Key clinical point: Patients with rheumatoid arthritis (RA) may be more susceptible to coronary atherosclerosis, and active intervention for RA may reduce the incidence of coronary atherosclerosis.

Major finding: Genetic predisposition to RA increased the risk for coronary atherosclerosis (odds ratio 1.0021; P < .05). However, genetic liability to coronary atherosclerosis did not increase the risk for RA (P  =  .06).

Study details: Findings are from a two-sample Mendelian randomization study that evaluated genetic variants associated with RA using the data of 14,361 patients and 42,923 control individuals and those associated with coronary atherosclerosis using data of 14,334 patients and 346,860 control individuals.

Disclosures: This study did not declare any specific source of funding. The authors declared no conflicts of interest.

Source: Nie Q et al. Rheumatoid arthritis and coronary atherosclerosis: A two-sample Mendelian randomization study. Front Cardiovasc Med. 2023;10:1033644 (Apr 28). Doi: 10.3389/fcvm.2023.1033644

Key clinical point: Patients with rheumatoid arthritis (RA) may be more susceptible to coronary atherosclerosis, and active intervention for RA may reduce the incidence of coronary atherosclerosis.

Major finding: Genetic predisposition to RA increased the risk for coronary atherosclerosis (odds ratio 1.0021; P < .05). However, genetic liability to coronary atherosclerosis did not increase the risk for RA (P  =  .06).

Study details: Findings are from a two-sample Mendelian randomization study that evaluated genetic variants associated with RA using the data of 14,361 patients and 42,923 control individuals and those associated with coronary atherosclerosis using data of 14,334 patients and 346,860 control individuals.

Disclosures: This study did not declare any specific source of funding. The authors declared no conflicts of interest.

Source: Nie Q et al. Rheumatoid arthritis and coronary atherosclerosis: A two-sample Mendelian randomization study. Front Cardiovasc Med. 2023;10:1033644 (Apr 28). Doi: 10.3389/fcvm.2023.1033644

Key clinical point: Patients with rheumatoid arthritis (RA) may be more susceptible to coronary atherosclerosis, and active intervention for RA may reduce the incidence of coronary atherosclerosis.

Major finding: Genetic predisposition to RA increased the risk for coronary atherosclerosis (odds ratio 1.0021; P < .05). However, genetic liability to coronary atherosclerosis did not increase the risk for RA (P  =  .06).

Study details: Findings are from a two-sample Mendelian randomization study that evaluated genetic variants associated with RA using the data of 14,361 patients and 42,923 control individuals and those associated with coronary atherosclerosis using data of 14,334 patients and 346,860 control individuals.

Disclosures: This study did not declare any specific source of funding. The authors declared no conflicts of interest.

Source: Nie Q et al. Rheumatoid arthritis and coronary atherosclerosis: A two-sample Mendelian randomization study. Front Cardiovasc Med. 2023;10:1033644 (Apr 28). Doi: 10.3389/fcvm.2023.1033644

Key clinical point: Risk for first primary cancer was not significantly different among patients with rheumatoid arthritis (RA) receiving Janus kinase inhibitors (JAKi) vs biologic disease-modifying antirheumatic drugs (bDMARD). However, excess risk cannot be ruled out among those receiving JAKi.

Major finding: Patients with RA treated with JAKi had a numerically higher but not statistically significantly higher risk for first primary cancer (hazard ratio 1.41; 95% CI 0.76-2.37) compared with those treated with bDMARD.

Study details: Findings are from an observational cohort study including patients with RA without prior cancer diagnosis who initiated JAKi (n = 875) or bDMARD (n = 4247).

Disclosures: This study received financial support from the Danish Rheumatism Association and Danish Cancer Society. Several authors declared being employees of, receiving research grants and honoraria from, participating in advisory boards of, or serving on steering committees for various sources.

Source: Westermann R et al. Cancer risk in patients with rheumatoid arthritis treated with Janus kinase inhibitors: A nationwide Danish register-based cohort study. Rheumatology (Oxford). 2023 (Apr 13). Doi: 10.1093/rheumatology/kead163

Key clinical point: Risk for first primary cancer was not significantly different among patients with rheumatoid arthritis (RA) receiving Janus kinase inhibitors (JAKi) vs biologic disease-modifying antirheumatic drugs (bDMARD). However, excess risk cannot be ruled out among those receiving JAKi.

Major finding: Patients with RA treated with JAKi had a numerically higher but not statistically significantly higher risk for first primary cancer (hazard ratio 1.41; 95% CI 0.76-2.37) compared with those treated with bDMARD.

Study details: Findings are from an observational cohort study including patients with RA without prior cancer diagnosis who initiated JAKi (n = 875) or bDMARD (n = 4247).

Disclosures: This study received financial support from the Danish Rheumatism Association and Danish Cancer Society. Several authors declared being employees of, receiving research grants and honoraria from, participating in advisory boards of, or serving on steering committees for various sources.

Source: Westermann R et al. Cancer risk in patients with rheumatoid arthritis treated with Janus kinase inhibitors: A nationwide Danish register-based cohort study. Rheumatology (Oxford). 2023 (Apr 13). Doi: 10.1093/rheumatology/kead163

Key clinical point: Risk for first primary cancer was not significantly different among patients with rheumatoid arthritis (RA) receiving Janus kinase inhibitors (JAKi) vs biologic disease-modifying antirheumatic drugs (bDMARD). However, excess risk cannot be ruled out among those receiving JAKi.

Major finding: Patients with RA treated with JAKi had a numerically higher but not statistically significantly higher risk for first primary cancer (hazard ratio 1.41; 95% CI 0.76-2.37) compared with those treated with bDMARD.

Study details: Findings are from an observational cohort study including patients with RA without prior cancer diagnosis who initiated JAKi (n = 875) or bDMARD (n = 4247).

Disclosures: This study received financial support from the Danish Rheumatism Association and Danish Cancer Society. Several authors declared being employees of, receiving research grants and honoraria from, participating in advisory boards of, or serving on steering committees for various sources.

Source: Westermann R et al. Cancer risk in patients with rheumatoid arthritis treated with Janus kinase inhibitors: A nationwide Danish register-based cohort study. Rheumatology (Oxford). 2023 (Apr 13). Doi: 10.1093/rheumatology/kead163

Key clinical point: Human papillomavirus (HPV) infection was associated with an increased prevalence of rheumatoid arthritis (RA), whereas HPV immunization lowered RA prevalence in adults aged 18-59 years.

Major finding: A significant association was observed between HPV infection and increased prevalence of RA (adjusted odds ratio [aOR] 1.074; 95% CI 1.071-1.076), whereas HPV immunization was associated with a significantly reduced RA prevalence (aOR 0.477; 95% CI 0.472-0.481).

Study details: Findings are from a population-based cohort study including adults age 18-59 years with complete data on HPV infection and history of RA (n = 15,677) and those with complete data on HPV vaccination and history of RA (n = 8944).

Disclosures: This study was supported by the Nanjing Medical University Science, China, and Technology Development Fund and other sources. The authors declared no conflicts of interest.

Source: Yang G et al. Association between human papillomavirus infection or immunization and risk for rheumatoid arthritis. Front Immunol. 2023;14:1130217 (Apr 14). Doi: 10.3389/fimmu.2023.1130217

Key clinical point: Human papillomavirus (HPV) infection was associated with an increased prevalence of rheumatoid arthritis (RA), whereas HPV immunization lowered RA prevalence in adults aged 18-59 years.

Major finding: A significant association was observed between HPV infection and increased prevalence of RA (adjusted odds ratio [aOR] 1.074; 95% CI 1.071-1.076), whereas HPV immunization was associated with a significantly reduced RA prevalence (aOR 0.477; 95% CI 0.472-0.481).

Study details: Findings are from a population-based cohort study including adults age 18-59 years with complete data on HPV infection and history of RA (n = 15,677) and those with complete data on HPV vaccination and history of RA (n = 8944).

Disclosures: This study was supported by the Nanjing Medical University Science, China, and Technology Development Fund and other sources. The authors declared no conflicts of interest.

Source: Yang G et al. Association between human papillomavirus infection or immunization and risk for rheumatoid arthritis. Front Immunol. 2023;14:1130217 (Apr 14). Doi: 10.3389/fimmu.2023.1130217

Key clinical point: Human papillomavirus (HPV) infection was associated with an increased prevalence of rheumatoid arthritis (RA), whereas HPV immunization lowered RA prevalence in adults aged 18-59 years.

Major finding: A significant association was observed between HPV infection and increased prevalence of RA (adjusted odds ratio [aOR] 1.074; 95% CI 1.071-1.076), whereas HPV immunization was associated with a significantly reduced RA prevalence (aOR 0.477; 95% CI 0.472-0.481).

Study details: Findings are from a population-based cohort study including adults age 18-59 years with complete data on HPV infection and history of RA (n = 15,677) and those with complete data on HPV vaccination and history of RA (n = 8944).

Disclosures: This study was supported by the Nanjing Medical University Science, China, and Technology Development Fund and other sources. The authors declared no conflicts of interest.

Source: Yang G et al. Association between human papillomavirus infection or immunization and risk for rheumatoid arthritis. Front Immunol. 2023;14:1130217 (Apr 14). Doi: 10.3389/fimmu.2023.1130217

Key clinical point: Patients with rheumatoid arthritis (RA) with better overall disease activity and longer etanercept treatment duration are more likely to remain in remission after transition from methotrexate+etanercept combination therapy to methotrexate or etanercept monotherapy.

Major finding: At week 48, the likelihood of patients remaining in Simple Disease Activity Index-based remission or maintaining low disease activity was 1.12 times higher with long-term etanercept monotherapy (P  =  .044) but was 0.93 times lower with each 1-point increase in Patient Global Assessment of Disease Activity (P  =  .012) and C-reactive protein (P  =  .033).

Study details: Findings are from the phase 3, SEAM-RA trial including 253 patients with RA who achieved remission with 24 weeks of methotrexate+etanercept combination therapy and were randomly assigned to continue combination therapy or transition to methotrexate+placebo or etanercept+placebo.

Disclosures: A wholly owned subsidiary of Amgen Inc., Immunex, funded this study. Three authors declared being employees and stockholders of Amgen Inc., and four authors declared ties with various sources, including Amgen.

Source: Curtis JR R et al. Factors associated with maintenance of remission following change from combination therapy to monotherapy in patients with rheumatoid arthritis. J Rheumatol. 2023 (Apr 15). Doi: 10.3899/jrheum.2022-1008.

Key clinical point: Patients with rheumatoid arthritis (RA) with better overall disease activity and longer etanercept treatment duration are more likely to remain in remission after transition from methotrexate+etanercept combination therapy to methotrexate or etanercept monotherapy.

Major finding: At week 48, the likelihood of patients remaining in Simple Disease Activity Index-based remission or maintaining low disease activity was 1.12 times higher with long-term etanercept monotherapy (P  =  .044) but was 0.93 times lower with each 1-point increase in Patient Global Assessment of Disease Activity (P  =  .012) and C-reactive protein (P  =  .033).

Study details: Findings are from the phase 3, SEAM-RA trial including 253 patients with RA who achieved remission with 24 weeks of methotrexate+etanercept combination therapy and were randomly assigned to continue combination therapy or transition to methotrexate+placebo or etanercept+placebo.

Disclosures: A wholly owned subsidiary of Amgen Inc., Immunex, funded this study. Three authors declared being employees and stockholders of Amgen Inc., and four authors declared ties with various sources, including Amgen.

Source: Curtis JR R et al. Factors associated with maintenance of remission following change from combination therapy to monotherapy in patients with rheumatoid arthritis. J Rheumatol. 2023 (Apr 15). Doi: 10.3899/jrheum.2022-1008.

Key clinical point: Patients with rheumatoid arthritis (RA) with better overall disease activity and longer etanercept treatment duration are more likely to remain in remission after transition from methotrexate+etanercept combination therapy to methotrexate or etanercept monotherapy.

Major finding: At week 48, the likelihood of patients remaining in Simple Disease Activity Index-based remission or maintaining low disease activity was 1.12 times higher with long-term etanercept monotherapy (P  =  .044) but was 0.93 times lower with each 1-point increase in Patient Global Assessment of Disease Activity (P  =  .012) and C-reactive protein (P  =  .033).

Study details: Findings are from the phase 3, SEAM-RA trial including 253 patients with RA who achieved remission with 24 weeks of methotrexate+etanercept combination therapy and were randomly assigned to continue combination therapy or transition to methotrexate+placebo or etanercept+placebo.

Disclosures: A wholly owned subsidiary of Amgen Inc., Immunex, funded this study. Three authors declared being employees and stockholders of Amgen Inc., and four authors declared ties with various sources, including Amgen.

Source: Curtis JR R et al. Factors associated with maintenance of remission following change from combination therapy to monotherapy in patients with rheumatoid arthritis. J Rheumatol. 2023 (Apr 15). Doi: 10.3899/jrheum.2022-1008.

Key clinical point: Blanket withdrawal of tofacitinib may not be suitable for all patients with rheumatoid arthritis (RA) who have achieved clinical remission as more than half relapsed after tofacitinib discontinuation. However, the majority regained remission after tofacitinib resumption.

Major finding: At week 104, the tofacitinib vs methotrexate discontinuation group had a numerically lower Clinical Disease Activity Index-based sustained remission rate (29.2% vs 50.0%) and higher relapse rate (58.3% vs 35.0%). However, 71.4% vs 28.6% of patients regained remission on tofacitinib vs methotrexate resumption.

Study details: This prospective randomized controlled trial included 113 patients with RA and an inadequate response to methotrexate with or without biologic disease-modifying antirheumatic drugs who received 52 weeks of tofacitinib plus methotrexate treatment and thereafter, were randomly assigned to discontinue tofacitinib or methotrexate if experiencing clinical remission.

Disclosures: This study was supported by the Japan Society for the Promotion of Science, KAKENHI. Several authors declared receiving consulting fees, speaking fees, research grants, or honoraria from various sources.

Source: Kubo S et al. Sustained remission following the discontinuation of tofacitinib in patients with rheumatoid arthritis (XANADU study): An open-label randomised study. RMD Open. 2023;9(2):e003029 (Apr 25). Doi: 10.1136/rmdopen-2023-003029

Key clinical point: Blanket withdrawal of tofacitinib may not be suitable for all patients with rheumatoid arthritis (RA) who have achieved clinical remission as more than half relapsed after tofacitinib discontinuation. However, the majority regained remission after tofacitinib resumption.

Major finding: At week 104, the tofacitinib vs methotrexate discontinuation group had a numerically lower Clinical Disease Activity Index-based sustained remission rate (29.2% vs 50.0%) and higher relapse rate (58.3% vs 35.0%). However, 71.4% vs 28.6% of patients regained remission on tofacitinib vs methotrexate resumption.

Study details: This prospective randomized controlled trial included 113 patients with RA and an inadequate response to methotrexate with or without biologic disease-modifying antirheumatic drugs who received 52 weeks of tofacitinib plus methotrexate treatment and thereafter, were randomly assigned to discontinue tofacitinib or methotrexate if experiencing clinical remission.

Disclosures: This study was supported by the Japan Society for the Promotion of Science, KAKENHI. Several authors declared receiving consulting fees, speaking fees, research grants, or honoraria from various sources.

Source: Kubo S et al. Sustained remission following the discontinuation of tofacitinib in patients with rheumatoid arthritis (XANADU study): An open-label randomised study. RMD Open. 2023;9(2):e003029 (Apr 25). Doi: 10.1136/rmdopen-2023-003029

Key clinical point: Blanket withdrawal of tofacitinib may not be suitable for all patients with rheumatoid arthritis (RA) who have achieved clinical remission as more than half relapsed after tofacitinib discontinuation. However, the majority regained remission after tofacitinib resumption.

Major finding: At week 104, the tofacitinib vs methotrexate discontinuation group had a numerically lower Clinical Disease Activity Index-based sustained remission rate (29.2% vs 50.0%) and higher relapse rate (58.3% vs 35.0%). However, 71.4% vs 28.6% of patients regained remission on tofacitinib vs methotrexate resumption.

Study details: This prospective randomized controlled trial included 113 patients with RA and an inadequate response to methotrexate with or without biologic disease-modifying antirheumatic drugs who received 52 weeks of tofacitinib plus methotrexate treatment and thereafter, were randomly assigned to discontinue tofacitinib or methotrexate if experiencing clinical remission.

Disclosures: This study was supported by the Japan Society for the Promotion of Science, KAKENHI. Several authors declared receiving consulting fees, speaking fees, research grants, or honoraria from various sources.

Source: Kubo S et al. Sustained remission following the discontinuation of tofacitinib in patients with rheumatoid arthritis (XANADU study): An open-label randomised study. RMD Open. 2023;9(2):e003029 (Apr 25). Doi: 10.1136/rmdopen-2023-003029

Key clinical point: Repair of joint space narrowing occurred but was rare in patients with early rheumatoid arthritis (RA) who underwent 8 years of treatment to a target disease activity score (DAS) ≤ 2.4. Therefore, suppression of damage progression should be the focus of clinical care.

Major finding: Only 5.3% of patients showed repair of joint space narrowing and bone erosions after 8 years of treatment to a target of DAS ≤ 2.4. No significant association was observed between achieving repair and suppression of disease activity, duration of previous remission, or other predictors of repair.

Study details: Findings are from a subanalysis of BeSt study including 508 patients with severe early RA who were treated to a target of DAS ≤ 2.4 and followed for 8 years.

Disclosures: The BeSt study was supported by grants from the Dutch College of Health Insurances, Schering-Plough B.V., and Janssen B.V. The authors did not declare any conflicts of interest.

Source: van der Pol JA et al. Repair of joint damage in patients with rheumatoid arthritis does not relate to previous suppression of inflammation: A subanalysis after 8 years treat-to-target in the BeSt-trial. RMD Open. 2023;9(2):e002995 (Apr 25). Doi: 10.1136/rmdopen-2023-002995

Key clinical point: Repair of joint space narrowing occurred but was rare in patients with early rheumatoid arthritis (RA) who underwent 8 years of treatment to a target disease activity score (DAS) ≤ 2.4. Therefore, suppression of damage progression should be the focus of clinical care.

Major finding: Only 5.3% of patients showed repair of joint space narrowing and bone erosions after 8 years of treatment to a target of DAS ≤ 2.4. No significant association was observed between achieving repair and suppression of disease activity, duration of previous remission, or other predictors of repair.

Study details: Findings are from a subanalysis of BeSt study including 508 patients with severe early RA who were treated to a target of DAS ≤ 2.4 and followed for 8 years.

Disclosures: The BeSt study was supported by grants from the Dutch College of Health Insurances, Schering-Plough B.V., and Janssen B.V. The authors did not declare any conflicts of interest.

Source: van der Pol JA et al. Repair of joint damage in patients with rheumatoid arthritis does not relate to previous suppression of inflammation: A subanalysis after 8 years treat-to-target in the BeSt-trial. RMD Open. 2023;9(2):e002995 (Apr 25). Doi: 10.1136/rmdopen-2023-002995

Key clinical point: Repair of joint space narrowing occurred but was rare in patients with early rheumatoid arthritis (RA) who underwent 8 years of treatment to a target disease activity score (DAS) ≤ 2.4. Therefore, suppression of damage progression should be the focus of clinical care.

Major finding: Only 5.3% of patients showed repair of joint space narrowing and bone erosions after 8 years of treatment to a target of DAS ≤ 2.4. No significant association was observed between achieving repair and suppression of disease activity, duration of previous remission, or other predictors of repair.

Study details: Findings are from a subanalysis of BeSt study including 508 patients with severe early RA who were treated to a target of DAS ≤ 2.4 and followed for 8 years.

Disclosures: The BeSt study was supported by grants from the Dutch College of Health Insurances, Schering-Plough B.V., and Janssen B.V. The authors did not declare any conflicts of interest.

Source: van der Pol JA et al. Repair of joint damage in patients with rheumatoid arthritis does not relate to previous suppression of inflammation: A subanalysis after 8 years treat-to-target in the BeSt-trial. RMD Open. 2023;9(2):e002995 (Apr 25). Doi: 10.1136/rmdopen-2023-002995

Key clinical point: Exposure to environmental polycyclic aromatic hydrocarbons (PAH) was significantly associated with an increased prevalence of rheumatoid arthritis (RA) in the US population, and PAH mediated the majority of the effects of smoking in RA.

Major finding: Risk of developing RA was significantly higher in participants in the highest vs lowest quartile of 1-hydroxynaphthalene level (adjusted odds ratio [aOR] 1.8; P  =  .020) and PAH body burden scores (aOR 2.2; P  =  .028). PAH body burden accounted for ~90% of the total effect of smoking on RA.

Study details: Findings are from a cross-sectional study including adult participants with (n = 1418) or without (n = 20,569) RA who underwent assessments for PAH, phthalate and plasticizer metabolite, and volatile organic compound body burden.

Disclosures: This study did not declare any specific funding source. The lead author declared receiving personal fees from Cleveland HeartLab, unrelated to this study, and holding a patent.

Source: Beidelschies M et al. Polycyclic aromatic hydrocarbons and risk of rheumatoid arthritis: A cross-sectional analysis of the National Health and Nutrition Examination Survey, 2007–2016. BMJ Open. 2023;13(5):e071514 (May 9). Doi: 10.1136/bmjopen-2022-071514

Key clinical point: Exposure to environmental polycyclic aromatic hydrocarbons (PAH) was significantly associated with an increased prevalence of rheumatoid arthritis (RA) in the US population, and PAH mediated the majority of the effects of smoking in RA.

Major finding: Risk of developing RA was significantly higher in participants in the highest vs lowest quartile of 1-hydroxynaphthalene level (adjusted odds ratio [aOR] 1.8; P  =  .020) and PAH body burden scores (aOR 2.2; P  =  .028). PAH body burden accounted for ~90% of the total effect of smoking on RA.

Study details: Findings are from a cross-sectional study including adult participants with (n = 1418) or without (n = 20,569) RA who underwent assessments for PAH, phthalate and plasticizer metabolite, and volatile organic compound body burden.

Disclosures: This study did not declare any specific funding source. The lead author declared receiving personal fees from Cleveland HeartLab, unrelated to this study, and holding a patent.

Source: Beidelschies M et al. Polycyclic aromatic hydrocarbons and risk of rheumatoid arthritis: A cross-sectional analysis of the National Health and Nutrition Examination Survey, 2007–2016. BMJ Open. 2023;13(5):e071514 (May 9). Doi: 10.1136/bmjopen-2022-071514

Key clinical point: Exposure to environmental polycyclic aromatic hydrocarbons (PAH) was significantly associated with an increased prevalence of rheumatoid arthritis (RA) in the US population, and PAH mediated the majority of the effects of smoking in RA.

Major finding: Risk of developing RA was significantly higher in participants in the highest vs lowest quartile of 1-hydroxynaphthalene level (adjusted odds ratio [aOR] 1.8; P  =  .020) and PAH body burden scores (aOR 2.2; P  =  .028). PAH body burden accounted for ~90% of the total effect of smoking on RA.

Study details: Findings are from a cross-sectional study including adult participants with (n = 1418) or without (n = 20,569) RA who underwent assessments for PAH, phthalate and plasticizer metabolite, and volatile organic compound body burden.

Disclosures: This study did not declare any specific funding source. The lead author declared receiving personal fees from Cleveland HeartLab, unrelated to this study, and holding a patent.

Source: Beidelschies M et al. Polycyclic aromatic hydrocarbons and risk of rheumatoid arthritis: A cross-sectional analysis of the National Health and Nutrition Examination Survey, 2007–2016. BMJ Open. 2023;13(5):e071514 (May 9). Doi: 10.1136/bmjopen-2022-071514

DUBLIN – Nearly half (45%) of adolescents assigned to semaglutide (Wegovy), a once-weekly glucagon-like peptide-1 (GLP-1) agonist, managed to lose enough weight to drop below the clinical threshold for obesity, according to a secondary analysis of the STEP TEENS (Semaglutide Treatment Effect in People With Obesity) trial.
 

By comparison, only 12.1% of adolescents with obesity taking placebo in the trial dropped below the obesity threshold.

The study also found that 74% of participants shifted down by at least one body mass index (BMI) category after receiving the GLP-1 agonist, compared with 19% of those taking placebo.

Semaglutide shifts BMI category

In this new secondary analysis of STEP TEENS, the authors examined the effect of subcutaneous semaglutide 2.4 mg on moving adolescents from one BMI category to another, including dropping below the obesity threshold into the overweight or normal weight categories.

The study also looked at the effect of semaglutide on glucose metabolism and cardiovascular risk factors, as well as safety and tolerability. However, this particular analysis only examined adolescents with obesity (only one person had overweight, and so they were excluded), who were divided into three further subclasses: obesity class I (BMI ≥ 95th to < 20% above the 95th percentile); obesity class II (BMI ≥ 20% to < 40% above 95th percentile); and obesity class III (BMI ≥ 40% above the 95th percentile).

After a 12-week run-in period of lifestyle intervention only, a total of 200 adolescents (12-18 years) with obesity (in the top 5% of BMI) were randomized (2:1) to once-weekly subcutaneous semaglutide 2.4 mg or placebo for 68 weeks, after a 16-week titration period. All participants continued to receive counseling about healthy nutrition and were set a goal of 60 minutes per day of moderate- to high-intensity physical activity.

Dr. Kelly and colleagues determined levels of improvement in BMI category and attainment of normal weight, or overweight, BMI category by week 68.

At baseline, the percentage of participants in obesity class I, II, or III, in those taking placebo was 39.7%, 41.4%, and 19.0%, or taking semaglutide was 31.4%, 31.4%, and 37.3%, respectively.

“After 68 weeks, not a lot happened [in placebo participants]; however, 12.1% of placebo participants did drop below the obesity threshold into overweight or normal-weight categories,” reported Dr. Kelly.

Referring to participants taking semaglutide, he added that “a total of 45% of patients on semaglutide dropped below the clinical BMI cut point for obesity, such that 19.5% dropped into the overweight category and 25.4% reduced their BMI into the normal-weight category.”

Turning to obesity class, Dr. Kelly reported that of those initially with obesity class III taking placebo, 91% remained in that class and 9.1% dropped to obesity class II at week 68. For those adolescents with obesity class III taking semaglutide, 36.4% dropped to obesity class II, 18.2% dropped to obesity class I, 11% dropped below the obesity threshold, and 34.1% remained in obesity class III, he added.

For obesity class II specifically, 71% of placebo participants stayed in that category, while 12% moved up a category. “On semaglutide, over 50% (51.2%) reduced their BMI below the obesity cut point,” noted Dr. Kelly.

In obesity class I, 26% of patients taking placebo reduced their BMI below the obesity cut point. “On semaglutide, nearly 80% reduced their BMI below the obesity threshold, with 57% dropping their BMI into the normal category,” he said.

“When we looked at baseline factors that might predict the response to semaglutide or placebo, we did not find any factors that were ... significant due to small sample sizes,” he said. However, he pointed out that “females tended to respond better to semaglutide, likewise younger adolescents, and middle body weights tended to respond better to the drug, and there was a similar pattern with obesity classes.”

Commenting on the study, Jesse Bittman, MD, University of British Columbia, Vancouver, said: “Good to see more data on different populations that some semaglutide is used in and the variability in response to it. The focus on BMI was interesting because in obesity medicine we spend a lot of time telling our patients not to focus on BMIs and ‘normals’ because there are more important tools, and we see that when these become the focus of research outcomes they can become problematic.”

Asked whether rapid weight loss in adolescents might be problematic in some respects, Dr. Bittman pointed out that “one concern with these medications is whether people are going to have loss of muscle mass or malnutrition, or whether they develop eating disorders and other disturbed eating behaviors.”

Dr. Kelly has reported engaging in unpaid consulting and educational activities for Boehringer Ingelheim, Eli Lilly, Novo Nordisk, and Vivus, and receiving donated drug/placebo from Novo Nordisk and Vivus for National Institutes of Health–funded clinical trials. Dr. O’Malley has declared having received grants in the past 3 years from the Health Research Board, Department of Health, Ireland, European Association for the Study of Obesity (via a Novo Nordisk educational grant), Healthy Ireland fund, and the Royal College of Surgeons in Ireland Strategic Academic Recruitment (StAR) Programme. Dr. Bittman has reported receiving funding from Novo Nordisk, Bayer, and Bausch Health.

A version of this article first appeared on Medscape.com.

DUBLIN – Nearly half (45%) of adolescents assigned to semaglutide (Wegovy), a once-weekly glucagon-like peptide-1 (GLP-1) agonist, managed to lose enough weight to drop below the clinical threshold for obesity, according to a secondary analysis of the STEP TEENS (Semaglutide Treatment Effect in People With Obesity) trial.
 

By comparison, only 12.1% of adolescents with obesity taking placebo in the trial dropped below the obesity threshold.

The study also found that 74% of participants shifted down by at least one body mass index (BMI) category after receiving the GLP-1 agonist, compared with 19% of those taking placebo.

Semaglutide shifts BMI category

In this new secondary analysis of STEP TEENS, the authors examined the effect of subcutaneous semaglutide 2.4 mg on moving adolescents from one BMI category to another, including dropping below the obesity threshold into the overweight or normal weight categories.

The study also looked at the effect of semaglutide on glucose metabolism and cardiovascular risk factors, as well as safety and tolerability. However, this particular analysis only examined adolescents with obesity (only one person had overweight, and so they were excluded), who were divided into three further subclasses: obesity class I (BMI ≥ 95th to < 20% above the 95th percentile); obesity class II (BMI ≥ 20% to < 40% above 95th percentile); and obesity class III (BMI ≥ 40% above the 95th percentile).

After a 12-week run-in period of lifestyle intervention only, a total of 200 adolescents (12-18 years) with obesity (in the top 5% of BMI) were randomized (2:1) to once-weekly subcutaneous semaglutide 2.4 mg or placebo for 68 weeks, after a 16-week titration period. All participants continued to receive counseling about healthy nutrition and were set a goal of 60 minutes per day of moderate- to high-intensity physical activity.

Dr. Kelly and colleagues determined levels of improvement in BMI category and attainment of normal weight, or overweight, BMI category by week 68.

At baseline, the percentage of participants in obesity class I, II, or III, in those taking placebo was 39.7%, 41.4%, and 19.0%, or taking semaglutide was 31.4%, 31.4%, and 37.3%, respectively.

“After 68 weeks, not a lot happened [in placebo participants]; however, 12.1% of placebo participants did drop below the obesity threshold into overweight or normal-weight categories,” reported Dr. Kelly.

Referring to participants taking semaglutide, he added that “a total of 45% of patients on semaglutide dropped below the clinical BMI cut point for obesity, such that 19.5% dropped into the overweight category and 25.4% reduced their BMI into the normal-weight category.”

Turning to obesity class, Dr. Kelly reported that of those initially with obesity class III taking placebo, 91% remained in that class and 9.1% dropped to obesity class II at week 68. For those adolescents with obesity class III taking semaglutide, 36.4% dropped to obesity class II, 18.2% dropped to obesity class I, 11% dropped below the obesity threshold, and 34.1% remained in obesity class III, he added.

For obesity class II specifically, 71% of placebo participants stayed in that category, while 12% moved up a category. “On semaglutide, over 50% (51.2%) reduced their BMI below the obesity cut point,” noted Dr. Kelly.

In obesity class I, 26% of patients taking placebo reduced their BMI below the obesity cut point. “On semaglutide, nearly 80% reduced their BMI below the obesity threshold, with 57% dropping their BMI into the normal category,” he said.

“When we looked at baseline factors that might predict the response to semaglutide or placebo, we did not find any factors that were ... significant due to small sample sizes,” he said. However, he pointed out that “females tended to respond better to semaglutide, likewise younger adolescents, and middle body weights tended to respond better to the drug, and there was a similar pattern with obesity classes.”

Commenting on the study, Jesse Bittman, MD, University of British Columbia, Vancouver, said: “Good to see more data on different populations that some semaglutide is used in and the variability in response to it. The focus on BMI was interesting because in obesity medicine we spend a lot of time telling our patients not to focus on BMIs and ‘normals’ because there are more important tools, and we see that when these become the focus of research outcomes they can become problematic.”

Asked whether rapid weight loss in adolescents might be problematic in some respects, Dr. Bittman pointed out that “one concern with these medications is whether people are going to have loss of muscle mass or malnutrition, or whether they develop eating disorders and other disturbed eating behaviors.”

Dr. Kelly has reported engaging in unpaid consulting and educational activities for Boehringer Ingelheim, Eli Lilly, Novo Nordisk, and Vivus, and receiving donated drug/placebo from Novo Nordisk and Vivus for National Institutes of Health–funded clinical trials. Dr. O’Malley has declared having received grants in the past 3 years from the Health Research Board, Department of Health, Ireland, European Association for the Study of Obesity (via a Novo Nordisk educational grant), Healthy Ireland fund, and the Royal College of Surgeons in Ireland Strategic Academic Recruitment (StAR) Programme. Dr. Bittman has reported receiving funding from Novo Nordisk, Bayer, and Bausch Health.

A version of this article first appeared on Medscape.com.

DUBLIN – Nearly half (45%) of adolescents assigned to semaglutide (Wegovy), a once-weekly glucagon-like peptide-1 (GLP-1) agonist, managed to lose enough weight to drop below the clinical threshold for obesity, according to a secondary analysis of the STEP TEENS (Semaglutide Treatment Effect in People With Obesity) trial.
 

By comparison, only 12.1% of adolescents with obesity taking placebo in the trial dropped below the obesity threshold.

The study also found that 74% of participants shifted down by at least one body mass index (BMI) category after receiving the GLP-1 agonist, compared with 19% of those taking placebo.

Semaglutide shifts BMI category

In this new secondary analysis of STEP TEENS, the authors examined the effect of subcutaneous semaglutide 2.4 mg on moving adolescents from one BMI category to another, including dropping below the obesity threshold into the overweight or normal weight categories.

The study also looked at the effect of semaglutide on glucose metabolism and cardiovascular risk factors, as well as safety and tolerability. However, this particular analysis only examined adolescents with obesity (only one person had overweight, and so they were excluded), who were divided into three further subclasses: obesity class I (BMI ≥ 95th to < 20% above the 95th percentile); obesity class II (BMI ≥ 20% to < 40% above 95th percentile); and obesity class III (BMI ≥ 40% above the 95th percentile).

After a 12-week run-in period of lifestyle intervention only, a total of 200 adolescents (12-18 years) with obesity (in the top 5% of BMI) were randomized (2:1) to once-weekly subcutaneous semaglutide 2.4 mg or placebo for 68 weeks, after a 16-week titration period. All participants continued to receive counseling about healthy nutrition and were set a goal of 60 minutes per day of moderate- to high-intensity physical activity.

Dr. Kelly and colleagues determined levels of improvement in BMI category and attainment of normal weight, or overweight, BMI category by week 68.

At baseline, the percentage of participants in obesity class I, II, or III, in those taking placebo was 39.7%, 41.4%, and 19.0%, or taking semaglutide was 31.4%, 31.4%, and 37.3%, respectively.

“After 68 weeks, not a lot happened [in placebo participants]; however, 12.1% of placebo participants did drop below the obesity threshold into overweight or normal-weight categories,” reported Dr. Kelly.

Referring to participants taking semaglutide, he added that “a total of 45% of patients on semaglutide dropped below the clinical BMI cut point for obesity, such that 19.5% dropped into the overweight category and 25.4% reduced their BMI into the normal-weight category.”

Turning to obesity class, Dr. Kelly reported that of those initially with obesity class III taking placebo, 91% remained in that class and 9.1% dropped to obesity class II at week 68. For those adolescents with obesity class III taking semaglutide, 36.4% dropped to obesity class II, 18.2% dropped to obesity class I, 11% dropped below the obesity threshold, and 34.1% remained in obesity class III, he added.

For obesity class II specifically, 71% of placebo participants stayed in that category, while 12% moved up a category. “On semaglutide, over 50% (51.2%) reduced their BMI below the obesity cut point,” noted Dr. Kelly.

In obesity class I, 26% of patients taking placebo reduced their BMI below the obesity cut point. “On semaglutide, nearly 80% reduced their BMI below the obesity threshold, with 57% dropping their BMI into the normal category,” he said.

“When we looked at baseline factors that might predict the response to semaglutide or placebo, we did not find any factors that were ... significant due to small sample sizes,” he said. However, he pointed out that “females tended to respond better to semaglutide, likewise younger adolescents, and middle body weights tended to respond better to the drug, and there was a similar pattern with obesity classes.”

Commenting on the study, Jesse Bittman, MD, University of British Columbia, Vancouver, said: “Good to see more data on different populations that some semaglutide is used in and the variability in response to it. The focus on BMI was interesting because in obesity medicine we spend a lot of time telling our patients not to focus on BMIs and ‘normals’ because there are more important tools, and we see that when these become the focus of research outcomes they can become problematic.”

Asked whether rapid weight loss in adolescents might be problematic in some respects, Dr. Bittman pointed out that “one concern with these medications is whether people are going to have loss of muscle mass or malnutrition, or whether they develop eating disorders and other disturbed eating behaviors.”

Dr. Kelly has reported engaging in unpaid consulting and educational activities for Boehringer Ingelheim, Eli Lilly, Novo Nordisk, and Vivus, and receiving donated drug/placebo from Novo Nordisk and Vivus for National Institutes of Health–funded clinical trials. Dr. O’Malley has declared having received grants in the past 3 years from the Health Research Board, Department of Health, Ireland, European Association for the Study of Obesity (via a Novo Nordisk educational grant), Healthy Ireland fund, and the Royal College of Surgeons in Ireland Strategic Academic Recruitment (StAR) Programme. Dr. Bittman has reported receiving funding from Novo Nordisk, Bayer, and Bausch Health.

A version of this article first appeared on Medscape.com.

DUBLIN – A swallowable gastric balloon (Allurion Balloon, formerly known as Elipse) combined with daily subcutaneous injections of the glucagonlike peptide 1 (GLP-1) agonist liraglutide (Saxenda, Novo Nordisk), leads to a significant average total body weight loss of 19% (18 kg or 40 lb) after around 4 months in people with obesity.

“The combination therapy [balloon and liraglutide] resulted in an additional weight loss compared to the two single treatments,” said Roberta Ienca, MD, from the Clinica Nuova Villa Claudia, Rome, who presented the findings at this year’s European Congress on Obesity.

“Despite both the balloon and liraglutide working on the early satiety feeling, the introduction of liraglutide around 1 month after [swallowing the balloon] or more frequently after 3-4 months, could sustain these feelings for a longer period of time,” she said in an interview.

Allurion Technologies

“The addition of the GLP-1 agonist therapy (liraglutide) to patients treated with the Allurion program [gastric balloon] is feasible, safe, and effective in those who need additional weight loss,” she emphasized.

The balloon stayed inside participants’ stomachs for an average of 16 weeks and liraglutide was continued for an average of 4 months, resulting in a mean reduction in body mass index (BMI) of 6.4 kg/m².

The Allurion is the world’s first and only swallowable gastric balloon placed without surgery, endoscopy, or anesthesia, and is excreted naturally after around 16 weeks.

The Allurion program delivered “excellent weight loss in individuals with overweight and obesity without going under the knife, and liraglutide has the potential to further safely enhance weight loss in cases of suboptimal adherence with the program,” Dr. Ienca said. “These two treatment approaches appear to have complementary mechanisms of action in a geographically and demographically diverse population.”

Adelardo Caballero, MD, director of the Institute of Obesity, Madrid, said that he had over 6 years of experience with the Allurion balloon in around 2,500 cases. “Over the last 3 years, we have been using Allurion balloons in combination with GLP-1 agonists. In Europe, use of the swallowable gastric balloon is common, the results are good, and it is a safe tool.”

“Using liraglutide daily in subcutaneous form is authorized in Europe and is useful in overweight and mild obesity, while use in the combination [with the balloon] is also very popular,” he explained. “In the future, the combined use of semaglutide once-weekly GLP-1 agonist or the use of dual GLP-1/gastric inhibitory polypeptide agonists [such as tirzepatide] with the swallowable intragastric balloon Allurion program or endoscopic sleeve gastroplasty will improve results,” he added.
 

Average 40-lb weight loss with balloon and liraglutide

For the current study, data from three international multidisciplinary obesity centers (in Italy, Spain, and Egypt) were retrospectively analyzed. All 181 patients received the combination of the Allurion balloon and liraglutide, with the latter added 4-16 weeks after swallowing the balloon.

During a 20-minute outpatient visit, participants swallowed the balloon, which was filled with liquid after reaching the stomach, and placement was confirmed by x-ray. The balloon remained inserted for around 15-17 weeks (mean 16 weeks) before natural excretion. All patients received liraglutide once daily for 1-6 months (mean 4 months). After excreting the balloon, patients started the Mediterranean diet for weight maintenance and were followed for at least 6 months.

Patients were monitored for weight loss, percentage total body weight loss, percentage excess weight loss, and BMI reduction. The timing of combining drug therapy with the Allurion program, metabolic results, and adverse event data were collected. However, Dr. Ienca explained that “the study was preliminary and aimed to evaluate feasibility and results of a combined treatment, so we didn’t collect long-term data.”

Liraglutide was mostly added in cases of unsatisfactory weight loss to boost weight reduction in patients with high BMIs, to sustain weight maintenance, and to aid diabetes control in patients with satisfactory weight loss. There were no criteria for time of onset of drug therapy in terms of a time point or percentage weight loss.

Before treatment, mean weight was 94.8 ± 21 kg and mean BMI was 33.7 ± 6.2 kg/m². After 4 months of balloon treatment, weight loss, percentage total body weight loss, percentage excess weight loss, and decrease in BMI were 13.1 ± 7 kg, 13.9% ± 7.7%, 74.3% ± 57.1%, and 4.5 ±1.4 kg/m² respectively.

After a mean duration of 4 months of liraglutide treatment (in addition to the gastric balloon), participants lost on average 18.1 ± 12.1 kg overall and 18.7% ± 12% of their initial total body weight. They shed 99.4% ± 84.9% of excess weight and reduced BMI by 6.4 ± 5.9 kg/m².

Dr. Ienca explained that the study did not explore the separate contributions of the balloon or drug therapy to weight loss. “However, existing literature shows that the Allurion program leads to a weight loss of approximately 14% of total body weight after 4 months, while liraglutide studies report 12% of total body weight loss at 1 year,” he noted.

When describing the mechanism of action, Dr. Ienca said the Allurion balloon induces satiety and delays gastric emptying but the feeling of satiety starts to decrease after the first month. “For a few patients, this feeling of satiety decreases more rapidly or they have more difficulty putting in place new alimentary habits. In these patients, the addition of liraglutide gives an additional boost to support this behavioral change.”

Liraglutide-related adverse events included nausea (16.5%), diarrhea (3.3%), constipation (2.2%), and headache (1.7%), as well as drug discontinuation due to tachycardia/chest pain (1.1%) and gastrointestinal symptoms (1.1%).

Balloon removal because of intolerance occurred in 1.1% of patients, gastric dilation in 0.5%, and early balloon deflation in 0.5%. Other expected balloon-related adverse events included nausea, vomiting, and abdominal cramps.

The researchers note that the Allurion program offers a more acceptable option to balloon placement by endoscopy.

“The ease of use, low rate of adverse events, and potentially lower cost of the Allurion Program could enable much wider application of this critical intervention, and ultimately, help the millions who struggle with obesity and its associated health complications.”

A version of this article originally appeared on Medscape.com.

DUBLIN – A swallowable gastric balloon (Allurion Balloon, formerly known as Elipse) combined with daily subcutaneous injections of the glucagonlike peptide 1 (GLP-1) agonist liraglutide (Saxenda, Novo Nordisk), leads to a significant average total body weight loss of 19% (18 kg or 40 lb) after around 4 months in people with obesity.

“The combination therapy [balloon and liraglutide] resulted in an additional weight loss compared to the two single treatments,” said Roberta Ienca, MD, from the Clinica Nuova Villa Claudia, Rome, who presented the findings at this year’s European Congress on Obesity.

“Despite both the balloon and liraglutide working on the early satiety feeling, the introduction of liraglutide around 1 month after [swallowing the balloon] or more frequently after 3-4 months, could sustain these feelings for a longer period of time,” she said in an interview.

Allurion Technologies

“The addition of the GLP-1 agonist therapy (liraglutide) to patients treated with the Allurion program [gastric balloon] is feasible, safe, and effective in those who need additional weight loss,” she emphasized.

The balloon stayed inside participants’ stomachs for an average of 16 weeks and liraglutide was continued for an average of 4 months, resulting in a mean reduction in body mass index (BMI) of 6.4 kg/m².

The Allurion is the world’s first and only swallowable gastric balloon placed without surgery, endoscopy, or anesthesia, and is excreted naturally after around 16 weeks.

The Allurion program delivered “excellent weight loss in individuals with overweight and obesity without going under the knife, and liraglutide has the potential to further safely enhance weight loss in cases of suboptimal adherence with the program,” Dr. Ienca said. “These two treatment approaches appear to have complementary mechanisms of action in a geographically and demographically diverse population.”

Adelardo Caballero, MD, director of the Institute of Obesity, Madrid, said that he had over 6 years of experience with the Allurion balloon in around 2,500 cases. “Over the last 3 years, we have been using Allurion balloons in combination with GLP-1 agonists. In Europe, use of the swallowable gastric balloon is common, the results are good, and it is a safe tool.”

“Using liraglutide daily in subcutaneous form is authorized in Europe and is useful in overweight and mild obesity, while use in the combination [with the balloon] is also very popular,” he explained. “In the future, the combined use of semaglutide once-weekly GLP-1 agonist or the use of dual GLP-1/gastric inhibitory polypeptide agonists [such as tirzepatide] with the swallowable intragastric balloon Allurion program or endoscopic sleeve gastroplasty will improve results,” he added.
 

Average 40-lb weight loss with balloon and liraglutide

For the current study, data from three international multidisciplinary obesity centers (in Italy, Spain, and Egypt) were retrospectively analyzed. All 181 patients received the combination of the Allurion balloon and liraglutide, with the latter added 4-16 weeks after swallowing the balloon.

During a 20-minute outpatient visit, participants swallowed the balloon, which was filled with liquid after reaching the stomach, and placement was confirmed by x-ray. The balloon remained inserted for around 15-17 weeks (mean 16 weeks) before natural excretion. All patients received liraglutide once daily for 1-6 months (mean 4 months). After excreting the balloon, patients started the Mediterranean diet for weight maintenance and were followed for at least 6 months.

Patients were monitored for weight loss, percentage total body weight loss, percentage excess weight loss, and BMI reduction. The timing of combining drug therapy with the Allurion program, metabolic results, and adverse event data were collected. However, Dr. Ienca explained that “the study was preliminary and aimed to evaluate feasibility and results of a combined treatment, so we didn’t collect long-term data.”

Liraglutide was mostly added in cases of unsatisfactory weight loss to boost weight reduction in patients with high BMIs, to sustain weight maintenance, and to aid diabetes control in patients with satisfactory weight loss. There were no criteria for time of onset of drug therapy in terms of a time point or percentage weight loss.

Before treatment, mean weight was 94.8 ± 21 kg and mean BMI was 33.7 ± 6.2 kg/m². After 4 months of balloon treatment, weight loss, percentage total body weight loss, percentage excess weight loss, and decrease in BMI were 13.1 ± 7 kg, 13.9% ± 7.7%, 74.3% ± 57.1%, and 4.5 ±1.4 kg/m² respectively.

After a mean duration of 4 months of liraglutide treatment (in addition to the gastric balloon), participants lost on average 18.1 ± 12.1 kg overall and 18.7% ± 12% of their initial total body weight. They shed 99.4% ± 84.9% of excess weight and reduced BMI by 6.4 ± 5.9 kg/m².

Dr. Ienca explained that the study did not explore the separate contributions of the balloon or drug therapy to weight loss. “However, existing literature shows that the Allurion program leads to a weight loss of approximately 14% of total body weight after 4 months, while liraglutide studies report 12% of total body weight loss at 1 year,” he noted.

When describing the mechanism of action, Dr. Ienca said the Allurion balloon induces satiety and delays gastric emptying but the feeling of satiety starts to decrease after the first month. “For a few patients, this feeling of satiety decreases more rapidly or they have more difficulty putting in place new alimentary habits. In these patients, the addition of liraglutide gives an additional boost to support this behavioral change.”

Liraglutide-related adverse events included nausea (16.5%), diarrhea (3.3%), constipation (2.2%), and headache (1.7%), as well as drug discontinuation due to tachycardia/chest pain (1.1%) and gastrointestinal symptoms (1.1%).

Balloon removal because of intolerance occurred in 1.1% of patients, gastric dilation in 0.5%, and early balloon deflation in 0.5%. Other expected balloon-related adverse events included nausea, vomiting, and abdominal cramps.

The researchers note that the Allurion program offers a more acceptable option to balloon placement by endoscopy.

“The ease of use, low rate of adverse events, and potentially lower cost of the Allurion Program could enable much wider application of this critical intervention, and ultimately, help the millions who struggle with obesity and its associated health complications.”

A version of this article originally appeared on Medscape.com.

DUBLIN – A swallowable gastric balloon (Allurion Balloon, formerly known as Elipse) combined with daily subcutaneous injections of the glucagonlike peptide 1 (GLP-1) agonist liraglutide (Saxenda, Novo Nordisk), leads to a significant average total body weight loss of 19% (18 kg or 40 lb) after around 4 months in people with obesity.

“The combination therapy [balloon and liraglutide] resulted in an additional weight loss compared to the two single treatments,” said Roberta Ienca, MD, from the Clinica Nuova Villa Claudia, Rome, who presented the findings at this year’s European Congress on Obesity.

“Despite both the balloon and liraglutide working on the early satiety feeling, the introduction of liraglutide around 1 month after [swallowing the balloon] or more frequently after 3-4 months, could sustain these feelings for a longer period of time,” she said in an interview.

Allurion Technologies

“The addition of the GLP-1 agonist therapy (liraglutide) to patients treated with the Allurion program [gastric balloon] is feasible, safe, and effective in those who need additional weight loss,” she emphasized.

The balloon stayed inside participants’ stomachs for an average of 16 weeks and liraglutide was continued for an average of 4 months, resulting in a mean reduction in body mass index (BMI) of 6.4 kg/m².

The Allurion is the world’s first and only swallowable gastric balloon placed without surgery, endoscopy, or anesthesia, and is excreted naturally after around 16 weeks.

The Allurion program delivered “excellent weight loss in individuals with overweight and obesity without going under the knife, and liraglutide has the potential to further safely enhance weight loss in cases of suboptimal adherence with the program,” Dr. Ienca said. “These two treatment approaches appear to have complementary mechanisms of action in a geographically and demographically diverse population.”

Adelardo Caballero, MD, director of the Institute of Obesity, Madrid, said that he had over 6 years of experience with the Allurion balloon in around 2,500 cases. “Over the last 3 years, we have been using Allurion balloons in combination with GLP-1 agonists. In Europe, use of the swallowable gastric balloon is common, the results are good, and it is a safe tool.”

“Using liraglutide daily in subcutaneous form is authorized in Europe and is useful in overweight and mild obesity, while use in the combination [with the balloon] is also very popular,” he explained. “In the future, the combined use of semaglutide once-weekly GLP-1 agonist or the use of dual GLP-1/gastric inhibitory polypeptide agonists [such as tirzepatide] with the swallowable intragastric balloon Allurion program or endoscopic sleeve gastroplasty will improve results,” he added.
 

Average 40-lb weight loss with balloon and liraglutide

For the current study, data from three international multidisciplinary obesity centers (in Italy, Spain, and Egypt) were retrospectively analyzed. All 181 patients received the combination of the Allurion balloon and liraglutide, with the latter added 4-16 weeks after swallowing the balloon.

During a 20-minute outpatient visit, participants swallowed the balloon, which was filled with liquid after reaching the stomach, and placement was confirmed by x-ray. The balloon remained inserted for around 15-17 weeks (mean 16 weeks) before natural excretion. All patients received liraglutide once daily for 1-6 months (mean 4 months). After excreting the balloon, patients started the Mediterranean diet for weight maintenance and were followed for at least 6 months.

Patients were monitored for weight loss, percentage total body weight loss, percentage excess weight loss, and BMI reduction. The timing of combining drug therapy with the Allurion program, metabolic results, and adverse event data were collected. However, Dr. Ienca explained that “the study was preliminary and aimed to evaluate feasibility and results of a combined treatment, so we didn’t collect long-term data.”

Liraglutide was mostly added in cases of unsatisfactory weight loss to boost weight reduction in patients with high BMIs, to sustain weight maintenance, and to aid diabetes control in patients with satisfactory weight loss. There were no criteria for time of onset of drug therapy in terms of a time point or percentage weight loss.

Before treatment, mean weight was 94.8 ± 21 kg and mean BMI was 33.7 ± 6.2 kg/m². After 4 months of balloon treatment, weight loss, percentage total body weight loss, percentage excess weight loss, and decrease in BMI were 13.1 ± 7 kg, 13.9% ± 7.7%, 74.3% ± 57.1%, and 4.5 ±1.4 kg/m² respectively.

After a mean duration of 4 months of liraglutide treatment (in addition to the gastric balloon), participants lost on average 18.1 ± 12.1 kg overall and 18.7% ± 12% of their initial total body weight. They shed 99.4% ± 84.9% of excess weight and reduced BMI by 6.4 ± 5.9 kg/m².

Dr. Ienca explained that the study did not explore the separate contributions of the balloon or drug therapy to weight loss. “However, existing literature shows that the Allurion program leads to a weight loss of approximately 14% of total body weight after 4 months, while liraglutide studies report 12% of total body weight loss at 1 year,” he noted.

When describing the mechanism of action, Dr. Ienca said the Allurion balloon induces satiety and delays gastric emptying but the feeling of satiety starts to decrease after the first month. “For a few patients, this feeling of satiety decreases more rapidly or they have more difficulty putting in place new alimentary habits. In these patients, the addition of liraglutide gives an additional boost to support this behavioral change.”

Liraglutide-related adverse events included nausea (16.5%), diarrhea (3.3%), constipation (2.2%), and headache (1.7%), as well as drug discontinuation due to tachycardia/chest pain (1.1%) and gastrointestinal symptoms (1.1%).

Balloon removal because of intolerance occurred in 1.1% of patients, gastric dilation in 0.5%, and early balloon deflation in 0.5%. Other expected balloon-related adverse events included nausea, vomiting, and abdominal cramps.

The researchers note that the Allurion program offers a more acceptable option to balloon placement by endoscopy.

“The ease of use, low rate of adverse events, and potentially lower cost of the Allurion Program could enable much wider application of this critical intervention, and ultimately, help the millions who struggle with obesity and its associated health complications.”

A version of this article originally appeared on Medscape.com.

The history and findings in this case are suggestive of inflammatory breast cancer.

Breast cancer is the leading life-threatening cancer diagnosed and the second-leading cause of cancer-related deaths in women worldwide. In the United States, estimates suggest that 287,850 new cases of invasive breast cancer were diagnosed in 2022 and 43,250 women died of the disease. Globally, approximately 2.3 million new diagnoses and 685,000 breast cancer–related deaths were reported in 2020.

Inflammatory breast cancer is a rare and highly aggressive subtype of locally advanced breast cancer. In the United States, inflammatory breast cancer accounts for approximately 2%-4% of breast cancer cases. Although its incidence is rare, 7% of breast cancer caused mortality is attributed to inflammatory breast cancer. Cases of inflammatory breast cancer tend to be diagnosed at a younger age compared with noninflammatory breast cancer cases. Risk factors include African-American race and obesity. 

The symptoms of inflammatory breast cancer can vary broadly, ranging from subtle skin erythema to diffuse breast involvement with skin dimpling and nipple inversion. Diagnostic criteria include erythema occupying at least one third of the breast, edema, peau d'orange, and/or warmth, with or without an underlying mass; rapid onset (< 3 months); and pathologic confirmation of invasive breast carcinoma. Histologic findings include florid tumor emboli that obstruct dermal lymphatics, which results in swelling and inflammation of the affected breast. 

Inflammatory breast cancer has been associated with a poor prognosis. However, treatment advances are helping to improve outcomes. Currently, 5-year survival rates are reported to be 40%-70%, with a median survival of 2-4 years. According to 2023 guidelines from the National Comprehensive Cancer Network (NCCN), the first-line treatment of inflammatory breast cancer involves neoadjuvant chemotherapy, modified radical mastectomy, and adjuvant radiation to the chest wall and regional nodes. Endocrine treatment should also be given to patients who are ER-positive and/or PR-positive (sequential chemotherapy followed by endocrine therapy). For patients who are HER2-positive, up to 1 year of HER2-targeted therapy should be given. HER2-targeted therapies can be administered concurrently with radiation and with endocrine therapy if indicated.

Delayed reconstruction after mastectomy remains the clinical standard for inflammatory breast cancer. This is because the need to resect involved skin negates the benefit of skin-sparing mastectomy for immediate reconstruction. Moreover, high rates of local and distant recurrence warrant comprehensive regional node irradiation in a timely fashion, which may be more challenging or subject to delay after immediate reconstruction. Rarely, the extent of skin excision at the time of mastectomy prohibits primary or local closure. In such cases, reconstruction of the chest wall defect with autologous tissue is required, and concomitant immediate reconstruction may be undertaken.

Detailed guidance on the treatment of inflammatory breast cancer, in the first line and beyond, are available from the NCCN.

Avan J. Armaghani, MD, Assistant Member, Department of Breast Oncology, Moffitt Cancer Center, University of South Florida, Tampa, FL.

Avan J. Armaghani, MD, has disclosed no relevant financial relationships.

Image Quizzes are fictional or fictionalized clinical scenarios intended to provide evidence-based educational takeaways.

The history and findings in this case are suggestive of inflammatory breast cancer.

Breast cancer is the leading life-threatening cancer diagnosed and the second-leading cause of cancer-related deaths in women worldwide. In the United States, estimates suggest that 287,850 new cases of invasive breast cancer were diagnosed in 2022 and 43,250 women died of the disease. Globally, approximately 2.3 million new diagnoses and 685,000 breast cancer–related deaths were reported in 2020.

Inflammatory breast cancer is a rare and highly aggressive subtype of locally advanced breast cancer. In the United States, inflammatory breast cancer accounts for approximately 2%-4% of breast cancer cases. Although its incidence is rare, 7% of breast cancer caused mortality is attributed to inflammatory breast cancer. Cases of inflammatory breast cancer tend to be diagnosed at a younger age compared with noninflammatory breast cancer cases. Risk factors include African-American race and obesity. 

The symptoms of inflammatory breast cancer can vary broadly, ranging from subtle skin erythema to diffuse breast involvement with skin dimpling and nipple inversion. Diagnostic criteria include erythema occupying at least one third of the breast, edema, peau d'orange, and/or warmth, with or without an underlying mass; rapid onset (< 3 months); and pathologic confirmation of invasive breast carcinoma. Histologic findings include florid tumor emboli that obstruct dermal lymphatics, which results in swelling and inflammation of the affected breast. 

Inflammatory breast cancer has been associated with a poor prognosis. However, treatment advances are helping to improve outcomes. Currently, 5-year survival rates are reported to be 40%-70%, with a median survival of 2-4 years. According to 2023 guidelines from the National Comprehensive Cancer Network (NCCN), the first-line treatment of inflammatory breast cancer involves neoadjuvant chemotherapy, modified radical mastectomy, and adjuvant radiation to the chest wall and regional nodes. Endocrine treatment should also be given to patients who are ER-positive and/or PR-positive (sequential chemotherapy followed by endocrine therapy). For patients who are HER2-positive, up to 1 year of HER2-targeted therapy should be given. HER2-targeted therapies can be administered concurrently with radiation and with endocrine therapy if indicated.

Delayed reconstruction after mastectomy remains the clinical standard for inflammatory breast cancer. This is because the need to resect involved skin negates the benefit of skin-sparing mastectomy for immediate reconstruction. Moreover, high rates of local and distant recurrence warrant comprehensive regional node irradiation in a timely fashion, which may be more challenging or subject to delay after immediate reconstruction. Rarely, the extent of skin excision at the time of mastectomy prohibits primary or local closure. In such cases, reconstruction of the chest wall defect with autologous tissue is required, and concomitant immediate reconstruction may be undertaken.

Detailed guidance on the treatment of inflammatory breast cancer, in the first line and beyond, are available from the NCCN.

Avan J. Armaghani, MD, Assistant Member, Department of Breast Oncology, Moffitt Cancer Center, University of South Florida, Tampa, FL.

Avan J. Armaghani, MD, has disclosed no relevant financial relationships.

Image Quizzes are fictional or fictionalized clinical scenarios intended to provide evidence-based educational takeaways.

The history and findings in this case are suggestive of inflammatory breast cancer.

Breast cancer is the leading life-threatening cancer diagnosed and the second-leading cause of cancer-related deaths in women worldwide. In the United States, estimates suggest that 287,850 new cases of invasive breast cancer were diagnosed in 2022 and 43,250 women died of the disease. Globally, approximately 2.3 million new diagnoses and 685,000 breast cancer–related deaths were reported in 2020.

Inflammatory breast cancer is a rare and highly aggressive subtype of locally advanced breast cancer. In the United States, inflammatory breast cancer accounts for approximately 2%-4% of breast cancer cases. Although its incidence is rare, 7% of breast cancer caused mortality is attributed to inflammatory breast cancer. Cases of inflammatory breast cancer tend to be diagnosed at a younger age compared with noninflammatory breast cancer cases. Risk factors include African-American race and obesity. 

The symptoms of inflammatory breast cancer can vary broadly, ranging from subtle skin erythema to diffuse breast involvement with skin dimpling and nipple inversion. Diagnostic criteria include erythema occupying at least one third of the breast, edema, peau d'orange, and/or warmth, with or without an underlying mass; rapid onset (< 3 months); and pathologic confirmation of invasive breast carcinoma. Histologic findings include florid tumor emboli that obstruct dermal lymphatics, which results in swelling and inflammation of the affected breast. 

Inflammatory breast cancer has been associated with a poor prognosis. However, treatment advances are helping to improve outcomes. Currently, 5-year survival rates are reported to be 40%-70%, with a median survival of 2-4 years. According to 2023 guidelines from the National Comprehensive Cancer Network (NCCN), the first-line treatment of inflammatory breast cancer involves neoadjuvant chemotherapy, modified radical mastectomy, and adjuvant radiation to the chest wall and regional nodes. Endocrine treatment should also be given to patients who are ER-positive and/or PR-positive (sequential chemotherapy followed by endocrine therapy). For patients who are HER2-positive, up to 1 year of HER2-targeted therapy should be given. HER2-targeted therapies can be administered concurrently with radiation and with endocrine therapy if indicated.

Delayed reconstruction after mastectomy remains the clinical standard for inflammatory breast cancer. This is because the need to resect involved skin negates the benefit of skin-sparing mastectomy for immediate reconstruction. Moreover, high rates of local and distant recurrence warrant comprehensive regional node irradiation in a timely fashion, which may be more challenging or subject to delay after immediate reconstruction. Rarely, the extent of skin excision at the time of mastectomy prohibits primary or local closure. In such cases, reconstruction of the chest wall defect with autologous tissue is required, and concomitant immediate reconstruction may be undertaken.

Detailed guidance on the treatment of inflammatory breast cancer, in the first line and beyond, are available from the NCCN.

Avan J. Armaghani, MD, Assistant Member, Department of Breast Oncology, Moffitt Cancer Center, University of South Florida, Tampa, FL.

Avan J. Armaghani, MD, has disclosed no relevant financial relationships.

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