Key clinical point: Younger age, higher disease activity, prevalent erosions, and monotherapy were significant risk factors for the development of new bone erosions in biologic disease-modifying antirheumatic drug (bDMARD)-treated patients with rheumatoid arthritis (RA).

Major finding: Risk of developing new bone erosions increased with younger age (adjusted odds ratio [aOR] 0.970; P < .001), higher Disease Activity Scores for 28 Joints-C-Reactive Protein (aOR per point increase 5.349; P < .001), presence of erosions at baseline (aOR 7.820; P < .001), and conventional DMARD-naive status (aOR 2.068; P  =  .033).

Study details: Findings are from a retrospective analysis of prospectively collected data of 578 patients with RA who started bDMARD treatment.

Disclosures: This study did not receive any funding. G Adami, D Gatti, and M Rossini declared receiving personal fees or serving as a consultant or speaker for various sources. The other authors declared no conflicts of interest.

Source: Adami G et al. Factors associated with radiographic progression in rheumatoid arthritis starting biological diseases modifying anti-rheumatic drugs (bDMARDs). Ther Adv Musculoskelet Dis. 2023;15:1759720X231174534 (Sep 28). doi: 10.1177/1759720X231174534

Key clinical point: Younger age, higher disease activity, prevalent erosions, and monotherapy were significant risk factors for the development of new bone erosions in biologic disease-modifying antirheumatic drug (bDMARD)-treated patients with rheumatoid arthritis (RA).

Major finding: Risk of developing new bone erosions increased with younger age (adjusted odds ratio [aOR] 0.970; P < .001), higher Disease Activity Scores for 28 Joints-C-Reactive Protein (aOR per point increase 5.349; P < .001), presence of erosions at baseline (aOR 7.820; P < .001), and conventional DMARD-naive status (aOR 2.068; P  =  .033).

Study details: Findings are from a retrospective analysis of prospectively collected data of 578 patients with RA who started bDMARD treatment.

Disclosures: This study did not receive any funding. G Adami, D Gatti, and M Rossini declared receiving personal fees or serving as a consultant or speaker for various sources. The other authors declared no conflicts of interest.

Source: Adami G et al. Factors associated with radiographic progression in rheumatoid arthritis starting biological diseases modifying anti-rheumatic drugs (bDMARDs). Ther Adv Musculoskelet Dis. 2023;15:1759720X231174534 (Sep 28). doi: 10.1177/1759720X231174534

Key clinical point: Younger age, higher disease activity, prevalent erosions, and monotherapy were significant risk factors for the development of new bone erosions in biologic disease-modifying antirheumatic drug (bDMARD)-treated patients with rheumatoid arthritis (RA).

Major finding: Risk of developing new bone erosions increased with younger age (adjusted odds ratio [aOR] 0.970; P < .001), higher Disease Activity Scores for 28 Joints-C-Reactive Protein (aOR per point increase 5.349; P < .001), presence of erosions at baseline (aOR 7.820; P < .001), and conventional DMARD-naive status (aOR 2.068; P  =  .033).

Study details: Findings are from a retrospective analysis of prospectively collected data of 578 patients with RA who started bDMARD treatment.

Disclosures: This study did not receive any funding. G Adami, D Gatti, and M Rossini declared receiving personal fees or serving as a consultant or speaker for various sources. The other authors declared no conflicts of interest.

Source: Adami G et al. Factors associated with radiographic progression in rheumatoid arthritis starting biological diseases modifying anti-rheumatic drugs (bDMARDs). Ther Adv Musculoskelet Dis. 2023;15:1759720X231174534 (Sep 28). doi: 10.1177/1759720X231174534

Key clinical point: Abatacept improved disease activity in patients with moderate-to-severe rheumatoid arthritis (RA), with those managed with treat-to-target (T2T) approach being more likely to achieve low disease activity (LDA) compared with routine care (RC).

Major finding: In each treatment group, abatacept treatment led to early and sustained improvement in disease activity (P < .0001). However, the odds of achieving Clinical Disease Activity Index LDA were significantly higher with T2T vs RC approach (odds ratio 1.33; P  =  .0263).

Study details: Findings are from the 12-month prospective, randomized Abatacept Best Care trial including 284 patients with moderate-to-severely active RA who initiated abatacept as first- or second-line biologic therapy and were randomly assigned to the T2T (n = 130) or RC (n = 154) group.

Disclosures: This study was managed by JSS Medical Research, and the trial was funded by Bristol Myers Squibb (BMS). Three authors declared being employees of or holding stock or stock options in BMS or JSS Medical Research. Several authors declared ties with various sources, including BMS.

Source: Bessette L et al. Effectiveness of a treat-to-target strategy in patients with moderate to severely active rheumatoid arthritis treated with abatacept. Arthritis Res Ther. 2023;25:183 (Sep 28). doi: 10.1186/s13075-023-03151-2

Key clinical point: Abatacept improved disease activity in patients with moderate-to-severe rheumatoid arthritis (RA), with those managed with treat-to-target (T2T) approach being more likely to achieve low disease activity (LDA) compared with routine care (RC).

Major finding: In each treatment group, abatacept treatment led to early and sustained improvement in disease activity (P < .0001). However, the odds of achieving Clinical Disease Activity Index LDA were significantly higher with T2T vs RC approach (odds ratio 1.33; P  =  .0263).

Study details: Findings are from the 12-month prospective, randomized Abatacept Best Care trial including 284 patients with moderate-to-severely active RA who initiated abatacept as first- or second-line biologic therapy and were randomly assigned to the T2T (n = 130) or RC (n = 154) group.

Disclosures: This study was managed by JSS Medical Research, and the trial was funded by Bristol Myers Squibb (BMS). Three authors declared being employees of or holding stock or stock options in BMS or JSS Medical Research. Several authors declared ties with various sources, including BMS.

Source: Bessette L et al. Effectiveness of a treat-to-target strategy in patients with moderate to severely active rheumatoid arthritis treated with abatacept. Arthritis Res Ther. 2023;25:183 (Sep 28). doi: 10.1186/s13075-023-03151-2

Key clinical point: Abatacept improved disease activity in patients with moderate-to-severe rheumatoid arthritis (RA), with those managed with treat-to-target (T2T) approach being more likely to achieve low disease activity (LDA) compared with routine care (RC).

Major finding: In each treatment group, abatacept treatment led to early and sustained improvement in disease activity (P < .0001). However, the odds of achieving Clinical Disease Activity Index LDA were significantly higher with T2T vs RC approach (odds ratio 1.33; P  =  .0263).

Study details: Findings are from the 12-month prospective, randomized Abatacept Best Care trial including 284 patients with moderate-to-severely active RA who initiated abatacept as first- or second-line biologic therapy and were randomly assigned to the T2T (n = 130) or RC (n = 154) group.

Disclosures: This study was managed by JSS Medical Research, and the trial was funded by Bristol Myers Squibb (BMS). Three authors declared being employees of or holding stock or stock options in BMS or JSS Medical Research. Several authors declared ties with various sources, including BMS.

Source: Bessette L et al. Effectiveness of a treat-to-target strategy in patients with moderate to severely active rheumatoid arthritis treated with abatacept. Arthritis Res Ther. 2023;25:183 (Sep 28). doi: 10.1186/s13075-023-03151-2

Key clinical point: Nearly half of the patients with rheumatoid arthritis-associated interstitial lung disease (RA-ILD) showed radiographic progression of fibrosis, and the presence of diabetes mellitus, high disease activity, and advanced high-resolution computed tomography (HRCT) scores significantly increased the fibrotic progression risk.

Major finding: HRCT-based radiographic progression of fibrosis was observed in 51.0% of patients with RA-ILD, with diabetes mellitus (hazard ratio [HR] 2.47; P < .01), Disease Activity Scores in 28 Joints-Erythrocyte Sedimentation Rate > 5.1 (HR 2.32; P  =  .04), and baseline HRCT scores > 5 (HR 3.04; P < .01) being significant risk factors for fibrotic progression.

Study details: Findings are from a retrospective cohort study including 371 patients with RA, of which 32.3% had RA-ILD.

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

Source: Chai D et al. Progression of radiographic fibrosis in rheumatoid arthritis-associated interstitial lung disease. Front Med (Lausanne). 2023;10:1265355 (Sep 22). doi: 10.3389/fmed.2023.1265355

Key clinical point: Nearly half of the patients with rheumatoid arthritis-associated interstitial lung disease (RA-ILD) showed radiographic progression of fibrosis, and the presence of diabetes mellitus, high disease activity, and advanced high-resolution computed tomography (HRCT) scores significantly increased the fibrotic progression risk.

Major finding: HRCT-based radiographic progression of fibrosis was observed in 51.0% of patients with RA-ILD, with diabetes mellitus (hazard ratio [HR] 2.47; P < .01), Disease Activity Scores in 28 Joints-Erythrocyte Sedimentation Rate > 5.1 (HR 2.32; P  =  .04), and baseline HRCT scores > 5 (HR 3.04; P < .01) being significant risk factors for fibrotic progression.

Study details: Findings are from a retrospective cohort study including 371 patients with RA, of which 32.3% had RA-ILD.

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

Source: Chai D et al. Progression of radiographic fibrosis in rheumatoid arthritis-associated interstitial lung disease. Front Med (Lausanne). 2023;10:1265355 (Sep 22). doi: 10.3389/fmed.2023.1265355

Key clinical point: Nearly half of the patients with rheumatoid arthritis-associated interstitial lung disease (RA-ILD) showed radiographic progression of fibrosis, and the presence of diabetes mellitus, high disease activity, and advanced high-resolution computed tomography (HRCT) scores significantly increased the fibrotic progression risk.

Major finding: HRCT-based radiographic progression of fibrosis was observed in 51.0% of patients with RA-ILD, with diabetes mellitus (hazard ratio [HR] 2.47; P < .01), Disease Activity Scores in 28 Joints-Erythrocyte Sedimentation Rate > 5.1 (HR 2.32; P  =  .04), and baseline HRCT scores > 5 (HR 3.04; P < .01) being significant risk factors for fibrotic progression.

Study details: Findings are from a retrospective cohort study including 371 patients with RA, of which 32.3% had RA-ILD.

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

Source: Chai D et al. Progression of radiographic fibrosis in rheumatoid arthritis-associated interstitial lung disease. Front Med (Lausanne). 2023;10:1265355 (Sep 22). doi: 10.3389/fmed.2023.1265355

Key clinical point: The findings demonstrate the feasibility of glucocorticoid discontinuation in patients with long-standing rheumatoid arthritis (RA) and inadequate response to methotrexate (MTX-IR) treated with tofacitinib, highlighting the steroid-sparing effect of tofacitinib.

Major finding: Overall, 30% and 40% of patients completely discontinued prednisone by weeks 12 and 24-48 of initiating tofacitinib, respectively. The median prednisone dose was reduced from 5 to 2.5 mg/day at week 12 (P < .00001), with nine patients further reducing the glucocorticoid dose to 1.25 mg/day from week 12 to week 48 (P < .00001).

Study details: This prospective, open-label, pilot study included 30 patients with moderate-to-severe RA and MTX-IR receiving a stable dose of glucocorticoids who initiated 5 mg tofacitinib twice daily, of which those who achieved at least a moderate European Alliance of Associations for Rheumatology response initiated glucocorticoid tapering until complete discontinuation.

Disclosures: This study was supported by a Pfizer Grant Award. FR Spinelli declared receiving a research grant from Pfizer. The other authors declared no conflicts of interest.

Source: Spinelli FR et al. Tapering and discontinuation of glucocorticoids in patients with rheumatoid arthritis treated with tofacitinib. Sci Rep. 2023;13:15537 (Sep 20). doi: 10.1038/s41598-023-42371-z

Key clinical point: The findings demonstrate the feasibility of glucocorticoid discontinuation in patients with long-standing rheumatoid arthritis (RA) and inadequate response to methotrexate (MTX-IR) treated with tofacitinib, highlighting the steroid-sparing effect of tofacitinib.

Major finding: Overall, 30% and 40% of patients completely discontinued prednisone by weeks 12 and 24-48 of initiating tofacitinib, respectively. The median prednisone dose was reduced from 5 to 2.5 mg/day at week 12 (P < .00001), with nine patients further reducing the glucocorticoid dose to 1.25 mg/day from week 12 to week 48 (P < .00001).

Study details: This prospective, open-label, pilot study included 30 patients with moderate-to-severe RA and MTX-IR receiving a stable dose of glucocorticoids who initiated 5 mg tofacitinib twice daily, of which those who achieved at least a moderate European Alliance of Associations for Rheumatology response initiated glucocorticoid tapering until complete discontinuation.

Disclosures: This study was supported by a Pfizer Grant Award. FR Spinelli declared receiving a research grant from Pfizer. The other authors declared no conflicts of interest.

Source: Spinelli FR et al. Tapering and discontinuation of glucocorticoids in patients with rheumatoid arthritis treated with tofacitinib. Sci Rep. 2023;13:15537 (Sep 20). doi: 10.1038/s41598-023-42371-z

Key clinical point: The findings demonstrate the feasibility of glucocorticoid discontinuation in patients with long-standing rheumatoid arthritis (RA) and inadequate response to methotrexate (MTX-IR) treated with tofacitinib, highlighting the steroid-sparing effect of tofacitinib.

Major finding: Overall, 30% and 40% of patients completely discontinued prednisone by weeks 12 and 24-48 of initiating tofacitinib, respectively. The median prednisone dose was reduced from 5 to 2.5 mg/day at week 12 (P < .00001), with nine patients further reducing the glucocorticoid dose to 1.25 mg/day from week 12 to week 48 (P < .00001).

Study details: This prospective, open-label, pilot study included 30 patients with moderate-to-severe RA and MTX-IR receiving a stable dose of glucocorticoids who initiated 5 mg tofacitinib twice daily, of which those who achieved at least a moderate European Alliance of Associations for Rheumatology response initiated glucocorticoid tapering until complete discontinuation.

Disclosures: This study was supported by a Pfizer Grant Award. FR Spinelli declared receiving a research grant from Pfizer. The other authors declared no conflicts of interest.

Source: Spinelli FR et al. Tapering and discontinuation of glucocorticoids in patients with rheumatoid arthritis treated with tofacitinib. Sci Rep. 2023;13:15537 (Sep 20). doi: 10.1038/s41598-023-42371-z

Key clinical point: Patients with microscopic colitis (MC) were at nearly 2-fold higher risk of developing rheumatoid arthritis (RA) compared with the general population, with a significant risk persisting up to 5 years after MC diagnosis.

Major finding: The risk for RA was significantly higher in patients with MC compared with matched reference individuals (adjusted hazard ratio [aHR] 1.83; 95% CI 1.39-2.41) and full siblings without MC (aHR 2.04; 95% CI 1.18-3.56). The risk was highest during the first year of follow-up (aHR 2.31; 95% CI 1.08-4.97) and remained significantly high up to 5 years after MC diagnosis (aHR 2.16; 95% CI 1.42-3.30).

Study details: Findings are from a population-based matched cohort study including 8179 patients with biopsy-verified MC, 36,400 matched reference individuals, and 8202 full siblings without MC.

Disclosures: This study was funded by Karolinska Institutet and other sources. Some authors declared serving as study coordinators or advisory board members for, receiving financial support from, and reporting agreements between various sources.

Source: Bergman D et al. Microscopic colitis and risk of incident rheumatoid arthritis: A nationwide population-based matched cohort study. Aliment Pharmacol Ther. 2023 (Sep 20). D+oi: 10.1111/apt.17708

Key clinical point: Patients with microscopic colitis (MC) were at nearly 2-fold higher risk of developing rheumatoid arthritis (RA) compared with the general population, with a significant risk persisting up to 5 years after MC diagnosis.

Major finding: The risk for RA was significantly higher in patients with MC compared with matched reference individuals (adjusted hazard ratio [aHR] 1.83; 95% CI 1.39-2.41) and full siblings without MC (aHR 2.04; 95% CI 1.18-3.56). The risk was highest during the first year of follow-up (aHR 2.31; 95% CI 1.08-4.97) and remained significantly high up to 5 years after MC diagnosis (aHR 2.16; 95% CI 1.42-3.30).

Study details: Findings are from a population-based matched cohort study including 8179 patients with biopsy-verified MC, 36,400 matched reference individuals, and 8202 full siblings without MC.

Disclosures: This study was funded by Karolinska Institutet and other sources. Some authors declared serving as study coordinators or advisory board members for, receiving financial support from, and reporting agreements between various sources.

Source: Bergman D et al. Microscopic colitis and risk of incident rheumatoid arthritis: A nationwide population-based matched cohort study. Aliment Pharmacol Ther. 2023 (Sep 20). D+oi: 10.1111/apt.17708

Key clinical point: Patients with microscopic colitis (MC) were at nearly 2-fold higher risk of developing rheumatoid arthritis (RA) compared with the general population, with a significant risk persisting up to 5 years after MC diagnosis.

Major finding: The risk for RA was significantly higher in patients with MC compared with matched reference individuals (adjusted hazard ratio [aHR] 1.83; 95% CI 1.39-2.41) and full siblings without MC (aHR 2.04; 95% CI 1.18-3.56). The risk was highest during the first year of follow-up (aHR 2.31; 95% CI 1.08-4.97) and remained significantly high up to 5 years after MC diagnosis (aHR 2.16; 95% CI 1.42-3.30).

Study details: Findings are from a population-based matched cohort study including 8179 patients with biopsy-verified MC, 36,400 matched reference individuals, and 8202 full siblings without MC.

Disclosures: This study was funded by Karolinska Institutet and other sources. Some authors declared serving as study coordinators or advisory board members for, receiving financial support from, and reporting agreements between various sources.

Source: Bergman D et al. Microscopic colitis and risk of incident rheumatoid arthritis: A nationwide population-based matched cohort study. Aliment Pharmacol Ther. 2023 (Sep 20). D+oi: 10.1111/apt.17708

Key clinical point: The use of oral contraceptives (OC) appeared to be protective against rheumatoid arthritis (RA), whereas the use of menopausal hormone therapy (MHT) increased the risk for late-onset RA.

Major finding: Compared with never-use, ever-use (hazard ratio [HR] 0.89; 95% CI 0.82-0.96) and current-use (HR 0.81; 95% CI 0.73-0.91) of OC decreased the risk for RA, whereas ever-use (HR 1.16; 95% CI 1.06-1.26) and former-use (HR 1.13; 95% CI 1.03-1.24) of MHT increased the risk for late-onset RA.

Study details: This prospective cohort study included 239,785 British women whose data were evaluated for the effect of OC (n = 236,602) or MHT (age ≥ 60 years, n = 102,466) on RA risk.

Disclosures: This study was funded by Agnes and Mac Rudbergs Foundation (Sweden), the Åke Wiberg Foundation (Sweden), the Marcus Borgström Foundation (Sweden), and various other sources. The authors declared no conflicts of interest.

Source: Hadizadeh F et al. Effects of oral contraceptives and menopausal hormone therapy on the risk of rheumatoid arthritis: A prospective cohort study. Rheumatology (Oxford). 2023 (Sep 29). doi: 10.1093/rheumatology/kead513

Key clinical point: The use of oral contraceptives (OC) appeared to be protective against rheumatoid arthritis (RA), whereas the use of menopausal hormone therapy (MHT) increased the risk for late-onset RA.

Major finding: Compared with never-use, ever-use (hazard ratio [HR] 0.89; 95% CI 0.82-0.96) and current-use (HR 0.81; 95% CI 0.73-0.91) of OC decreased the risk for RA, whereas ever-use (HR 1.16; 95% CI 1.06-1.26) and former-use (HR 1.13; 95% CI 1.03-1.24) of MHT increased the risk for late-onset RA.

Study details: This prospective cohort study included 239,785 British women whose data were evaluated for the effect of OC (n = 236,602) or MHT (age ≥ 60 years, n = 102,466) on RA risk.

Disclosures: This study was funded by Agnes and Mac Rudbergs Foundation (Sweden), the Åke Wiberg Foundation (Sweden), the Marcus Borgström Foundation (Sweden), and various other sources. The authors declared no conflicts of interest.

Source: Hadizadeh F et al. Effects of oral contraceptives and menopausal hormone therapy on the risk of rheumatoid arthritis: A prospective cohort study. Rheumatology (Oxford). 2023 (Sep 29). doi: 10.1093/rheumatology/kead513

Key clinical point: The use of oral contraceptives (OC) appeared to be protective against rheumatoid arthritis (RA), whereas the use of menopausal hormone therapy (MHT) increased the risk for late-onset RA.

Major finding: Compared with never-use, ever-use (hazard ratio [HR] 0.89; 95% CI 0.82-0.96) and current-use (HR 0.81; 95% CI 0.73-0.91) of OC decreased the risk for RA, whereas ever-use (HR 1.16; 95% CI 1.06-1.26) and former-use (HR 1.13; 95% CI 1.03-1.24) of MHT increased the risk for late-onset RA.

Study details: This prospective cohort study included 239,785 British women whose data were evaluated for the effect of OC (n = 236,602) or MHT (age ≥ 60 years, n = 102,466) on RA risk.

Disclosures: This study was funded by Agnes and Mac Rudbergs Foundation (Sweden), the Åke Wiberg Foundation (Sweden), the Marcus Borgström Foundation (Sweden), and various other sources. The authors declared no conflicts of interest.

Source: Hadizadeh F et al. Effects of oral contraceptives and menopausal hormone therapy on the risk of rheumatoid arthritis: A prospective cohort study. Rheumatology (Oxford). 2023 (Sep 29). doi: 10.1093/rheumatology/kead513

A device that stimulates the median nerve and a D1 receptor antagonist are among the promising new treatment approaches for patients with Tourette syndrome (TS), according to an overview of new therapies presented at the XXVI World Congress of Neurology.

One recent study by University of Nottingham researchers showed a wrist-worn stimulating device significantly reduces the frequency and severity of tics – repetitive movements or vocalizations that can occur several times a day.

“Wearable nerve stimulation holds great promise because it will be good across the age spectrum; adults can wear it to work, and children can go to school with it to help them concentrate on their schoolwork, and then they take it off at night,” Eileen Joyce, PhD, MB BChir, professor of neuropsychiatry at the Institute of Neurology, University College London, told this news organization.

Dr. Joyce, who was not part of the study, discussed this and other new advances in tic therapy at the meeting.

About 24% of children will suffer from tics at some point. The prevalence of Tourette syndrome among males is about four times that of females, Dr. Joyce told delegates. She added the typical age of onset is about 7 years with peak severity at about 12 years.

Predictors of tics persisting into adulthood include comorbid attention deficit hyperactivity disorder (ADHD), obsessive–compulsive disorder, and autism spectrum disorder, said Dr. Joyce, who also discussed the “highly heritable” nature of the syndrome and the numerous related genes identified to date.
 

Current and emerging treatments

Current treatments include psychological therapy, Botox for focal tics, and medications such as antipsychotics. Emerging therapies included deep brain stimulation and the new median nerve stimulation approach.

A study published  earlier this year included 135 patients with moderate to severe tic disorder who were randomly assigned to receive the investigational neuromodulation treatment, a sham treatment, or a wait-list treatment group.

The intervention involves rhythmic pulse trains of median nerve stimulation delivered via a device worn at the wrist. The device was programmed to deliver rhythmic (10 Hz) trains of low-intensity (1-19 mA) electrical stimulation to the median nerve at home once daily, 5 days a week for 4 weeks.

At 4 weeks, tic severity, as measured by the Yale Global Tic Severity Scale-Total Tic Severity Score (YGTSS-TTSS), was reduced by 7.1 points (35% reduction) in the active stimulation group compared to 2.13 points in the sham and 2.11 points in wait-list control groups.

The reduction for active stimulation was substantially larger, clinically meaningful (effect size, 0.5), and statistically significant (P = .02) compared to both the sham stimulation and wait-list control groups, which did not differ from one another.

Tic frequency (tics per minute or TPM) was reduced more in the active than sham stimulation groups (−15.6 TPM vs. −7.7 TPM; P < .03) and the reduction in tic frequency was clinically meaningful (>25% reduction; effect-size, 0.3).

When the active stimulator was turned off, the tics worsened, noted Dr. Joyce.

“The study showed that if you stimulate the median nerve at the wrist, you can train brain oscillations that are linked to the suppression of movement,” Dr. Joyce said. “So based on physiological knowledge, they have developed a median nerve stimulator to entrain cortical rhythms.”
 

Simple and exciting

The new device is “really exciting”, she added. “It’s not invasive and is quite simple to use and could help a lot of people with Tourette syndrome.”

Asked to comment, Alan Carson, MD, consultant neuropsychiatrist and honorary professor of neuropsychiatry, University of Edinburgh, who co-chaired the neuropsychiatry session featuring this presentation, called the device “promising.”

“Deep brain stimulation appears to be very effective but it’s a major procedure, so a simple wearable device seems highly desirable,” Dr. Carson said.

Dr. Joyce also discussed a study on the efficacy of cannabis (nabiximols; Sativex) as an intervention for tic management in males, those with severe tics, and those with comorbid ADHD.

And a new oral medication, ecopipam, a highly selective D1 receptor antagonist, is also raising hopes, said Dr. Joyce, with results from a randomized controlled trial  showing the drug significantly improved tics and had few adverse effects.

Dr. Joyce and Dr. Carson report no relevant financial relationships.

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

A device that stimulates the median nerve and a D1 receptor antagonist are among the promising new treatment approaches for patients with Tourette syndrome (TS), according to an overview of new therapies presented at the XXVI World Congress of Neurology.

One recent study by University of Nottingham researchers showed a wrist-worn stimulating device significantly reduces the frequency and severity of tics – repetitive movements or vocalizations that can occur several times a day.

“Wearable nerve stimulation holds great promise because it will be good across the age spectrum; adults can wear it to work, and children can go to school with it to help them concentrate on their schoolwork, and then they take it off at night,” Eileen Joyce, PhD, MB BChir, professor of neuropsychiatry at the Institute of Neurology, University College London, told this news organization.

Dr. Joyce, who was not part of the study, discussed this and other new advances in tic therapy at the meeting.

About 24% of children will suffer from tics at some point. The prevalence of Tourette syndrome among males is about four times that of females, Dr. Joyce told delegates. She added the typical age of onset is about 7 years with peak severity at about 12 years.

Predictors of tics persisting into adulthood include comorbid attention deficit hyperactivity disorder (ADHD), obsessive–compulsive disorder, and autism spectrum disorder, said Dr. Joyce, who also discussed the “highly heritable” nature of the syndrome and the numerous related genes identified to date.
 

Current and emerging treatments

Current treatments include psychological therapy, Botox for focal tics, and medications such as antipsychotics. Emerging therapies included deep brain stimulation and the new median nerve stimulation approach.

A study published  earlier this year included 135 patients with moderate to severe tic disorder who were randomly assigned to receive the investigational neuromodulation treatment, a sham treatment, or a wait-list treatment group.

The intervention involves rhythmic pulse trains of median nerve stimulation delivered via a device worn at the wrist. The device was programmed to deliver rhythmic (10 Hz) trains of low-intensity (1-19 mA) electrical stimulation to the median nerve at home once daily, 5 days a week for 4 weeks.

At 4 weeks, tic severity, as measured by the Yale Global Tic Severity Scale-Total Tic Severity Score (YGTSS-TTSS), was reduced by 7.1 points (35% reduction) in the active stimulation group compared to 2.13 points in the sham and 2.11 points in wait-list control groups.

The reduction for active stimulation was substantially larger, clinically meaningful (effect size, 0.5), and statistically significant (P = .02) compared to both the sham stimulation and wait-list control groups, which did not differ from one another.

Tic frequency (tics per minute or TPM) was reduced more in the active than sham stimulation groups (−15.6 TPM vs. −7.7 TPM; P < .03) and the reduction in tic frequency was clinically meaningful (>25% reduction; effect-size, 0.3).

When the active stimulator was turned off, the tics worsened, noted Dr. Joyce.

“The study showed that if you stimulate the median nerve at the wrist, you can train brain oscillations that are linked to the suppression of movement,” Dr. Joyce said. “So based on physiological knowledge, they have developed a median nerve stimulator to entrain cortical rhythms.”
 

Simple and exciting

The new device is “really exciting”, she added. “It’s not invasive and is quite simple to use and could help a lot of people with Tourette syndrome.”

Asked to comment, Alan Carson, MD, consultant neuropsychiatrist and honorary professor of neuropsychiatry, University of Edinburgh, who co-chaired the neuropsychiatry session featuring this presentation, called the device “promising.”

“Deep brain stimulation appears to be very effective but it’s a major procedure, so a simple wearable device seems highly desirable,” Dr. Carson said.

Dr. Joyce also discussed a study on the efficacy of cannabis (nabiximols; Sativex) as an intervention for tic management in males, those with severe tics, and those with comorbid ADHD.

And a new oral medication, ecopipam, a highly selective D1 receptor antagonist, is also raising hopes, said Dr. Joyce, with results from a randomized controlled trial  showing the drug significantly improved tics and had few adverse effects.

Dr. Joyce and Dr. Carson report no relevant financial relationships.

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

A device that stimulates the median nerve and a D1 receptor antagonist are among the promising new treatment approaches for patients with Tourette syndrome (TS), according to an overview of new therapies presented at the XXVI World Congress of Neurology.

One recent study by University of Nottingham researchers showed a wrist-worn stimulating device significantly reduces the frequency and severity of tics – repetitive movements or vocalizations that can occur several times a day.

“Wearable nerve stimulation holds great promise because it will be good across the age spectrum; adults can wear it to work, and children can go to school with it to help them concentrate on their schoolwork, and then they take it off at night,” Eileen Joyce, PhD, MB BChir, professor of neuropsychiatry at the Institute of Neurology, University College London, told this news organization.

Dr. Joyce, who was not part of the study, discussed this and other new advances in tic therapy at the meeting.

About 24% of children will suffer from tics at some point. The prevalence of Tourette syndrome among males is about four times that of females, Dr. Joyce told delegates. She added the typical age of onset is about 7 years with peak severity at about 12 years.

Predictors of tics persisting into adulthood include comorbid attention deficit hyperactivity disorder (ADHD), obsessive–compulsive disorder, and autism spectrum disorder, said Dr. Joyce, who also discussed the “highly heritable” nature of the syndrome and the numerous related genes identified to date.
 

Current and emerging treatments

Current treatments include psychological therapy, Botox for focal tics, and medications such as antipsychotics. Emerging therapies included deep brain stimulation and the new median nerve stimulation approach.

A study published  earlier this year included 135 patients with moderate to severe tic disorder who were randomly assigned to receive the investigational neuromodulation treatment, a sham treatment, or a wait-list treatment group.

The intervention involves rhythmic pulse trains of median nerve stimulation delivered via a device worn at the wrist. The device was programmed to deliver rhythmic (10 Hz) trains of low-intensity (1-19 mA) electrical stimulation to the median nerve at home once daily, 5 days a week for 4 weeks.

At 4 weeks, tic severity, as measured by the Yale Global Tic Severity Scale-Total Tic Severity Score (YGTSS-TTSS), was reduced by 7.1 points (35% reduction) in the active stimulation group compared to 2.13 points in the sham and 2.11 points in wait-list control groups.

The reduction for active stimulation was substantially larger, clinically meaningful (effect size, 0.5), and statistically significant (P = .02) compared to both the sham stimulation and wait-list control groups, which did not differ from one another.

Tic frequency (tics per minute or TPM) was reduced more in the active than sham stimulation groups (−15.6 TPM vs. −7.7 TPM; P < .03) and the reduction in tic frequency was clinically meaningful (>25% reduction; effect-size, 0.3).

When the active stimulator was turned off, the tics worsened, noted Dr. Joyce.

“The study showed that if you stimulate the median nerve at the wrist, you can train brain oscillations that are linked to the suppression of movement,” Dr. Joyce said. “So based on physiological knowledge, they have developed a median nerve stimulator to entrain cortical rhythms.”
 

Simple and exciting

The new device is “really exciting”, she added. “It’s not invasive and is quite simple to use and could help a lot of people with Tourette syndrome.”

Asked to comment, Alan Carson, MD, consultant neuropsychiatrist and honorary professor of neuropsychiatry, University of Edinburgh, who co-chaired the neuropsychiatry session featuring this presentation, called the device “promising.”

“Deep brain stimulation appears to be very effective but it’s a major procedure, so a simple wearable device seems highly desirable,” Dr. Carson said.

Dr. Joyce also discussed a study on the efficacy of cannabis (nabiximols; Sativex) as an intervention for tic management in males, those with severe tics, and those with comorbid ADHD.

And a new oral medication, ecopipam, a highly selective D1 receptor antagonist, is also raising hopes, said Dr. Joyce, with results from a randomized controlled trial  showing the drug significantly improved tics and had few adverse effects.

Dr. Joyce and Dr. Carson report no relevant financial relationships.

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

VANCOUVER – In contrast to some previous research, investigators found no significant correlation between common biologic and oral small molecule treatments for inflammatory bowel disease (IBD) and an increased risk of major adverse cardiovascular events (MACE).

In addition, biologics such as infliximab, adalimumab, golimumab, certolizumab, vedolizumab, natalizumab, and ustekinumab not only did not increase risk, but they were also linked to a significantly lower risk of major cardiovascular and thromboembolic events.

Risk reduction with biologics ranged from 15% for venous thromboembolism to 34% for myocardial infarction.

“The decrease in MACE with biologics was significant – and a bit surprising – but it correlates with the theory that by decreasing inflammation, there is a decrease in MACE,” said Miguel Regueiro, MD, chief of the Digestive Disease Institute at Cleveland Clinic, and senior author of the study.

“Our thought was that we would not see an increase in MACE and it would be equivalent between patients with IBD treated with advanced therapies and patients not treated with advanced therapies,” he told this news organization.

The findings “are consistent with some of the emerging long-term extension data from IBD clinical trials,” Dr. Regueiro reported at the ACG: American College of Gastroenterology annual scientific meeting. “And I’ll make an editorial comment for those that treat and practice in inflammatory bowel disease: I think these data continue to support, affirm, and hopefully comfort us.”
 

Therapies previously implicated in increased MACE risk

IBD itself is associated with increased MACE risk, likely because of chronic inflammation and endothelial dysfunction, the researchers note. While biologic and small molecule therapies are effective IBD treatments, some therapies have been implicated in an increased risk for MACE.

The Oral Surveillance postmarketing safety study of tofacitinib in rheumatoid arthritis, for example, linked the agent to higher MACE and venous thromboembolism rates vs. a TNF inhibitor. As a result, the FDA restricted the JAK inhibitor drug class that includes tofacitinib.

While long-term extension studies in IBD have not linked oral small molecules to increases in MACE, the sample sizes and duration of follow-up have been limited, the authors noted. For this reason, Dr. Regueiro and colleagues decided to further evaluate the potential associations in people with IBD.

The cohorts included 67,607 adults with IBD taking a biologic and another 67,607 with IBD not receiving a biologic between January 2021 and June 2023. The researchers also compared 3,194 adults with IBD taking an oral small molecule treatment vs. another 3,194 people with IBD not receiving these medications. These large sample sizes were possible through use of TriNetX, a large U.S. claims database that includes millions of patients.
 

Key findings

The propensity matched study revealed that adults with IBD on biologics had a significantly lower risk for coronary artery disease (adjusted odds ratio, 0.69; 95% confidence interval, 0.66-0.72; P < .0001), myocardial infarction (aOR, 0.66; 95% CI, 0.61-0.72; P < .0001) or stroke (aOR, 0.71; 95% CI, 0.65-0.77; P < .0001), compared with IBD patients not on biological therapy.

The researchers also found a lower risk for venous thromboembolism associated with biologics (aOR, 0.85; 95% CI, 0.81-0.89; P < .0001).

Dr. Regueiro said that active inflammation in the bowel or anywhere in the body is associated with higher rates of blood clot formation. “The thought is that decreasing inflammation with treatment may actually decrease the rates of blood clots. So, in essence, we think that biologics may actually decrease MACE.”

IBD patients receiving an oral small molecule did not have a significantly increased risk for coronary artery disease (aOR, 1.05; 95% CI, 0.82-1.33; P = .7148) or myocardial infarction (aOR, 1.04; 95% CI, 0.60-1.78; P = .8903). The risk of stroke was lower but not significantly different (aOR, 0.87; 95% CI, 0.57-1.33; P = .5148).

In addition, there was no significant change in risk for venous thromboembolism (aOR 1.07; 95% CI, 0.83-1.39; P = .5957).

All cohorts were matched for age, race, sex, cardiovascular risk factors, and medications including immunomodulators, 5-aminosalicylic acids, and steroids. MACE and VTE were noted by ICD-10 codes at least 30 days after starting treatment.

Strengths of the study included large sample size, diverse cohorts, and propensity score matching. Limitations included the study’s retrospective design.
 

Difference in IBD and rheumatoid arthritis populations

The authors noted: “Although further study is needed, it is possible that adequate treatment of bowel inflammation in IBD patients results in a decreased risk of MACE.”

Dr. Regueiro and colleagues are updating and expanding the research to increase the number of patients. They are also planning to evaluate the long-term extension data with individual biologics and small molecules to assess the consistency of their findings. “On preliminary glance, we believe that our results will be consistent with future study.”

“When you look at the studies, the increase in cardiac risk issues we’re seeing are in rheumatoid arthritis. And when we look at the patients with inflammatory bowel disease, we don’t see it,” session co-moderator John Leighton, MD, said when asked to comment. “So we think that there is a difference in the two populations, and this study gives further credence to that.”

“There are probably some high-risk populations that we still want to be careful with,” added Dr. Leighton, professor of medicine and chair of the division of gastroenterology at Mayo Clinic in Phoenix. “But the risk is not as great as they initially saw in the rheumatoid [arthritis] patients – and it’s a good thing because these drugs work very well.”

The study was independently supported. Lead author Dr. Qapaja had no relevant financial relationships. Dr. Regueiro is an advisory committee or board member and consultant for Alfasigma, Allergan, Amgen, Eli Lilly, Miraca Labs, Prometheus, Salix, Seres, and Target RWE. He serves in these roles and receives unrestricted educational grants from AbbVie, Bristol-Myers Squibb, Celgene, Genentech, Gilead Sciences, Janssen, Pfizer, Takeda, and UCB. He also receives royalties from Wolters Kluwer Health. Dr. Leighton is an advisory committee/board member for Braintree.

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

VANCOUVER – In contrast to some previous research, investigators found no significant correlation between common biologic and oral small molecule treatments for inflammatory bowel disease (IBD) and an increased risk of major adverse cardiovascular events (MACE).

In addition, biologics such as infliximab, adalimumab, golimumab, certolizumab, vedolizumab, natalizumab, and ustekinumab not only did not increase risk, but they were also linked to a significantly lower risk of major cardiovascular and thromboembolic events.

Risk reduction with biologics ranged from 15% for venous thromboembolism to 34% for myocardial infarction.

“The decrease in MACE with biologics was significant – and a bit surprising – but it correlates with the theory that by decreasing inflammation, there is a decrease in MACE,” said Miguel Regueiro, MD, chief of the Digestive Disease Institute at Cleveland Clinic, and senior author of the study.

“Our thought was that we would not see an increase in MACE and it would be equivalent between patients with IBD treated with advanced therapies and patients not treated with advanced therapies,” he told this news organization.

The findings “are consistent with some of the emerging long-term extension data from IBD clinical trials,” Dr. Regueiro reported at the ACG: American College of Gastroenterology annual scientific meeting. “And I’ll make an editorial comment for those that treat and practice in inflammatory bowel disease: I think these data continue to support, affirm, and hopefully comfort us.”
 

Therapies previously implicated in increased MACE risk

IBD itself is associated with increased MACE risk, likely because of chronic inflammation and endothelial dysfunction, the researchers note. While biologic and small molecule therapies are effective IBD treatments, some therapies have been implicated in an increased risk for MACE.

The Oral Surveillance postmarketing safety study of tofacitinib in rheumatoid arthritis, for example, linked the agent to higher MACE and venous thromboembolism rates vs. a TNF inhibitor. As a result, the FDA restricted the JAK inhibitor drug class that includes tofacitinib.

While long-term extension studies in IBD have not linked oral small molecules to increases in MACE, the sample sizes and duration of follow-up have been limited, the authors noted. For this reason, Dr. Regueiro and colleagues decided to further evaluate the potential associations in people with IBD.

The cohorts included 67,607 adults with IBD taking a biologic and another 67,607 with IBD not receiving a biologic between January 2021 and June 2023. The researchers also compared 3,194 adults with IBD taking an oral small molecule treatment vs. another 3,194 people with IBD not receiving these medications. These large sample sizes were possible through use of TriNetX, a large U.S. claims database that includes millions of patients.
 

Key findings

The propensity matched study revealed that adults with IBD on biologics had a significantly lower risk for coronary artery disease (adjusted odds ratio, 0.69; 95% confidence interval, 0.66-0.72; P < .0001), myocardial infarction (aOR, 0.66; 95% CI, 0.61-0.72; P < .0001) or stroke (aOR, 0.71; 95% CI, 0.65-0.77; P < .0001), compared with IBD patients not on biological therapy.

The researchers also found a lower risk for venous thromboembolism associated with biologics (aOR, 0.85; 95% CI, 0.81-0.89; P < .0001).

Dr. Regueiro said that active inflammation in the bowel or anywhere in the body is associated with higher rates of blood clot formation. “The thought is that decreasing inflammation with treatment may actually decrease the rates of blood clots. So, in essence, we think that biologics may actually decrease MACE.”

IBD patients receiving an oral small molecule did not have a significantly increased risk for coronary artery disease (aOR, 1.05; 95% CI, 0.82-1.33; P = .7148) or myocardial infarction (aOR, 1.04; 95% CI, 0.60-1.78; P = .8903). The risk of stroke was lower but not significantly different (aOR, 0.87; 95% CI, 0.57-1.33; P = .5148).

In addition, there was no significant change in risk for venous thromboembolism (aOR 1.07; 95% CI, 0.83-1.39; P = .5957).

All cohorts were matched for age, race, sex, cardiovascular risk factors, and medications including immunomodulators, 5-aminosalicylic acids, and steroids. MACE and VTE were noted by ICD-10 codes at least 30 days after starting treatment.

Strengths of the study included large sample size, diverse cohorts, and propensity score matching. Limitations included the study’s retrospective design.
 

Difference in IBD and rheumatoid arthritis populations

The authors noted: “Although further study is needed, it is possible that adequate treatment of bowel inflammation in IBD patients results in a decreased risk of MACE.”

Dr. Regueiro and colleagues are updating and expanding the research to increase the number of patients. They are also planning to evaluate the long-term extension data with individual biologics and small molecules to assess the consistency of their findings. “On preliminary glance, we believe that our results will be consistent with future study.”

“When you look at the studies, the increase in cardiac risk issues we’re seeing are in rheumatoid arthritis. And when we look at the patients with inflammatory bowel disease, we don’t see it,” session co-moderator John Leighton, MD, said when asked to comment. “So we think that there is a difference in the two populations, and this study gives further credence to that.”

“There are probably some high-risk populations that we still want to be careful with,” added Dr. Leighton, professor of medicine and chair of the division of gastroenterology at Mayo Clinic in Phoenix. “But the risk is not as great as they initially saw in the rheumatoid [arthritis] patients – and it’s a good thing because these drugs work very well.”

The study was independently supported. Lead author Dr. Qapaja had no relevant financial relationships. Dr. Regueiro is an advisory committee or board member and consultant for Alfasigma, Allergan, Amgen, Eli Lilly, Miraca Labs, Prometheus, Salix, Seres, and Target RWE. He serves in these roles and receives unrestricted educational grants from AbbVie, Bristol-Myers Squibb, Celgene, Genentech, Gilead Sciences, Janssen, Pfizer, Takeda, and UCB. He also receives royalties from Wolters Kluwer Health. Dr. Leighton is an advisory committee/board member for Braintree.

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

VANCOUVER – In contrast to some previous research, investigators found no significant correlation between common biologic and oral small molecule treatments for inflammatory bowel disease (IBD) and an increased risk of major adverse cardiovascular events (MACE).

In addition, biologics such as infliximab, adalimumab, golimumab, certolizumab, vedolizumab, natalizumab, and ustekinumab not only did not increase risk, but they were also linked to a significantly lower risk of major cardiovascular and thromboembolic events.

Risk reduction with biologics ranged from 15% for venous thromboembolism to 34% for myocardial infarction.

“The decrease in MACE with biologics was significant – and a bit surprising – but it correlates with the theory that by decreasing inflammation, there is a decrease in MACE,” said Miguel Regueiro, MD, chief of the Digestive Disease Institute at Cleveland Clinic, and senior author of the study.

“Our thought was that we would not see an increase in MACE and it would be equivalent between patients with IBD treated with advanced therapies and patients not treated with advanced therapies,” he told this news organization.

The findings “are consistent with some of the emerging long-term extension data from IBD clinical trials,” Dr. Regueiro reported at the ACG: American College of Gastroenterology annual scientific meeting. “And I’ll make an editorial comment for those that treat and practice in inflammatory bowel disease: I think these data continue to support, affirm, and hopefully comfort us.”
 

Therapies previously implicated in increased MACE risk

IBD itself is associated with increased MACE risk, likely because of chronic inflammation and endothelial dysfunction, the researchers note. While biologic and small molecule therapies are effective IBD treatments, some therapies have been implicated in an increased risk for MACE.

The Oral Surveillance postmarketing safety study of tofacitinib in rheumatoid arthritis, for example, linked the agent to higher MACE and venous thromboembolism rates vs. a TNF inhibitor. As a result, the FDA restricted the JAK inhibitor drug class that includes tofacitinib.

While long-term extension studies in IBD have not linked oral small molecules to increases in MACE, the sample sizes and duration of follow-up have been limited, the authors noted. For this reason, Dr. Regueiro and colleagues decided to further evaluate the potential associations in people with IBD.

The cohorts included 67,607 adults with IBD taking a biologic and another 67,607 with IBD not receiving a biologic between January 2021 and June 2023. The researchers also compared 3,194 adults with IBD taking an oral small molecule treatment vs. another 3,194 people with IBD not receiving these medications. These large sample sizes were possible through use of TriNetX, a large U.S. claims database that includes millions of patients.
 

Key findings

The propensity matched study revealed that adults with IBD on biologics had a significantly lower risk for coronary artery disease (adjusted odds ratio, 0.69; 95% confidence interval, 0.66-0.72; P < .0001), myocardial infarction (aOR, 0.66; 95% CI, 0.61-0.72; P < .0001) or stroke (aOR, 0.71; 95% CI, 0.65-0.77; P < .0001), compared with IBD patients not on biological therapy.

The researchers also found a lower risk for venous thromboembolism associated with biologics (aOR, 0.85; 95% CI, 0.81-0.89; P < .0001).

Dr. Regueiro said that active inflammation in the bowel or anywhere in the body is associated with higher rates of blood clot formation. “The thought is that decreasing inflammation with treatment may actually decrease the rates of blood clots. So, in essence, we think that biologics may actually decrease MACE.”

IBD patients receiving an oral small molecule did not have a significantly increased risk for coronary artery disease (aOR, 1.05; 95% CI, 0.82-1.33; P = .7148) or myocardial infarction (aOR, 1.04; 95% CI, 0.60-1.78; P = .8903). The risk of stroke was lower but not significantly different (aOR, 0.87; 95% CI, 0.57-1.33; P = .5148).

In addition, there was no significant change in risk for venous thromboembolism (aOR 1.07; 95% CI, 0.83-1.39; P = .5957).

All cohorts were matched for age, race, sex, cardiovascular risk factors, and medications including immunomodulators, 5-aminosalicylic acids, and steroids. MACE and VTE were noted by ICD-10 codes at least 30 days after starting treatment.

Strengths of the study included large sample size, diverse cohorts, and propensity score matching. Limitations included the study’s retrospective design.
 

Difference in IBD and rheumatoid arthritis populations

The authors noted: “Although further study is needed, it is possible that adequate treatment of bowel inflammation in IBD patients results in a decreased risk of MACE.”

Dr. Regueiro and colleagues are updating and expanding the research to increase the number of patients. They are also planning to evaluate the long-term extension data with individual biologics and small molecules to assess the consistency of their findings. “On preliminary glance, we believe that our results will be consistent with future study.”

“When you look at the studies, the increase in cardiac risk issues we’re seeing are in rheumatoid arthritis. And when we look at the patients with inflammatory bowel disease, we don’t see it,” session co-moderator John Leighton, MD, said when asked to comment. “So we think that there is a difference in the two populations, and this study gives further credence to that.”

“There are probably some high-risk populations that we still want to be careful with,” added Dr. Leighton, professor of medicine and chair of the division of gastroenterology at Mayo Clinic in Phoenix. “But the risk is not as great as they initially saw in the rheumatoid [arthritis] patients – and it’s a good thing because these drugs work very well.”

The study was independently supported. Lead author Dr. Qapaja had no relevant financial relationships. Dr. Regueiro is an advisory committee or board member and consultant for Alfasigma, Allergan, Amgen, Eli Lilly, Miraca Labs, Prometheus, Salix, Seres, and Target RWE. He serves in these roles and receives unrestricted educational grants from AbbVie, Bristol-Myers Squibb, Celgene, Genentech, Gilead Sciences, Janssen, Pfizer, Takeda, and UCB. He also receives royalties from Wolters Kluwer Health. Dr. Leighton is an advisory committee/board member for Braintree.

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

MADRID – Should patients with resectable non–small cell lung cancer (NSCLC) receive adjuvant therapy, neoadjuvant therapy, or both, experts asked during a special session at the European Society for Medical Oncology 2023 Congress.

Though immunotherapy is beneficial in resectable NSCLC, “we actually don’t know how much of the effect [is due to] the adjuvant and how much to the neoadjuvant therapy,” said Silke Gillessen, MD, head of the department of medical oncology, Università della Svizzera Italiana in Lugano, Switzerland.

Opening the session, Enriqueta Felip, MD, PhD, argued in favor of adjuvant therapy alone in resectable NSCLC.

Adjuvant immunotherapy after adjuvant chemotherapy is already considered standard of care for patients with resected NSCLC who don’t harbor EGFR and ALK mutations, explained Dr. Felip, head of the lung cancer unit at Vall d’Hebron University Hospital in Barcelona.

One major benefit to providing adjuvant therapy is that curative surgery won’t be delayed. Neoadjuvant therapy, on the other hand, leads about 15% of patients to forgo surgery, and about 30% who have both neoadjuvant therapy and surgery end up not receiving their planned adjuvant immunotherapy.

Another benefit: Emerging evidence suggests that the adjuvant-only option can improve disease-free and overall survival in select patients.

In the IMpower010 trial, for instance, adjuvant atezolizumab led to a marked improvement in disease-free survival, compared with best supportive care in patients with stage II-IIIA NSCLC. Patients with programmed death–ligand 1 expression of 50% or higher also demonstrated an overall survival benefit (hazard ratio, 0.42).

In the KEYNOTE-091 trial, adjuvant pembrolizumab significantly improved disease-free survival in all comers vs. placebo in patients with stage IB, II, or IIIA NSCLC who had surgery (HR, 0.76).

Providing adjuvant-only immunotherapy also allows for biomarker testing in resected specimens, Dr. Felip said, which may affect the choice of systemic therapy.

Next, Rafal Dziadziuszko, MD, PhD, argued in favor of neoadjuvant therapy alone in the setting of resectable NSCLC.

The advantages of providing treatment before surgery include initiating systemic treatment at an earlier point when most relapses are distant, possibly reducing the risk for tumor cell seeding during surgery as well as potentially leading to less invasive surgery by shrinking the tumors.

Dr. Dziadziuszko, from the Medical University of Gdansk in Poland, highlighted data from the Checkmate 816 trial, which showed that neoadjuvant nivolumab plus chemotherapy vs. chemotherapy alone increased the chance of having a pathologic complete response by nearly 14-fold in patients with IB-IIIA resectable NSCLC. Patients in the combination arm also demonstrated marked improvements in event-free survival, 31.6 months vs. 20.8 months, and overall survival.

The NADIM II trial, which coupled nivolumab and chemotherapy in stage III disease, found that neoadjuvant chemoimmunotherapy led to a pathologic complete response as well as a 52% improvement in progression-free survival and a 60% improvement in overall survival, compared with chemotherapy alone.

Despite these findings, several important questions remain, said Dr. Dziadziuszko. How many cycles of neoadjuvant immunochemotherapy should a patient receive before surgery? Will neoadjuvant therapy lead to treatment-related adverse events that preclude surgery? And for those who don’t have a strong response to neoadjuvant therapy, who should also receive adjuvant immunotherapy and for how long?

The latter question represents the “elephant in the room,” session chair Tony S. K. Mok, MD, chairman, department of clinical oncology, The Chinese University of Hong Kong.

With a paucity of overall survival data to provide a definitive answer, oncologists still face the age-old concern of “giving too much therapy in those who don’t need it” and “giving not enough therapy for those who need more,” said Dr. Mok.

Federico Cappuzzo, MD, PhD, argued that the key to patient selection for adjuvant therapy after neoadjuvant therapy and surgery lies in who has a pathologic complete response.

The current data suggest that patients receiving neoadjuvant therapy who achieve a pathologic complete response likely do not need adjuvant therapy whereas those who don’t achieve a complete response should receive adjuvant therapy, explained Dr. Cappuzzo, director of the department of oncology and hematology, AUSL della Romagna, Ravenna, Italy.

But, Dr. Mok asked, what about patients who achieve a major pathologic response in which the percentage of residual viable tumor is 10% or less or achieve less than a major pathologic response?

Dr. Mok suggested that measurable residual disease, which is indicative of recurrence, could potentially be used to determine the treatment pathway after neoadjuvant therapy and signal who may benefit from adjuvant therapy. However, he noted, studies evaluating the benefit of adjuvant therapy in this population would need to be done.

For patients who don’t respond well to neoadjuvant therapy and may benefit from adjuvant therapy, the question also becomes: “Do we give more of that same therapy?” asked Zofia Piotrowska, MD, a lung cancer medical oncologist at Massachusetts General Hospital Cancer Center, Boston, who was not involved in the debate.

“I think we really need to rethink that paradigm and try to develop new therapies that may work more effectively for those patients, to improve their outcomes,” Dr. Piotrowska said.

Dr. Mok declared relationships with a range of companies, including AstraZeneca, Boehringer Ingelheim, Pfizer, Novartis, SFJ Pharmaceuticals Roche, Merck Sharp & Dohme, and HutchMed. Dr. Felip declared relationships with AbbVie, Amgen, AstraZeneca, Bayer, Bristol-Myers Squibb, Daiichi Sankyo, Eli Lilly, F Hoffman–La Roche, Genentech, GlaxoSmithKline, Novartis, and others. Dr. Dziadziuszko declared relationships with Roche, AstraZeneca, Bristol-Myers Squibb, Takeda, Pfizer, Novartis, and others. Dr. Cappuzzo declared relationships with Roche, AstraZeneca, Bristol-Myers Squibb, Pfizer, Takeda, Lilly, Bayer, Amgen, Sanofi, and others.

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

MADRID – Should patients with resectable non–small cell lung cancer (NSCLC) receive adjuvant therapy, neoadjuvant therapy, or both, experts asked during a special session at the European Society for Medical Oncology 2023 Congress.

Though immunotherapy is beneficial in resectable NSCLC, “we actually don’t know how much of the effect [is due to] the adjuvant and how much to the neoadjuvant therapy,” said Silke Gillessen, MD, head of the department of medical oncology, Università della Svizzera Italiana in Lugano, Switzerland.

Opening the session, Enriqueta Felip, MD, PhD, argued in favor of adjuvant therapy alone in resectable NSCLC.

Adjuvant immunotherapy after adjuvant chemotherapy is already considered standard of care for patients with resected NSCLC who don’t harbor EGFR and ALK mutations, explained Dr. Felip, head of the lung cancer unit at Vall d’Hebron University Hospital in Barcelona.

One major benefit to providing adjuvant therapy is that curative surgery won’t be delayed. Neoadjuvant therapy, on the other hand, leads about 15% of patients to forgo surgery, and about 30% who have both neoadjuvant therapy and surgery end up not receiving their planned adjuvant immunotherapy.

Another benefit: Emerging evidence suggests that the adjuvant-only option can improve disease-free and overall survival in select patients.

In the IMpower010 trial, for instance, adjuvant atezolizumab led to a marked improvement in disease-free survival, compared with best supportive care in patients with stage II-IIIA NSCLC. Patients with programmed death–ligand 1 expression of 50% or higher also demonstrated an overall survival benefit (hazard ratio, 0.42).

In the KEYNOTE-091 trial, adjuvant pembrolizumab significantly improved disease-free survival in all comers vs. placebo in patients with stage IB, II, or IIIA NSCLC who had surgery (HR, 0.76).

Providing adjuvant-only immunotherapy also allows for biomarker testing in resected specimens, Dr. Felip said, which may affect the choice of systemic therapy.

Next, Rafal Dziadziuszko, MD, PhD, argued in favor of neoadjuvant therapy alone in the setting of resectable NSCLC.

The advantages of providing treatment before surgery include initiating systemic treatment at an earlier point when most relapses are distant, possibly reducing the risk for tumor cell seeding during surgery as well as potentially leading to less invasive surgery by shrinking the tumors.

Dr. Dziadziuszko, from the Medical University of Gdansk in Poland, highlighted data from the Checkmate 816 trial, which showed that neoadjuvant nivolumab plus chemotherapy vs. chemotherapy alone increased the chance of having a pathologic complete response by nearly 14-fold in patients with IB-IIIA resectable NSCLC. Patients in the combination arm also demonstrated marked improvements in event-free survival, 31.6 months vs. 20.8 months, and overall survival.

The NADIM II trial, which coupled nivolumab and chemotherapy in stage III disease, found that neoadjuvant chemoimmunotherapy led to a pathologic complete response as well as a 52% improvement in progression-free survival and a 60% improvement in overall survival, compared with chemotherapy alone.

Despite these findings, several important questions remain, said Dr. Dziadziuszko. How many cycles of neoadjuvant immunochemotherapy should a patient receive before surgery? Will neoadjuvant therapy lead to treatment-related adverse events that preclude surgery? And for those who don’t have a strong response to neoadjuvant therapy, who should also receive adjuvant immunotherapy and for how long?

The latter question represents the “elephant in the room,” session chair Tony S. K. Mok, MD, chairman, department of clinical oncology, The Chinese University of Hong Kong.

With a paucity of overall survival data to provide a definitive answer, oncologists still face the age-old concern of “giving too much therapy in those who don’t need it” and “giving not enough therapy for those who need more,” said Dr. Mok.

Federico Cappuzzo, MD, PhD, argued that the key to patient selection for adjuvant therapy after neoadjuvant therapy and surgery lies in who has a pathologic complete response.

The current data suggest that patients receiving neoadjuvant therapy who achieve a pathologic complete response likely do not need adjuvant therapy whereas those who don’t achieve a complete response should receive adjuvant therapy, explained Dr. Cappuzzo, director of the department of oncology and hematology, AUSL della Romagna, Ravenna, Italy.

But, Dr. Mok asked, what about patients who achieve a major pathologic response in which the percentage of residual viable tumor is 10% or less or achieve less than a major pathologic response?

Dr. Mok suggested that measurable residual disease, which is indicative of recurrence, could potentially be used to determine the treatment pathway after neoadjuvant therapy and signal who may benefit from adjuvant therapy. However, he noted, studies evaluating the benefit of adjuvant therapy in this population would need to be done.

For patients who don’t respond well to neoadjuvant therapy and may benefit from adjuvant therapy, the question also becomes: “Do we give more of that same therapy?” asked Zofia Piotrowska, MD, a lung cancer medical oncologist at Massachusetts General Hospital Cancer Center, Boston, who was not involved in the debate.

“I think we really need to rethink that paradigm and try to develop new therapies that may work more effectively for those patients, to improve their outcomes,” Dr. Piotrowska said.

Dr. Mok declared relationships with a range of companies, including AstraZeneca, Boehringer Ingelheim, Pfizer, Novartis, SFJ Pharmaceuticals Roche, Merck Sharp & Dohme, and HutchMed. Dr. Felip declared relationships with AbbVie, Amgen, AstraZeneca, Bayer, Bristol-Myers Squibb, Daiichi Sankyo, Eli Lilly, F Hoffman–La Roche, Genentech, GlaxoSmithKline, Novartis, and others. Dr. Dziadziuszko declared relationships with Roche, AstraZeneca, Bristol-Myers Squibb, Takeda, Pfizer, Novartis, and others. Dr. Cappuzzo declared relationships with Roche, AstraZeneca, Bristol-Myers Squibb, Pfizer, Takeda, Lilly, Bayer, Amgen, Sanofi, and others.

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

MADRID – Should patients with resectable non–small cell lung cancer (NSCLC) receive adjuvant therapy, neoadjuvant therapy, or both, experts asked during a special session at the European Society for Medical Oncology 2023 Congress.

Though immunotherapy is beneficial in resectable NSCLC, “we actually don’t know how much of the effect [is due to] the adjuvant and how much to the neoadjuvant therapy,” said Silke Gillessen, MD, head of the department of medical oncology, Università della Svizzera Italiana in Lugano, Switzerland.

Opening the session, Enriqueta Felip, MD, PhD, argued in favor of adjuvant therapy alone in resectable NSCLC.

Adjuvant immunotherapy after adjuvant chemotherapy is already considered standard of care for patients with resected NSCLC who don’t harbor EGFR and ALK mutations, explained Dr. Felip, head of the lung cancer unit at Vall d’Hebron University Hospital in Barcelona.

One major benefit to providing adjuvant therapy is that curative surgery won’t be delayed. Neoadjuvant therapy, on the other hand, leads about 15% of patients to forgo surgery, and about 30% who have both neoadjuvant therapy and surgery end up not receiving their planned adjuvant immunotherapy.

Another benefit: Emerging evidence suggests that the adjuvant-only option can improve disease-free and overall survival in select patients.

In the IMpower010 trial, for instance, adjuvant atezolizumab led to a marked improvement in disease-free survival, compared with best supportive care in patients with stage II-IIIA NSCLC. Patients with programmed death–ligand 1 expression of 50% or higher also demonstrated an overall survival benefit (hazard ratio, 0.42).

In the KEYNOTE-091 trial, adjuvant pembrolizumab significantly improved disease-free survival in all comers vs. placebo in patients with stage IB, II, or IIIA NSCLC who had surgery (HR, 0.76).

Providing adjuvant-only immunotherapy also allows for biomarker testing in resected specimens, Dr. Felip said, which may affect the choice of systemic therapy.

Next, Rafal Dziadziuszko, MD, PhD, argued in favor of neoadjuvant therapy alone in the setting of resectable NSCLC.

The advantages of providing treatment before surgery include initiating systemic treatment at an earlier point when most relapses are distant, possibly reducing the risk for tumor cell seeding during surgery as well as potentially leading to less invasive surgery by shrinking the tumors.

Dr. Dziadziuszko, from the Medical University of Gdansk in Poland, highlighted data from the Checkmate 816 trial, which showed that neoadjuvant nivolumab plus chemotherapy vs. chemotherapy alone increased the chance of having a pathologic complete response by nearly 14-fold in patients with IB-IIIA resectable NSCLC. Patients in the combination arm also demonstrated marked improvements in event-free survival, 31.6 months vs. 20.8 months, and overall survival.

The NADIM II trial, which coupled nivolumab and chemotherapy in stage III disease, found that neoadjuvant chemoimmunotherapy led to a pathologic complete response as well as a 52% improvement in progression-free survival and a 60% improvement in overall survival, compared with chemotherapy alone.

Despite these findings, several important questions remain, said Dr. Dziadziuszko. How many cycles of neoadjuvant immunochemotherapy should a patient receive before surgery? Will neoadjuvant therapy lead to treatment-related adverse events that preclude surgery? And for those who don’t have a strong response to neoadjuvant therapy, who should also receive adjuvant immunotherapy and for how long?

The latter question represents the “elephant in the room,” session chair Tony S. K. Mok, MD, chairman, department of clinical oncology, The Chinese University of Hong Kong.

With a paucity of overall survival data to provide a definitive answer, oncologists still face the age-old concern of “giving too much therapy in those who don’t need it” and “giving not enough therapy for those who need more,” said Dr. Mok.

Federico Cappuzzo, MD, PhD, argued that the key to patient selection for adjuvant therapy after neoadjuvant therapy and surgery lies in who has a pathologic complete response.

The current data suggest that patients receiving neoadjuvant therapy who achieve a pathologic complete response likely do not need adjuvant therapy whereas those who don’t achieve a complete response should receive adjuvant therapy, explained Dr. Cappuzzo, director of the department of oncology and hematology, AUSL della Romagna, Ravenna, Italy.

But, Dr. Mok asked, what about patients who achieve a major pathologic response in which the percentage of residual viable tumor is 10% or less or achieve less than a major pathologic response?

Dr. Mok suggested that measurable residual disease, which is indicative of recurrence, could potentially be used to determine the treatment pathway after neoadjuvant therapy and signal who may benefit from adjuvant therapy. However, he noted, studies evaluating the benefit of adjuvant therapy in this population would need to be done.

For patients who don’t respond well to neoadjuvant therapy and may benefit from adjuvant therapy, the question also becomes: “Do we give more of that same therapy?” asked Zofia Piotrowska, MD, a lung cancer medical oncologist at Massachusetts General Hospital Cancer Center, Boston, who was not involved in the debate.

“I think we really need to rethink that paradigm and try to develop new therapies that may work more effectively for those patients, to improve their outcomes,” Dr. Piotrowska said.

Dr. Mok declared relationships with a range of companies, including AstraZeneca, Boehringer Ingelheim, Pfizer, Novartis, SFJ Pharmaceuticals Roche, Merck Sharp & Dohme, and HutchMed. Dr. Felip declared relationships with AbbVie, Amgen, AstraZeneca, Bayer, Bristol-Myers Squibb, Daiichi Sankyo, Eli Lilly, F Hoffman–La Roche, Genentech, GlaxoSmithKline, Novartis, and others. Dr. Dziadziuszko declared relationships with Roche, AstraZeneca, Bristol-Myers Squibb, Takeda, Pfizer, Novartis, and others. Dr. Cappuzzo declared relationships with Roche, AstraZeneca, Bristol-Myers Squibb, Pfizer, Takeda, Lilly, Bayer, Amgen, Sanofi, and others.

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

TOPLINE:

The risk for Guillain-Barré syndrome (GBS) is six times higher in people with COVID-19 in the 6 weeks following infection, according to a new study that also showed receipt of the Pfizer-BioNTech mRNA vaccine reduced GSB risk by 59%.

METHODOLOGY:

• The nested-case control study analyzed data from the largest healthcare provider in Israel for 3.2 million patients aged 16 years and older, with no history of GBS.
• GBS cases (n = 76) were identified based on hospital discharge data from January 2021 to June 2022.
• For every GBS case, investigators chose 10 controls at random, matched for age, gender, and follow-up duration (n = 760).
• Investigators examined the association between GBS and SARS-CoV-2 infection, established through documentation of prior positive SARS-CoV-2 test (PCR or antigen), and any COVID-19 vaccine administration.

TAKEAWAY:

• Among those diagnosed with GBS, 8 were exposed to SARS-CoV-2 infection only, 7 were exposed to COVID-19 vaccination only, and 1 patient was exposed to both SARS-CoV-2 infection and COVID-19 vaccination in the prior 6 weeks, leaving 60 GBS patients without exposure to either infection or vaccination.
• All COVID-19 vaccine doses administered in GBS cases within 6 weeks of the index date, and all but two doses administered in controls in the same timeframe, were Pfizer-BioNTech vaccines.
• Compared with people without GBS, those with the condition were more than six times as likely to have had SARS-CoV-2 infection within 6 weeks of GBS diagnosis (adjusted odds ratio, 6.30; 95% confidence interval, 2.55-15.56).
• People who received the COVID-19 vaccine were 59% less likely to develop GBS than those who did not get the vaccine (aOR, 0.41; 95% CI, 0.17-0.96).

IN PRACTICE:

“While Guillain-Barré is extremely rare, people should be aware that having a COVID infection can increase their risk of developing the disorder, and receiving an mRNA vaccine can decrease their risk,” study author Anat Arbel, MD, of Lady Davis Carmel Medical Center and the Technion-Israel Institute of Technology, Haifa, Israel, said in a press release.

SOURCE:

In addition to Dr. Arbel, the other lead author is Haya Bishara, MD, of Lady Davis Carmel Medical Center. The research was published online  in the journal Neurology.

LIMITATIONS:

There is a possibility of misclassification of SARS-CoV-2 infection, which could lead to an overestimation of the magnitude of association between infection and GBS. The diagnosis of GBS relied solely on ICD-9 coding, which has been shown in prior studies to contain errors.

DISCLOSURES:

The study was unfunded. Dr. Bishara and Dr. Arbel report no relevant financial relationships. One co-author, Eitan Auriel, MD, has received lecturer fees from Novo Nordisk, Pfizer, Boehringer Ingelheim, and Medison.

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

TOPLINE:

The risk for Guillain-Barré syndrome (GBS) is six times higher in people with COVID-19 in the 6 weeks following infection, according to a new study that also showed receipt of the Pfizer-BioNTech mRNA vaccine reduced GSB risk by 59%.

METHODOLOGY:

• The nested-case control study analyzed data from the largest healthcare provider in Israel for 3.2 million patients aged 16 years and older, with no history of GBS.
• GBS cases (n = 76) were identified based on hospital discharge data from January 2021 to June 2022.
• For every GBS case, investigators chose 10 controls at random, matched for age, gender, and follow-up duration (n = 760).
• Investigators examined the association between GBS and SARS-CoV-2 infection, established through documentation of prior positive SARS-CoV-2 test (PCR or antigen), and any COVID-19 vaccine administration.

TAKEAWAY:

• Among those diagnosed with GBS, 8 were exposed to SARS-CoV-2 infection only, 7 were exposed to COVID-19 vaccination only, and 1 patient was exposed to both SARS-CoV-2 infection and COVID-19 vaccination in the prior 6 weeks, leaving 60 GBS patients without exposure to either infection or vaccination.
• All COVID-19 vaccine doses administered in GBS cases within 6 weeks of the index date, and all but two doses administered in controls in the same timeframe, were Pfizer-BioNTech vaccines.
• Compared with people without GBS, those with the condition were more than six times as likely to have had SARS-CoV-2 infection within 6 weeks of GBS diagnosis (adjusted odds ratio, 6.30; 95% confidence interval, 2.55-15.56).
• People who received the COVID-19 vaccine were 59% less likely to develop GBS than those who did not get the vaccine (aOR, 0.41; 95% CI, 0.17-0.96).

IN PRACTICE:

“While Guillain-Barré is extremely rare, people should be aware that having a COVID infection can increase their risk of developing the disorder, and receiving an mRNA vaccine can decrease their risk,” study author Anat Arbel, MD, of Lady Davis Carmel Medical Center and the Technion-Israel Institute of Technology, Haifa, Israel, said in a press release.

SOURCE:

In addition to Dr. Arbel, the other lead author is Haya Bishara, MD, of Lady Davis Carmel Medical Center. The research was published online  in the journal Neurology.

LIMITATIONS:

There is a possibility of misclassification of SARS-CoV-2 infection, which could lead to an overestimation of the magnitude of association between infection and GBS. The diagnosis of GBS relied solely on ICD-9 coding, which has been shown in prior studies to contain errors.

DISCLOSURES:

The study was unfunded. Dr. Bishara and Dr. Arbel report no relevant financial relationships. One co-author, Eitan Auriel, MD, has received lecturer fees from Novo Nordisk, Pfizer, Boehringer Ingelheim, and Medison.

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

TOPLINE:

The risk for Guillain-Barré syndrome (GBS) is six times higher in people with COVID-19 in the 6 weeks following infection, according to a new study that also showed receipt of the Pfizer-BioNTech mRNA vaccine reduced GSB risk by 59%.

METHODOLOGY:

• The nested-case control study analyzed data from the largest healthcare provider in Israel for 3.2 million patients aged 16 years and older, with no history of GBS.
• GBS cases (n = 76) were identified based on hospital discharge data from January 2021 to June 2022.
• For every GBS case, investigators chose 10 controls at random, matched for age, gender, and follow-up duration (n = 760).
• Investigators examined the association between GBS and SARS-CoV-2 infection, established through documentation of prior positive SARS-CoV-2 test (PCR or antigen), and any COVID-19 vaccine administration.

TAKEAWAY:

• Among those diagnosed with GBS, 8 were exposed to SARS-CoV-2 infection only, 7 were exposed to COVID-19 vaccination only, and 1 patient was exposed to both SARS-CoV-2 infection and COVID-19 vaccination in the prior 6 weeks, leaving 60 GBS patients without exposure to either infection or vaccination.
• All COVID-19 vaccine doses administered in GBS cases within 6 weeks of the index date, and all but two doses administered in controls in the same timeframe, were Pfizer-BioNTech vaccines.
• Compared with people without GBS, those with the condition were more than six times as likely to have had SARS-CoV-2 infection within 6 weeks of GBS diagnosis (adjusted odds ratio, 6.30; 95% confidence interval, 2.55-15.56).
• People who received the COVID-19 vaccine were 59% less likely to develop GBS than those who did not get the vaccine (aOR, 0.41; 95% CI, 0.17-0.96).

IN PRACTICE:

“While Guillain-Barré is extremely rare, people should be aware that having a COVID infection can increase their risk of developing the disorder, and receiving an mRNA vaccine can decrease their risk,” study author Anat Arbel, MD, of Lady Davis Carmel Medical Center and the Technion-Israel Institute of Technology, Haifa, Israel, said in a press release.

SOURCE:

In addition to Dr. Arbel, the other lead author is Haya Bishara, MD, of Lady Davis Carmel Medical Center. The research was published online  in the journal Neurology.

LIMITATIONS:

There is a possibility of misclassification of SARS-CoV-2 infection, which could lead to an overestimation of the magnitude of association between infection and GBS. The diagnosis of GBS relied solely on ICD-9 coding, which has been shown in prior studies to contain errors.

DISCLOSURES:

The study was unfunded. Dr. Bishara and Dr. Arbel report no relevant financial relationships. One co-author, Eitan Auriel, MD, has received lecturer fees from Novo Nordisk, Pfizer, Boehringer Ingelheim, and Medison.

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