User login
Anti-TNF therapy increases risk for herpes zoster in patients with IBD
Key clinical point: The use of antitumor necrosis factor (anti-TNF) therapy was associated with an increased risk for herpes zoster (HZ) in patients with inflammatory bowel disease (IBD).
Major finding: Compared with nonuse, current use of anti-TNF therapy was associated with an increased risk for HZ (adjusted odds ratio [aOR], 1.5; 95% confidence interval [CI], 1.1-2.1), particularly in patients below 50 years of age (aOR, 2.0; 95% CI, 1.2-3.5) and those additionally using steroids and immunosuppressants (aOR, 4.1; 95% CI, 2.3-7.2).
Study details: This was a nested case-control study of 15,454 patients with incident IBD. Patients diagnosed with HZ (n=824) were matched with 8,240 HZ-free controls.
Disclosures: The study was supported by the Division of Gastroenterology and Hepatology McGill University health center. Some of the authors reported serving as a speaker, advisory board member, and/or receiving unrestricted research grants from various sources.
Source: Santella C et al. Inflamm Bowel Dis. 2021 May 17. doi: 10.1093/ibd/izab092.
Key clinical point: The use of antitumor necrosis factor (anti-TNF) therapy was associated with an increased risk for herpes zoster (HZ) in patients with inflammatory bowel disease (IBD).
Major finding: Compared with nonuse, current use of anti-TNF therapy was associated with an increased risk for HZ (adjusted odds ratio [aOR], 1.5; 95% confidence interval [CI], 1.1-2.1), particularly in patients below 50 years of age (aOR, 2.0; 95% CI, 1.2-3.5) and those additionally using steroids and immunosuppressants (aOR, 4.1; 95% CI, 2.3-7.2).
Study details: This was a nested case-control study of 15,454 patients with incident IBD. Patients diagnosed with HZ (n=824) were matched with 8,240 HZ-free controls.
Disclosures: The study was supported by the Division of Gastroenterology and Hepatology McGill University health center. Some of the authors reported serving as a speaker, advisory board member, and/or receiving unrestricted research grants from various sources.
Source: Santella C et al. Inflamm Bowel Dis. 2021 May 17. doi: 10.1093/ibd/izab092.
Key clinical point: The use of antitumor necrosis factor (anti-TNF) therapy was associated with an increased risk for herpes zoster (HZ) in patients with inflammatory bowel disease (IBD).
Major finding: Compared with nonuse, current use of anti-TNF therapy was associated with an increased risk for HZ (adjusted odds ratio [aOR], 1.5; 95% confidence interval [CI], 1.1-2.1), particularly in patients below 50 years of age (aOR, 2.0; 95% CI, 1.2-3.5) and those additionally using steroids and immunosuppressants (aOR, 4.1; 95% CI, 2.3-7.2).
Study details: This was a nested case-control study of 15,454 patients with incident IBD. Patients diagnosed with HZ (n=824) were matched with 8,240 HZ-free controls.
Disclosures: The study was supported by the Division of Gastroenterology and Hepatology McGill University health center. Some of the authors reported serving as a speaker, advisory board member, and/or receiving unrestricted research grants from various sources.
Source: Santella C et al. Inflamm Bowel Dis. 2021 May 17. doi: 10.1093/ibd/izab092.
Obesity tied to early readmission risk in patients hospitalized with IBD
Key clinical point: Obesity among patients with inflammatory bowel disease (IBD) was associated with significantly higher all-cause early readmission than nonobese patients with IBD.
Major finding: Independent association was observed between obesity and higher all-cause readmission rates at 30 days (adjusted odds ratio [aOR], 1.16; P = .005) and 90 days (aOR, 1.27; P less than .0001) compared with those without obesity.
Study details: Findings are from a retrospective cohort study of 143,190 patients hospitalized with IBD, of which 9.1% of patients were obese (body mass index [BMI], 30 kg/m2 or higher) and the remaining 90.9% were nonobese (BMI less than 30 kg/m2).
Disclosures: No funding information was reported. The authors had no financial disclosures and conflicts of interest relevant to this article.
Source: Weissman S et al. J Crohns Colitis. 2021 May 17. doi: 10.1093/ecco-jcc/jjab088.
Key clinical point: Obesity among patients with inflammatory bowel disease (IBD) was associated with significantly higher all-cause early readmission than nonobese patients with IBD.
Major finding: Independent association was observed between obesity and higher all-cause readmission rates at 30 days (adjusted odds ratio [aOR], 1.16; P = .005) and 90 days (aOR, 1.27; P less than .0001) compared with those without obesity.
Study details: Findings are from a retrospective cohort study of 143,190 patients hospitalized with IBD, of which 9.1% of patients were obese (body mass index [BMI], 30 kg/m2 or higher) and the remaining 90.9% were nonobese (BMI less than 30 kg/m2).
Disclosures: No funding information was reported. The authors had no financial disclosures and conflicts of interest relevant to this article.
Source: Weissman S et al. J Crohns Colitis. 2021 May 17. doi: 10.1093/ecco-jcc/jjab088.
Key clinical point: Obesity among patients with inflammatory bowel disease (IBD) was associated with significantly higher all-cause early readmission than nonobese patients with IBD.
Major finding: Independent association was observed between obesity and higher all-cause readmission rates at 30 days (adjusted odds ratio [aOR], 1.16; P = .005) and 90 days (aOR, 1.27; P less than .0001) compared with those without obesity.
Study details: Findings are from a retrospective cohort study of 143,190 patients hospitalized with IBD, of which 9.1% of patients were obese (body mass index [BMI], 30 kg/m2 or higher) and the remaining 90.9% were nonobese (BMI less than 30 kg/m2).
Disclosures: No funding information was reported. The authors had no financial disclosures and conflicts of interest relevant to this article.
Source: Weissman S et al. J Crohns Colitis. 2021 May 17. doi: 10.1093/ecco-jcc/jjab088.
Hyperbaric oxygen therapy safe and effective in various IBD phenotypes
Key clinical point: Hyperbaric oxygen therapy (HBOT) was safe and associated with substantial rates of clinical remission in patients with various inflammatory bowel disease (IBD) phenotypes refractory to conventional therapies.
Major finding: HBOT resulted in substantial rates of clinical remission across multiple IBD phenotypes including ulcerative colitis (67%; 95% confidence interval [CI], 39%-86%), luminal Crohn’s disease (CD; 87.5%; 95% CI, 46.3%-98.3%), perianal CD (55%; 95% CI, 44%-65%), inflammatory disorders of the pouch (31%; 95% CI, 16%-50%), pyoderma gangrenosum (91.7%; 95% CI, 37.8%-99.5%), and perianal sinus/metastatic CD (65.2%; 95% CI, 10%-96.9%). Overall, 15% of patients reported minor adverse events.
Study details: Data come from a systematic review and proportional meta-analysis of 19 studies.
Disclosures: No information on funding was available. Some of the authors disclosed receiving consultancy fees and/or honoraria from multiple sources. All other authors had no conflicts of interest to disclose.
Source: McCurdy J et al. Inflamm Bowel Dis. 2021 May 18. doi: 10.1093/ibd/izab098.
Key clinical point: Hyperbaric oxygen therapy (HBOT) was safe and associated with substantial rates of clinical remission in patients with various inflammatory bowel disease (IBD) phenotypes refractory to conventional therapies.
Major finding: HBOT resulted in substantial rates of clinical remission across multiple IBD phenotypes including ulcerative colitis (67%; 95% confidence interval [CI], 39%-86%), luminal Crohn’s disease (CD; 87.5%; 95% CI, 46.3%-98.3%), perianal CD (55%; 95% CI, 44%-65%), inflammatory disorders of the pouch (31%; 95% CI, 16%-50%), pyoderma gangrenosum (91.7%; 95% CI, 37.8%-99.5%), and perianal sinus/metastatic CD (65.2%; 95% CI, 10%-96.9%). Overall, 15% of patients reported minor adverse events.
Study details: Data come from a systematic review and proportional meta-analysis of 19 studies.
Disclosures: No information on funding was available. Some of the authors disclosed receiving consultancy fees and/or honoraria from multiple sources. All other authors had no conflicts of interest to disclose.
Source: McCurdy J et al. Inflamm Bowel Dis. 2021 May 18. doi: 10.1093/ibd/izab098.
Key clinical point: Hyperbaric oxygen therapy (HBOT) was safe and associated with substantial rates of clinical remission in patients with various inflammatory bowel disease (IBD) phenotypes refractory to conventional therapies.
Major finding: HBOT resulted in substantial rates of clinical remission across multiple IBD phenotypes including ulcerative colitis (67%; 95% confidence interval [CI], 39%-86%), luminal Crohn’s disease (CD; 87.5%; 95% CI, 46.3%-98.3%), perianal CD (55%; 95% CI, 44%-65%), inflammatory disorders of the pouch (31%; 95% CI, 16%-50%), pyoderma gangrenosum (91.7%; 95% CI, 37.8%-99.5%), and perianal sinus/metastatic CD (65.2%; 95% CI, 10%-96.9%). Overall, 15% of patients reported minor adverse events.
Study details: Data come from a systematic review and proportional meta-analysis of 19 studies.
Disclosures: No information on funding was available. Some of the authors disclosed receiving consultancy fees and/or honoraria from multiple sources. All other authors had no conflicts of interest to disclose.
Source: McCurdy J et al. Inflamm Bowel Dis. 2021 May 18. doi: 10.1093/ibd/izab098.
Multiple switches from infliximab to biosimilars effective and safe in IBD
Key clinical point: In patients with inflammatory bowel disease (IBD), multiple successive switching from originator infliximab (IFX) to biosimilars (CT-P13 and SB2) was effective and safe, particularly if patients were in remission during the switch.
Major finding: At 12 months after the most recent switch, 76.9%, 65.7%, and 76.9% of patients successively switching from IFX to CT-P13 and then to SB2, from CT-P13 to SB2, and from IFX to CT-P13, respectively, were in clinical remission. Rate of clinical remission (P = .375), C-reactive protein (P = .582), and fecal calprotectin remission (P = .641) was not significantly different between the 3 groups. Overall, infusion reactions occurred in 1.7% of patients.
Study details: Data come from a multicenter prospective cohort study of 176 patients with IBD who switched from originator IFX to CT-P13 and then to SB2 (n=69), from CT-P13 to SB2 (n=80), or from IFX to CT-P13 (n=27).
Disclosures: No information on funding was available. Some of the authors reported serving on advisory boards or as a speaker or consultant for and receiving speaker’s fees, consultancy fees, and/or honoraria from multiple sources.
Source: Hanzel J et al. Inflamm Bowel Dis. 2021 May 20. doi: 10.1093/ibd/izab099.
Key clinical point: In patients with inflammatory bowel disease (IBD), multiple successive switching from originator infliximab (IFX) to biosimilars (CT-P13 and SB2) was effective and safe, particularly if patients were in remission during the switch.
Major finding: At 12 months after the most recent switch, 76.9%, 65.7%, and 76.9% of patients successively switching from IFX to CT-P13 and then to SB2, from CT-P13 to SB2, and from IFX to CT-P13, respectively, were in clinical remission. Rate of clinical remission (P = .375), C-reactive protein (P = .582), and fecal calprotectin remission (P = .641) was not significantly different between the 3 groups. Overall, infusion reactions occurred in 1.7% of patients.
Study details: Data come from a multicenter prospective cohort study of 176 patients with IBD who switched from originator IFX to CT-P13 and then to SB2 (n=69), from CT-P13 to SB2 (n=80), or from IFX to CT-P13 (n=27).
Disclosures: No information on funding was available. Some of the authors reported serving on advisory boards or as a speaker or consultant for and receiving speaker’s fees, consultancy fees, and/or honoraria from multiple sources.
Source: Hanzel J et al. Inflamm Bowel Dis. 2021 May 20. doi: 10.1093/ibd/izab099.
Key clinical point: In patients with inflammatory bowel disease (IBD), multiple successive switching from originator infliximab (IFX) to biosimilars (CT-P13 and SB2) was effective and safe, particularly if patients were in remission during the switch.
Major finding: At 12 months after the most recent switch, 76.9%, 65.7%, and 76.9% of patients successively switching from IFX to CT-P13 and then to SB2, from CT-P13 to SB2, and from IFX to CT-P13, respectively, were in clinical remission. Rate of clinical remission (P = .375), C-reactive protein (P = .582), and fecal calprotectin remission (P = .641) was not significantly different between the 3 groups. Overall, infusion reactions occurred in 1.7% of patients.
Study details: Data come from a multicenter prospective cohort study of 176 patients with IBD who switched from originator IFX to CT-P13 and then to SB2 (n=69), from CT-P13 to SB2 (n=80), or from IFX to CT-P13 (n=27).
Disclosures: No information on funding was available. Some of the authors reported serving on advisory boards or as a speaker or consultant for and receiving speaker’s fees, consultancy fees, and/or honoraria from multiple sources.
Source: Hanzel J et al. Inflamm Bowel Dis. 2021 May 20. doi: 10.1093/ibd/izab099.
Crohn’s disease: Comparative efficacy of higher vs. standard dose adalimumab maintenance regimen
Key clinical point: High-dose (HD) adalimumab maintenance regimen was associated with lower risk for treatment failure than standard dose (SD) regimen in patients with Crohn’s disease (CD) who failed antitumor necrosis factor (anti-TNF) therapy.
Major finding: The median time to treatment failure was 6.6 years vs. 3.0 years in the HD vs. SD group (log-rank test P = .006). The risk for treatment failure was lower in the HD vs. SD group (hazard ratio, 0.27; P = .002).
Study details: Findings are from a retrospective study of 117 patients with CD who failed anti-TNF and received adalimumab. Post induction, patients received either HD (40 mg weekly or 80 mg every other week; n=40) or SD (40 mg every other week; n=77) adalimumab maintenance regimen.
Disclosures: No information on funding was available. Some of the authors reported receiving honoraria, research grants/support, and/or consulting fees from various sources.
Source: Narula N et al. J Gastroenterol Hepatol. 2021 May 21. doi: 10.1111/jgh.15551.
Key clinical point: High-dose (HD) adalimumab maintenance regimen was associated with lower risk for treatment failure than standard dose (SD) regimen in patients with Crohn’s disease (CD) who failed antitumor necrosis factor (anti-TNF) therapy.
Major finding: The median time to treatment failure was 6.6 years vs. 3.0 years in the HD vs. SD group (log-rank test P = .006). The risk for treatment failure was lower in the HD vs. SD group (hazard ratio, 0.27; P = .002).
Study details: Findings are from a retrospective study of 117 patients with CD who failed anti-TNF and received adalimumab. Post induction, patients received either HD (40 mg weekly or 80 mg every other week; n=40) or SD (40 mg every other week; n=77) adalimumab maintenance regimen.
Disclosures: No information on funding was available. Some of the authors reported receiving honoraria, research grants/support, and/or consulting fees from various sources.
Source: Narula N et al. J Gastroenterol Hepatol. 2021 May 21. doi: 10.1111/jgh.15551.
Key clinical point: High-dose (HD) adalimumab maintenance regimen was associated with lower risk for treatment failure than standard dose (SD) regimen in patients with Crohn’s disease (CD) who failed antitumor necrosis factor (anti-TNF) therapy.
Major finding: The median time to treatment failure was 6.6 years vs. 3.0 years in the HD vs. SD group (log-rank test P = .006). The risk for treatment failure was lower in the HD vs. SD group (hazard ratio, 0.27; P = .002).
Study details: Findings are from a retrospective study of 117 patients with CD who failed anti-TNF and received adalimumab. Post induction, patients received either HD (40 mg weekly or 80 mg every other week; n=40) or SD (40 mg every other week; n=77) adalimumab maintenance regimen.
Disclosures: No information on funding was available. Some of the authors reported receiving honoraria, research grants/support, and/or consulting fees from various sources.
Source: Narula N et al. J Gastroenterol Hepatol. 2021 May 21. doi: 10.1111/jgh.15551.
Encouraging evidence supports tofacitinib use in refractory pediatric IBD
Key clinical point: Tofacitinib induced rapid clinical response with sustained efficacy in nearly half of the pediatric and young adults with medically refractory inflammatory bowel disease (IBD) with a safety profile similar to that in adults.
Major finding: By the end of 12-week induction period, 81% of patients remained on tofacitinib therapy with 42.9% showing clinical response and 33.3% in steroid-free remission. By 52 weeks, 58.8% remained on tofacitinib and 41.2% showed clinical response and were in steroid-free remission. There were 11 serious adverse events requiring hospitalization including 1 instance of sterile intra-abdominal abscess. Instances of thrombi, zoster reactivation, or clinically significant hyperlipidemia were not observed.
Study details: Findings are from a retrospective chart review of 21 patients aged 21 years or younger who were initiated on tofacitinib after failing at least 1 previous biologic therapy.
Disclosures: The authors do not disclose funding source.
Source: Moore H et al. J Pediatr Gastroenterol Nutr. 2021 Jun 1. doi: 10.1097/MPG.0000000000003190.
Key clinical point: Tofacitinib induced rapid clinical response with sustained efficacy in nearly half of the pediatric and young adults with medically refractory inflammatory bowel disease (IBD) with a safety profile similar to that in adults.
Major finding: By the end of 12-week induction period, 81% of patients remained on tofacitinib therapy with 42.9% showing clinical response and 33.3% in steroid-free remission. By 52 weeks, 58.8% remained on tofacitinib and 41.2% showed clinical response and were in steroid-free remission. There were 11 serious adverse events requiring hospitalization including 1 instance of sterile intra-abdominal abscess. Instances of thrombi, zoster reactivation, or clinically significant hyperlipidemia were not observed.
Study details: Findings are from a retrospective chart review of 21 patients aged 21 years or younger who were initiated on tofacitinib after failing at least 1 previous biologic therapy.
Disclosures: The authors do not disclose funding source.
Source: Moore H et al. J Pediatr Gastroenterol Nutr. 2021 Jun 1. doi: 10.1097/MPG.0000000000003190.
Key clinical point: Tofacitinib induced rapid clinical response with sustained efficacy in nearly half of the pediatric and young adults with medically refractory inflammatory bowel disease (IBD) with a safety profile similar to that in adults.
Major finding: By the end of 12-week induction period, 81% of patients remained on tofacitinib therapy with 42.9% showing clinical response and 33.3% in steroid-free remission. By 52 weeks, 58.8% remained on tofacitinib and 41.2% showed clinical response and were in steroid-free remission. There were 11 serious adverse events requiring hospitalization including 1 instance of sterile intra-abdominal abscess. Instances of thrombi, zoster reactivation, or clinically significant hyperlipidemia were not observed.
Study details: Findings are from a retrospective chart review of 21 patients aged 21 years or younger who were initiated on tofacitinib after failing at least 1 previous biologic therapy.
Disclosures: The authors do not disclose funding source.
Source: Moore H et al. J Pediatr Gastroenterol Nutr. 2021 Jun 1. doi: 10.1097/MPG.0000000000003190.
IBD: No link between prior anti-TNF immunogenicity and increased anti-drug antibodies to VDZ or UST
Key clinical point: Prior immunogenicity to anti-tumor necrosis factor (TNF) agents did not confer an increased risk for subsequent immunogenicity to ustekinumab (UST) or vedolizumab (VED) in patients with inflammatory bowel disease (IBD).
Major finding: The rates of anti-drug antibody (ADA) development to VDZ and UST were not significantly different among patients with vs. without prior immunogenecity to anti-TNF therapy (2.7% vs. 0.9%; P = .54).
Study details: Findings are from a retrospective study of pediatric and adult patients with IBD who had previous exposure to anti-TNF drugs with ADA levels monitored and were subsequently exposed to VDZ or UST drug and had ADA levels checked during maintenance.
Disclosures: The study did not receive any funding. MC Dubinsky and RC Ungaro declared being consultant and/or advisory board member and/or receiving research support from various sources. The other authors declared no conflicts of interest.
Source: Costable NJ et al. Dig Dis Sci. 2021 May 21. doi: 10.1007/s10620-021-07046-7.
Key clinical point: Prior immunogenicity to anti-tumor necrosis factor (TNF) agents did not confer an increased risk for subsequent immunogenicity to ustekinumab (UST) or vedolizumab (VED) in patients with inflammatory bowel disease (IBD).
Major finding: The rates of anti-drug antibody (ADA) development to VDZ and UST were not significantly different among patients with vs. without prior immunogenecity to anti-TNF therapy (2.7% vs. 0.9%; P = .54).
Study details: Findings are from a retrospective study of pediatric and adult patients with IBD who had previous exposure to anti-TNF drugs with ADA levels monitored and were subsequently exposed to VDZ or UST drug and had ADA levels checked during maintenance.
Disclosures: The study did not receive any funding. MC Dubinsky and RC Ungaro declared being consultant and/or advisory board member and/or receiving research support from various sources. The other authors declared no conflicts of interest.
Source: Costable NJ et al. Dig Dis Sci. 2021 May 21. doi: 10.1007/s10620-021-07046-7.
Key clinical point: Prior immunogenicity to anti-tumor necrosis factor (TNF) agents did not confer an increased risk for subsequent immunogenicity to ustekinumab (UST) or vedolizumab (VED) in patients with inflammatory bowel disease (IBD).
Major finding: The rates of anti-drug antibody (ADA) development to VDZ and UST were not significantly different among patients with vs. without prior immunogenecity to anti-TNF therapy (2.7% vs. 0.9%; P = .54).
Study details: Findings are from a retrospective study of pediatric and adult patients with IBD who had previous exposure to anti-TNF drugs with ADA levels monitored and were subsequently exposed to VDZ or UST drug and had ADA levels checked during maintenance.
Disclosures: The study did not receive any funding. MC Dubinsky and RC Ungaro declared being consultant and/or advisory board member and/or receiving research support from various sources. The other authors declared no conflicts of interest.
Source: Costable NJ et al. Dig Dis Sci. 2021 May 21. doi: 10.1007/s10620-021-07046-7.
IBD: Switching from ADA originator to biosimilar SB5 appears effective and safe
Key clinical point: Switching from adalimumab (ADA) originator to the biosimilar SB5 was safe with acceptable drug persistence and no change in biochemical activity over time in a large real-world cohort of patients with inflammatory bowel disease (IBD).
Major finding: At 26 and 52 weeks, 84.6% and 70.8% of patients who switched from ADA to SB5 remained on SB5 treatment, respectively. The proportion of patients in biochemical remission (P = .80), fecal biomarker remission (P = .40), and clinical remission (P = .53) was similar at baseline, week 26, and week 52 following the switch. Injection-site pain was the most commonly reported adverse event.
Study details: Findings are from a retrospective observational study of patients with IBD who underwent an elective switch from the ADA originator to the biosimilar SB5 (n=256).
Disclosures: No funding information was reported. LAAP Derikx, SI Siakavellas, N Plevris, and CW Lees declared serving as speaker, being on advisory boards, and/or receiving grant support from various sources. The other authors had no disclosures.
Source: Derikx LAAP et al. J Crohns Colitis. 2021 Jun 5. doi: 10.1093/ecco-jcc/jjab100.
Key clinical point: Switching from adalimumab (ADA) originator to the biosimilar SB5 was safe with acceptable drug persistence and no change in biochemical activity over time in a large real-world cohort of patients with inflammatory bowel disease (IBD).
Major finding: At 26 and 52 weeks, 84.6% and 70.8% of patients who switched from ADA to SB5 remained on SB5 treatment, respectively. The proportion of patients in biochemical remission (P = .80), fecal biomarker remission (P = .40), and clinical remission (P = .53) was similar at baseline, week 26, and week 52 following the switch. Injection-site pain was the most commonly reported adverse event.
Study details: Findings are from a retrospective observational study of patients with IBD who underwent an elective switch from the ADA originator to the biosimilar SB5 (n=256).
Disclosures: No funding information was reported. LAAP Derikx, SI Siakavellas, N Plevris, and CW Lees declared serving as speaker, being on advisory boards, and/or receiving grant support from various sources. The other authors had no disclosures.
Source: Derikx LAAP et al. J Crohns Colitis. 2021 Jun 5. doi: 10.1093/ecco-jcc/jjab100.
Key clinical point: Switching from adalimumab (ADA) originator to the biosimilar SB5 was safe with acceptable drug persistence and no change in biochemical activity over time in a large real-world cohort of patients with inflammatory bowel disease (IBD).
Major finding: At 26 and 52 weeks, 84.6% and 70.8% of patients who switched from ADA to SB5 remained on SB5 treatment, respectively. The proportion of patients in biochemical remission (P = .80), fecal biomarker remission (P = .40), and clinical remission (P = .53) was similar at baseline, week 26, and week 52 following the switch. Injection-site pain was the most commonly reported adverse event.
Study details: Findings are from a retrospective observational study of patients with IBD who underwent an elective switch from the ADA originator to the biosimilar SB5 (n=256).
Disclosures: No funding information was reported. LAAP Derikx, SI Siakavellas, N Plevris, and CW Lees declared serving as speaker, being on advisory boards, and/or receiving grant support from various sources. The other authors had no disclosures.
Source: Derikx LAAP et al. J Crohns Colitis. 2021 Jun 5. doi: 10.1093/ecco-jcc/jjab100.
IBD: Full vaccination effectively reduces risk for SARS-CoV-2 infection in older patients
Key clinical point: Completion of vaccination series against SARS-CoV-2 effectively reduced subsequent infection in a Veterans Affair cohort of patients with inflammatory bowel disease (IBD) with diverse exposure to immunosuppressive medications.
Major finding: Full vaccination (more than 7 days after the second dose) was associated with a 69% reduced risk for SARS-CoV-2 infection compared with unvaccinated individuals (hazard ratio, 0.31; P less than .001). The corresponding vaccine effectiveness for full and partial vaccination status was 80.4% and 25.1%, respectively.
Study details: This retrospective study used data from Veterans Health Administration to evaluate 14,697 patients with a diagnosis of ulcerative colitis or Crohn’s disease and diverse exposure to immunosuppressive agents. About 45.2% and 54.8% of patients received the Pfizer and Moderna vaccine with 91.2% of Pfizer and 88.7% of Moderna patients receiving both vaccine doses.
Disclosures: The study did not receive any funding. Dr. N Khan declared receiving research grant from Pfizer, Luitpold, Takeda Pharmaceuticals, and Samsung BioEpis. Dr. N Mahmud is supported by an American College of Gastroenterology junior faculty development award and a Leonard Davis Institute COVID-19 rapid response grant.
Source: Khan N et al. Gastroenterology. 2021 May 25. doi: 10.1053/j.gastro.2021.05.044.
Key clinical point: Completion of vaccination series against SARS-CoV-2 effectively reduced subsequent infection in a Veterans Affair cohort of patients with inflammatory bowel disease (IBD) with diverse exposure to immunosuppressive medications.
Major finding: Full vaccination (more than 7 days after the second dose) was associated with a 69% reduced risk for SARS-CoV-2 infection compared with unvaccinated individuals (hazard ratio, 0.31; P less than .001). The corresponding vaccine effectiveness for full and partial vaccination status was 80.4% and 25.1%, respectively.
Study details: This retrospective study used data from Veterans Health Administration to evaluate 14,697 patients with a diagnosis of ulcerative colitis or Crohn’s disease and diverse exposure to immunosuppressive agents. About 45.2% and 54.8% of patients received the Pfizer and Moderna vaccine with 91.2% of Pfizer and 88.7% of Moderna patients receiving both vaccine doses.
Disclosures: The study did not receive any funding. Dr. N Khan declared receiving research grant from Pfizer, Luitpold, Takeda Pharmaceuticals, and Samsung BioEpis. Dr. N Mahmud is supported by an American College of Gastroenterology junior faculty development award and a Leonard Davis Institute COVID-19 rapid response grant.
Source: Khan N et al. Gastroenterology. 2021 May 25. doi: 10.1053/j.gastro.2021.05.044.
Key clinical point: Completion of vaccination series against SARS-CoV-2 effectively reduced subsequent infection in a Veterans Affair cohort of patients with inflammatory bowel disease (IBD) with diverse exposure to immunosuppressive medications.
Major finding: Full vaccination (more than 7 days after the second dose) was associated with a 69% reduced risk for SARS-CoV-2 infection compared with unvaccinated individuals (hazard ratio, 0.31; P less than .001). The corresponding vaccine effectiveness for full and partial vaccination status was 80.4% and 25.1%, respectively.
Study details: This retrospective study used data from Veterans Health Administration to evaluate 14,697 patients with a diagnosis of ulcerative colitis or Crohn’s disease and diverse exposure to immunosuppressive agents. About 45.2% and 54.8% of patients received the Pfizer and Moderna vaccine with 91.2% of Pfizer and 88.7% of Moderna patients receiving both vaccine doses.
Disclosures: The study did not receive any funding. Dr. N Khan declared receiving research grant from Pfizer, Luitpold, Takeda Pharmaceuticals, and Samsung BioEpis. Dr. N Mahmud is supported by an American College of Gastroenterology junior faculty development award and a Leonard Davis Institute COVID-19 rapid response grant.
Source: Khan N et al. Gastroenterology. 2021 May 25. doi: 10.1053/j.gastro.2021.05.044.
Ulcerative colitis: Filgotinib shows promise in phase 2b/3
Key clinical point: Filgotinib 200 mg once daily for up to 58 weeks effectively induced and maintained clinical remission (CR) and was well tolerated compared with placebo in both biologic-naive and biologic-experienced patients with moderately to severely active ulcerative colitis.
Major finding: CR was achieved by a greater proportion of patients treated with filgotinib 200 mg vs. placebo in both biologic-naïve (absolute difference [AD], 10.8%; P = .0157) and biologic-experienced (AD, 7.2%; P = .0103) patients at weeks 10 and 58 (AD, 26.0%; P less than .0001). Incidence of adverse events of interest and serious adverse events was similar across treatment arms.
Study details: Findings are from phase 2b/3 SELECTION trial involving 659 biologic-naive and 689 biologic-experienced patients with moderately to severely active ulcerative colitis randomly allocated to oral filgotinib 200 mg, filgotinib 100 mg, or placebo once daily.
Disclosures: The study was funded by Gilead Sciences. Some of the authors declared receiving grants, personal/consultancy fees, travel expense and/or non-financial support from; being an employee of; and/or holding stocks of various sources including Gilead Sciences.
Source: Feagan BG et al. Lancet. 2021 Jun 3. doi: 10.1016/S0140-6736(21)00666-8.
Key clinical point: Filgotinib 200 mg once daily for up to 58 weeks effectively induced and maintained clinical remission (CR) and was well tolerated compared with placebo in both biologic-naive and biologic-experienced patients with moderately to severely active ulcerative colitis.
Major finding: CR was achieved by a greater proportion of patients treated with filgotinib 200 mg vs. placebo in both biologic-naïve (absolute difference [AD], 10.8%; P = .0157) and biologic-experienced (AD, 7.2%; P = .0103) patients at weeks 10 and 58 (AD, 26.0%; P less than .0001). Incidence of adverse events of interest and serious adverse events was similar across treatment arms.
Study details: Findings are from phase 2b/3 SELECTION trial involving 659 biologic-naive and 689 biologic-experienced patients with moderately to severely active ulcerative colitis randomly allocated to oral filgotinib 200 mg, filgotinib 100 mg, or placebo once daily.
Disclosures: The study was funded by Gilead Sciences. Some of the authors declared receiving grants, personal/consultancy fees, travel expense and/or non-financial support from; being an employee of; and/or holding stocks of various sources including Gilead Sciences.
Source: Feagan BG et al. Lancet. 2021 Jun 3. doi: 10.1016/S0140-6736(21)00666-8.
Key clinical point: Filgotinib 200 mg once daily for up to 58 weeks effectively induced and maintained clinical remission (CR) and was well tolerated compared with placebo in both biologic-naive and biologic-experienced patients with moderately to severely active ulcerative colitis.
Major finding: CR was achieved by a greater proportion of patients treated with filgotinib 200 mg vs. placebo in both biologic-naïve (absolute difference [AD], 10.8%; P = .0157) and biologic-experienced (AD, 7.2%; P = .0103) patients at weeks 10 and 58 (AD, 26.0%; P less than .0001). Incidence of adverse events of interest and serious adverse events was similar across treatment arms.
Study details: Findings are from phase 2b/3 SELECTION trial involving 659 biologic-naive and 689 biologic-experienced patients with moderately to severely active ulcerative colitis randomly allocated to oral filgotinib 200 mg, filgotinib 100 mg, or placebo once daily.
Disclosures: The study was funded by Gilead Sciences. Some of the authors declared receiving grants, personal/consultancy fees, travel expense and/or non-financial support from; being an employee of; and/or holding stocks of various sources including Gilead Sciences.
Source: Feagan BG et al. Lancet. 2021 Jun 3. doi: 10.1016/S0140-6736(21)00666-8.