IBD & Intestinal Disorders

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.

The efficacy of vaccination against SARS-CoV-2 in patients with IBD and complications from a COVID-19 infection unique to patients with IBD have not been well elucidated. This month, three manuscripts were published in Gastroenterology examining real-world data on vaccine efficacy and COVID infection outcomes in IBD patients.

Over 60% of Israelis have been fully vaccinated.  Ben-Tov and colleagues evaluated the efficacy of BNT162b2 vaccination in 12,231 IBD patients matched to 36,254 using data from the second largest state-mandated healthcare provider in Israel. Seven days after the second vaccination, breakthrough infections were observed in 0.19% of IBD patients and 0.15% of control patients.  Of the 23 breakthrough infections in IBD patients, 2 patients were hospitalized, and one patient died.  Crohn’s disease patients were at greater risk of breakthrough infections in a multivariable analysis [HR3.56 (95% CI-1.29,9.83). Patients with UC and those on immune modifying agents did not have a higher risk of breakthrough infections. It should be noted that that these results may not be generalizable to other populations, as the median age was 47 and there were limited patients on immunosuppressive therapies (10.8% on anti-TNF, 1.4% on methotrexate, 4.8% on thiopurines).

A similar study by Hadi et al.  retrospectively examined the safety and efficacy of vaccination in IBD patients using a large United States research network encompassing >800,000 vaccinated patients. Of these patients, 5,562 had a diagnosis of IBD (3,740 received both vaccine doses). In contrast to the previous study, 53% of patients were on a biologic and/or thiopurine. In this analysis, there were no differences in the rate of adverse events reported, subsequent COVID-19 infections, or COVID-19 related hospitalizations between IBD and non-IBD patients. In addition, there was not a higher rate of adverse events after vaccination between those on a biologic or immunomodulator compared. The authors state that there were ≤10 breakthrough infections in patients on a biologic or immunomodulator, although did not perform a statistical comparison to IBD patients not on immunosuppressive therapies.

These manuscripts evaluated outcomes in large cohorts of IBD patients, although the results are limited by the fact that they relied on diagnosis coding for inclusion of IBD patients and recording of events. Furthermore, it is likely that many patients with SARS-CoV-2 infections are diagnosed outside an individuals’ healthcare system limiting capturing of events for their analyses. Nevertheless, these studies clearly demonstrate safety and efficacy of COVID-19 vaccination in patients with IBD. Further work is needed, however, to evaluate real-world long-term efficacy of vaccination in IBD patients on immunosuppressive therapy.

Both IBD and SARS-CoV-2 increase an individual’s risk of a venous thromboembolism (VTE). Using a veteran’s administrations (VA) cohort, Mahmud and colleagues identified 428 patients with IBD who developed a VTE within the one year study period. After adjusting for recent hospitalizations and steroid exposure, SARS-CoV-2 infection was associated with an 8.15-fold increased risk of VTE (95% CI 4.34-15.30). This study is limited by the fact that there were just 21 events of VTE after a SARS-CoV-2 infection. If the results are validated in an independent larger cohort of patients, however, practitioners should consider VTE prophylaxis in IBD patients with a SARS-CoV-2 infection.

The efficacy of vaccination against SARS-CoV-2 in patients with IBD and complications from a COVID-19 infection unique to patients with IBD have not been well elucidated. This month, three manuscripts were published in Gastroenterology examining real-world data on vaccine efficacy and COVID infection outcomes in IBD patients.

Over 60% of Israelis have been fully vaccinated.  Ben-Tov and colleagues evaluated the efficacy of BNT162b2 vaccination in 12,231 IBD patients matched to 36,254 using data from the second largest state-mandated healthcare provider in Israel. Seven days after the second vaccination, breakthrough infections were observed in 0.19% of IBD patients and 0.15% of control patients.  Of the 23 breakthrough infections in IBD patients, 2 patients were hospitalized, and one patient died.  Crohn’s disease patients were at greater risk of breakthrough infections in a multivariable analysis [HR3.56 (95% CI-1.29,9.83). Patients with UC and those on immune modifying agents did not have a higher risk of breakthrough infections. It should be noted that that these results may not be generalizable to other populations, as the median age was 47 and there were limited patients on immunosuppressive therapies (10.8% on anti-TNF, 1.4% on methotrexate, 4.8% on thiopurines).

A similar study by Hadi et al.  retrospectively examined the safety and efficacy of vaccination in IBD patients using a large United States research network encompassing >800,000 vaccinated patients. Of these patients, 5,562 had a diagnosis of IBD (3,740 received both vaccine doses). In contrast to the previous study, 53% of patients were on a biologic and/or thiopurine. In this analysis, there were no differences in the rate of adverse events reported, subsequent COVID-19 infections, or COVID-19 related hospitalizations between IBD and non-IBD patients. In addition, there was not a higher rate of adverse events after vaccination between those on a biologic or immunomodulator compared. The authors state that there were ≤10 breakthrough infections in patients on a biologic or immunomodulator, although did not perform a statistical comparison to IBD patients not on immunosuppressive therapies.

These manuscripts evaluated outcomes in large cohorts of IBD patients, although the results are limited by the fact that they relied on diagnosis coding for inclusion of IBD patients and recording of events. Furthermore, it is likely that many patients with SARS-CoV-2 infections are diagnosed outside an individuals’ healthcare system limiting capturing of events for their analyses. Nevertheless, these studies clearly demonstrate safety and efficacy of COVID-19 vaccination in patients with IBD. Further work is needed, however, to evaluate real-world long-term efficacy of vaccination in IBD patients on immunosuppressive therapy.

Both IBD and SARS-CoV-2 increase an individual’s risk of a venous thromboembolism (VTE). Using a veteran’s administrations (VA) cohort, Mahmud and colleagues identified 428 patients with IBD who developed a VTE within the one year study period. After adjusting for recent hospitalizations and steroid exposure, SARS-CoV-2 infection was associated with an 8.15-fold increased risk of VTE (95% CI 4.34-15.30). This study is limited by the fact that there were just 21 events of VTE after a SARS-CoV-2 infection. If the results are validated in an independent larger cohort of patients, however, practitioners should consider VTE prophylaxis in IBD patients with a SARS-CoV-2 infection.

The efficacy of vaccination against SARS-CoV-2 in patients with IBD and complications from a COVID-19 infection unique to patients with IBD have not been well elucidated. This month, three manuscripts were published in Gastroenterology examining real-world data on vaccine efficacy and COVID infection outcomes in IBD patients.

Over 60% of Israelis have been fully vaccinated.  Ben-Tov and colleagues evaluated the efficacy of BNT162b2 vaccination in 12,231 IBD patients matched to 36,254 using data from the second largest state-mandated healthcare provider in Israel. Seven days after the second vaccination, breakthrough infections were observed in 0.19% of IBD patients and 0.15% of control patients.  Of the 23 breakthrough infections in IBD patients, 2 patients were hospitalized, and one patient died.  Crohn’s disease patients were at greater risk of breakthrough infections in a multivariable analysis [HR3.56 (95% CI-1.29,9.83). Patients with UC and those on immune modifying agents did not have a higher risk of breakthrough infections. It should be noted that that these results may not be generalizable to other populations, as the median age was 47 and there were limited patients on immunosuppressive therapies (10.8% on anti-TNF, 1.4% on methotrexate, 4.8% on thiopurines).

A similar study by Hadi et al.  retrospectively examined the safety and efficacy of vaccination in IBD patients using a large United States research network encompassing >800,000 vaccinated patients. Of these patients, 5,562 had a diagnosis of IBD (3,740 received both vaccine doses). In contrast to the previous study, 53% of patients were on a biologic and/or thiopurine. In this analysis, there were no differences in the rate of adverse events reported, subsequent COVID-19 infections, or COVID-19 related hospitalizations between IBD and non-IBD patients. In addition, there was not a higher rate of adverse events after vaccination between those on a biologic or immunomodulator compared. The authors state that there were ≤10 breakthrough infections in patients on a biologic or immunomodulator, although did not perform a statistical comparison to IBD patients not on immunosuppressive therapies.

These manuscripts evaluated outcomes in large cohorts of IBD patients, although the results are limited by the fact that they relied on diagnosis coding for inclusion of IBD patients and recording of events. Furthermore, it is likely that many patients with SARS-CoV-2 infections are diagnosed outside an individuals’ healthcare system limiting capturing of events for their analyses. Nevertheless, these studies clearly demonstrate safety and efficacy of COVID-19 vaccination in patients with IBD. Further work is needed, however, to evaluate real-world long-term efficacy of vaccination in IBD patients on immunosuppressive therapy.

Both IBD and SARS-CoV-2 increase an individual’s risk of a venous thromboembolism (VTE). Using a veteran’s administrations (VA) cohort, Mahmud and colleagues identified 428 patients with IBD who developed a VTE within the one year study period. After adjusting for recent hospitalizations and steroid exposure, SARS-CoV-2 infection was associated with an 8.15-fold increased risk of VTE (95% CI 4.34-15.30). This study is limited by the fact that there were just 21 events of VTE after a SARS-CoV-2 infection. If the results are validated in an independent larger cohort of patients, however, practitioners should consider VTE prophylaxis in IBD patients with a SARS-CoV-2 infection.

In a real-world test, tofacitinib had a similar safety profile to what was seen in clinical trials. The majority of adverse events seen were infections, and few were serious; however, the study did find evidence of rare venous thromboembolism (VTE) in patients with preexisting risk factors, which suggests that precaution is warranted in this group.

Tofacitinib, a Janus kinase inhibitor, was approved by the Food and Drug Administration in 2018 for adults with moderate to severe ulcerative colitis (UC). Three phase 3 clinical trials and an open-label, long-term extension trial found that the drug was associated with increased infection rates and higher lipid levels.

In rheumatoid arthritis patients, an interim analysis of a safety clinical trial of twice-daily doses of 10 mg tofacitinib showed increased rates of pulmonary embolism and all-cause mortality, compared to treatment with a dose of 5 mg or a tumor necrosis factor antagonist. That finding led to a black box label warning against thrombosis.

The current study, led by Parakkal Deepak, MBBS, MS, and colleagues and published in Clinical Gastroenterology and Hepatology, included patients from six centers in the United States.

The findings suggest that patients should be counseled about the potential risk for herpes zoster (HZ) reactivation, especially older patients taking corticosteroids. The authors also recommended vaccination with an inactivated HZ vaccine. “Our data suggest a careful risk-benefit discussion before starting tofacitinib, especially in patients with preexisting risk factors for VTE, dose deescalation to the lowest clinically feasible dose, and monitoring for clinical signs of VTE, especially among those who continue on a dose of 10 mg twice a day,” the authors wrote.

The researchers followed 260 patients over a median of 6 months (median age, 38 years; 58.1% male; 71.9% non-Hispanic). Overall, 88.5% had previously received treatment with a biologic, most often an anti–TNF-alpha agent (76.5%). During follow-up, 15.7% experienced adverse events, most commonly infections (5.0%) and rash (3.5%). Joint pain (1.5%) and anemia (1.5%) also occurred. The incidence rate for any adverse event was 27.2 per 100 person-years. Adverse events occurred more often in older patients (mean age, 42 vs. 37 years; P = .02) and those who had not undergone previous anti-TNF therapy (63.4% vs 79.8%; P = .03). There was no association between concomitant steroid use and adverse events on univariate analysis. Of the overall cohort, 5.8% experienced a severe adverse event, with the most common being herpes zoster rash (26.7% of severe adverse events). Therapy was discontinued by 4.6%.

Five patients developed herpes zoster (3.29 per 100 person-years; 95% CI, 1.37-7.90). Risk factors for VTE were seen in 31.2% of the cohort, and two cases of VTE occurred during follow-up (1.32 per 100 person-years; 95% CI, 0.33-5.28), both in patients with extensive UC. There was no increased risk of complications following abdominal surgery.

At baseline, 38.4% had an abnormal lipid profile, and this increased to 48.3% following 8 weeks of treatment.

Overall, 45% of patients were anemic at baseline. Females experienced a significant improvement by week 26 (median hemoglobin level, 13.0 g/dL; interquartile range, 12.5-13.8), while a similar improvement occurred by week 52 in males (median hemoglobin level, 13.6 g/dL; IQR, 12.57-14.0). At 52 weeks, the mean increase in hemoglobin was 5% (IQR, 0%-11.1%). The increase was greater in females (7.7%; IQR, 4.2%-11.7%) than in males (2.1%; IQR, –0.5% to 11.3%).

Limitations of the study include its retrospective nature and that the tools by which data were collected could have missed some adverse events because they were not adequately captured in the treating clinician’s notes. However, the data trend similarly to a prospective study.

“In summary, we report safety signals on a real-world cohort of patients with UC initiated on tofacitinib in whom increasing age is a risk factor for AEs and consistent with recent reports of a dose-dependent risk of HZ reactivation and VTE events in patients with a risk factor for VTE on the 10-mg twice-daily dosing,” the authors concluded.

The study was funded by the American College of Gastroenterology, the Crohn’s and Colitis Foundation, the Givin’ it all for Guts Foundation, and the Lawrence C. Pakula, MD, Inflammatory Bowel Disease Research Innovation and Education Fund. The authors have financial ties with various pharmaceutical companies.

This article was updated July 19, 2021.

In a real-world test, tofacitinib had a similar safety profile to what was seen in clinical trials. The majority of adverse events seen were infections, and few were serious; however, the study did find evidence of rare venous thromboembolism (VTE) in patients with preexisting risk factors, which suggests that precaution is warranted in this group.

Tofacitinib, a Janus kinase inhibitor, was approved by the Food and Drug Administration in 2018 for adults with moderate to severe ulcerative colitis (UC). Three phase 3 clinical trials and an open-label, long-term extension trial found that the drug was associated with increased infection rates and higher lipid levels.

In rheumatoid arthritis patients, an interim analysis of a safety clinical trial of twice-daily doses of 10 mg tofacitinib showed increased rates of pulmonary embolism and all-cause mortality, compared to treatment with a dose of 5 mg or a tumor necrosis factor antagonist. That finding led to a black box label warning against thrombosis.

The current study, led by Parakkal Deepak, MBBS, MS, and colleagues and published in Clinical Gastroenterology and Hepatology, included patients from six centers in the United States.

The findings suggest that patients should be counseled about the potential risk for herpes zoster (HZ) reactivation, especially older patients taking corticosteroids. The authors also recommended vaccination with an inactivated HZ vaccine. “Our data suggest a careful risk-benefit discussion before starting tofacitinib, especially in patients with preexisting risk factors for VTE, dose deescalation to the lowest clinically feasible dose, and monitoring for clinical signs of VTE, especially among those who continue on a dose of 10 mg twice a day,” the authors wrote.

The researchers followed 260 patients over a median of 6 months (median age, 38 years; 58.1% male; 71.9% non-Hispanic). Overall, 88.5% had previously received treatment with a biologic, most often an anti–TNF-alpha agent (76.5%). During follow-up, 15.7% experienced adverse events, most commonly infections (5.0%) and rash (3.5%). Joint pain (1.5%) and anemia (1.5%) also occurred. The incidence rate for any adverse event was 27.2 per 100 person-years. Adverse events occurred more often in older patients (mean age, 42 vs. 37 years; P = .02) and those who had not undergone previous anti-TNF therapy (63.4% vs 79.8%; P = .03). There was no association between concomitant steroid use and adverse events on univariate analysis. Of the overall cohort, 5.8% experienced a severe adverse event, with the most common being herpes zoster rash (26.7% of severe adverse events). Therapy was discontinued by 4.6%.

Five patients developed herpes zoster (3.29 per 100 person-years; 95% CI, 1.37-7.90). Risk factors for VTE were seen in 31.2% of the cohort, and two cases of VTE occurred during follow-up (1.32 per 100 person-years; 95% CI, 0.33-5.28), both in patients with extensive UC. There was no increased risk of complications following abdominal surgery.

At baseline, 38.4% had an abnormal lipid profile, and this increased to 48.3% following 8 weeks of treatment.

Overall, 45% of patients were anemic at baseline. Females experienced a significant improvement by week 26 (median hemoglobin level, 13.0 g/dL; interquartile range, 12.5-13.8), while a similar improvement occurred by week 52 in males (median hemoglobin level, 13.6 g/dL; IQR, 12.57-14.0). At 52 weeks, the mean increase in hemoglobin was 5% (IQR, 0%-11.1%). The increase was greater in females (7.7%; IQR, 4.2%-11.7%) than in males (2.1%; IQR, –0.5% to 11.3%).

Limitations of the study include its retrospective nature and that the tools by which data were collected could have missed some adverse events because they were not adequately captured in the treating clinician’s notes. However, the data trend similarly to a prospective study.

“In summary, we report safety signals on a real-world cohort of patients with UC initiated on tofacitinib in whom increasing age is a risk factor for AEs and consistent with recent reports of a dose-dependent risk of HZ reactivation and VTE events in patients with a risk factor for VTE on the 10-mg twice-daily dosing,” the authors concluded.

The study was funded by the American College of Gastroenterology, the Crohn’s and Colitis Foundation, the Givin’ it all for Guts Foundation, and the Lawrence C. Pakula, MD, Inflammatory Bowel Disease Research Innovation and Education Fund. The authors have financial ties with various pharmaceutical companies.

This article was updated July 19, 2021.

In a real-world test, tofacitinib had a similar safety profile to what was seen in clinical trials. The majority of adverse events seen were infections, and few were serious; however, the study did find evidence of rare venous thromboembolism (VTE) in patients with preexisting risk factors, which suggests that precaution is warranted in this group.

Tofacitinib, a Janus kinase inhibitor, was approved by the Food and Drug Administration in 2018 for adults with moderate to severe ulcerative colitis (UC). Three phase 3 clinical trials and an open-label, long-term extension trial found that the drug was associated with increased infection rates and higher lipid levels.

In rheumatoid arthritis patients, an interim analysis of a safety clinical trial of twice-daily doses of 10 mg tofacitinib showed increased rates of pulmonary embolism and all-cause mortality, compared to treatment with a dose of 5 mg or a tumor necrosis factor antagonist. That finding led to a black box label warning against thrombosis.

The current study, led by Parakkal Deepak, MBBS, MS, and colleagues and published in Clinical Gastroenterology and Hepatology, included patients from six centers in the United States.

The findings suggest that patients should be counseled about the potential risk for herpes zoster (HZ) reactivation, especially older patients taking corticosteroids. The authors also recommended vaccination with an inactivated HZ vaccine. “Our data suggest a careful risk-benefit discussion before starting tofacitinib, especially in patients with preexisting risk factors for VTE, dose deescalation to the lowest clinically feasible dose, and monitoring for clinical signs of VTE, especially among those who continue on a dose of 10 mg twice a day,” the authors wrote.

The researchers followed 260 patients over a median of 6 months (median age, 38 years; 58.1% male; 71.9% non-Hispanic). Overall, 88.5% had previously received treatment with a biologic, most often an anti–TNF-alpha agent (76.5%). During follow-up, 15.7% experienced adverse events, most commonly infections (5.0%) and rash (3.5%). Joint pain (1.5%) and anemia (1.5%) also occurred. The incidence rate for any adverse event was 27.2 per 100 person-years. Adverse events occurred more often in older patients (mean age, 42 vs. 37 years; P = .02) and those who had not undergone previous anti-TNF therapy (63.4% vs 79.8%; P = .03). There was no association between concomitant steroid use and adverse events on univariate analysis. Of the overall cohort, 5.8% experienced a severe adverse event, with the most common being herpes zoster rash (26.7% of severe adverse events). Therapy was discontinued by 4.6%.

Five patients developed herpes zoster (3.29 per 100 person-years; 95% CI, 1.37-7.90). Risk factors for VTE were seen in 31.2% of the cohort, and two cases of VTE occurred during follow-up (1.32 per 100 person-years; 95% CI, 0.33-5.28), both in patients with extensive UC. There was no increased risk of complications following abdominal surgery.

At baseline, 38.4% had an abnormal lipid profile, and this increased to 48.3% following 8 weeks of treatment.

Overall, 45% of patients were anemic at baseline. Females experienced a significant improvement by week 26 (median hemoglobin level, 13.0 g/dL; interquartile range, 12.5-13.8), while a similar improvement occurred by week 52 in males (median hemoglobin level, 13.6 g/dL; IQR, 12.57-14.0). At 52 weeks, the mean increase in hemoglobin was 5% (IQR, 0%-11.1%). The increase was greater in females (7.7%; IQR, 4.2%-11.7%) than in males (2.1%; IQR, –0.5% to 11.3%).

Limitations of the study include its retrospective nature and that the tools by which data were collected could have missed some adverse events because they were not adequately captured in the treating clinician’s notes. However, the data trend similarly to a prospective study.

“In summary, we report safety signals on a real-world cohort of patients with UC initiated on tofacitinib in whom increasing age is a risk factor for AEs and consistent with recent reports of a dose-dependent risk of HZ reactivation and VTE events in patients with a risk factor for VTE on the 10-mg twice-daily dosing,” the authors concluded.

The study was funded by the American College of Gastroenterology, the Crohn’s and Colitis Foundation, the Givin’ it all for Guts Foundation, and the Lawrence C. Pakula, MD, Inflammatory Bowel Disease Research Innovation and Education Fund. The authors have financial ties with various pharmaceutical companies.

This article was updated July 19, 2021.