Key clinical point: Risk for serious infection requiring hospitalization was 9-fold higher in children with inflammatory bowel disease (IBD) compared with the general population.

Major finding: Risk for serious infection was significantly higher among children with IBD vs the reference group (hazard ratio [HR], 9.50; 95% confidence interval [CI], 8.56-10.5). In addition to a higher risk for gastrointestinal infections (HR, 31.8; 95% CI, 25.6-39.3), children with IBD were at a substantially higher risk for opportunistic infections (HR, 11.8; 95% CI, 6.17-22.5) and sepsis (HR, 26.1; 95% CI, 15.6-43.7).

Study details: Findings are from an analysis of 5,767 children with incident IBD diagnosed before 18 years of age who were compared with 58,418 matched reference individuals.

Disclosures: No funding interests were declared. O Olén, P Malmborg, and J Järås declared receiving research grants and/or serving as a speaker for various sources.

Source: Ludvigsson JF et al. J Pediatr. 2021 Jun 30. doi: 10.1016/j.jpeds.2021.06.076.

Key clinical point: Risk for serious infection requiring hospitalization was 9-fold higher in children with inflammatory bowel disease (IBD) compared with the general population.

Major finding: Risk for serious infection was significantly higher among children with IBD vs the reference group (hazard ratio [HR], 9.50; 95% confidence interval [CI], 8.56-10.5). In addition to a higher risk for gastrointestinal infections (HR, 31.8; 95% CI, 25.6-39.3), children with IBD were at a substantially higher risk for opportunistic infections (HR, 11.8; 95% CI, 6.17-22.5) and sepsis (HR, 26.1; 95% CI, 15.6-43.7).

Study details: Findings are from an analysis of 5,767 children with incident IBD diagnosed before 18 years of age who were compared with 58,418 matched reference individuals.

Disclosures: No funding interests were declared. O Olén, P Malmborg, and J Järås declared receiving research grants and/or serving as a speaker for various sources.

Source: Ludvigsson JF et al. J Pediatr. 2021 Jun 30. doi: 10.1016/j.jpeds.2021.06.076.

Key clinical point: Risk for serious infection requiring hospitalization was 9-fold higher in children with inflammatory bowel disease (IBD) compared with the general population.

Major finding: Risk for serious infection was significantly higher among children with IBD vs the reference group (hazard ratio [HR], 9.50; 95% confidence interval [CI], 8.56-10.5). In addition to a higher risk for gastrointestinal infections (HR, 31.8; 95% CI, 25.6-39.3), children with IBD were at a substantially higher risk for opportunistic infections (HR, 11.8; 95% CI, 6.17-22.5) and sepsis (HR, 26.1; 95% CI, 15.6-43.7).

Study details: Findings are from an analysis of 5,767 children with incident IBD diagnosed before 18 years of age who were compared with 58,418 matched reference individuals.

Disclosures: No funding interests were declared. O Olén, P Malmborg, and J Järås declared receiving research grants and/or serving as a speaker for various sources.

Source: Ludvigsson JF et al. J Pediatr. 2021 Jun 30. doi: 10.1016/j.jpeds.2021.06.076.

Key clinical point: In a nationwide cohort of patients with inflammatory bowel disease (IBD), vedolizumab showed similar therapeutic efficacy among elderly and younger patients, with a similar proportion of patients in steroid-free remission after vedolizumab initiation.

Major finding: The proportion of patients in steroid-free remission while still on vedolizumab during the 6- to 12-month period after vedolizumab initiation was not significantly different among patients younger than 60 years of age (younger group; 46.8%) and those aged 60 years or older (elderly group; 40.1%; P = .2374). IBD-related hospitalization (P = .9737) and surgeries (P = .9851) within 1 year were similar between younger and elderly groups.

Study details: Findings are from a retrospective cohort study of 568 patients with IBD from the US national Veterans Affairs Healthcare System. Patients were categorized into elderly (n=279) and younger (n=289) groups based on their age at vedolizumab initiation.

Disclosures: The study was supported by Takeda Pharmaceutical Company Limited. N Khan declared receiving an unrestricted research grant from Pfizer, Luitpold, Takeda Pharmaceuticals, and Samsung BioEpis. Other authors had no disclosures.

Source: Khan N et al. Inflamm Bowel Dis. 2021 Jul 10. doi: 10.1093/ibd/izab163.

Key clinical point: In a nationwide cohort of patients with inflammatory bowel disease (IBD), vedolizumab showed similar therapeutic efficacy among elderly and younger patients, with a similar proportion of patients in steroid-free remission after vedolizumab initiation.

Major finding: The proportion of patients in steroid-free remission while still on vedolizumab during the 6- to 12-month period after vedolizumab initiation was not significantly different among patients younger than 60 years of age (younger group; 46.8%) and those aged 60 years or older (elderly group; 40.1%; P = .2374). IBD-related hospitalization (P = .9737) and surgeries (P = .9851) within 1 year were similar between younger and elderly groups.

Study details: Findings are from a retrospective cohort study of 568 patients with IBD from the US national Veterans Affairs Healthcare System. Patients were categorized into elderly (n=279) and younger (n=289) groups based on their age at vedolizumab initiation.

Disclosures: The study was supported by Takeda Pharmaceutical Company Limited. N Khan declared receiving an unrestricted research grant from Pfizer, Luitpold, Takeda Pharmaceuticals, and Samsung BioEpis. Other authors had no disclosures.

Source: Khan N et al. Inflamm Bowel Dis. 2021 Jul 10. doi: 10.1093/ibd/izab163.

Key clinical point: In a nationwide cohort of patients with inflammatory bowel disease (IBD), vedolizumab showed similar therapeutic efficacy among elderly and younger patients, with a similar proportion of patients in steroid-free remission after vedolizumab initiation.

Major finding: The proportion of patients in steroid-free remission while still on vedolizumab during the 6- to 12-month period after vedolizumab initiation was not significantly different among patients younger than 60 years of age (younger group; 46.8%) and those aged 60 years or older (elderly group; 40.1%; P = .2374). IBD-related hospitalization (P = .9737) and surgeries (P = .9851) within 1 year were similar between younger and elderly groups.

Study details: Findings are from a retrospective cohort study of 568 patients with IBD from the US national Veterans Affairs Healthcare System. Patients were categorized into elderly (n=279) and younger (n=289) groups based on their age at vedolizumab initiation.

Disclosures: The study was supported by Takeda Pharmaceutical Company Limited. N Khan declared receiving an unrestricted research grant from Pfizer, Luitpold, Takeda Pharmaceuticals, and Samsung BioEpis. Other authors had no disclosures.

Source: Khan N et al. Inflamm Bowel Dis. 2021 Jul 10. doi: 10.1093/ibd/izab163.

Key clinical point: Vedolizumab showed superior histological outcomes than adalimumab in patients with moderate-to-severe ulcerative colitis (UC).

Major finding: At 52 weeks, vedolizumab induced greater histologic remission (Robarts Histology Index [RHI], 2 or lower; Δ, 17.6%; P less than .0001) and minimal histologic disease activity (RHI, 4 or lower; Δ, 16.6%; P less than .0001) than adalimumab. Findings were similar in both antitumor necrosis factor-naive and -failure subgroups.

Study details: VARSITY, a phase 3b trial included 769 adult patients with moderately to severely active UC randomly assigned to intravenous vedolizumab or subcutaneous adalimumab.

Disclosures: This study was funded by Takeda. Some of the authors declared receiving grant support, personal fees, consultancy, and/or lecture fees from various sources. R Rogers, RA Lirio, JD Bornstein, and J Chen declared being employees and holding stocks of Takeda.

Source: Peyrin-Biroulet L et al. Gastroenterology. 2021 Jun 15. doi: 10.1053/j.gastro.2021.06.015.

Key clinical point: Vedolizumab showed superior histological outcomes than adalimumab in patients with moderate-to-severe ulcerative colitis (UC).

Major finding: At 52 weeks, vedolizumab induced greater histologic remission (Robarts Histology Index [RHI], 2 or lower; Δ, 17.6%; P less than .0001) and minimal histologic disease activity (RHI, 4 or lower; Δ, 16.6%; P less than .0001) than adalimumab. Findings were similar in both antitumor necrosis factor-naive and -failure subgroups.

Study details: VARSITY, a phase 3b trial included 769 adult patients with moderately to severely active UC randomly assigned to intravenous vedolizumab or subcutaneous adalimumab.

Disclosures: This study was funded by Takeda. Some of the authors declared receiving grant support, personal fees, consultancy, and/or lecture fees from various sources. R Rogers, RA Lirio, JD Bornstein, and J Chen declared being employees and holding stocks of Takeda.

Source: Peyrin-Biroulet L et al. Gastroenterology. 2021 Jun 15. doi: 10.1053/j.gastro.2021.06.015.

Key clinical point: Vedolizumab showed superior histological outcomes than adalimumab in patients with moderate-to-severe ulcerative colitis (UC).

Major finding: At 52 weeks, vedolizumab induced greater histologic remission (Robarts Histology Index [RHI], 2 or lower; Δ, 17.6%; P less than .0001) and minimal histologic disease activity (RHI, 4 or lower; Δ, 16.6%; P less than .0001) than adalimumab. Findings were similar in both antitumor necrosis factor-naive and -failure subgroups.

Study details: VARSITY, a phase 3b trial included 769 adult patients with moderately to severely active UC randomly assigned to intravenous vedolizumab or subcutaneous adalimumab.

Disclosures: This study was funded by Takeda. Some of the authors declared receiving grant support, personal fees, consultancy, and/or lecture fees from various sources. R Rogers, RA Lirio, JD Bornstein, and J Chen declared being employees and holding stocks of Takeda.

Source: Peyrin-Biroulet L et al. Gastroenterology. 2021 Jun 15. doi: 10.1053/j.gastro.2021.06.015.

Key clinical point: Infliximab de-escalation is safe and well tolerated in patients with Crohn’s disease (CD) in clinical remission and with supratherapeutic trough levels.

Major finding: More than half of the patients had a trough level of 10 ug/mL or higher at baseline. Trough levels were not significant among patients de-escalating to 5 mg/kg and 3 mg/kg at the final infusion (11.9 vs 9.2, respectively; P = .55). At the final visit, all patients were in clinical remission and remained on their de-escalated dose.

Study details: This was a prospective pilot trial of 52 patients with CD in clinical remission on infliximab at a consistent dose for at least 1 year. Thirteen and 6 patients de-escalated from 10/7.5 mg/kg to 5 mg/kg and from 5 mg/kg to 3 mg/kg, respectively.

Disclosures: No source of funding was declared. JR Allegretti and MJ Hamilton declared serving as a consultant and receiving grant support from various sources.

Source: Allegretti JR et al. Inflamm Bowel Dis. 2021 Jun 18. doi: 10.1093/ibd/izab131.

Key clinical point: Infliximab de-escalation is safe and well tolerated in patients with Crohn’s disease (CD) in clinical remission and with supratherapeutic trough levels.

Major finding: More than half of the patients had a trough level of 10 ug/mL or higher at baseline. Trough levels were not significant among patients de-escalating to 5 mg/kg and 3 mg/kg at the final infusion (11.9 vs 9.2, respectively; P = .55). At the final visit, all patients were in clinical remission and remained on their de-escalated dose.

Study details: This was a prospective pilot trial of 52 patients with CD in clinical remission on infliximab at a consistent dose for at least 1 year. Thirteen and 6 patients de-escalated from 10/7.5 mg/kg to 5 mg/kg and from 5 mg/kg to 3 mg/kg, respectively.

Disclosures: No source of funding was declared. JR Allegretti and MJ Hamilton declared serving as a consultant and receiving grant support from various sources.

Source: Allegretti JR et al. Inflamm Bowel Dis. 2021 Jun 18. doi: 10.1093/ibd/izab131.

Key clinical point: Infliximab de-escalation is safe and well tolerated in patients with Crohn’s disease (CD) in clinical remission and with supratherapeutic trough levels.

Major finding: More than half of the patients had a trough level of 10 ug/mL or higher at baseline. Trough levels were not significant among patients de-escalating to 5 mg/kg and 3 mg/kg at the final infusion (11.9 vs 9.2, respectively; P = .55). At the final visit, all patients were in clinical remission and remained on their de-escalated dose.

Study details: This was a prospective pilot trial of 52 patients with CD in clinical remission on infliximab at a consistent dose for at least 1 year. Thirteen and 6 patients de-escalated from 10/7.5 mg/kg to 5 mg/kg and from 5 mg/kg to 3 mg/kg, respectively.

Disclosures: No source of funding was declared. JR Allegretti and MJ Hamilton declared serving as a consultant and receiving grant support from various sources.

Source: Allegretti JR et al. Inflamm Bowel Dis. 2021 Jun 18. doi: 10.1093/ibd/izab131.

Key clinical point: Patients with inflammatory bowel disease (IBD) who contract SARS-CoV-2 infection are at a significantly higher risk for venous thromboembolism (VTE) and thus may benefit from thromboprophylaxis.

Major finding: SARS-CoV-2 infection was associated with 8.15-fold increased odds of VTE (P less than .001). The risk was however mitigated in patients on chronic anticoagulation (odds ratio [OR], 0.63; P = .66) and was even stronger among patients not previously on anticoagulation (OR, 14.31; P less than .001).

Study details: This was a case-crossover study of 482 patients with IBD who developed VTE between April 1, 2020, and March 30, 2021, in an established Veterans Affairs cohort.

Disclosures: The study was supported by grants from Pfizer Pharmaceuticals. J Lewis and N Khan declared receiving research funding and serving as a consultant or on data safety monitoring boards for various sources including Pfizer. Other authors had no disclosures.

Source: Mahmud N et al. Gastroenterology. 2021 Jun 14. doi: 10.1053/j.gastro.2021.06.012.

Key clinical point: Patients with inflammatory bowel disease (IBD) who contract SARS-CoV-2 infection are at a significantly higher risk for venous thromboembolism (VTE) and thus may benefit from thromboprophylaxis.

Major finding: SARS-CoV-2 infection was associated with 8.15-fold increased odds of VTE (P less than .001). The risk was however mitigated in patients on chronic anticoagulation (odds ratio [OR], 0.63; P = .66) and was even stronger among patients not previously on anticoagulation (OR, 14.31; P less than .001).

Study details: This was a case-crossover study of 482 patients with IBD who developed VTE between April 1, 2020, and March 30, 2021, in an established Veterans Affairs cohort.

Disclosures: The study was supported by grants from Pfizer Pharmaceuticals. J Lewis and N Khan declared receiving research funding and serving as a consultant or on data safety monitoring boards for various sources including Pfizer. Other authors had no disclosures.

Source: Mahmud N et al. Gastroenterology. 2021 Jun 14. doi: 10.1053/j.gastro.2021.06.012.

Key clinical point: Patients with inflammatory bowel disease (IBD) who contract SARS-CoV-2 infection are at a significantly higher risk for venous thromboembolism (VTE) and thus may benefit from thromboprophylaxis.

Major finding: SARS-CoV-2 infection was associated with 8.15-fold increased odds of VTE (P less than .001). The risk was however mitigated in patients on chronic anticoagulation (odds ratio [OR], 0.63; P = .66) and was even stronger among patients not previously on anticoagulation (OR, 14.31; P less than .001).

Study details: This was a case-crossover study of 482 patients with IBD who developed VTE between April 1, 2020, and March 30, 2021, in an established Veterans Affairs cohort.

Disclosures: The study was supported by grants from Pfizer Pharmaceuticals. J Lewis and N Khan declared receiving research funding and serving as a consultant or on data safety monitoring boards for various sources including Pfizer. Other authors had no disclosures.

Source: Mahmud N et al. Gastroenterology. 2021 Jun 14. doi: 10.1053/j.gastro.2021.06.012.

Key clinical point: SARS-CoV-2 mRNA vaccine is safe and effective in patients with inflammatory bowel disease (IBD).

Major finding: The immediate adverse reaction after vaccination was rare. Adverse events of special interest (relative risk [RR], 1.15; 95% confidence interval [CI], 0.88-1.51) and new diagnosis of COVID-19 (RR, 0.95; 95% CI, 0.51-1.78) were small and similar between matched IBD and non-IBD cohorts.

Study details: Findings are from a retrospective study of 864,575 patients from multiple institutes across the USA who received the SARS-CoV-2 mRNA vaccine, of which 5,562 patients had a previous diagnosis for IBD. One and 2 vaccine doses were administered in 1,822 and 3,740 patients with IBD, respectively.

Disclosures: The authors declared receiving no financial support or grants for this study. The authors declared no relevant disclosures.

Source: Hadi YB et al. Gastroenterology. 2021 Jun 15. doi: 10.1053/j.gastro.2021.06.014.

Key clinical point: SARS-CoV-2 mRNA vaccine is safe and effective in patients with inflammatory bowel disease (IBD).

Major finding: The immediate adverse reaction after vaccination was rare. Adverse events of special interest (relative risk [RR], 1.15; 95% confidence interval [CI], 0.88-1.51) and new diagnosis of COVID-19 (RR, 0.95; 95% CI, 0.51-1.78) were small and similar between matched IBD and non-IBD cohorts.

Study details: Findings are from a retrospective study of 864,575 patients from multiple institutes across the USA who received the SARS-CoV-2 mRNA vaccine, of which 5,562 patients had a previous diagnosis for IBD. One and 2 vaccine doses were administered in 1,822 and 3,740 patients with IBD, respectively.

Disclosures: The authors declared receiving no financial support or grants for this study. The authors declared no relevant disclosures.

Source: Hadi YB et al. Gastroenterology. 2021 Jun 15. doi: 10.1053/j.gastro.2021.06.014.

Key clinical point: SARS-CoV-2 mRNA vaccine is safe and effective in patients with inflammatory bowel disease (IBD).

Major finding: The immediate adverse reaction after vaccination was rare. Adverse events of special interest (relative risk [RR], 1.15; 95% confidence interval [CI], 0.88-1.51) and new diagnosis of COVID-19 (RR, 0.95; 95% CI, 0.51-1.78) were small and similar between matched IBD and non-IBD cohorts.

Study details: Findings are from a retrospective study of 864,575 patients from multiple institutes across the USA who received the SARS-CoV-2 mRNA vaccine, of which 5,562 patients had a previous diagnosis for IBD. One and 2 vaccine doses were administered in 1,822 and 3,740 patients with IBD, respectively.

Disclosures: The authors declared receiving no financial support or grants for this study. The authors declared no relevant disclosures.

Source: Hadi YB et al. Gastroenterology. 2021 Jun 15. doi: 10.1053/j.gastro.2021.06.014.

Key clinical point: Patients with inflammatory bowel disease (IBD) who switched from one infliximab biosimilar to another had no adverse impact on infliximab trough levels and clinical disease activity, regardless of whether switching for the first or second time.

Major finding: Median infliximab trough levels were higher after vs before switch (5.5 vs 4.9 μg/mL; P = .007). C-reactive protein (P = .43) and disease activity scores (P = .82) did not change significantly before vs early after switch, regardless of whether switching for the first or second time; the proportion of patients in remission also did not change significantly (91% vs 92%; P = .75).

Study details: Findings are from a prospective observational cohort study of 222 patients with IBD treated with infliximab biosimilar CT-P13 who underwent a nonmedical switch to SB2, of which 99 patients underwent a second switch.

Disclosures: No funding interests were declared. RP Luber, S Honap, MA Samaan, and PM Irving declared receiving grants and serving as speaker, consultant, and/or on advisory board for various sources.

Source: Luber RP et al. Aliment Pharmacol Ther. 2021 Jul 5. doi: 10.1111/apt.16497.

Key clinical point: Patients with inflammatory bowel disease (IBD) who switched from one infliximab biosimilar to another had no adverse impact on infliximab trough levels and clinical disease activity, regardless of whether switching for the first or second time.

Major finding: Median infliximab trough levels were higher after vs before switch (5.5 vs 4.9 μg/mL; P = .007). C-reactive protein (P = .43) and disease activity scores (P = .82) did not change significantly before vs early after switch, regardless of whether switching for the first or second time; the proportion of patients in remission also did not change significantly (91% vs 92%; P = .75).

Study details: Findings are from a prospective observational cohort study of 222 patients with IBD treated with infliximab biosimilar CT-P13 who underwent a nonmedical switch to SB2, of which 99 patients underwent a second switch.

Disclosures: No funding interests were declared. RP Luber, S Honap, MA Samaan, and PM Irving declared receiving grants and serving as speaker, consultant, and/or on advisory board for various sources.

Source: Luber RP et al. Aliment Pharmacol Ther. 2021 Jul 5. doi: 10.1111/apt.16497.

Key clinical point: Patients with inflammatory bowel disease (IBD) who switched from one infliximab biosimilar to another had no adverse impact on infliximab trough levels and clinical disease activity, regardless of whether switching for the first or second time.

Major finding: Median infliximab trough levels were higher after vs before switch (5.5 vs 4.9 μg/mL; P = .007). C-reactive protein (P = .43) and disease activity scores (P = .82) did not change significantly before vs early after switch, regardless of whether switching for the first or second time; the proportion of patients in remission also did not change significantly (91% vs 92%; P = .75).

Study details: Findings are from a prospective observational cohort study of 222 patients with IBD treated with infliximab biosimilar CT-P13 who underwent a nonmedical switch to SB2, of which 99 patients underwent a second switch.

Disclosures: No funding interests were declared. RP Luber, S Honap, MA Samaan, and PM Irving declared receiving grants and serving as speaker, consultant, and/or on advisory board for various sources.

Source: Luber RP et al. Aliment Pharmacol Ther. 2021 Jul 5. doi: 10.1111/apt.16497.

Key clinical point: Tofacitinib appears to be a promising treatment option as rescue therapy in patients hospitalized for a severe flare of refractory ulcerative colitis (UC).

Major finding: Overall, 27.3% of patients underwent colectomy during a median follow-up duration of 6.5 months. The estimated colectomy-free survival at 3 and 6 months was 78.9% (95% confidence interval [CI], 68.5%-90.9%) and 73.6% (95% CI, 61.9%-87.3%), respectively. At week 14, rates of clinical response, clinical remission, and steroid-free clinical remission were 41.8%, 34.5%, and 32.7%, respectively. No deaths were reported; however, 3 patients discontinued tofacitinib because of adverse events.

Study details: Findings are from an observational cohort study of 55 patients who received tofacitinib as rescue therapy for a flare of UC that required hospitalization.

Disclosures: No source of funding was declared. Some of the authors declared receiving personal interests like counseling, boards, transports, or fees from various sources.

Source: Uzzan M et al. Aliment Pharmacol Ther. 2021 Jun 20. doi: 10.1111/apt.16463.

Key clinical point: Tofacitinib appears to be a promising treatment option as rescue therapy in patients hospitalized for a severe flare of refractory ulcerative colitis (UC).

Major finding: Overall, 27.3% of patients underwent colectomy during a median follow-up duration of 6.5 months. The estimated colectomy-free survival at 3 and 6 months was 78.9% (95% confidence interval [CI], 68.5%-90.9%) and 73.6% (95% CI, 61.9%-87.3%), respectively. At week 14, rates of clinical response, clinical remission, and steroid-free clinical remission were 41.8%, 34.5%, and 32.7%, respectively. No deaths were reported; however, 3 patients discontinued tofacitinib because of adverse events.

Study details: Findings are from an observational cohort study of 55 patients who received tofacitinib as rescue therapy for a flare of UC that required hospitalization.

Disclosures: No source of funding was declared. Some of the authors declared receiving personal interests like counseling, boards, transports, or fees from various sources.

Source: Uzzan M et al. Aliment Pharmacol Ther. 2021 Jun 20. doi: 10.1111/apt.16463.

Key clinical point: Tofacitinib appears to be a promising treatment option as rescue therapy in patients hospitalized for a severe flare of refractory ulcerative colitis (UC).

Major finding: Overall, 27.3% of patients underwent colectomy during a median follow-up duration of 6.5 months. The estimated colectomy-free survival at 3 and 6 months was 78.9% (95% confidence interval [CI], 68.5%-90.9%) and 73.6% (95% CI, 61.9%-87.3%), respectively. At week 14, rates of clinical response, clinical remission, and steroid-free clinical remission were 41.8%, 34.5%, and 32.7%, respectively. No deaths were reported; however, 3 patients discontinued tofacitinib because of adverse events.

Study details: Findings are from an observational cohort study of 55 patients who received tofacitinib as rescue therapy for a flare of UC that required hospitalization.

Disclosures: No source of funding was declared. Some of the authors declared receiving personal interests like counseling, boards, transports, or fees from various sources.

Source: Uzzan M et al. Aliment Pharmacol Ther. 2021 Jun 20. doi: 10.1111/apt.16463.

Key clinical point: Preliminary real-world data show excellent efficacy of BNT162b2 mRNA COVID-19 vaccine with very low absolute breakthrough infection rate in fully vaccinated patients with inflammatory bowel disease (IBD), which was comparable to that of the reference population.

Major finding: The rate of breakthrough infection more than 7 and 14 days after the second dose in patients with IBD vs matched reference cohort was 0.19% vs 0.15% and 0.14% vs 0.10%, respectively. The relative risk for breakthrough infection among patients with IBD vs matched cohort more than 7 and 14 days after the second dose was 1.21 (95% confidence interval [CI], 0.74-1.97) and 1.26 (95% CI, 0.71-2.23), respectively.

Study details: Findings are from a retrospective cohort study of 12,231 BNT162b2 mRNA COVID-19 vaccines with IBD-aged 16 years and older from the Maccabi Healthcare Services IBD registry and 36,254 vaccinated matched reference patients.

Disclosures: The study received no external funding. The authors declared no conflicts of interest.

Source: Ben-Tov A et al. Gastroenterology. 2021 Jul 2. doi: 10.1053/j.gastro.2021.06.076.

Key clinical point: Preliminary real-world data show excellent efficacy of BNT162b2 mRNA COVID-19 vaccine with very low absolute breakthrough infection rate in fully vaccinated patients with inflammatory bowel disease (IBD), which was comparable to that of the reference population.

Major finding: The rate of breakthrough infection more than 7 and 14 days after the second dose in patients with IBD vs matched reference cohort was 0.19% vs 0.15% and 0.14% vs 0.10%, respectively. The relative risk for breakthrough infection among patients with IBD vs matched cohort more than 7 and 14 days after the second dose was 1.21 (95% confidence interval [CI], 0.74-1.97) and 1.26 (95% CI, 0.71-2.23), respectively.

Study details: Findings are from a retrospective cohort study of 12,231 BNT162b2 mRNA COVID-19 vaccines with IBD-aged 16 years and older from the Maccabi Healthcare Services IBD registry and 36,254 vaccinated matched reference patients.

Disclosures: The study received no external funding. The authors declared no conflicts of interest.

Source: Ben-Tov A et al. Gastroenterology. 2021 Jul 2. doi: 10.1053/j.gastro.2021.06.076.

Key clinical point: Preliminary real-world data show excellent efficacy of BNT162b2 mRNA COVID-19 vaccine with very low absolute breakthrough infection rate in fully vaccinated patients with inflammatory bowel disease (IBD), which was comparable to that of the reference population.

Major finding: The rate of breakthrough infection more than 7 and 14 days after the second dose in patients with IBD vs matched reference cohort was 0.19% vs 0.15% and 0.14% vs 0.10%, respectively. The relative risk for breakthrough infection among patients with IBD vs matched cohort more than 7 and 14 days after the second dose was 1.21 (95% confidence interval [CI], 0.74-1.97) and 1.26 (95% CI, 0.71-2.23), respectively.

Study details: Findings are from a retrospective cohort study of 12,231 BNT162b2 mRNA COVID-19 vaccines with IBD-aged 16 years and older from the Maccabi Healthcare Services IBD registry and 36,254 vaccinated matched reference patients.

Disclosures: The study received no external funding. The authors declared no conflicts of interest.

Source: Ben-Tov A et al. Gastroenterology. 2021 Jul 2. doi: 10.1053/j.gastro.2021.06.076.

Key clinical point: Adalimumab was effective and well tolerated in children with moderate-to-severe ulcerative colitis (UC).

Major finding: A significantly higher proportion of patients receiving high-dose induction adalimumab vs external placebo were in partial Mayo score (MS) remission at week 8 (60% vs 19.8%; P = .0001). The full MS remission at week 52 was achieved by a significantly higher proportion of patients receiving high-dose maintenance adalimumab vs external placebo (45% vs 18.4%; P = .0001). No new safety signals were identified.

Study details: The phase 3 ENVISION I trial included 93 children with moderate-to-severe UC despite stable doses of concurrent oral corticosteroids or immunosuppressants randomly assigned to either high-dose or standard-dose induction adalimumab. Patients with a response at week 8 were randomly assigned to either high-dose or standard-dose maintenance adalimumab or placebo up to week 52.

Disclosures: The study was funded by AbbVie. Some of the authors including the lead author reported receiving research funding, advisory board fees, consultation fees, and honoraria from various sources including AbbVie. Six of the authors declared being full-time employees at AbbVie and/or owning stocks/stock options.

Source: Croft NM et al. Lancet Gastroenterol Hepatol. 2021 Jun 18. doi: 10.1016/S2468-1253(21)00142-4.

Key clinical point: Adalimumab was effective and well tolerated in children with moderate-to-severe ulcerative colitis (UC).

Major finding: A significantly higher proportion of patients receiving high-dose induction adalimumab vs external placebo were in partial Mayo score (MS) remission at week 8 (60% vs 19.8%; P = .0001). The full MS remission at week 52 was achieved by a significantly higher proportion of patients receiving high-dose maintenance adalimumab vs external placebo (45% vs 18.4%; P = .0001). No new safety signals were identified.

Study details: The phase 3 ENVISION I trial included 93 children with moderate-to-severe UC despite stable doses of concurrent oral corticosteroids or immunosuppressants randomly assigned to either high-dose or standard-dose induction adalimumab. Patients with a response at week 8 were randomly assigned to either high-dose or standard-dose maintenance adalimumab or placebo up to week 52.

Disclosures: The study was funded by AbbVie. Some of the authors including the lead author reported receiving research funding, advisory board fees, consultation fees, and honoraria from various sources including AbbVie. Six of the authors declared being full-time employees at AbbVie and/or owning stocks/stock options.

Source: Croft NM et al. Lancet Gastroenterol Hepatol. 2021 Jun 18. doi: 10.1016/S2468-1253(21)00142-4.

Key clinical point: Adalimumab was effective and well tolerated in children with moderate-to-severe ulcerative colitis (UC).

Major finding: A significantly higher proportion of patients receiving high-dose induction adalimumab vs external placebo were in partial Mayo score (MS) remission at week 8 (60% vs 19.8%; P = .0001). The full MS remission at week 52 was achieved by a significantly higher proportion of patients receiving high-dose maintenance adalimumab vs external placebo (45% vs 18.4%; P = .0001). No new safety signals were identified.

Study details: The phase 3 ENVISION I trial included 93 children with moderate-to-severe UC despite stable doses of concurrent oral corticosteroids or immunosuppressants randomly assigned to either high-dose or standard-dose induction adalimumab. Patients with a response at week 8 were randomly assigned to either high-dose or standard-dose maintenance adalimumab or placebo up to week 52.

Disclosures: The study was funded by AbbVie. Some of the authors including the lead author reported receiving research funding, advisory board fees, consultation fees, and honoraria from various sources including AbbVie. Six of the authors declared being full-time employees at AbbVie and/or owning stocks/stock options.

Source: Croft NM et al. Lancet Gastroenterol Hepatol. 2021 Jun 18. doi: 10.1016/S2468-1253(21)00142-4.