Article

Key clinical point: Intradermal (ID) hepatitis B virus (HBV) vaccination with topical imiquimod pretreatment (ID-Imq) to the injection site was safe and provided superior seroprotection compared with intramuscular (IM) HBV vaccination with aqueous cream pretreatment (IM-Aq) in patients with inflammatory bowel disease (IBD).

Major finding: Patients who received ID-Imq vs. IM-Aq showed a significantly higher seroprotection rate at 12 months (91% vs. 69%; P = .005). Overall, 59% and 55% of patients in the ID-Imq and IM-Aq groups reported any adverse events, respectively, with local reactions being more common in the ID-Imq group.

Study details: Findings are from a phase 2 and 3 trial including 104 patients with IBD and no evidence of HBV infection or immunity who were randomly assigned to receive ID-Imq (n = 53) or IM-Aq (n = 51) at 0, 1, and 6 months.

Disclosures: This study was partly funded by a Young Investigator Research Grant from the Hong Kong College of Physicians. WK Leung reported serving as a speaker for Ferring, Janssen, and Takeda.

Source: Ko K-L et al. Clinical trial: Intra-dermal hepatitis B vaccination with topical imiquimod versus intra-muscular hepatitis B vaccination in inflammatory bowel disease patients. Aliment Pharmacol Ther. 2022 (May 11).  Doi: 10.1111/apt.16970

Key clinical point: Intradermal (ID) hepatitis B virus (HBV) vaccination with topical imiquimod pretreatment (ID-Imq) to the injection site was safe and provided superior seroprotection compared with intramuscular (IM) HBV vaccination with aqueous cream pretreatment (IM-Aq) in patients with inflammatory bowel disease (IBD).

Major finding: Patients who received ID-Imq vs. IM-Aq showed a significantly higher seroprotection rate at 12 months (91% vs. 69%; P = .005). Overall, 59% and 55% of patients in the ID-Imq and IM-Aq groups reported any adverse events, respectively, with local reactions being more common in the ID-Imq group.

Study details: Findings are from a phase 2 and 3 trial including 104 patients with IBD and no evidence of HBV infection or immunity who were randomly assigned to receive ID-Imq (n = 53) or IM-Aq (n = 51) at 0, 1, and 6 months.

Disclosures: This study was partly funded by a Young Investigator Research Grant from the Hong Kong College of Physicians. WK Leung reported serving as a speaker for Ferring, Janssen, and Takeda.

Source: Ko K-L et al. Clinical trial: Intra-dermal hepatitis B vaccination with topical imiquimod versus intra-muscular hepatitis B vaccination in inflammatory bowel disease patients. Aliment Pharmacol Ther. 2022 (May 11).  Doi: 10.1111/apt.16970

Key clinical point: Intradermal (ID) hepatitis B virus (HBV) vaccination with topical imiquimod pretreatment (ID-Imq) to the injection site was safe and provided superior seroprotection compared with intramuscular (IM) HBV vaccination with aqueous cream pretreatment (IM-Aq) in patients with inflammatory bowel disease (IBD).

Major finding: Patients who received ID-Imq vs. IM-Aq showed a significantly higher seroprotection rate at 12 months (91% vs. 69%; P = .005). Overall, 59% and 55% of patients in the ID-Imq and IM-Aq groups reported any adverse events, respectively, with local reactions being more common in the ID-Imq group.

Study details: Findings are from a phase 2 and 3 trial including 104 patients with IBD and no evidence of HBV infection or immunity who were randomly assigned to receive ID-Imq (n = 53) or IM-Aq (n = 51) at 0, 1, and 6 months.

Disclosures: This study was partly funded by a Young Investigator Research Grant from the Hong Kong College of Physicians. WK Leung reported serving as a speaker for Ferring, Janssen, and Takeda.

Source: Ko K-L et al. Clinical trial: Intra-dermal hepatitis B vaccination with topical imiquimod versus intra-muscular hepatitis B vaccination in inflammatory bowel disease patients. Aliment Pharmacol Ther. 2022 (May 11).  Doi: 10.1111/apt.16970

Key clinical point: Excess exposure to steroids has a significant negative impact on patients with inflammatory bowel disease (IBD).

Major finding: Steroid excess was observed in 15% of patients. The risks for ≥1 hospitalizations for IBD (odds ratio [OR] 12.33; 95% CI 8.89-17.11) and infections (OR 2.89; 95% CI 1.82-4.61) and ≥1 courses of general practitioner-prescribed antibiotics (OR 1.41; 95% CI 1.07-1.86) were significantly higher in patients with steroid excess vs. those without steroid exposure.

Study details: Findings are from a retrospective study including 2246 patients with IBD and primary care information.

Disclosures: This study was supported by a research grant from AbbVie. T Raine and CP Selinger declared receiving research/educational grants or speaker/consultation fees from various sources, including AbbVie.

Source: Rosiou K et al. Sources of excess steroid prescriptions and clinical adverse outcomes associated with steroid excess in patients with inflammatory bowel disease: The Leeds IBD Steroids study. Aliment Pharmacol Ther. 2022 (May 24). Doi: 10.1111/apt.17039

Key clinical point: Excess exposure to steroids has a significant negative impact on patients with inflammatory bowel disease (IBD).

Major finding: Steroid excess was observed in 15% of patients. The risks for ≥1 hospitalizations for IBD (odds ratio [OR] 12.33; 95% CI 8.89-17.11) and infections (OR 2.89; 95% CI 1.82-4.61) and ≥1 courses of general practitioner-prescribed antibiotics (OR 1.41; 95% CI 1.07-1.86) were significantly higher in patients with steroid excess vs. those without steroid exposure.

Study details: Findings are from a retrospective study including 2246 patients with IBD and primary care information.

Disclosures: This study was supported by a research grant from AbbVie. T Raine and CP Selinger declared receiving research/educational grants or speaker/consultation fees from various sources, including AbbVie.

Source: Rosiou K et al. Sources of excess steroid prescriptions and clinical adverse outcomes associated with steroid excess in patients with inflammatory bowel disease: The Leeds IBD Steroids study. Aliment Pharmacol Ther. 2022 (May 24). Doi: 10.1111/apt.17039

Key clinical point: Excess exposure to steroids has a significant negative impact on patients with inflammatory bowel disease (IBD).

Major finding: Steroid excess was observed in 15% of patients. The risks for ≥1 hospitalizations for IBD (odds ratio [OR] 12.33; 95% CI 8.89-17.11) and infections (OR 2.89; 95% CI 1.82-4.61) and ≥1 courses of general practitioner-prescribed antibiotics (OR 1.41; 95% CI 1.07-1.86) were significantly higher in patients with steroid excess vs. those without steroid exposure.

Study details: Findings are from a retrospective study including 2246 patients with IBD and primary care information.

Disclosures: This study was supported by a research grant from AbbVie. T Raine and CP Selinger declared receiving research/educational grants or speaker/consultation fees from various sources, including AbbVie.

Source: Rosiou K et al. Sources of excess steroid prescriptions and clinical adverse outcomes associated with steroid excess in patients with inflammatory bowel disease: The Leeds IBD Steroids study. Aliment Pharmacol Ther. 2022 (May 24). Doi: 10.1111/apt.17039

Key clinical point: Induction therapy with tofacitinib or prednisone significantly increased serum lipid levels in patients with inflammatory bowel disease (IBD), whereas no changes were observed with immunomodulators or biologics.

Major finding: At 10 weeks, the total cholesterol, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol levels increased significantly in patients who initiated tofacitinib (+20%, +25%, and +26%, respectively; all P < .05) or prednisone (+26%, +31%, and +12%, respectively; all P < .05) therapy. The changes in lipid levels were not significant with other biologics or immunomodulators.

Study details: This was a prospective study that included 198 patients with ulcerative colitis (n = 61), Crohn’s disease (n = 137), or unclassified IBD (n = 8) who initiated prednisone, thiopurine, methotrexate, an anti-tumor necrosis factor alpha agent, ustekinumab, vedolizumab, or tofacitinib.

Disclosures: This study did not receive any funding. AC de Vries and CJ van der Woude declared receiving research funding and serving as advisory board members for various sources.

Source: Sleutjes JAM et al. Lipid changes after induction therapy in patients with inflammatory bowel disease: Effect of different drug classes and inflammation. Inflamm Bowel Dis. 2022 (May 19). Doi: 10.1093/ibd/izac100

Key clinical point: Induction therapy with tofacitinib or prednisone significantly increased serum lipid levels in patients with inflammatory bowel disease (IBD), whereas no changes were observed with immunomodulators or biologics.

Major finding: At 10 weeks, the total cholesterol, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol levels increased significantly in patients who initiated tofacitinib (+20%, +25%, and +26%, respectively; all P < .05) or prednisone (+26%, +31%, and +12%, respectively; all P < .05) therapy. The changes in lipid levels were not significant with other biologics or immunomodulators.

Study details: This was a prospective study that included 198 patients with ulcerative colitis (n = 61), Crohn’s disease (n = 137), or unclassified IBD (n = 8) who initiated prednisone, thiopurine, methotrexate, an anti-tumor necrosis factor alpha agent, ustekinumab, vedolizumab, or tofacitinib.

Disclosures: This study did not receive any funding. AC de Vries and CJ van der Woude declared receiving research funding and serving as advisory board members for various sources.

Source: Sleutjes JAM et al. Lipid changes after induction therapy in patients with inflammatory bowel disease: Effect of different drug classes and inflammation. Inflamm Bowel Dis. 2022 (May 19). Doi: 10.1093/ibd/izac100

Key clinical point: Induction therapy with tofacitinib or prednisone significantly increased serum lipid levels in patients with inflammatory bowel disease (IBD), whereas no changes were observed with immunomodulators or biologics.

Major finding: At 10 weeks, the total cholesterol, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol levels increased significantly in patients who initiated tofacitinib (+20%, +25%, and +26%, respectively; all P < .05) or prednisone (+26%, +31%, and +12%, respectively; all P < .05) therapy. The changes in lipid levels were not significant with other biologics or immunomodulators.

Study details: This was a prospective study that included 198 patients with ulcerative colitis (n = 61), Crohn’s disease (n = 137), or unclassified IBD (n = 8) who initiated prednisone, thiopurine, methotrexate, an anti-tumor necrosis factor alpha agent, ustekinumab, vedolizumab, or tofacitinib.

Disclosures: This study did not receive any funding. AC de Vries and CJ van der Woude declared receiving research funding and serving as advisory board members for various sources.

Source: Sleutjes JAM et al. Lipid changes after induction therapy in patients with inflammatory bowel disease: Effect of different drug classes and inflammation. Inflamm Bowel Dis. 2022 (May 19). Doi: 10.1093/ibd/izac100

Key clinical point: Vedolizumab can be considered a safe and valid option for elderly patients with inflammatory bowel disease, with efficacy being unaffected by age in Crohn’s disease (CD), but slightly reduced in elderly vs. nonelderly patients with ulcerative colitis (UC).

Major finding: Nonelderly vs. elderly patients with UC showed significantly higher clinical remission at 24 months (47.3% vs. 34.3%; P < .05) and persistence (67.6% vs. 51.4%; P = .02), both of which were not significantly different between elderly and nonelderly patients with CD. Adverse events were comparable among elderly and nonelderly patients.

Study details: This was a retrospective-prospective study that included 198 elderly patients aged ≥ 65 years with UC (n = 108) or CD (n = 90) and 396 matched nonelderly patients with UC (n = 205) or CD (n = 191), all of whom received vedolizumab.

Disclosures: This study was funded by Takeda. Some authors reported receiving consulting, lecture, or speakers’ fees, or serving as advisory board members for various sources, including Takeda.

Source: Pugliese D et al. Effectiveness and safety of vedolizumab in a matched cohort of elderly and nonelderly patients with inflammatory bowel disease: The IG-IBD LIVE study. Aliment Pharmacol Ther. 2022;56(1):95-109 (May 12). Doi: 10.1111/apt.16923

Key clinical point: Vedolizumab can be considered a safe and valid option for elderly patients with inflammatory bowel disease, with efficacy being unaffected by age in Crohn’s disease (CD), but slightly reduced in elderly vs. nonelderly patients with ulcerative colitis (UC).

Major finding: Nonelderly vs. elderly patients with UC showed significantly higher clinical remission at 24 months (47.3% vs. 34.3%; P < .05) and persistence (67.6% vs. 51.4%; P = .02), both of which were not significantly different between elderly and nonelderly patients with CD. Adverse events were comparable among elderly and nonelderly patients.

Study details: This was a retrospective-prospective study that included 198 elderly patients aged ≥ 65 years with UC (n = 108) or CD (n = 90) and 396 matched nonelderly patients with UC (n = 205) or CD (n = 191), all of whom received vedolizumab.

Disclosures: This study was funded by Takeda. Some authors reported receiving consulting, lecture, or speakers’ fees, or serving as advisory board members for various sources, including Takeda.

Source: Pugliese D et al. Effectiveness and safety of vedolizumab in a matched cohort of elderly and nonelderly patients with inflammatory bowel disease: The IG-IBD LIVE study. Aliment Pharmacol Ther. 2022;56(1):95-109 (May 12). Doi: 10.1111/apt.16923

Key clinical point: Vedolizumab can be considered a safe and valid option for elderly patients with inflammatory bowel disease, with efficacy being unaffected by age in Crohn’s disease (CD), but slightly reduced in elderly vs. nonelderly patients with ulcerative colitis (UC).

Major finding: Nonelderly vs. elderly patients with UC showed significantly higher clinical remission at 24 months (47.3% vs. 34.3%; P < .05) and persistence (67.6% vs. 51.4%; P = .02), both of which were not significantly different between elderly and nonelderly patients with CD. Adverse events were comparable among elderly and nonelderly patients.

Study details: This was a retrospective-prospective study that included 198 elderly patients aged ≥ 65 years with UC (n = 108) or CD (n = 90) and 396 matched nonelderly patients with UC (n = 205) or CD (n = 191), all of whom received vedolizumab.

Disclosures: This study was funded by Takeda. Some authors reported receiving consulting, lecture, or speakers’ fees, or serving as advisory board members for various sources, including Takeda.

Source: Pugliese D et al. Effectiveness and safety of vedolizumab in a matched cohort of elderly and nonelderly patients with inflammatory bowel disease: The IG-IBD LIVE study. Aliment Pharmacol Ther. 2022;56(1):95-109 (May 12). Doi: 10.1111/apt.16923

Key clinical point: Early treatment with postoperative biological therapy decreased endoscopic recurrence rates and improved long-term outcomes in patients who underwent Crohn’s disease (CD)-related surgery.

Major finding: The rate of endoscopic recurrence was higher in patients not treated vs. treated with early postoperative biological therapy (80.8% vs. 45.2%; P < .000024), with the risk of experiencing hospitalization or surgery at 5 years being 23.3% higher (P = .02221) and the rate of medical therapy escalation being significantly higher (66.0% vs. 14.0%; P < .00001) in the no-treatment vs. treatment group.

Study details: Findings are from a retrospective cohort study including 141 patients with CD who underwent surgery and colonoscopy at 6-12 months postoperatively.

Disclosures: This study did not receive any funding. Some authors declared receiving consulting fees, lecture fees, speaker’s fees, grants, or serving as advisory board members for various sources.

Source: D'Amico F et al. Early biological therapy in operated Crohn’s disease patients is associated with a lower rate of endoscopic recurrence and improved long-term outcomes: A single-center experience. Inflamm Bowel Dis. 2022 (May 28). Doi: 10.1093/ibd/izac110

Key clinical point: Early treatment with postoperative biological therapy decreased endoscopic recurrence rates and improved long-term outcomes in patients who underwent Crohn’s disease (CD)-related surgery.

Major finding: The rate of endoscopic recurrence was higher in patients not treated vs. treated with early postoperative biological therapy (80.8% vs. 45.2%; P < .000024), with the risk of experiencing hospitalization or surgery at 5 years being 23.3% higher (P = .02221) and the rate of medical therapy escalation being significantly higher (66.0% vs. 14.0%; P < .00001) in the no-treatment vs. treatment group.

Study details: Findings are from a retrospective cohort study including 141 patients with CD who underwent surgery and colonoscopy at 6-12 months postoperatively.

Disclosures: This study did not receive any funding. Some authors declared receiving consulting fees, lecture fees, speaker’s fees, grants, or serving as advisory board members for various sources.

Source: D'Amico F et al. Early biological therapy in operated Crohn’s disease patients is associated with a lower rate of endoscopic recurrence and improved long-term outcomes: A single-center experience. Inflamm Bowel Dis. 2022 (May 28). Doi: 10.1093/ibd/izac110

Key clinical point: Early treatment with postoperative biological therapy decreased endoscopic recurrence rates and improved long-term outcomes in patients who underwent Crohn’s disease (CD)-related surgery.

Major finding: The rate of endoscopic recurrence was higher in patients not treated vs. treated with early postoperative biological therapy (80.8% vs. 45.2%; P < .000024), with the risk of experiencing hospitalization or surgery at 5 years being 23.3% higher (P = .02221) and the rate of medical therapy escalation being significantly higher (66.0% vs. 14.0%; P < .00001) in the no-treatment vs. treatment group.

Study details: Findings are from a retrospective cohort study including 141 patients with CD who underwent surgery and colonoscopy at 6-12 months postoperatively.

Disclosures: This study did not receive any funding. Some authors declared receiving consulting fees, lecture fees, speaker’s fees, grants, or serving as advisory board members for various sources.

Source: D'Amico F et al. Early biological therapy in operated Crohn’s disease patients is associated with a lower rate of endoscopic recurrence and improved long-term outcomes: A single-center experience. Inflamm Bowel Dis. 2022 (May 28). Doi: 10.1093/ibd/izac110

Key clinical point: Risk for overall cancer was 17% higher and cancer-specific mortality 26% higher in patients with inflammatory bowel disease (IBD) compared with non-IBD individuals.

Major finding: Risk for overall cancer (adjusted hazard ratio [aHR] 1.17; P < .001), particularly digestive cancer (aHR 1.33; P = .001), skin cancer (aHR 1.25; P < .001), and male genital cancer (aHR 1.29; P = .003), and cancer-specific mortality (aHR 1.26; P < .001) was significantly higher among patients with IBD vs. non-IBD individuals.

Study details: Findings are from a prospective study that included 5142 patients with ulcerative colitis (n = 3258), Crohn’s disease (n = 1449), or unclassified IBD (n = 435) and who were compared with 450,785 non-IBD reference individuals from the UK Biobank cohort.

Disclosures: The study was supported by the National Natural Science Foundation of China. The authors declared no conflicts of interest.

Source: Wu S et al. Inflammatory bowel disease and long-term risk of cancer: A prospective cohort study among half a million adults in UK Biobank. Inflamm Bowel Dis. 2022 (May 27). Doi:  10.1093/ibd/izac096

Key clinical point: Risk for overall cancer was 17% higher and cancer-specific mortality 26% higher in patients with inflammatory bowel disease (IBD) compared with non-IBD individuals.

Major finding: Risk for overall cancer (adjusted hazard ratio [aHR] 1.17; P < .001), particularly digestive cancer (aHR 1.33; P = .001), skin cancer (aHR 1.25; P < .001), and male genital cancer (aHR 1.29; P = .003), and cancer-specific mortality (aHR 1.26; P < .001) was significantly higher among patients with IBD vs. non-IBD individuals.

Study details: Findings are from a prospective study that included 5142 patients with ulcerative colitis (n = 3258), Crohn’s disease (n = 1449), or unclassified IBD (n = 435) and who were compared with 450,785 non-IBD reference individuals from the UK Biobank cohort.

Disclosures: The study was supported by the National Natural Science Foundation of China. The authors declared no conflicts of interest.

Source: Wu S et al. Inflammatory bowel disease and long-term risk of cancer: A prospective cohort study among half a million adults in UK Biobank. Inflamm Bowel Dis. 2022 (May 27). Doi:  10.1093/ibd/izac096

Key clinical point: Risk for overall cancer was 17% higher and cancer-specific mortality 26% higher in patients with inflammatory bowel disease (IBD) compared with non-IBD individuals.

Major finding: Risk for overall cancer (adjusted hazard ratio [aHR] 1.17; P < .001), particularly digestive cancer (aHR 1.33; P = .001), skin cancer (aHR 1.25; P < .001), and male genital cancer (aHR 1.29; P = .003), and cancer-specific mortality (aHR 1.26; P < .001) was significantly higher among patients with IBD vs. non-IBD individuals.

Study details: Findings are from a prospective study that included 5142 patients with ulcerative colitis (n = 3258), Crohn’s disease (n = 1449), or unclassified IBD (n = 435) and who were compared with 450,785 non-IBD reference individuals from the UK Biobank cohort.

Disclosures: The study was supported by the National Natural Science Foundation of China. The authors declared no conflicts of interest.

Source: Wu S et al. Inflammatory bowel disease and long-term risk of cancer: A prospective cohort study among half a million adults in UK Biobank. Inflamm Bowel Dis. 2022 (May 27). Doi:  10.1093/ibd/izac096

Key Clinical Point: Maintenance therapy with subcutaneous risankizumab showed superior efficacy than withdrawal from risankizumab to receive subcutaneous placebo in patients with moderate-to-severe Crohn’s disease (CD). It also had a tolerable safety profile.

Major finding: At week 52, patients receiving maintenance 360 mg risankizumab vs. placebo showed higher rates of Crohn’s Disease Activity Index clinical remission (adjusted difference [Δ] 15%; 95% CI 4%-25%) and endoscopic response (Δ 28%; 95% CI 19%-37%), with findings being similar for 180 mg risankizumab. The incidence of adverse events was similar across treatment groups.

Study details: Findings are from the phase 3 FORTIFY trial including 542 patients with moderate-to-severe CD who showed a clinical response to risankizumab in the ADVANCE and MOTIVATE induction trials and were randomly assigned to receive subcutaneous risankizumab (180 or 360 mg) or placebo.

Disclosures: This study was funded by AbbVie. Some authors declared being employees or holding stocks at AbbVie, and other authors reported receiving grants, speakers’ fees, consulting fees, or serving as advisory board members for various sources, including AbbVie.

Source: Ferrante M et al. Risankizumab as maintenance therapy for moderately to severely active Crohn's disease: Results from the multicentre, randomised, double-blind, placebo-controlled, withdrawal phase 3 FORTIFY maintenance trial. Lancet. 2022;399(10340):2031-2046 (May 28). Doi: 10.1016/S0140-6736(22)00466-4

Key Clinical Point: Maintenance therapy with subcutaneous risankizumab showed superior efficacy than withdrawal from risankizumab to receive subcutaneous placebo in patients with moderate-to-severe Crohn’s disease (CD). It also had a tolerable safety profile.

Major finding: At week 52, patients receiving maintenance 360 mg risankizumab vs. placebo showed higher rates of Crohn’s Disease Activity Index clinical remission (adjusted difference [Δ] 15%; 95% CI 4%-25%) and endoscopic response (Δ 28%; 95% CI 19%-37%), with findings being similar for 180 mg risankizumab. The incidence of adverse events was similar across treatment groups.

Study details: Findings are from the phase 3 FORTIFY trial including 542 patients with moderate-to-severe CD who showed a clinical response to risankizumab in the ADVANCE and MOTIVATE induction trials and were randomly assigned to receive subcutaneous risankizumab (180 or 360 mg) or placebo.

Disclosures: This study was funded by AbbVie. Some authors declared being employees or holding stocks at AbbVie, and other authors reported receiving grants, speakers’ fees, consulting fees, or serving as advisory board members for various sources, including AbbVie.

Source: Ferrante M et al. Risankizumab as maintenance therapy for moderately to severely active Crohn's disease: Results from the multicentre, randomised, double-blind, placebo-controlled, withdrawal phase 3 FORTIFY maintenance trial. Lancet. 2022;399(10340):2031-2046 (May 28). Doi: 10.1016/S0140-6736(22)00466-4

Key Clinical Point: Maintenance therapy with subcutaneous risankizumab showed superior efficacy than withdrawal from risankizumab to receive subcutaneous placebo in patients with moderate-to-severe Crohn’s disease (CD). It also had a tolerable safety profile.

Major finding: At week 52, patients receiving maintenance 360 mg risankizumab vs. placebo showed higher rates of Crohn’s Disease Activity Index clinical remission (adjusted difference [Δ] 15%; 95% CI 4%-25%) and endoscopic response (Δ 28%; 95% CI 19%-37%), with findings being similar for 180 mg risankizumab. The incidence of adverse events was similar across treatment groups.

Study details: Findings are from the phase 3 FORTIFY trial including 542 patients with moderate-to-severe CD who showed a clinical response to risankizumab in the ADVANCE and MOTIVATE induction trials and were randomly assigned to receive subcutaneous risankizumab (180 or 360 mg) or placebo.

Disclosures: This study was funded by AbbVie. Some authors declared being employees or holding stocks at AbbVie, and other authors reported receiving grants, speakers’ fees, consulting fees, or serving as advisory board members for various sources, including AbbVie.

Source: Ferrante M et al. Risankizumab as maintenance therapy for moderately to severely active Crohn's disease: Results from the multicentre, randomised, double-blind, placebo-controlled, withdrawal phase 3 FORTIFY maintenance trial. Lancet. 2022;399(10340):2031-2046 (May 28). Doi: 10.1016/S0140-6736(22)00466-4

Key Clinical Point: Maintenance therapy with subcutaneous risankizumab showed superior efficacy than withdrawal from risankizumab to receive subcutaneous placebo in patients with moderate-to-severe Crohn’s disease (CD). It also had a tolerable safety profile.

Major finding: At week 52, patients receiving maintenance 360 mg risankizumab vs. placebo showed higher rates of Crohn’s Disease Activity Index clinical remission (adjusted difference [Δ] 15%; 95% CI 4%-25%) and endoscopic response (Δ 28%; 95% CI 19%-37%), with findings being similar for 180 mg risankizumab. The incidence of adverse events was similar across treatment groups.

Study details: Findings are from the phase 3 FORTIFY trial including 542 patients with moderate-to-severe CD who showed a clinical response to risankizumab in the ADVANCE and MOTIVATE induction trials and were randomly assigned to receive subcutaneous risankizumab (180 or 360 mg) or placebo.

Disclosures: This study was funded by AbbVie. Some authors declared being employees or holding stocks at AbbVie, and other authors reported receiving grants, speakers’ fees, consulting fees, or serving as advisory board members for various sources, including AbbVie.

Source: Ferrante M et al. Risankizumab as maintenance therapy for moderately to severely active Crohn's disease: Results from the multicentre, randomised, double-blind, placebo-controlled, withdrawal phase 3 FORTIFY maintenance trial. Lancet. 2022;399(10340):2031-2046 (May 28). Doi: 10.1016/S0140-6736(22)00466-4

Key Clinical Point: Maintenance therapy with subcutaneous risankizumab showed superior efficacy than withdrawal from risankizumab to receive subcutaneous placebo in patients with moderate-to-severe Crohn’s disease (CD). It also had a tolerable safety profile.

Major finding: At week 52, patients receiving maintenance 360 mg risankizumab vs. placebo showed higher rates of Crohn’s Disease Activity Index clinical remission (adjusted difference [Δ] 15%; 95% CI 4%-25%) and endoscopic response (Δ 28%; 95% CI 19%-37%), with findings being similar for 180 mg risankizumab. The incidence of adverse events was similar across treatment groups.

Study details: Findings are from the phase 3 FORTIFY trial including 542 patients with moderate-to-severe CD who showed a clinical response to risankizumab in the ADVANCE and MOTIVATE induction trials and were randomly assigned to receive subcutaneous risankizumab (180 or 360 mg) or placebo.

Disclosures: This study was funded by AbbVie. Some authors declared being employees or holding stocks at AbbVie, and other authors reported receiving grants, speakers’ fees, consulting fees, or serving as advisory board members for various sources, including AbbVie.

Source: Ferrante M et al. Risankizumab as maintenance therapy for moderately to severely active Crohn's disease: Results from the multicentre, randomised, double-blind, placebo-controlled, withdrawal phase 3 FORTIFY maintenance trial. Lancet. 2022;399(10340):2031-2046 (May 28). Doi: 10.1016/S0140-6736(22)00466-4

Key Clinical Point: Maintenance therapy with subcutaneous risankizumab showed superior efficacy than withdrawal from risankizumab to receive subcutaneous placebo in patients with moderate-to-severe Crohn’s disease (CD). It also had a tolerable safety profile.

Major finding: At week 52, patients receiving maintenance 360 mg risankizumab vs. placebo showed higher rates of Crohn’s Disease Activity Index clinical remission (adjusted difference [Δ] 15%; 95% CI 4%-25%) and endoscopic response (Δ 28%; 95% CI 19%-37%), with findings being similar for 180 mg risankizumab. The incidence of adverse events was similar across treatment groups.

Study details: Findings are from the phase 3 FORTIFY trial including 542 patients with moderate-to-severe CD who showed a clinical response to risankizumab in the ADVANCE and MOTIVATE induction trials and were randomly assigned to receive subcutaneous risankizumab (180 or 360 mg) or placebo.

Disclosures: This study was funded by AbbVie. Some authors declared being employees or holding stocks at AbbVie, and other authors reported receiving grants, speakers’ fees, consulting fees, or serving as advisory board members for various sources, including AbbVie.

Source: Ferrante M et al. Risankizumab as maintenance therapy for moderately to severely active Crohn's disease: Results from the multicentre, randomised, double-blind, placebo-controlled, withdrawal phase 3 FORTIFY maintenance trial. Lancet. 2022;399(10340):2031-2046 (May 28). Doi: 10.1016/S0140-6736(22)00466-4

Key clinical point: Tofacitinib showed higher efficacy and comparable safety to vedolizumab in patients with ulcerative colitis (UC) with prior treatment failure with anti-tumor necrosis factor (anti-TNF) therapy.

Major finding: Patients treated with tofacitinib vs. vedolizumab were more likely to achieve corticosteroid-free remission at weeks 12 (odds ratio [OR] 6.33; P < .01), 24 (OR 3.02; P < .01), and 52 (OR 1.86; P = .01). The overall risk for adverse events (AE) was higher in patients treated with vedolizumab (OR 1.83; P = .02), whereas the risk for serious AE was similar in both the groups.

Study details: This was a prospective cohort study of 148 patients with UC from the Initiative on Crohn and Colitis (ICC) registry who were treated with vedolizumab (n = 83) or tofacitinib (n = 65) after the failure of treatment with at least one anti-TNF agent.

Disclosures: The ICC fellowship was sponsored by AbbVie, Pfizer, and others. Some authors reported receiving grants, consulting fees, speakers’ fees, presentation fees from, or serving on advisory boards for various sources, including the sponsors of the ICC Fellowship.

Source: Straatmijer T et al. Superior effectiveness of tofacitinib compared to vedolizumab in anti-TNF experienced ulcerative colitis patients: A nationwide Dutch Registry study. Clin Gastroenterol Hepatol. 2022 (May 26). Doi: 10.1016/j.cgh.2022.04.038

Key clinical point: Tofacitinib showed higher efficacy and comparable safety to vedolizumab in patients with ulcerative colitis (UC) with prior treatment failure with anti-tumor necrosis factor (anti-TNF) therapy.

Major finding: Patients treated with tofacitinib vs. vedolizumab were more likely to achieve corticosteroid-free remission at weeks 12 (odds ratio [OR] 6.33; P < .01), 24 (OR 3.02; P < .01), and 52 (OR 1.86; P = .01). The overall risk for adverse events (AE) was higher in patients treated with vedolizumab (OR 1.83; P = .02), whereas the risk for serious AE was similar in both the groups.

Study details: This was a prospective cohort study of 148 patients with UC from the Initiative on Crohn and Colitis (ICC) registry who were treated with vedolizumab (n = 83) or tofacitinib (n = 65) after the failure of treatment with at least one anti-TNF agent.

Disclosures: The ICC fellowship was sponsored by AbbVie, Pfizer, and others. Some authors reported receiving grants, consulting fees, speakers’ fees, presentation fees from, or serving on advisory boards for various sources, including the sponsors of the ICC Fellowship.

Source: Straatmijer T et al. Superior effectiveness of tofacitinib compared to vedolizumab in anti-TNF experienced ulcerative colitis patients: A nationwide Dutch Registry study. Clin Gastroenterol Hepatol. 2022 (May 26). Doi: 10.1016/j.cgh.2022.04.038

Key clinical point: Tofacitinib showed higher efficacy and comparable safety to vedolizumab in patients with ulcerative colitis (UC) with prior treatment failure with anti-tumor necrosis factor (anti-TNF) therapy.

Major finding: Patients treated with tofacitinib vs. vedolizumab were more likely to achieve corticosteroid-free remission at weeks 12 (odds ratio [OR] 6.33; P < .01), 24 (OR 3.02; P < .01), and 52 (OR 1.86; P = .01). The overall risk for adverse events (AE) was higher in patients treated with vedolizumab (OR 1.83; P = .02), whereas the risk for serious AE was similar in both the groups.

Study details: This was a prospective cohort study of 148 patients with UC from the Initiative on Crohn and Colitis (ICC) registry who were treated with vedolizumab (n = 83) or tofacitinib (n = 65) after the failure of treatment with at least one anti-TNF agent.

Disclosures: The ICC fellowship was sponsored by AbbVie, Pfizer, and others. Some authors reported receiving grants, consulting fees, speakers’ fees, presentation fees from, or serving on advisory boards for various sources, including the sponsors of the ICC Fellowship.

Source: Straatmijer T et al. Superior effectiveness of tofacitinib compared to vedolizumab in anti-TNF experienced ulcerative colitis patients: A nationwide Dutch Registry study. Clin Gastroenterol Hepatol. 2022 (May 26). Doi: 10.1016/j.cgh.2022.04.038

Key Clinical Point: Intravenous risankizumab induction therapy is safe and effective in patients with moderate-to-severe Crohn’s disease (CD).

Major finding: In the ADVANCE trial, Crohn’s Disease Activity Index clinical remission at week 12 was higher with 600 mg risankizumab (adjusted difference [Δ] 21%) and 1200 mg (Δ 17%) vs. placebo, with the endoscopic response being higher with 600 mg risankizumab (Δ 28%) and 1200 mg (Δ 20%; all P < .0001) vs. placebo. The MOTIVATE trial reported similar findings. The incidence of adverse events was similar across all treatment groups.

Study details: This study included patients with moderate-to-severe CD and intolerance/inadequate response to biologics or conventional therapy from the phase 3 ADVANCE (n=931) and MOTIVATE  (n = 618) trials who were randomly assigned to receive risankizumab (600 or 1200 mg) or placebo.

Disclosures: This study was funded by AbbVie. Some authors declared being employees or holding stocks at AbbVie, and other authors reported receiving grants, speaker’s fees, or consulting fees or serving as advisory board members for various sources, including AbbVie.

Source: D’Haens G et al. Risankizumab as induction therapy for Crohn's disease: Results from the phase 3 ADVANCE and MOTIVATE induction trials. Lancet. 2022;399(10340):2015-2030 (May 28). Doi: 10.1016/S0140-6736(22)00467-6

Key Clinical Point: Intravenous risankizumab induction therapy is safe and effective in patients with moderate-to-severe Crohn’s disease (CD).

Major finding: In the ADVANCE trial, Crohn’s Disease Activity Index clinical remission at week 12 was higher with 600 mg risankizumab (adjusted difference [Δ] 21%) and 1200 mg (Δ 17%) vs. placebo, with the endoscopic response being higher with 600 mg risankizumab (Δ 28%) and 1200 mg (Δ 20%; all P < .0001) vs. placebo. The MOTIVATE trial reported similar findings. The incidence of adverse events was similar across all treatment groups.

Study details: This study included patients with moderate-to-severe CD and intolerance/inadequate response to biologics or conventional therapy from the phase 3 ADVANCE (n=931) and MOTIVATE  (n = 618) trials who were randomly assigned to receive risankizumab (600 or 1200 mg) or placebo.

Disclosures: This study was funded by AbbVie. Some authors declared being employees or holding stocks at AbbVie, and other authors reported receiving grants, speaker’s fees, or consulting fees or serving as advisory board members for various sources, including AbbVie.

Source: D’Haens G et al. Risankizumab as induction therapy for Crohn's disease: Results from the phase 3 ADVANCE and MOTIVATE induction trials. Lancet. 2022;399(10340):2015-2030 (May 28). Doi: 10.1016/S0140-6736(22)00467-6

Key Clinical Point: Intravenous risankizumab induction therapy is safe and effective in patients with moderate-to-severe Crohn’s disease (CD).

Major finding: In the ADVANCE trial, Crohn’s Disease Activity Index clinical remission at week 12 was higher with 600 mg risankizumab (adjusted difference [Δ] 21%) and 1200 mg (Δ 17%) vs. placebo, with the endoscopic response being higher with 600 mg risankizumab (Δ 28%) and 1200 mg (Δ 20%; all P < .0001) vs. placebo. The MOTIVATE trial reported similar findings. The incidence of adverse events was similar across all treatment groups.

Study details: This study included patients with moderate-to-severe CD and intolerance/inadequate response to biologics or conventional therapy from the phase 3 ADVANCE (n=931) and MOTIVATE  (n = 618) trials who were randomly assigned to receive risankizumab (600 or 1200 mg) or placebo.

Disclosures: This study was funded by AbbVie. Some authors declared being employees or holding stocks at AbbVie, and other authors reported receiving grants, speaker’s fees, or consulting fees or serving as advisory board members for various sources, including AbbVie.

Source: D’Haens G et al. Risankizumab as induction therapy for Crohn's disease: Results from the phase 3 ADVANCE and MOTIVATE induction trials. Lancet. 2022;399(10340):2015-2030 (May 28). Doi: 10.1016/S0140-6736(22)00467-6