disclosures: The study was funded by Gilead Sciences. Some of the authors declared receiving grants, personal/consultancy fees, travel expense and/or non-financial support from; being an employee of; and/or holding stocks of various sources including Gilead Sciences.
Source: Feagan BG et al. Lancet. 2021 Jun 3. doi: 10.1016/S0140-6736(21)00666-8.
Key clinical point: Filgotinib 200 mg once daily for up to 58 weeks effectively induced and maintained clinical remission (CR) and was well tolerated compared with placebo in both biologic-naive and biologic-experienced patients with moderately to severely active ulcerative colitis.
Major finding: CR was achieved by a greater proportion of patients treated with filgotinib 200 mg vs. placebo in both biologic-naïve (absolute difference [AD], 10.8%; P = .0157) and biologic-experienced (AD, 7.2%; P = .0103) patients at weeks 10 and 58 (AD, 26.0%; P less than .0001). Incidence of adverse events of interest and serious adverse events was similar across treatment arms.
Study details: Findings are from phase 2b/3 SELECTION trial involving 659 biologic-naive and 689 biologic-experienced patients with moderately to severely active ulcerative colitis randomly allocated to oral filgotinib 200 mg, filgotinib 100 mg, or placebo once daily.
Disclosures: The study was funded by Gilead Sciences. Some of the authors declared receiving grants, personal/consultancy fees, travel expense and/or non-financial support from; being an employee of; and/or holding stocks of various sources including Gilead Sciences.
Source: Feagan BG et al. Lancet. 2021 Jun 3. doi: 10.1016/S0140-6736(21)00666-8.