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Lupus highlights from EULAR 2021
Dr. Richard Furie presents highlights in systemic lupus erythematosus (SLE) and its various complications—such as lupus nephritis (LN), pulmonary involvement, and cutaneous manifestations—from the EULAR 2021 Virtual Congress.
The 6-month open-label extension of BLISS-LN assessed patients with LN after 2 years of double-blind treatment. Primary efficacy renal response and complete renal response (CRR) increased in both the belimumab-naïve and belimumab-experienced groups, with no new safety concerns.
The phase 2 TULIP-LN trial evaluated anifrolumab vs placebo alongside standard therapy in patients with active proliferative LN. Anifrolumab 900 mg for 3 doses, 300 mg thereafter was associated with improvements in CRR at week 52.
Another phase 2 study assessed BI 655064 vs placebo in patients with active proliferative LN. A high response to placebo prompted an exploratory analysis requiring confirmation of endpoint during weeks 46 and 52. Proportions of patients achieving confirmed CRR were higher in the 180- and 240-mg dosing groups vs placebo.
A single-center cohort of 300 patients assessed the frequency of pulmonary involvement; 16% had interstitial lung disease, nearly 7% had pulmonary hypertension, and 3% had shrinking lung syndrome.
The last 2 presentations are on cutaneous lupus. In one study, iberdomide had beneficial effects on cutaneous manifestations in patients with SLE, particularly those with subacute and chronic acute subtypes as well as those with high Aiolos or interferon gene expression signatures.
Lastly, a post hoc analysis of a phase 2 study evaluated the effects of BIIB059 on cutaneous lupus, and found that a greater proportion of participants achieved milder skin disease or clear/almost clear skin status in the BIIB059 groups vs placebo.
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Professor, Department of Medicine, Zucker School of Medicine, Hofstra/Northwell, Hempstead;
Chief, Department of Medicine, Division of Rheumatology, Northwell Health
Great Neck, New York
Richard Furie, MD, has disclosed the following relevant financial relationships:
Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AstraZeneca; Biogen; Boehringer Ingelheim; Bristol-Myers Squibb; GlaxoSmithKline
Received research grant from: AstraZeneca; Biogen; Bristol-Myers Squibb; Boehringer Ingelheim; GlaxoSmithKline
Received income in an amount equal to or greater than $250 from: AstraZeneca; Biogen; Bristol-Myers Squibb; Boehringer Ingelheim; GlaxoSmithKline
Dr. Richard Furie presents highlights in systemic lupus erythematosus (SLE) and its various complications—such as lupus nephritis (LN), pulmonary involvement, and cutaneous manifestations—from the EULAR 2021 Virtual Congress.
The 6-month open-label extension of BLISS-LN assessed patients with LN after 2 years of double-blind treatment. Primary efficacy renal response and complete renal response (CRR) increased in both the belimumab-naïve and belimumab-experienced groups, with no new safety concerns.
The phase 2 TULIP-LN trial evaluated anifrolumab vs placebo alongside standard therapy in patients with active proliferative LN. Anifrolumab 900 mg for 3 doses, 300 mg thereafter was associated with improvements in CRR at week 52.
Another phase 2 study assessed BI 655064 vs placebo in patients with active proliferative LN. A high response to placebo prompted an exploratory analysis requiring confirmation of endpoint during weeks 46 and 52. Proportions of patients achieving confirmed CRR were higher in the 180- and 240-mg dosing groups vs placebo.
A single-center cohort of 300 patients assessed the frequency of pulmonary involvement; 16% had interstitial lung disease, nearly 7% had pulmonary hypertension, and 3% had shrinking lung syndrome.
The last 2 presentations are on cutaneous lupus. In one study, iberdomide had beneficial effects on cutaneous manifestations in patients with SLE, particularly those with subacute and chronic acute subtypes as well as those with high Aiolos or interferon gene expression signatures.
Lastly, a post hoc analysis of a phase 2 study evaluated the effects of BIIB059 on cutaneous lupus, and found that a greater proportion of participants achieved milder skin disease or clear/almost clear skin status in the BIIB059 groups vs placebo.
--
Professor, Department of Medicine, Zucker School of Medicine, Hofstra/Northwell, Hempstead;
Chief, Department of Medicine, Division of Rheumatology, Northwell Health
Great Neck, New York
Richard Furie, MD, has disclosed the following relevant financial relationships:
Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AstraZeneca; Biogen; Boehringer Ingelheim; Bristol-Myers Squibb; GlaxoSmithKline
Received research grant from: AstraZeneca; Biogen; Bristol-Myers Squibb; Boehringer Ingelheim; GlaxoSmithKline
Received income in an amount equal to or greater than $250 from: AstraZeneca; Biogen; Bristol-Myers Squibb; Boehringer Ingelheim; GlaxoSmithKline
Dr. Richard Furie presents highlights in systemic lupus erythematosus (SLE) and its various complications—such as lupus nephritis (LN), pulmonary involvement, and cutaneous manifestations—from the EULAR 2021 Virtual Congress.
The 6-month open-label extension of BLISS-LN assessed patients with LN after 2 years of double-blind treatment. Primary efficacy renal response and complete renal response (CRR) increased in both the belimumab-naïve and belimumab-experienced groups, with no new safety concerns.
The phase 2 TULIP-LN trial evaluated anifrolumab vs placebo alongside standard therapy in patients with active proliferative LN. Anifrolumab 900 mg for 3 doses, 300 mg thereafter was associated with improvements in CRR at week 52.
Another phase 2 study assessed BI 655064 vs placebo in patients with active proliferative LN. A high response to placebo prompted an exploratory analysis requiring confirmation of endpoint during weeks 46 and 52. Proportions of patients achieving confirmed CRR were higher in the 180- and 240-mg dosing groups vs placebo.
A single-center cohort of 300 patients assessed the frequency of pulmonary involvement; 16% had interstitial lung disease, nearly 7% had pulmonary hypertension, and 3% had shrinking lung syndrome.
The last 2 presentations are on cutaneous lupus. In one study, iberdomide had beneficial effects on cutaneous manifestations in patients with SLE, particularly those with subacute and chronic acute subtypes as well as those with high Aiolos or interferon gene expression signatures.
Lastly, a post hoc analysis of a phase 2 study evaluated the effects of BIIB059 on cutaneous lupus, and found that a greater proportion of participants achieved milder skin disease or clear/almost clear skin status in the BIIB059 groups vs placebo.
--
Professor, Department of Medicine, Zucker School of Medicine, Hofstra/Northwell, Hempstead;
Chief, Department of Medicine, Division of Rheumatology, Northwell Health
Great Neck, New York
Richard Furie, MD, has disclosed the following relevant financial relationships:
Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AstraZeneca; Biogen; Boehringer Ingelheim; Bristol-Myers Squibb; GlaxoSmithKline
Received research grant from: AstraZeneca; Biogen; Bristol-Myers Squibb; Boehringer Ingelheim; GlaxoSmithKline
Received income in an amount equal to or greater than $250 from: AstraZeneca; Biogen; Bristol-Myers Squibb; Boehringer Ingelheim; GlaxoSmithKline

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.