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.

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.

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.

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.

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.

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.

Janus kinase inhibitors (JAK inhibitors) have demonstrated efficacy in several immune mediated inflammatory conditions. Tofacitinib, which inhibits JAK3 and JAK1 greater than JAK2, was the first JAK inhibitor approved by the FDA for ulcerative colitis. In contrast to tofacitinib, filgotinib, preferentially inhibits JAK1. The efficacy of filgotinib during induction and maintenance therapy in ulcerative colitis was studied in a phase 2b/3 randomized control trial, the SELECTION trial. In this trial, 659 biologic-naïve and 689 biologic-experienced patients with moderate to severely active ulcerative colitis were randomized 2:2:1 to receive filgotinib 200mg daily, filgotinib 100mg daily, or placebo for 11 weeks. Responders to treatment with filgotinib at week 10 were rerandomized to their original dose or placebo in a 2:1 manner for a total treatment course of 58 weeks. The primary endpoint of the study was clinical remission which was defined as a Mayo endoscopy subscore of 0 or 1, rectal bleeding subscore of 0, and at least a 1-point decrease in stool frequency from baseline for a subscore of 0 or 1.

In biologic naïve patients, 26.1% of patients treated with filgotinib 200mg (P = .016) and 19.1% treated with filgotinib 100mg (P = 0.34) compared to 15.3% in the placebo groups achieved clinical remission at week 10. In patients previously treated with an anti-TNF agent or vedolizumab, 4.2% of patients receiving placebo compared to 11.5% taking filgotinib 200mg (P = 0.01) and 9.5% taking filgotinib 100 mg (P = .065) achieved clinical remission at week 10. Endoscopic remission was observed after induction therapy in 12.2% of patients receiving filgotinib 200 mg compared with 3.6% placebo in biologic naïve patients (P = .0047) and 3.4% of patients receiving filgotinib 200 mg compared to 2.1% of patients receiving placebo in biologic experienced patients (P = .43). Histologic remission was achieved in both biologic-naïve and biologic-experienced patients at the 200 mg dose significantly more frequently than in patients receiving placebo. At week 58, 37.2% of patients receiving filgotinib 200 mg and 11.2% of patients receiving placebo (P < .0001) were in clinical remission. In addition, 23.8% of patients receiving 100 mg were in clinical remission compared to 13.2% of patients in the placebo arm (P = .04). These results support that filgotinib may be another effective option for treating patients with moderate to severe ulcerative colitis.

Biosimilars to infliximab are increasingly used in clinical practice. Previous studies have demonstrated safety and efficacy of a single switch from originator to biosimilar infliximab. There is limited data, however, on performing multiple successive switches. In a multicenter prospective cohort, Hanzel et al evaluated 176 patients with inflammatory bowel disease (IBD). The investigators compared outcomes in three groups: group 1 (infliximab originator [INX] to CT-P13 to SB2; 2 switches), group 2 (CT-P13 to SB2; 1 switch) and group 3 (INX to CT-P13; 1 switch). After 12 months, there were no differences in the rates of clinical remission, treatment persistence, or fecal calprotectin. There were 3 infusion reactions in patients switched from CT-P13 to SB2 and none in the other 2 groups.  In conclusion, 2 switches of biosimilars in this prospective cohort were not associated with a change in effectiveness or safety.

The effectiveness of SARS-CoV2 vaccinations in an IBD population is not well known. In a retrospective cohort study with a median age of 68 years including 7376 unvaccinated and 7321 vaccinated veterans, Khan and Mahmud demonstrated the efficacy of full vaccination with the Pfizer or Moderna vaccine in preventing infection, severe infection, and death. In this cohort, less than half of patients were on a biologic or immunomodulator. Of the 6253 patients who were fully vaccinated, there were 7 infections and 3 serious infections compared to 197 infections, 47 serious infections, and 97 deaths in the 14,697 individuals monitored during an unvaccinated time period. Full vaccination (compared to unvaccinated) was 80.4% effective at preventing infection, 70.1% at preventing serious infection, and 87.3% effective and preventing all-cause mortality, whereas partial vaccination was 25.1% effective at preventing infection, 36.8% at preventing severe infection, and 27.3% at preventing all-cause mortality.

This study demonstrates the efficacy of full vaccination in patients with IBD with limited protection for patients receiving partial vaccination. It is limited by the fact that many patients considered unvaccinated may have been vaccinated outside the VA system, the relatively few numbers of events in vaccinated individuals, and lack of generalizability to other settings of patients with IBD as this study involved older men with relatively low rates of immunosuppression.

Janus kinase inhibitors (JAK inhibitors) have demonstrated efficacy in several immune mediated inflammatory conditions. Tofacitinib, which inhibits JAK3 and JAK1 greater than JAK2, was the first JAK inhibitor approved by the FDA for ulcerative colitis. In contrast to tofacitinib, filgotinib, preferentially inhibits JAK1. The efficacy of filgotinib during induction and maintenance therapy in ulcerative colitis was studied in a phase 2b/3 randomized control trial, the SELECTION trial. In this trial, 659 biologic-naïve and 689 biologic-experienced patients with moderate to severely active ulcerative colitis were randomized 2:2:1 to receive filgotinib 200mg daily, filgotinib 100mg daily, or placebo for 11 weeks. Responders to treatment with filgotinib at week 10 were rerandomized to their original dose or placebo in a 2:1 manner for a total treatment course of 58 weeks. The primary endpoint of the study was clinical remission which was defined as a Mayo endoscopy subscore of 0 or 1, rectal bleeding subscore of 0, and at least a 1-point decrease in stool frequency from baseline for a subscore of 0 or 1.

In biologic naïve patients, 26.1% of patients treated with filgotinib 200mg (P = .016) and 19.1% treated with filgotinib 100mg (P = 0.34) compared to 15.3% in the placebo groups achieved clinical remission at week 10. In patients previously treated with an anti-TNF agent or vedolizumab, 4.2% of patients receiving placebo compared to 11.5% taking filgotinib 200mg (P = 0.01) and 9.5% taking filgotinib 100 mg (P = .065) achieved clinical remission at week 10. Endoscopic remission was observed after induction therapy in 12.2% of patients receiving filgotinib 200 mg compared with 3.6% placebo in biologic naïve patients (P = .0047) and 3.4% of patients receiving filgotinib 200 mg compared to 2.1% of patients receiving placebo in biologic experienced patients (P = .43). Histologic remission was achieved in both biologic-naïve and biologic-experienced patients at the 200 mg dose significantly more frequently than in patients receiving placebo. At week 58, 37.2% of patients receiving filgotinib 200 mg and 11.2% of patients receiving placebo (P < .0001) were in clinical remission. In addition, 23.8% of patients receiving 100 mg were in clinical remission compared to 13.2% of patients in the placebo arm (P = .04). These results support that filgotinib may be another effective option for treating patients with moderate to severe ulcerative colitis.

Biosimilars to infliximab are increasingly used in clinical practice. Previous studies have demonstrated safety and efficacy of a single switch from originator to biosimilar infliximab. There is limited data, however, on performing multiple successive switches. In a multicenter prospective cohort, Hanzel et al evaluated 176 patients with inflammatory bowel disease (IBD). The investigators compared outcomes in three groups: group 1 (infliximab originator [INX] to CT-P13 to SB2; 2 switches), group 2 (CT-P13 to SB2; 1 switch) and group 3 (INX to CT-P13; 1 switch). After 12 months, there were no differences in the rates of clinical remission, treatment persistence, or fecal calprotectin. There were 3 infusion reactions in patients switched from CT-P13 to SB2 and none in the other 2 groups.  In conclusion, 2 switches of biosimilars in this prospective cohort were not associated with a change in effectiveness or safety.

The effectiveness of SARS-CoV2 vaccinations in an IBD population is not well known. In a retrospective cohort study with a median age of 68 years including 7376 unvaccinated and 7321 vaccinated veterans, Khan and Mahmud demonstrated the efficacy of full vaccination with the Pfizer or Moderna vaccine in preventing infection, severe infection, and death. In this cohort, less than half of patients were on a biologic or immunomodulator. Of the 6253 patients who were fully vaccinated, there were 7 infections and 3 serious infections compared to 197 infections, 47 serious infections, and 97 deaths in the 14,697 individuals monitored during an unvaccinated time period. Full vaccination (compared to unvaccinated) was 80.4% effective at preventing infection, 70.1% at preventing serious infection, and 87.3% effective and preventing all-cause mortality, whereas partial vaccination was 25.1% effective at preventing infection, 36.8% at preventing severe infection, and 27.3% at preventing all-cause mortality.

This study demonstrates the efficacy of full vaccination in patients with IBD with limited protection for patients receiving partial vaccination. It is limited by the fact that many patients considered unvaccinated may have been vaccinated outside the VA system, the relatively few numbers of events in vaccinated individuals, and lack of generalizability to other settings of patients with IBD as this study involved older men with relatively low rates of immunosuppression.

Janus kinase inhibitors (JAK inhibitors) have demonstrated efficacy in several immune mediated inflammatory conditions. Tofacitinib, which inhibits JAK3 and JAK1 greater than JAK2, was the first JAK inhibitor approved by the FDA for ulcerative colitis. In contrast to tofacitinib, filgotinib, preferentially inhibits JAK1. The efficacy of filgotinib during induction and maintenance therapy in ulcerative colitis was studied in a phase 2b/3 randomized control trial, the SELECTION trial. In this trial, 659 biologic-naïve and 689 biologic-experienced patients with moderate to severely active ulcerative colitis were randomized 2:2:1 to receive filgotinib 200mg daily, filgotinib 100mg daily, or placebo for 11 weeks. Responders to treatment with filgotinib at week 10 were rerandomized to their original dose or placebo in a 2:1 manner for a total treatment course of 58 weeks. The primary endpoint of the study was clinical remission which was defined as a Mayo endoscopy subscore of 0 or 1, rectal bleeding subscore of 0, and at least a 1-point decrease in stool frequency from baseline for a subscore of 0 or 1.

In biologic naïve patients, 26.1% of patients treated with filgotinib 200mg (P = .016) and 19.1% treated with filgotinib 100mg (P = 0.34) compared to 15.3% in the placebo groups achieved clinical remission at week 10. In patients previously treated with an anti-TNF agent or vedolizumab, 4.2% of patients receiving placebo compared to 11.5% taking filgotinib 200mg (P = 0.01) and 9.5% taking filgotinib 100 mg (P = .065) achieved clinical remission at week 10. Endoscopic remission was observed after induction therapy in 12.2% of patients receiving filgotinib 200 mg compared with 3.6% placebo in biologic naïve patients (P = .0047) and 3.4% of patients receiving filgotinib 200 mg compared to 2.1% of patients receiving placebo in biologic experienced patients (P = .43). Histologic remission was achieved in both biologic-naïve and biologic-experienced patients at the 200 mg dose significantly more frequently than in patients receiving placebo. At week 58, 37.2% of patients receiving filgotinib 200 mg and 11.2% of patients receiving placebo (P < .0001) were in clinical remission. In addition, 23.8% of patients receiving 100 mg were in clinical remission compared to 13.2% of patients in the placebo arm (P = .04). These results support that filgotinib may be another effective option for treating patients with moderate to severe ulcerative colitis.

Biosimilars to infliximab are increasingly used in clinical practice. Previous studies have demonstrated safety and efficacy of a single switch from originator to biosimilar infliximab. There is limited data, however, on performing multiple successive switches. In a multicenter prospective cohort, Hanzel et al evaluated 176 patients with inflammatory bowel disease (IBD). The investigators compared outcomes in three groups: group 1 (infliximab originator [INX] to CT-P13 to SB2; 2 switches), group 2 (CT-P13 to SB2; 1 switch) and group 3 (INX to CT-P13; 1 switch). After 12 months, there were no differences in the rates of clinical remission, treatment persistence, or fecal calprotectin. There were 3 infusion reactions in patients switched from CT-P13 to SB2 and none in the other 2 groups.  In conclusion, 2 switches of biosimilars in this prospective cohort were not associated with a change in effectiveness or safety.

The effectiveness of SARS-CoV2 vaccinations in an IBD population is not well known. In a retrospective cohort study with a median age of 68 years including 7376 unvaccinated and 7321 vaccinated veterans, Khan and Mahmud demonstrated the efficacy of full vaccination with the Pfizer or Moderna vaccine in preventing infection, severe infection, and death. In this cohort, less than half of patients were on a biologic or immunomodulator. Of the 6253 patients who were fully vaccinated, there were 7 infections and 3 serious infections compared to 197 infections, 47 serious infections, and 97 deaths in the 14,697 individuals monitored during an unvaccinated time period. Full vaccination (compared to unvaccinated) was 80.4% effective at preventing infection, 70.1% at preventing serious infection, and 87.3% effective and preventing all-cause mortality, whereas partial vaccination was 25.1% effective at preventing infection, 36.8% at preventing severe infection, and 27.3% at preventing all-cause mortality.

This study demonstrates the efficacy of full vaccination in patients with IBD with limited protection for patients receiving partial vaccination. It is limited by the fact that many patients considered unvaccinated may have been vaccinated outside the VA system, the relatively few numbers of events in vaccinated individuals, and lack of generalizability to other settings of patients with IBD as this study involved older men with relatively low rates of immunosuppression.

Key clinical point: Prognosis was similar among patients with metastatic colorectal cancer (mCRC) receiving intensive chemotherapy aged 80 years or older vs. those younger than 80 years. These findings do not recommend avoiding intensive chemotherapy for patients with mCRC only because of older age.

Major finding: Among patients who received intensive chemotherapy, the 5-year overall survival (OS) was comparable among those aged 80 years vs. those younger (13.6% vs. 21.4%; P = .58). Moreover, age of 80 years and older was not an independent risk factor for OS (adjusted hazard ratio, 1.29; 95% confidence interval, 0.84-2.00).

Study details: Findings are from a population-based cohort study of 1,260 patients with mCRC. Patients were classified into those aged 80 years or older (n=234) or those younger than 80 years (n=1,026) during diagnosis.

Disclosures: There was no financial support for this research. The authors declared no conflicts of interest.

Source: Nakayama Y et al. Int J Clin Oncol. 2021 Jun 5. doi: 10.1007/s10147-021-01909-9.

Key clinical point: Prognosis was similar among patients with metastatic colorectal cancer (mCRC) receiving intensive chemotherapy aged 80 years or older vs. those younger than 80 years. These findings do not recommend avoiding intensive chemotherapy for patients with mCRC only because of older age.

Major finding: Among patients who received intensive chemotherapy, the 5-year overall survival (OS) was comparable among those aged 80 years vs. those younger (13.6% vs. 21.4%; P = .58). Moreover, age of 80 years and older was not an independent risk factor for OS (adjusted hazard ratio, 1.29; 95% confidence interval, 0.84-2.00).

Study details: Findings are from a population-based cohort study of 1,260 patients with mCRC. Patients were classified into those aged 80 years or older (n=234) or those younger than 80 years (n=1,026) during diagnosis.

Disclosures: There was no financial support for this research. The authors declared no conflicts of interest.

Source: Nakayama Y et al. Int J Clin Oncol. 2021 Jun 5. doi: 10.1007/s10147-021-01909-9.

Key clinical point: Prognosis was similar among patients with metastatic colorectal cancer (mCRC) receiving intensive chemotherapy aged 80 years or older vs. those younger than 80 years. These findings do not recommend avoiding intensive chemotherapy for patients with mCRC only because of older age.

Major finding: Among patients who received intensive chemotherapy, the 5-year overall survival (OS) was comparable among those aged 80 years vs. those younger (13.6% vs. 21.4%; P = .58). Moreover, age of 80 years and older was not an independent risk factor for OS (adjusted hazard ratio, 1.29; 95% confidence interval, 0.84-2.00).

Study details: Findings are from a population-based cohort study of 1,260 patients with mCRC. Patients were classified into those aged 80 years or older (n=234) or those younger than 80 years (n=1,026) during diagnosis.

Disclosures: There was no financial support for this research. The authors declared no conflicts of interest.

Source: Nakayama Y et al. Int J Clin Oncol. 2021 Jun 5. doi: 10.1007/s10147-021-01909-9.

Key clinical point: Implementation of fecal immunochemical tests (FIT) as a triage test during assessment of suspected symptomatic colorectal cancer (CRC) in primary care may improve the efficiency of referrals without missing cases of CRC.

Major finding: At a cutoff value of fecal hemoglobin (f-Hb) 150 μg Hb/g or higher, FIT identified more than half of CRC cases using few resources (sensitivity, 64.1%; specificity, 95.0%), whereas an f-Hb threshold of 20 μg Hb/g feces ruled out more than 85% of CRC (specificity, 86.6%; sensitivity 84.1%) at an expected prevalence of 1%-3%.

Study details: Findings are from a systematic review and meta-analysis of 22 studies including 69,536 symptomatic patients who consulted for abdominal symptoms in primary care.

Disclosures: This study was financed by Spain’s Carlos III Health Care Institute. The authors declared no conflicts of interest.

Source: Pin-Vieito N et al. Gut. 2021 Jun 9. doi: 10.1136/gutjnl-2021-324856. 

Key clinical point: Implementation of fecal immunochemical tests (FIT) as a triage test during assessment of suspected symptomatic colorectal cancer (CRC) in primary care may improve the efficiency of referrals without missing cases of CRC.

Major finding: At a cutoff value of fecal hemoglobin (f-Hb) 150 μg Hb/g or higher, FIT identified more than half of CRC cases using few resources (sensitivity, 64.1%; specificity, 95.0%), whereas an f-Hb threshold of 20 μg Hb/g feces ruled out more than 85% of CRC (specificity, 86.6%; sensitivity 84.1%) at an expected prevalence of 1%-3%.

Study details: Findings are from a systematic review and meta-analysis of 22 studies including 69,536 symptomatic patients who consulted for abdominal symptoms in primary care.

Disclosures: This study was financed by Spain’s Carlos III Health Care Institute. The authors declared no conflicts of interest.

Source: Pin-Vieito N et al. Gut. 2021 Jun 9. doi: 10.1136/gutjnl-2021-324856. 

Key clinical point: Implementation of fecal immunochemical tests (FIT) as a triage test during assessment of suspected symptomatic colorectal cancer (CRC) in primary care may improve the efficiency of referrals without missing cases of CRC.

Major finding: At a cutoff value of fecal hemoglobin (f-Hb) 150 μg Hb/g or higher, FIT identified more than half of CRC cases using few resources (sensitivity, 64.1%; specificity, 95.0%), whereas an f-Hb threshold of 20 μg Hb/g feces ruled out more than 85% of CRC (specificity, 86.6%; sensitivity 84.1%) at an expected prevalence of 1%-3%.

Study details: Findings are from a systematic review and meta-analysis of 22 studies including 69,536 symptomatic patients who consulted for abdominal symptoms in primary care.

Disclosures: This study was financed by Spain’s Carlos III Health Care Institute. The authors declared no conflicts of interest.

Source: Pin-Vieito N et al. Gut. 2021 Jun 9. doi: 10.1136/gutjnl-2021-324856. 

Key clinical point: Trifluridine/tipiracil (FTD/TPI) was effective and well tolerated in elderly patients with advanced colorectal cancer.

Major finding: Mean progression-free survival (PFS) was 2.3 (95% confidence interval [CI], 1.9-4.3) months, with the study meeting its predefined primary endpoint of PFS with the lower limit of 95% CI being more than 1.0 month. The median overall survival was 5.7 (95% CI, 3.7-8.9) months. Grade 3 or 4 adverse events were observed in 80% of patients, the most common being neutropenia, anemia, and anorexia.

Study details: Findings are from a single-arm phase 2 trial of 30 elderly patients aged 65 years or older who had fluoropyrimidine-refractory advanced colorectal cancer and received FTD/TPI.

Disclosures: This study was supported by the Tohoku Clinical Oncology Research and Education Society. M Takahashi and C Ishioka reported receiving lecture fees and/or funding from various sources. The remaining authors declared no conflicts of interest.

Source: Takahashi M et al. Cancer Chemother Pharmacol. 2021 May 24. doi: 10.1007/s00280-021-04277-3.

Key clinical point: Trifluridine/tipiracil (FTD/TPI) was effective and well tolerated in elderly patients with advanced colorectal cancer.

Major finding: Mean progression-free survival (PFS) was 2.3 (95% confidence interval [CI], 1.9-4.3) months, with the study meeting its predefined primary endpoint of PFS with the lower limit of 95% CI being more than 1.0 month. The median overall survival was 5.7 (95% CI, 3.7-8.9) months. Grade 3 or 4 adverse events were observed in 80% of patients, the most common being neutropenia, anemia, and anorexia.

Study details: Findings are from a single-arm phase 2 trial of 30 elderly patients aged 65 years or older who had fluoropyrimidine-refractory advanced colorectal cancer and received FTD/TPI.

Disclosures: This study was supported by the Tohoku Clinical Oncology Research and Education Society. M Takahashi and C Ishioka reported receiving lecture fees and/or funding from various sources. The remaining authors declared no conflicts of interest.

Source: Takahashi M et al. Cancer Chemother Pharmacol. 2021 May 24. doi: 10.1007/s00280-021-04277-3.

Key clinical point: Trifluridine/tipiracil (FTD/TPI) was effective and well tolerated in elderly patients with advanced colorectal cancer.

Major finding: Mean progression-free survival (PFS) was 2.3 (95% confidence interval [CI], 1.9-4.3) months, with the study meeting its predefined primary endpoint of PFS with the lower limit of 95% CI being more than 1.0 month. The median overall survival was 5.7 (95% CI, 3.7-8.9) months. Grade 3 or 4 adverse events were observed in 80% of patients, the most common being neutropenia, anemia, and anorexia.

Study details: Findings are from a single-arm phase 2 trial of 30 elderly patients aged 65 years or older who had fluoropyrimidine-refractory advanced colorectal cancer and received FTD/TPI.

Disclosures: This study was supported by the Tohoku Clinical Oncology Research and Education Society. M Takahashi and C Ishioka reported receiving lecture fees and/or funding from various sources. The remaining authors declared no conflicts of interest.

Source: Takahashi M et al. Cancer Chemother Pharmacol. 2021 May 24. doi: 10.1007/s00280-021-04277-3.