Systematic review spotlights the use of nutraceuticals for acne

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Vitamin B6, vitamin D, green tea, and probiotics are among the oral nutraceuticals that may benefit patients with acne, results from a systematic literature review suggest.

Dr. John S. Barbieri

“While many topical and systemic prescription options are available for the treatment of acne, some patients may be interested in natural and complementary therapies as either an adjunctive or an alternative to prescription medications,” researchers led by John S. Barbieri, MD, MBA, of the department of dermatology at Brigham and Women’s Hospital, Boston, wrote in their study, which was published online in JAMA Dermatology. The researchers defined nutraceuticals as products derived from food sources that provide both nutritional and medicinal benefits, such as vitamins, dietary supplements, and herbal products. “Although patients may be interested in nutraceuticals as a potential treatment option for acne, there is uncertainty regarding the efficacy and safety of these products,” they wrote.

For the systematic review, they searched the PubMed, Embase, Cochrane Central Register of Controlled Trials, and Web of Science databases from inception through January 30, 2023, to identify randomized clinical trials that evaluated oral nutraceutical interventions such as vitamins and minerals, botanical extracts, prebiotics, and probiotics in individuals with acne. They extracted clinician-reported outcomes, patient-reported outcomes, and adverse events from the included studies, and used the Cochrane Risk of Bias checklist tool to assess the quality of evidence in randomized clinical trials. Based on this tool, they used Agency for Healthcare Research and Quality standards to categorize the articles as good, fair, or poor quality.

The search yielded 42 unique studies with 3,346 participants. Of these 42 studies, 27 were considered poor quality, 11 were considered fair quality, and 4 were considered good quality. The good-quality studies separately evaluated four interventions: vitamin D, green tea extract, probiotics, and cheongsangbangpoong-tang, an herbal formula approved for use in acne by the Korea Food and Drug Administration.



The 11 fair-quality studies suggested potential effectiveness for pantothenic acid (vitamin B5), the fatty acids omega-3 (eicosapentaenoic acid [EPA] and/or docosahexaenoic acid [DHA]) and omega-6 (gamma-linoleic acid), and probiotics.

Zinc was the most studied nutraceutical identified in the review, but “there was substantial heterogeneity in the results, with only slightly greater than one-half of studies finding zinc to be efficacious,” the authors noted. “Studies using higher doses more often found zinc to be efficacious,” they said, adding that zinc “had the highest rate of adverse effect reporting of any nutraceuticals assessed in this review.”

Dr. Barbieri and colleagues acknowledged limitations of their analysis, including the fact that few of the nutraceuticals considered to have good or fair evidence for their use were evaluated in more than one study. “In addition, some studies had inconsistent results depending on the outcome measure assessed,” they wrote. “For instance, although green tea extract led to statistically significant improvements in lesion counts, it did not result in statistically significant improvements in quality of life, suggesting the observed lesion count differences may not be clinically meaningful to patients.”

And while probiotics had the most studies supporting their efficacy, they were generally of very small sample size.

Dr. Jonette Keri
Dr. Jonette Keri

Asked to comment on the study, Jonette Keri, MD, PhD, a dermatologist who directs the Acne and Rosacea Treatment Center at the University of Miami, who was not involved with the study, said that while the review was exhaustive, more research is needed to better determine the efficacy and side effects of the products studied. “The real strength of this wonderful review is now we have all of this information in one place, and this will serve as a great patient care resource,” she told this news organization.

Dr. Barbieri reported personal fees from Dexcel Pharma for consulting outside the submitted work. Dr. Keri disclosed that she is a consultant for L’Oréal.

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Vitamin B6, vitamin D, green tea, and probiotics are among the oral nutraceuticals that may benefit patients with acne, results from a systematic literature review suggest.

Dr. John S. Barbieri

“While many topical and systemic prescription options are available for the treatment of acne, some patients may be interested in natural and complementary therapies as either an adjunctive or an alternative to prescription medications,” researchers led by John S. Barbieri, MD, MBA, of the department of dermatology at Brigham and Women’s Hospital, Boston, wrote in their study, which was published online in JAMA Dermatology. The researchers defined nutraceuticals as products derived from food sources that provide both nutritional and medicinal benefits, such as vitamins, dietary supplements, and herbal products. “Although patients may be interested in nutraceuticals as a potential treatment option for acne, there is uncertainty regarding the efficacy and safety of these products,” they wrote.

For the systematic review, they searched the PubMed, Embase, Cochrane Central Register of Controlled Trials, and Web of Science databases from inception through January 30, 2023, to identify randomized clinical trials that evaluated oral nutraceutical interventions such as vitamins and minerals, botanical extracts, prebiotics, and probiotics in individuals with acne. They extracted clinician-reported outcomes, patient-reported outcomes, and adverse events from the included studies, and used the Cochrane Risk of Bias checklist tool to assess the quality of evidence in randomized clinical trials. Based on this tool, they used Agency for Healthcare Research and Quality standards to categorize the articles as good, fair, or poor quality.

The search yielded 42 unique studies with 3,346 participants. Of these 42 studies, 27 were considered poor quality, 11 were considered fair quality, and 4 were considered good quality. The good-quality studies separately evaluated four interventions: vitamin D, green tea extract, probiotics, and cheongsangbangpoong-tang, an herbal formula approved for use in acne by the Korea Food and Drug Administration.



The 11 fair-quality studies suggested potential effectiveness for pantothenic acid (vitamin B5), the fatty acids omega-3 (eicosapentaenoic acid [EPA] and/or docosahexaenoic acid [DHA]) and omega-6 (gamma-linoleic acid), and probiotics.

Zinc was the most studied nutraceutical identified in the review, but “there was substantial heterogeneity in the results, with only slightly greater than one-half of studies finding zinc to be efficacious,” the authors noted. “Studies using higher doses more often found zinc to be efficacious,” they said, adding that zinc “had the highest rate of adverse effect reporting of any nutraceuticals assessed in this review.”

Dr. Barbieri and colleagues acknowledged limitations of their analysis, including the fact that few of the nutraceuticals considered to have good or fair evidence for their use were evaluated in more than one study. “In addition, some studies had inconsistent results depending on the outcome measure assessed,” they wrote. “For instance, although green tea extract led to statistically significant improvements in lesion counts, it did not result in statistically significant improvements in quality of life, suggesting the observed lesion count differences may not be clinically meaningful to patients.”

And while probiotics had the most studies supporting their efficacy, they were generally of very small sample size.

Dr. Jonette Keri
Dr. Jonette Keri

Asked to comment on the study, Jonette Keri, MD, PhD, a dermatologist who directs the Acne and Rosacea Treatment Center at the University of Miami, who was not involved with the study, said that while the review was exhaustive, more research is needed to better determine the efficacy and side effects of the products studied. “The real strength of this wonderful review is now we have all of this information in one place, and this will serve as a great patient care resource,” she told this news organization.

Dr. Barbieri reported personal fees from Dexcel Pharma for consulting outside the submitted work. Dr. Keri disclosed that she is a consultant for L’Oréal.

Vitamin B6, vitamin D, green tea, and probiotics are among the oral nutraceuticals that may benefit patients with acne, results from a systematic literature review suggest.

Dr. John S. Barbieri

“While many topical and systemic prescription options are available for the treatment of acne, some patients may be interested in natural and complementary therapies as either an adjunctive or an alternative to prescription medications,” researchers led by John S. Barbieri, MD, MBA, of the department of dermatology at Brigham and Women’s Hospital, Boston, wrote in their study, which was published online in JAMA Dermatology. The researchers defined nutraceuticals as products derived from food sources that provide both nutritional and medicinal benefits, such as vitamins, dietary supplements, and herbal products. “Although patients may be interested in nutraceuticals as a potential treatment option for acne, there is uncertainty regarding the efficacy and safety of these products,” they wrote.

For the systematic review, they searched the PubMed, Embase, Cochrane Central Register of Controlled Trials, and Web of Science databases from inception through January 30, 2023, to identify randomized clinical trials that evaluated oral nutraceutical interventions such as vitamins and minerals, botanical extracts, prebiotics, and probiotics in individuals with acne. They extracted clinician-reported outcomes, patient-reported outcomes, and adverse events from the included studies, and used the Cochrane Risk of Bias checklist tool to assess the quality of evidence in randomized clinical trials. Based on this tool, they used Agency for Healthcare Research and Quality standards to categorize the articles as good, fair, or poor quality.

The search yielded 42 unique studies with 3,346 participants. Of these 42 studies, 27 were considered poor quality, 11 were considered fair quality, and 4 were considered good quality. The good-quality studies separately evaluated four interventions: vitamin D, green tea extract, probiotics, and cheongsangbangpoong-tang, an herbal formula approved for use in acne by the Korea Food and Drug Administration.



The 11 fair-quality studies suggested potential effectiveness for pantothenic acid (vitamin B5), the fatty acids omega-3 (eicosapentaenoic acid [EPA] and/or docosahexaenoic acid [DHA]) and omega-6 (gamma-linoleic acid), and probiotics.

Zinc was the most studied nutraceutical identified in the review, but “there was substantial heterogeneity in the results, with only slightly greater than one-half of studies finding zinc to be efficacious,” the authors noted. “Studies using higher doses more often found zinc to be efficacious,” they said, adding that zinc “had the highest rate of adverse effect reporting of any nutraceuticals assessed in this review.”

Dr. Barbieri and colleagues acknowledged limitations of their analysis, including the fact that few of the nutraceuticals considered to have good or fair evidence for their use were evaluated in more than one study. “In addition, some studies had inconsistent results depending on the outcome measure assessed,” they wrote. “For instance, although green tea extract led to statistically significant improvements in lesion counts, it did not result in statistically significant improvements in quality of life, suggesting the observed lesion count differences may not be clinically meaningful to patients.”

And while probiotics had the most studies supporting their efficacy, they were generally of very small sample size.

Dr. Jonette Keri
Dr. Jonette Keri

Asked to comment on the study, Jonette Keri, MD, PhD, a dermatologist who directs the Acne and Rosacea Treatment Center at the University of Miami, who was not involved with the study, said that while the review was exhaustive, more research is needed to better determine the efficacy and side effects of the products studied. “The real strength of this wonderful review is now we have all of this information in one place, and this will serve as a great patient care resource,” she told this news organization.

Dr. Barbieri reported personal fees from Dexcel Pharma for consulting outside the submitted work. Dr. Keri disclosed that she is a consultant for L’Oréal.

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Deciphering difficult-to-treat RA in patients receiving b/tsDMARD

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Key clinical point: Patients with difficult-to-treat (D2T) rheumatoid arthritis (RA) had a higher disease activity despite treatment with biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARD) and demonstrated higher withdrawal rates due to inefficacy.

 

Major finding: Patients with vs without D2T RA had a higher Simplified Disease Activity Index (SDAI; P  =  .003) and higher withdrawal rates for b/tsDMARD due to inefficacy (P < .001). Higher SDAI (adjusted odds ratio [aOR] 1.06; P  =  .014), longer disease duration (aOR 1.06; P < .001), and lower prior use of methotrexate (aOR 0.44; P  =  .008), sulfasalazine (aOR 0.59; P  =  .003), and leflunomide (aOR 0.67; P  =  .013) were associated with D2T RA.

 

Study details: Findings are from a retrospective study including 2321 patients with RA from the Korean College of Rheumatology Biologics Registry who initiated or switched to b/tsDMARD, of which 271 patients had D2T RA.

 

Disclosures: This study was supported by a grant from the Yuhan Corporation, Seoul. The authors declared no conflicts of interest.

 

Source: Jung J-Y et al. Unveiling difficult-to-treat rheumatoid arthritis: Long-term impact of biologic or targeted synthetic DMARDs from the KOBIO registry. Arthritis Res Ther. 2023;25:174 (Sep 19). doi: 10.1186/s13075-023-03165-w

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Key clinical point: Patients with difficult-to-treat (D2T) rheumatoid arthritis (RA) had a higher disease activity despite treatment with biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARD) and demonstrated higher withdrawal rates due to inefficacy.

 

Major finding: Patients with vs without D2T RA had a higher Simplified Disease Activity Index (SDAI; P  =  .003) and higher withdrawal rates for b/tsDMARD due to inefficacy (P < .001). Higher SDAI (adjusted odds ratio [aOR] 1.06; P  =  .014), longer disease duration (aOR 1.06; P < .001), and lower prior use of methotrexate (aOR 0.44; P  =  .008), sulfasalazine (aOR 0.59; P  =  .003), and leflunomide (aOR 0.67; P  =  .013) were associated with D2T RA.

 

Study details: Findings are from a retrospective study including 2321 patients with RA from the Korean College of Rheumatology Biologics Registry who initiated or switched to b/tsDMARD, of which 271 patients had D2T RA.

 

Disclosures: This study was supported by a grant from the Yuhan Corporation, Seoul. The authors declared no conflicts of interest.

 

Source: Jung J-Y et al. Unveiling difficult-to-treat rheumatoid arthritis: Long-term impact of biologic or targeted synthetic DMARDs from the KOBIO registry. Arthritis Res Ther. 2023;25:174 (Sep 19). doi: 10.1186/s13075-023-03165-w

Key clinical point: Patients with difficult-to-treat (D2T) rheumatoid arthritis (RA) had a higher disease activity despite treatment with biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARD) and demonstrated higher withdrawal rates due to inefficacy.

 

Major finding: Patients with vs without D2T RA had a higher Simplified Disease Activity Index (SDAI; P  =  .003) and higher withdrawal rates for b/tsDMARD due to inefficacy (P < .001). Higher SDAI (adjusted odds ratio [aOR] 1.06; P  =  .014), longer disease duration (aOR 1.06; P < .001), and lower prior use of methotrexate (aOR 0.44; P  =  .008), sulfasalazine (aOR 0.59; P  =  .003), and leflunomide (aOR 0.67; P  =  .013) were associated with D2T RA.

 

Study details: Findings are from a retrospective study including 2321 patients with RA from the Korean College of Rheumatology Biologics Registry who initiated or switched to b/tsDMARD, of which 271 patients had D2T RA.

 

Disclosures: This study was supported by a grant from the Yuhan Corporation, Seoul. The authors declared no conflicts of interest.

 

Source: Jung J-Y et al. Unveiling difficult-to-treat rheumatoid arthritis: Long-term impact of biologic or targeted synthetic DMARDs from the KOBIO registry. Arthritis Res Ther. 2023;25:174 (Sep 19). doi: 10.1186/s13075-023-03165-w

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Differential joint-specific treatment response to tofacitinib and methotrexate in RA

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Key clinical point: Methotrexate-naive patients with rheumatoid arthritis (RA) showed varied joint-specific clinical responses to tofacitinib and methotrexate monotherapies, with those receiving methotrexate demonstrating more radiographic progression in the foot joints despite improved clinical response.

 

Major finding: At 12 months, tofacitinib vs methotrexate improved the clinical response in most tender and swollen joints, except some foot joints. Methotrexate improved the clinical response in most foot joints; however, radiographic progression was significantly worse with methotrexate vs tofacitinib (P < .05).

 

Study details: Findings are from a post hoc analysis of the phase 3 ORAL Start trial including 956 methotrexate-naive patients with RA who were randomly assigned to receive monotherapy with 5 mg (n = 373) or 10 mg (n = 397) tofacitinib or methotrexate (n = 186).

 

Disclosures: This study was sponsored by Pfizer, Inc. Four authors declared being current or former employees or shareholders of Pfizer or Syneos Health. Some authors declared receiving grants, honoraria, or research funding or having other ties with various sources, including Pfizer.

 

Source: Ciurea A et al. Joint-level responses to tofacitinib and methotrexate: A post hoc analysis of data from ORAL Start. Arthritis Res Ther. 2023;25:185 (Sep 29). doi: 10.1186/s13075-023-03144-1

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Key clinical point: Methotrexate-naive patients with rheumatoid arthritis (RA) showed varied joint-specific clinical responses to tofacitinib and methotrexate monotherapies, with those receiving methotrexate demonstrating more radiographic progression in the foot joints despite improved clinical response.

 

Major finding: At 12 months, tofacitinib vs methotrexate improved the clinical response in most tender and swollen joints, except some foot joints. Methotrexate improved the clinical response in most foot joints; however, radiographic progression was significantly worse with methotrexate vs tofacitinib (P < .05).

 

Study details: Findings are from a post hoc analysis of the phase 3 ORAL Start trial including 956 methotrexate-naive patients with RA who were randomly assigned to receive monotherapy with 5 mg (n = 373) or 10 mg (n = 397) tofacitinib or methotrexate (n = 186).

 

Disclosures: This study was sponsored by Pfizer, Inc. Four authors declared being current or former employees or shareholders of Pfizer or Syneos Health. Some authors declared receiving grants, honoraria, or research funding or having other ties with various sources, including Pfizer.

 

Source: Ciurea A et al. Joint-level responses to tofacitinib and methotrexate: A post hoc analysis of data from ORAL Start. Arthritis Res Ther. 2023;25:185 (Sep 29). doi: 10.1186/s13075-023-03144-1

Key clinical point: Methotrexate-naive patients with rheumatoid arthritis (RA) showed varied joint-specific clinical responses to tofacitinib and methotrexate monotherapies, with those receiving methotrexate demonstrating more radiographic progression in the foot joints despite improved clinical response.

 

Major finding: At 12 months, tofacitinib vs methotrexate improved the clinical response in most tender and swollen joints, except some foot joints. Methotrexate improved the clinical response in most foot joints; however, radiographic progression was significantly worse with methotrexate vs tofacitinib (P < .05).

 

Study details: Findings are from a post hoc analysis of the phase 3 ORAL Start trial including 956 methotrexate-naive patients with RA who were randomly assigned to receive monotherapy with 5 mg (n = 373) or 10 mg (n = 397) tofacitinib or methotrexate (n = 186).

 

Disclosures: This study was sponsored by Pfizer, Inc. Four authors declared being current or former employees or shareholders of Pfizer or Syneos Health. Some authors declared receiving grants, honoraria, or research funding or having other ties with various sources, including Pfizer.

 

Source: Ciurea A et al. Joint-level responses to tofacitinib and methotrexate: A post hoc analysis of data from ORAL Start. Arthritis Res Ther. 2023;25:185 (Sep 29). doi: 10.1186/s13075-023-03144-1

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Risk factors for radiographic progression in bDMARD-treated RA

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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

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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

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Real-world effectiveness of T2T and routine care in abatacept-treated moderate-to-severe RA

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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

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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

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Prevalence and risk factors for fibrotic progression in patients with RA-ILD

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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

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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

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Encouraging evidence to consider glucocorticoid tapering and discontinuation in RA

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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

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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

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Microscopic colitis raises risk for incident RA

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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

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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

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Oral contraceptives protective against rheumatoid arthritis

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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

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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

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Promising new therapies for managing Tourette syndrome

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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.

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.

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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.

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.

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.

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