Clinical Edge Journal Scan

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Key clinical point: A novel biomarker incorporating albumin, lymphocytes, and C-reactive protein levels, known as the CALLY index, was a significant independent predictor of 5-year survival in HCC patients who underwent hepatectomy.

Major finding: In a multivariate analysis, 5-year survival was significantly higher in patients with a CALLY index of 5 or higher than in those with a CALLY index less than 5 (73% vs 48%).

Study details: The data come from 384 adults with HCC who underwent hepatectomy at four hospitals in Japan between January 2011 and December 2013. Researchers compared outcomes for 200 patients with a CALLY index of 5 or higher to 184 patients with an index less than 5. The index was validated using an external cohort of 267 patients from three additional hospitals.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Iida H et al. HPB (Oxford). 2021 Jun 22. doi: 10.1016/j.hpb.2021.06.414.

Key clinical point: A novel biomarker incorporating albumin, lymphocytes, and C-reactive protein levels, known as the CALLY index, was a significant independent predictor of 5-year survival in HCC patients who underwent hepatectomy.

Major finding: In a multivariate analysis, 5-year survival was significantly higher in patients with a CALLY index of 5 or higher than in those with a CALLY index less than 5 (73% vs 48%).

Study details: The data come from 384 adults with HCC who underwent hepatectomy at four hospitals in Japan between January 2011 and December 2013. Researchers compared outcomes for 200 patients with a CALLY index of 5 or higher to 184 patients with an index less than 5. The index was validated using an external cohort of 267 patients from three additional hospitals.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Iida H et al. HPB (Oxford). 2021 Jun 22. doi: 10.1016/j.hpb.2021.06.414.

Key clinical point: A novel biomarker incorporating albumin, lymphocytes, and C-reactive protein levels, known as the CALLY index, was a significant independent predictor of 5-year survival in HCC patients who underwent hepatectomy.

Major finding: In a multivariate analysis, 5-year survival was significantly higher in patients with a CALLY index of 5 or higher than in those with a CALLY index less than 5 (73% vs 48%).

Study details: The data come from 384 adults with HCC who underwent hepatectomy at four hospitals in Japan between January 2011 and December 2013. Researchers compared outcomes for 200 patients with a CALLY index of 5 or higher to 184 patients with an index less than 5. The index was validated using an external cohort of 267 patients from three additional hospitals.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Iida H et al. HPB (Oxford). 2021 Jun 22. doi: 10.1016/j.hpb.2021.06.414.

Key clinical point: Overall survival, cancer-specific survival, and 3-year recurrence-free survival rates were similar in patients with early treated microwave ablation (MWA) or robot-assisted hepatectomy (RH).

Major finding: The 3-year recurrence-free survival, overall survival, and cancer-specific survival in patients treated with MWA and RH were 52.2% and 65.8%, 91.5% and 91.3%, and 91.5% and 91.3%, respectively. 

Study details: The data come from 401 adults with early hepatocellular carcinoma treated with microwave ablation (240) or robot-assisted hepatectomy (161).

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Ding W et al. Dig Liver Dis. 2021 Jul 6. doi: 10.1016/j.dld.2021.04.008.

Key clinical point: Overall survival, cancer-specific survival, and 3-year recurrence-free survival rates were similar in patients with early treated microwave ablation (MWA) or robot-assisted hepatectomy (RH).

Major finding: The 3-year recurrence-free survival, overall survival, and cancer-specific survival in patients treated with MWA and RH were 52.2% and 65.8%, 91.5% and 91.3%, and 91.5% and 91.3%, respectively. 

Study details: The data come from 401 adults with early hepatocellular carcinoma treated with microwave ablation (240) or robot-assisted hepatectomy (161).

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Ding W et al. Dig Liver Dis. 2021 Jul 6. doi: 10.1016/j.dld.2021.04.008.

Key clinical point: Overall survival, cancer-specific survival, and 3-year recurrence-free survival rates were similar in patients with early treated microwave ablation (MWA) or robot-assisted hepatectomy (RH).

Major finding: The 3-year recurrence-free survival, overall survival, and cancer-specific survival in patients treated with MWA and RH were 52.2% and 65.8%, 91.5% and 91.3%, and 91.5% and 91.3%, respectively. 

Study details: The data come from 401 adults with early hepatocellular carcinoma treated with microwave ablation (240) or robot-assisted hepatectomy (161).

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Ding W et al. Dig Liver Dis. 2021 Jul 6. doi: 10.1016/j.dld.2021.04.008.

Key clinical point: In the real-world setting, patients with unresectable HCC who did not meet clinical trial criteria had similar responses to the treatment combination as those who met clinical trial criteria.

Major finding: The objective response rates and disease control rates of 5.2% and 82.8% at 6 weeks and 10.0% and 84.0% at 12 weeks, respectively, were similar between patients who met and did not meet the IMbrave150 clinical trial criteria, as were safety profiles.

Study details: The data come from a multicenter study of 64 adults with unresectable hepatocellular carcinoma, including 46 who did not meet the study criteria. All patients were treated with a combination of atezolizumab plus bevacizumab. Treatment response and safety issues were assessed at 6 weeks and 12 weeks.

Disclosures: The study was supported by the Japan Agency for Medical Research and Development. The researchers had no financial conflicts to disclose.

Source: Sho T et al. Hepatol Res. 2021 Jul 10. doi: 10.1111/hepr.13693.

Key clinical point: In the real-world setting, patients with unresectable HCC who did not meet clinical trial criteria had similar responses to the treatment combination as those who met clinical trial criteria.

Major finding: The objective response rates and disease control rates of 5.2% and 82.8% at 6 weeks and 10.0% and 84.0% at 12 weeks, respectively, were similar between patients who met and did not meet the IMbrave150 clinical trial criteria, as were safety profiles.

Study details: The data come from a multicenter study of 64 adults with unresectable hepatocellular carcinoma, including 46 who did not meet the study criteria. All patients were treated with a combination of atezolizumab plus bevacizumab. Treatment response and safety issues were assessed at 6 weeks and 12 weeks.

Disclosures: The study was supported by the Japan Agency for Medical Research and Development. The researchers had no financial conflicts to disclose.

Source: Sho T et al. Hepatol Res. 2021 Jul 10. doi: 10.1111/hepr.13693.

Key clinical point: In the real-world setting, patients with unresectable HCC who did not meet clinical trial criteria had similar responses to the treatment combination as those who met clinical trial criteria.

Major finding: The objective response rates and disease control rates of 5.2% and 82.8% at 6 weeks and 10.0% and 84.0% at 12 weeks, respectively, were similar between patients who met and did not meet the IMbrave150 clinical trial criteria, as were safety profiles.

Study details: The data come from a multicenter study of 64 adults with unresectable hepatocellular carcinoma, including 46 who did not meet the study criteria. All patients were treated with a combination of atezolizumab plus bevacizumab. Treatment response and safety issues were assessed at 6 weeks and 12 weeks.

Disclosures: The study was supported by the Japan Agency for Medical Research and Development. The researchers had no financial conflicts to disclose.

Source: Sho T et al. Hepatol Res. 2021 Jul 10. doi: 10.1111/hepr.13693.

Several recent studies have evaluated risks of therapy in rheumatoid arthritis (RA). One question regarding treatment of early RA is whether different initial treatment strategies confer different risks. In a systematic review with network meta-analysis, Adas et al reviewed differences between methotrexate, biologic disease-modifying antirheumatic drug (bDMARD), and steroid use in early RA. Overall, risk of serious adverse events was higher with bDMARD monotherapy than methotrexate monotherapy. Of note, while generally long-term steroid use is disfavored due to adverse effects, serious adverse events were not increased in patients treated with methotrexate and steroids together. The size of differences in risk was small and study heterogeneity, including the class of bDMARDs, limits generalizability of this information; thus, variations in the studies themselves may account for these differences.

Pazmino et al also looked at treatment strategies in early RA in a post hoc analysis of participants at “low-risk” for poor prognosis in the CareRA trial, in which patients were randomized to step-up methotrexate without glucocorticoids or step-down with glucocorticoids. While pain scores and disease activity scores were similar among the two groups, analgesic use (including non-steroidal anti-inflammatory drugs [NSAIDs] and opioids) was significantly lower among those randomized to the glucocorticoid-bridging arm. Though this information is reassuring as to the utility of glucocorticoids, it is not clear that this correlation is broadly applicable, for example, among the “higher-risk” patients who might otherwise be more likely to receive glucocorticoids.

A recent analysis of the COVID-19 global rheumatology alliance physician registry by Sparks et al of cases of COVID-19 in patients with rheumatic disease looked more specifically at COVID-19 outcomes in patients with RA on biologic therapy. These are of interest due both to the risk of immunosuppression overall as well as the use of immunosuppressive medications in COVID-19-associated hyperinflammation. The study evaluated outcomes of hospitalization (including respiratory support and mortality). While hospitalization is difficult to evaluate as an outcome without knowing the background rate of COVID in the different areas, of the hospitalized patients, patients who used Janus kinase inhibitors (JAKi) and rituximab received oxygen or ventilator support and had higher mortality than those who were on abatacept, IL-6 inhibitors, or TNF inhibitors. Wider interpretation is difficult due to lack of knowledge of when medications were given (including rituximab dosing), but the results suggest that concern is warranted in improving outcomes for patients with RA on these therapies.

Finally, regarding the well-known cardiovascular risk associated with RA, several observational studies have suggested that methotrexate is associated with reduction in risk of cardiovascular events. This cohort study of the Veterans Affairs RA registry followed over 2000 patients for a mean of about 5 years; a reduction in incidence of cardiovascular events was associated with methotrexate use, independent of age, body mass index (BMI), cardiovascular risk factors, RA disease activity, and other RA therapies. It may be that methotrexate use is associated with an unknown mediator of cardiovascular disease not evaluated in this study, such as reduced glucocorticoid or NSAID use, but this area deserves further investigation.

Several recent studies have evaluated risks of therapy in rheumatoid arthritis (RA). One question regarding treatment of early RA is whether different initial treatment strategies confer different risks. In a systematic review with network meta-analysis, Adas et al reviewed differences between methotrexate, biologic disease-modifying antirheumatic drug (bDMARD), and steroid use in early RA. Overall, risk of serious adverse events was higher with bDMARD monotherapy than methotrexate monotherapy. Of note, while generally long-term steroid use is disfavored due to adverse effects, serious adverse events were not increased in patients treated with methotrexate and steroids together. The size of differences in risk was small and study heterogeneity, including the class of bDMARDs, limits generalizability of this information; thus, variations in the studies themselves may account for these differences.

Pazmino et al also looked at treatment strategies in early RA in a post hoc analysis of participants at “low-risk” for poor prognosis in the CareRA trial, in which patients were randomized to step-up methotrexate without glucocorticoids or step-down with glucocorticoids. While pain scores and disease activity scores were similar among the two groups, analgesic use (including non-steroidal anti-inflammatory drugs [NSAIDs] and opioids) was significantly lower among those randomized to the glucocorticoid-bridging arm. Though this information is reassuring as to the utility of glucocorticoids, it is not clear that this correlation is broadly applicable, for example, among the “higher-risk” patients who might otherwise be more likely to receive glucocorticoids.

A recent analysis of the COVID-19 global rheumatology alliance physician registry by Sparks et al of cases of COVID-19 in patients with rheumatic disease looked more specifically at COVID-19 outcomes in patients with RA on biologic therapy. These are of interest due both to the risk of immunosuppression overall as well as the use of immunosuppressive medications in COVID-19-associated hyperinflammation. The study evaluated outcomes of hospitalization (including respiratory support and mortality). While hospitalization is difficult to evaluate as an outcome without knowing the background rate of COVID in the different areas, of the hospitalized patients, patients who used Janus kinase inhibitors (JAKi) and rituximab received oxygen or ventilator support and had higher mortality than those who were on abatacept, IL-6 inhibitors, or TNF inhibitors. Wider interpretation is difficult due to lack of knowledge of when medications were given (including rituximab dosing), but the results suggest that concern is warranted in improving outcomes for patients with RA on these therapies.

Finally, regarding the well-known cardiovascular risk associated with RA, several observational studies have suggested that methotrexate is associated with reduction in risk of cardiovascular events. This cohort study of the Veterans Affairs RA registry followed over 2000 patients for a mean of about 5 years; a reduction in incidence of cardiovascular events was associated with methotrexate use, independent of age, body mass index (BMI), cardiovascular risk factors, RA disease activity, and other RA therapies. It may be that methotrexate use is associated with an unknown mediator of cardiovascular disease not evaluated in this study, such as reduced glucocorticoid or NSAID use, but this area deserves further investigation.

Several recent studies have evaluated risks of therapy in rheumatoid arthritis (RA). One question regarding treatment of early RA is whether different initial treatment strategies confer different risks. In a systematic review with network meta-analysis, Adas et al reviewed differences between methotrexate, biologic disease-modifying antirheumatic drug (bDMARD), and steroid use in early RA. Overall, risk of serious adverse events was higher with bDMARD monotherapy than methotrexate monotherapy. Of note, while generally long-term steroid use is disfavored due to adverse effects, serious adverse events were not increased in patients treated with methotrexate and steroids together. The size of differences in risk was small and study heterogeneity, including the class of bDMARDs, limits generalizability of this information; thus, variations in the studies themselves may account for these differences.

Pazmino et al also looked at treatment strategies in early RA in a post hoc analysis of participants at “low-risk” for poor prognosis in the CareRA trial, in which patients were randomized to step-up methotrexate without glucocorticoids or step-down with glucocorticoids. While pain scores and disease activity scores were similar among the two groups, analgesic use (including non-steroidal anti-inflammatory drugs [NSAIDs] and opioids) was significantly lower among those randomized to the glucocorticoid-bridging arm. Though this information is reassuring as to the utility of glucocorticoids, it is not clear that this correlation is broadly applicable, for example, among the “higher-risk” patients who might otherwise be more likely to receive glucocorticoids.

A recent analysis of the COVID-19 global rheumatology alliance physician registry by Sparks et al of cases of COVID-19 in patients with rheumatic disease looked more specifically at COVID-19 outcomes in patients with RA on biologic therapy. These are of interest due both to the risk of immunosuppression overall as well as the use of immunosuppressive medications in COVID-19-associated hyperinflammation. The study evaluated outcomes of hospitalization (including respiratory support and mortality). While hospitalization is difficult to evaluate as an outcome without knowing the background rate of COVID in the different areas, of the hospitalized patients, patients who used Janus kinase inhibitors (JAKi) and rituximab received oxygen or ventilator support and had higher mortality than those who were on abatacept, IL-6 inhibitors, or TNF inhibitors. Wider interpretation is difficult due to lack of knowledge of when medications were given (including rituximab dosing), but the results suggest that concern is warranted in improving outcomes for patients with RA on these therapies.

Finally, regarding the well-known cardiovascular risk associated with RA, several observational studies have suggested that methotrexate is associated with reduction in risk of cardiovascular events. This cohort study of the Veterans Affairs RA registry followed over 2000 patients for a mean of about 5 years; a reduction in incidence of cardiovascular events was associated with methotrexate use, independent of age, body mass index (BMI), cardiovascular risk factors, RA disease activity, and other RA therapies. It may be that methotrexate use is associated with an unknown mediator of cardiovascular disease not evaluated in this study, such as reduced glucocorticoid or NSAID use, but this area deserves further investigation.

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.

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.