Molecular Stool Testing Could Cut Post-Polypectomy Colonoscopies by 15%-41%

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Noninvasive surveillance with multitarget stool DNA testing or fecal immunochemical testing (FIT) could potentially match colonoscopy for reducing long-term colorectal cancer (CRC) incidence and mortality. It might also reduce colonoscopies by an estimated 15%-41%.

The greatest reduction would likely be achieved by annual FIT-based surveillance, especially with FIT FOB-Gold at a threshold of at least 32 µg/g feces, according to findings from the Dutch MOCCAS study published in Gastroenterology.

In this cross-sectional observational study, the multitarget DNA test outperformed FIT for detecting advanced precursor lesions, especially serrated polyps. According to long-term-impact mathematical modeling, however, DNA-based surveillance would be more costly than colonoscopy surveillance, whereas FIT would save costs.

“With the worldwide implementation of FIT-based screening programs, following a positive test, many more people enter surveillance programs after polypectomy. This results in an increased pressure on the colonoscopy capacity and healthcare budgets,” lead author Beatriz Carvalho, PhD, a molecular biologist in the Department of Pathology of the Netherlands Cancer Institute in Amsterdam, said in an interview.

Netherlands Cancer Institute
Dr. Beatriz Carvalho


A noninvasive strategy could ease the surveillance burden on healthcare resources and be more palatable to patients. Post-polypectomy guidelines have already been relaxed to allow less intensive surveillance.

“Our working hypothesis was that although the sensitivity of a singular molecular test to detect CRC or advanced adenomas is lower than that of colonoscopy, repeating molecular stool testing would yield similar detection rates as colonoscopy-based surveillance. And our hypothesis was confirmed,” Carvalho said.

The results of the MOCCAS study align with those of other studies that found that FIT could be safely applied as a triage test in post-polypectomy surveillance and could safely extend the interval of surveillance colonoscopy. “But these studies did not include a long-term impact analysis,” she said. “The next step is to run a prospective interventional study to validate the MOCCAS findings.”

Offering an outsider’s perspective on the findings, Uri Ladabaum, MD, director of the Gastrointestinal Cancer Prevention Program and a professor of medicine at Stanford University School of Medicine in Palo Alto, California, said the real-world results on lesion detection and the multi-year-horizon modeling performed are provocative and point to the potential to base post-polypectomy surveillance on stool tests.

Stanford University
Dr. Uri Ladabaum


He cautioned, however, that the proposed paradigm requires the ability to deploy FIT-based surveillance with broad flexibility in relation to hemoglobin-detection thresholds and testing interval, depending on the specific FIT that is chosen, with the possibility these may differ by setting based on the characteristics of the population and the relevant epidemiology.

“Such flexibility may or may not be technically feasible in all settings — for instance, in the current US regulatory context, it would be challenging to implement FIT-based testing at newly adjusted detection thresholds,” he said.

Nevertheless, the study provides a strong rationale for a real-world study of FIT-based surveillance, he added. “The choice of specific FIT and detection threshold will be critical. Multiple rounds of FIT-based surveillance, that is, years of prospective surveillance, will be needed to constitute a properly designed comparison with surveillance colonoscopy.”
 

 

 

Study Details

The cross-sectional observational study included individuals aged 50-75 years who provided stool samples for the DNA test and two FITs. Test accuracy was calculated for all surveillance indications.

For the post-polypectomy indication only, which is the most common and associated with a relatively low CRC risk, the long-term impact of stool-based surveillance was evaluated with the Adenoma and Serrated Pathway to Colorectal Cancer model. Stool-based strategies were simulated to tune each test’s positivity threshold to obtain strategies that are at least as effective as colonoscopy surveillance.

A total of 3453 individuals had results for all stool tests and colonoscopy; among them, 2226 had previously undergone polypectomy, 1003 had a history of CRC, and 224 had a familial risk.

Areas under the receiver operating characteristic curve for advanced neoplasia were as follows:

  • 0.72 (95% CI, 0.69-0.75) for the multitarget stool DNA test
  • 0.61 (95% CI, 0.58-0.64) for the FIT OC-SENSOR 
  • 0.59 (95% CI, 0.56-0.61) for the FIT FOB-Gold 

Stool-based surveillance was estimated to be at least as effective as colonoscopy surveillance and required 5.6 to 9.5 stool tests over a person’s lifetime. DNA-based surveillance was more costly than colonoscopy surveillance, whereas FIT-based surveillance saved costs.

“These findings provide a basis to embark on a prospective intervention study to assess the clinical utility of FIT as an alternative to colonoscopy surveillance in a post-polypectomy CRC surveillance population,” the authors wrote.

In the United States, Ladabaum said, it would likely be possible to find FIT-based strategies that closely approximate or match surveillance colonoscopy — “if we could deploy FIT with the required flexibility, for example, by adjusting the threshold and if the reference surveillance standard were somewhat relaxed compared with current guidelines.”

He worries, however, that if FIT for screening and FIT for surveillance were optimized at different hemoglobin detection thresholds, “there could be confusion and room for error in real-world clinical implementation.”

The authors called for research to increase understanding of the mechanisms underlying progression from adenomas to malignancy over time, which may yield better biomarkers to improve stool test accuracy.

This study was funded by the Alpe d’HuZes charity and the Dutch Cancer Society. Exact Sciences provided test equipment and performed multitarget stool DNA test analysis. Sentinel Diagnostics provided equipment and reagents.

Carvalho and Veerle M. H. Coupé, PhD, disclosed several patents pending and/or issued. Other coauthors disclosed multiple financial relationships with private companies, including Exact Sciences and Sentinel, for research support, travel, board membership, advisory or speaker fees, consulting, employment, stock ownership, or patents.

Ladabaum disclosed no competing interests relevant to his comments.

A version of this article appeared on Medscape.com.

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Noninvasive surveillance with multitarget stool DNA testing or fecal immunochemical testing (FIT) could potentially match colonoscopy for reducing long-term colorectal cancer (CRC) incidence and mortality. It might also reduce colonoscopies by an estimated 15%-41%.

The greatest reduction would likely be achieved by annual FIT-based surveillance, especially with FIT FOB-Gold at a threshold of at least 32 µg/g feces, according to findings from the Dutch MOCCAS study published in Gastroenterology.

In this cross-sectional observational study, the multitarget DNA test outperformed FIT for detecting advanced precursor lesions, especially serrated polyps. According to long-term-impact mathematical modeling, however, DNA-based surveillance would be more costly than colonoscopy surveillance, whereas FIT would save costs.

“With the worldwide implementation of FIT-based screening programs, following a positive test, many more people enter surveillance programs after polypectomy. This results in an increased pressure on the colonoscopy capacity and healthcare budgets,” lead author Beatriz Carvalho, PhD, a molecular biologist in the Department of Pathology of the Netherlands Cancer Institute in Amsterdam, said in an interview.

Netherlands Cancer Institute
Dr. Beatriz Carvalho


A noninvasive strategy could ease the surveillance burden on healthcare resources and be more palatable to patients. Post-polypectomy guidelines have already been relaxed to allow less intensive surveillance.

“Our working hypothesis was that although the sensitivity of a singular molecular test to detect CRC or advanced adenomas is lower than that of colonoscopy, repeating molecular stool testing would yield similar detection rates as colonoscopy-based surveillance. And our hypothesis was confirmed,” Carvalho said.

The results of the MOCCAS study align with those of other studies that found that FIT could be safely applied as a triage test in post-polypectomy surveillance and could safely extend the interval of surveillance colonoscopy. “But these studies did not include a long-term impact analysis,” she said. “The next step is to run a prospective interventional study to validate the MOCCAS findings.”

Offering an outsider’s perspective on the findings, Uri Ladabaum, MD, director of the Gastrointestinal Cancer Prevention Program and a professor of medicine at Stanford University School of Medicine in Palo Alto, California, said the real-world results on lesion detection and the multi-year-horizon modeling performed are provocative and point to the potential to base post-polypectomy surveillance on stool tests.

Stanford University
Dr. Uri Ladabaum


He cautioned, however, that the proposed paradigm requires the ability to deploy FIT-based surveillance with broad flexibility in relation to hemoglobin-detection thresholds and testing interval, depending on the specific FIT that is chosen, with the possibility these may differ by setting based on the characteristics of the population and the relevant epidemiology.

“Such flexibility may or may not be technically feasible in all settings — for instance, in the current US regulatory context, it would be challenging to implement FIT-based testing at newly adjusted detection thresholds,” he said.

Nevertheless, the study provides a strong rationale for a real-world study of FIT-based surveillance, he added. “The choice of specific FIT and detection threshold will be critical. Multiple rounds of FIT-based surveillance, that is, years of prospective surveillance, will be needed to constitute a properly designed comparison with surveillance colonoscopy.”
 

 

 

Study Details

The cross-sectional observational study included individuals aged 50-75 years who provided stool samples for the DNA test and two FITs. Test accuracy was calculated for all surveillance indications.

For the post-polypectomy indication only, which is the most common and associated with a relatively low CRC risk, the long-term impact of stool-based surveillance was evaluated with the Adenoma and Serrated Pathway to Colorectal Cancer model. Stool-based strategies were simulated to tune each test’s positivity threshold to obtain strategies that are at least as effective as colonoscopy surveillance.

A total of 3453 individuals had results for all stool tests and colonoscopy; among them, 2226 had previously undergone polypectomy, 1003 had a history of CRC, and 224 had a familial risk.

Areas under the receiver operating characteristic curve for advanced neoplasia were as follows:

  • 0.72 (95% CI, 0.69-0.75) for the multitarget stool DNA test
  • 0.61 (95% CI, 0.58-0.64) for the FIT OC-SENSOR 
  • 0.59 (95% CI, 0.56-0.61) for the FIT FOB-Gold 

Stool-based surveillance was estimated to be at least as effective as colonoscopy surveillance and required 5.6 to 9.5 stool tests over a person’s lifetime. DNA-based surveillance was more costly than colonoscopy surveillance, whereas FIT-based surveillance saved costs.

“These findings provide a basis to embark on a prospective intervention study to assess the clinical utility of FIT as an alternative to colonoscopy surveillance in a post-polypectomy CRC surveillance population,” the authors wrote.

In the United States, Ladabaum said, it would likely be possible to find FIT-based strategies that closely approximate or match surveillance colonoscopy — “if we could deploy FIT with the required flexibility, for example, by adjusting the threshold and if the reference surveillance standard were somewhat relaxed compared with current guidelines.”

He worries, however, that if FIT for screening and FIT for surveillance were optimized at different hemoglobin detection thresholds, “there could be confusion and room for error in real-world clinical implementation.”

The authors called for research to increase understanding of the mechanisms underlying progression from adenomas to malignancy over time, which may yield better biomarkers to improve stool test accuracy.

This study was funded by the Alpe d’HuZes charity and the Dutch Cancer Society. Exact Sciences provided test equipment and performed multitarget stool DNA test analysis. Sentinel Diagnostics provided equipment and reagents.

Carvalho and Veerle M. H. Coupé, PhD, disclosed several patents pending and/or issued. Other coauthors disclosed multiple financial relationships with private companies, including Exact Sciences and Sentinel, for research support, travel, board membership, advisory or speaker fees, consulting, employment, stock ownership, or patents.

Ladabaum disclosed no competing interests relevant to his comments.

A version of this article appeared on Medscape.com.

Noninvasive surveillance with multitarget stool DNA testing or fecal immunochemical testing (FIT) could potentially match colonoscopy for reducing long-term colorectal cancer (CRC) incidence and mortality. It might also reduce colonoscopies by an estimated 15%-41%.

The greatest reduction would likely be achieved by annual FIT-based surveillance, especially with FIT FOB-Gold at a threshold of at least 32 µg/g feces, according to findings from the Dutch MOCCAS study published in Gastroenterology.

In this cross-sectional observational study, the multitarget DNA test outperformed FIT for detecting advanced precursor lesions, especially serrated polyps. According to long-term-impact mathematical modeling, however, DNA-based surveillance would be more costly than colonoscopy surveillance, whereas FIT would save costs.

“With the worldwide implementation of FIT-based screening programs, following a positive test, many more people enter surveillance programs after polypectomy. This results in an increased pressure on the colonoscopy capacity and healthcare budgets,” lead author Beatriz Carvalho, PhD, a molecular biologist in the Department of Pathology of the Netherlands Cancer Institute in Amsterdam, said in an interview.

Netherlands Cancer Institute
Dr. Beatriz Carvalho


A noninvasive strategy could ease the surveillance burden on healthcare resources and be more palatable to patients. Post-polypectomy guidelines have already been relaxed to allow less intensive surveillance.

“Our working hypothesis was that although the sensitivity of a singular molecular test to detect CRC or advanced adenomas is lower than that of colonoscopy, repeating molecular stool testing would yield similar detection rates as colonoscopy-based surveillance. And our hypothesis was confirmed,” Carvalho said.

The results of the MOCCAS study align with those of other studies that found that FIT could be safely applied as a triage test in post-polypectomy surveillance and could safely extend the interval of surveillance colonoscopy. “But these studies did not include a long-term impact analysis,” she said. “The next step is to run a prospective interventional study to validate the MOCCAS findings.”

Offering an outsider’s perspective on the findings, Uri Ladabaum, MD, director of the Gastrointestinal Cancer Prevention Program and a professor of medicine at Stanford University School of Medicine in Palo Alto, California, said the real-world results on lesion detection and the multi-year-horizon modeling performed are provocative and point to the potential to base post-polypectomy surveillance on stool tests.

Stanford University
Dr. Uri Ladabaum


He cautioned, however, that the proposed paradigm requires the ability to deploy FIT-based surveillance with broad flexibility in relation to hemoglobin-detection thresholds and testing interval, depending on the specific FIT that is chosen, with the possibility these may differ by setting based on the characteristics of the population and the relevant epidemiology.

“Such flexibility may or may not be technically feasible in all settings — for instance, in the current US regulatory context, it would be challenging to implement FIT-based testing at newly adjusted detection thresholds,” he said.

Nevertheless, the study provides a strong rationale for a real-world study of FIT-based surveillance, he added. “The choice of specific FIT and detection threshold will be critical. Multiple rounds of FIT-based surveillance, that is, years of prospective surveillance, will be needed to constitute a properly designed comparison with surveillance colonoscopy.”
 

 

 

Study Details

The cross-sectional observational study included individuals aged 50-75 years who provided stool samples for the DNA test and two FITs. Test accuracy was calculated for all surveillance indications.

For the post-polypectomy indication only, which is the most common and associated with a relatively low CRC risk, the long-term impact of stool-based surveillance was evaluated with the Adenoma and Serrated Pathway to Colorectal Cancer model. Stool-based strategies were simulated to tune each test’s positivity threshold to obtain strategies that are at least as effective as colonoscopy surveillance.

A total of 3453 individuals had results for all stool tests and colonoscopy; among them, 2226 had previously undergone polypectomy, 1003 had a history of CRC, and 224 had a familial risk.

Areas under the receiver operating characteristic curve for advanced neoplasia were as follows:

  • 0.72 (95% CI, 0.69-0.75) for the multitarget stool DNA test
  • 0.61 (95% CI, 0.58-0.64) for the FIT OC-SENSOR 
  • 0.59 (95% CI, 0.56-0.61) for the FIT FOB-Gold 

Stool-based surveillance was estimated to be at least as effective as colonoscopy surveillance and required 5.6 to 9.5 stool tests over a person’s lifetime. DNA-based surveillance was more costly than colonoscopy surveillance, whereas FIT-based surveillance saved costs.

“These findings provide a basis to embark on a prospective intervention study to assess the clinical utility of FIT as an alternative to colonoscopy surveillance in a post-polypectomy CRC surveillance population,” the authors wrote.

In the United States, Ladabaum said, it would likely be possible to find FIT-based strategies that closely approximate or match surveillance colonoscopy — “if we could deploy FIT with the required flexibility, for example, by adjusting the threshold and if the reference surveillance standard were somewhat relaxed compared with current guidelines.”

He worries, however, that if FIT for screening and FIT for surveillance were optimized at different hemoglobin detection thresholds, “there could be confusion and room for error in real-world clinical implementation.”

The authors called for research to increase understanding of the mechanisms underlying progression from adenomas to malignancy over time, which may yield better biomarkers to improve stool test accuracy.

This study was funded by the Alpe d’HuZes charity and the Dutch Cancer Society. Exact Sciences provided test equipment and performed multitarget stool DNA test analysis. Sentinel Diagnostics provided equipment and reagents.

Carvalho and Veerle M. H. Coupé, PhD, disclosed several patents pending and/or issued. Other coauthors disclosed multiple financial relationships with private companies, including Exact Sciences and Sentinel, for research support, travel, board membership, advisory or speaker fees, consulting, employment, stock ownership, or patents.

Ladabaum disclosed no competing interests relevant to his comments.

A version of this article appeared on Medscape.com.

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Dactylitis Represents More Active and Severe PsA Phenotype

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Mon, 10/21/2024 - 11:23

Key clinical point: The presence of clinical or subclinical dactylitis represented a more active and severe form of psoriatic arthritis (PsA), characterized by increased disease activity, swollen joint counts (SJCs), and tender joint counts (TJCs).

Major finding: PsA with dactylitis (clinical or subclinical) vs without dactylitis was associated with higher median disease activity index in PsA (DAPSA) scores (25.5 vs 16.1; P < .01), SJCs (4 vs 2; P < .001), and TJCs (4 vs 3; P < .01). PsA with subclinical dactylitis vs without dactylitis was associated with even higher DAPSA scores (27.2 vs 16.1; P < .05), SJCs (4.5 vs 2; P < .01), and TJCs (5 vs 3; P < .05).

Study details: This case-control study included 223 patients with PsA who were stratified on the basis of the presence of dactylitis (clinical or subclinical) or its absence at baseline.

Disclosures: This study was supported by the Youth Clinical Research Project of Peking University First Hospital and other sources. No conflicts of interest were reported.

Source: Song Z, Geng Y, Zhang X, Deng X, Zhang Z. Subclinical dactylitis represents a more active phenotype of psoriatic arthritis. Joint Bone Spine. Published online September 24, 2024. Source

 

 

 

 

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Key clinical point: The presence of clinical or subclinical dactylitis represented a more active and severe form of psoriatic arthritis (PsA), characterized by increased disease activity, swollen joint counts (SJCs), and tender joint counts (TJCs).

Major finding: PsA with dactylitis (clinical or subclinical) vs without dactylitis was associated with higher median disease activity index in PsA (DAPSA) scores (25.5 vs 16.1; P < .01), SJCs (4 vs 2; P < .001), and TJCs (4 vs 3; P < .01). PsA with subclinical dactylitis vs without dactylitis was associated with even higher DAPSA scores (27.2 vs 16.1; P < .05), SJCs (4.5 vs 2; P < .01), and TJCs (5 vs 3; P < .05).

Study details: This case-control study included 223 patients with PsA who were stratified on the basis of the presence of dactylitis (clinical or subclinical) or its absence at baseline.

Disclosures: This study was supported by the Youth Clinical Research Project of Peking University First Hospital and other sources. No conflicts of interest were reported.

Source: Song Z, Geng Y, Zhang X, Deng X, Zhang Z. Subclinical dactylitis represents a more active phenotype of psoriatic arthritis. Joint Bone Spine. Published online September 24, 2024. Source

 

 

 

 

Key clinical point: The presence of clinical or subclinical dactylitis represented a more active and severe form of psoriatic arthritis (PsA), characterized by increased disease activity, swollen joint counts (SJCs), and tender joint counts (TJCs).

Major finding: PsA with dactylitis (clinical or subclinical) vs without dactylitis was associated with higher median disease activity index in PsA (DAPSA) scores (25.5 vs 16.1; P < .01), SJCs (4 vs 2; P < .001), and TJCs (4 vs 3; P < .01). PsA with subclinical dactylitis vs without dactylitis was associated with even higher DAPSA scores (27.2 vs 16.1; P < .05), SJCs (4.5 vs 2; P < .01), and TJCs (5 vs 3; P < .05).

Study details: This case-control study included 223 patients with PsA who were stratified on the basis of the presence of dactylitis (clinical or subclinical) or its absence at baseline.

Disclosures: This study was supported by the Youth Clinical Research Project of Peking University First Hospital and other sources. No conflicts of interest were reported.

Source: Song Z, Geng Y, Zhang X, Deng X, Zhang Z. Subclinical dactylitis represents a more active phenotype of psoriatic arthritis. Joint Bone Spine. Published online September 24, 2024. Source

 

 

 

 

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Guselkumab Demonstrates Sustained Efficacy and Safety in PsA

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Mon, 10/21/2024 - 11:22

Key clinical point: Guselkumab administered every 4 weeks (Q4W) or every 8 weeks (Q8W) yielded better clinical outcomes than placebo in patients with psoriatic arthritis (PsA), without any new safety concerns.

Major findings: At week 24, a higher proportion of patients receiving guselkumab Q4W (60%) and Q8W (51%) vs placebo (30%) achieved a ≥ 20% improvement in the American College of Rheumatology (ACR)20 response. The response rates increased through week 52 (69%-78) and were consistent at week 100 (76%-80%) across all the groups. Similar trends were observed for ACR50, with no new safety signals.

Study details: This post hoc analysis of the phase 3 trials DISCOVER-1 and DISCOVER-2 included 1002 biologic-naive patients with PsA who received 100 mg guselkumab Q4W, 100 mg guselkumab at weeks 0 and 4 and then Q8W, or placebo through week 24 with crossover to 100 mg guselkumab Q4W.

Disclosure: The study was sponsored by Janssen-Cilag Ltd. Four authors were employees of Johnson & Johnson. Several authors received research grants, consulting fees, or had ties with various sources.

Source: Mease P, Korotaeva T, Shesternya P, et al. Guselkumab in biologic-naïve patients with active psoriatic arthritis in Russia: A post hoc analysis of the DISCOVER-1 and -2 randomized clinical trials. Rheumatol Ther. Published online September 25, 2024. Source

 

 

 

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Key clinical point: Guselkumab administered every 4 weeks (Q4W) or every 8 weeks (Q8W) yielded better clinical outcomes than placebo in patients with psoriatic arthritis (PsA), without any new safety concerns.

Major findings: At week 24, a higher proportion of patients receiving guselkumab Q4W (60%) and Q8W (51%) vs placebo (30%) achieved a ≥ 20% improvement in the American College of Rheumatology (ACR)20 response. The response rates increased through week 52 (69%-78) and were consistent at week 100 (76%-80%) across all the groups. Similar trends were observed for ACR50, with no new safety signals.

Study details: This post hoc analysis of the phase 3 trials DISCOVER-1 and DISCOVER-2 included 1002 biologic-naive patients with PsA who received 100 mg guselkumab Q4W, 100 mg guselkumab at weeks 0 and 4 and then Q8W, or placebo through week 24 with crossover to 100 mg guselkumab Q4W.

Disclosure: The study was sponsored by Janssen-Cilag Ltd. Four authors were employees of Johnson & Johnson. Several authors received research grants, consulting fees, or had ties with various sources.

Source: Mease P, Korotaeva T, Shesternya P, et al. Guselkumab in biologic-naïve patients with active psoriatic arthritis in Russia: A post hoc analysis of the DISCOVER-1 and -2 randomized clinical trials. Rheumatol Ther. Published online September 25, 2024. Source

 

 

 

Key clinical point: Guselkumab administered every 4 weeks (Q4W) or every 8 weeks (Q8W) yielded better clinical outcomes than placebo in patients with psoriatic arthritis (PsA), without any new safety concerns.

Major findings: At week 24, a higher proportion of patients receiving guselkumab Q4W (60%) and Q8W (51%) vs placebo (30%) achieved a ≥ 20% improvement in the American College of Rheumatology (ACR)20 response. The response rates increased through week 52 (69%-78) and were consistent at week 100 (76%-80%) across all the groups. Similar trends were observed for ACR50, with no new safety signals.

Study details: This post hoc analysis of the phase 3 trials DISCOVER-1 and DISCOVER-2 included 1002 biologic-naive patients with PsA who received 100 mg guselkumab Q4W, 100 mg guselkumab at weeks 0 and 4 and then Q8W, or placebo through week 24 with crossover to 100 mg guselkumab Q4W.

Disclosure: The study was sponsored by Janssen-Cilag Ltd. Four authors were employees of Johnson & Johnson. Several authors received research grants, consulting fees, or had ties with various sources.

Source: Mease P, Korotaeva T, Shesternya P, et al. Guselkumab in biologic-naïve patients with active psoriatic arthritis in Russia: A post hoc analysis of the DISCOVER-1 and -2 randomized clinical trials. Rheumatol Ther. Published online September 25, 2024. Source

 

 

 

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Impact of Smoking on Treatment Outcomes of Tofacitinib in PsA

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Mon, 10/21/2024 - 11:21

Key clinical point: In patients with psoriatic arthritis (PsA), tofacitinib demonstrated higher efficacy than placebo, regardless of smoking status; however, current or past smokers experienced increased rates of adverse events.

Major finding: At 3 months, 10 mg tofacitinib showed higher rates of a 50% improvement in the American College of Rheumatology response than placebo in current or past smokers (odds ratio [OR], 3.01; 95% CI, 1.43-6.33) and never smokers (OR, 6.53; 95% CI, 3.46-12.33). The incidence rates of treatment-emergent adverse events were higher in current or past smokers vs never smokers (adjusted incidence rate, 263.2 vs 208.9); 5 mg tofacitinib had comparable outcomes.

Study details: This post hoc analysis pooled data from phase 2 and 3 trials and a long-term extension study, involving 914 patients with PsA and 372 patients with ankylosing spondylitis who received tofacitinib (5 or 10 mg twice daily) or placebo, while considering their smoking status.

Disclosures: This study was sponsored by Pfizer. Four authors declared being current or former employees or shareholders of Pfizer. Other authors declared having ties with various sources.

Source: Ogdie A, Kristensen LE, Soriano ER, et al. Efficacy and safety of tofacitinib in patients with psoriatic arthritis or ankylosing spondylitis by cigarette smoking status. Rheumatol Ther. Published online September 25, 2024. Source

 

 

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Key clinical point: In patients with psoriatic arthritis (PsA), tofacitinib demonstrated higher efficacy than placebo, regardless of smoking status; however, current or past smokers experienced increased rates of adverse events.

Major finding: At 3 months, 10 mg tofacitinib showed higher rates of a 50% improvement in the American College of Rheumatology response than placebo in current or past smokers (odds ratio [OR], 3.01; 95% CI, 1.43-6.33) and never smokers (OR, 6.53; 95% CI, 3.46-12.33). The incidence rates of treatment-emergent adverse events were higher in current or past smokers vs never smokers (adjusted incidence rate, 263.2 vs 208.9); 5 mg tofacitinib had comparable outcomes.

Study details: This post hoc analysis pooled data from phase 2 and 3 trials and a long-term extension study, involving 914 patients with PsA and 372 patients with ankylosing spondylitis who received tofacitinib (5 or 10 mg twice daily) or placebo, while considering their smoking status.

Disclosures: This study was sponsored by Pfizer. Four authors declared being current or former employees or shareholders of Pfizer. Other authors declared having ties with various sources.

Source: Ogdie A, Kristensen LE, Soriano ER, et al. Efficacy and safety of tofacitinib in patients with psoriatic arthritis or ankylosing spondylitis by cigarette smoking status. Rheumatol Ther. Published online September 25, 2024. Source

 

 

Key clinical point: In patients with psoriatic arthritis (PsA), tofacitinib demonstrated higher efficacy than placebo, regardless of smoking status; however, current or past smokers experienced increased rates of adverse events.

Major finding: At 3 months, 10 mg tofacitinib showed higher rates of a 50% improvement in the American College of Rheumatology response than placebo in current or past smokers (odds ratio [OR], 3.01; 95% CI, 1.43-6.33) and never smokers (OR, 6.53; 95% CI, 3.46-12.33). The incidence rates of treatment-emergent adverse events were higher in current or past smokers vs never smokers (adjusted incidence rate, 263.2 vs 208.9); 5 mg tofacitinib had comparable outcomes.

Study details: This post hoc analysis pooled data from phase 2 and 3 trials and a long-term extension study, involving 914 patients with PsA and 372 patients with ankylosing spondylitis who received tofacitinib (5 or 10 mg twice daily) or placebo, while considering their smoking status.

Disclosures: This study was sponsored by Pfizer. Four authors declared being current or former employees or shareholders of Pfizer. Other authors declared having ties with various sources.

Source: Ogdie A, Kristensen LE, Soriano ER, et al. Efficacy and safety of tofacitinib in patients with psoriatic arthritis or ankylosing spondylitis by cigarette smoking status. Rheumatol Ther. Published online September 25, 2024. Source

 

 

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Intravenous Secukinumab Effective and Safe in PsA

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Key clinical point: In patients with active psoriatic arthritis (PsA), intravenous secukinumab every 4 weeks demonstrated rapid and sustained efficacy, along with a safety profile consistent with that of subcutaneous secukinumab.

Major finding: At week 16, intravenous secukinumab vs placebo significantly improved the American College of Rheumatology 50 response rate (31.4% vs 6.3%; adjusted P < .0001). Improvements were observed as early as week 4 (P < .0005) and were sustained through week 52, regardless of whether patients continued intravenous secukinumab (58.0%) or switched from placebo to intravenous secukinumab (64.0%). No new safety signals were reported.

Study details: In this phase 3 INVIGORATE-2 trial, 381 patients with active PsA and either plaque psoriasis or nail psoriasis were randomly assigned to receive intravenous secukinumab or placebo with crossover to intravenous secukinumab at week 16.

Disclosures: This study was supported by Novartis. Five authors declared being employees of and owning stocks in Novartis. Several authors declared having ties with various sources, including Novartis.

Source: Kivitz A, Sedova L, Churchill M, et al. Efficacy and safety of intravenous secukinumab for the treatment of active psoriatic arthritis: Results from the randomized, placebo-controlled phase III INVIGORATE-2 study. Arthritis Rheumatol. Published online September 19, 2024. Source

 

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Key clinical point: In patients with active psoriatic arthritis (PsA), intravenous secukinumab every 4 weeks demonstrated rapid and sustained efficacy, along with a safety profile consistent with that of subcutaneous secukinumab.

Major finding: At week 16, intravenous secukinumab vs placebo significantly improved the American College of Rheumatology 50 response rate (31.4% vs 6.3%; adjusted P < .0001). Improvements were observed as early as week 4 (P < .0005) and were sustained through week 52, regardless of whether patients continued intravenous secukinumab (58.0%) or switched from placebo to intravenous secukinumab (64.0%). No new safety signals were reported.

Study details: In this phase 3 INVIGORATE-2 trial, 381 patients with active PsA and either plaque psoriasis or nail psoriasis were randomly assigned to receive intravenous secukinumab or placebo with crossover to intravenous secukinumab at week 16.

Disclosures: This study was supported by Novartis. Five authors declared being employees of and owning stocks in Novartis. Several authors declared having ties with various sources, including Novartis.

Source: Kivitz A, Sedova L, Churchill M, et al. Efficacy and safety of intravenous secukinumab for the treatment of active psoriatic arthritis: Results from the randomized, placebo-controlled phase III INVIGORATE-2 study. Arthritis Rheumatol. Published online September 19, 2024. Source

 

Key clinical point: In patients with active psoriatic arthritis (PsA), intravenous secukinumab every 4 weeks demonstrated rapid and sustained efficacy, along with a safety profile consistent with that of subcutaneous secukinumab.

Major finding: At week 16, intravenous secukinumab vs placebo significantly improved the American College of Rheumatology 50 response rate (31.4% vs 6.3%; adjusted P < .0001). Improvements were observed as early as week 4 (P < .0005) and were sustained through week 52, regardless of whether patients continued intravenous secukinumab (58.0%) or switched from placebo to intravenous secukinumab (64.0%). No new safety signals were reported.

Study details: In this phase 3 INVIGORATE-2 trial, 381 patients with active PsA and either plaque psoriasis or nail psoriasis were randomly assigned to receive intravenous secukinumab or placebo with crossover to intravenous secukinumab at week 16.

Disclosures: This study was supported by Novartis. Five authors declared being employees of and owning stocks in Novartis. Several authors declared having ties with various sources, including Novartis.

Source: Kivitz A, Sedova L, Churchill M, et al. Efficacy and safety of intravenous secukinumab for the treatment of active psoriatic arthritis: Results from the randomized, placebo-controlled phase III INVIGORATE-2 study. Arthritis Rheumatol. Published online September 19, 2024. Source

 

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Guselkumab Shows Persistent Effects in PsA

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Key clinical point: In biologic-naive patients with active psoriatic arthritis (PsA), guselkumab administered every 8 weeks (Q8W) led to consistent patient-level improvements in joint disease activity, which persisted for 2 years.

Major finding: Guselkumab maintained high rates of minimal clinically important improvements (MCII) in the clinical Disease Activity Index for PsA (cDAPSA; 94%-99%), with improvements of ≥ 5.7 from baseline through week 52 with a dosing of 100 mg guselkumab Q8W. Among those achieving MCII by week 24, maintenance rates were 69.2% for the cDAPSA and 89.0% for the Psoriatic Arthritis Disease Activity Score at 100 weeks post-achievement.

Study details: This post hoc analysis of the phase 3 DISCOVER-2 trial included 248 biologic-naive patients with active PsA who received 100 mg guselkumab Q8W for 100 weeks.

Disclosures: This study was supported by Janssen Research & Development, LLC. Several authors disclosed holding stock or stock options; receiving grants, payment, honoraria, or consulting fees; or having other ties with various sources, including Janssen.

Source: Mease PJ, Baraliakos X, Chandran V, et al. Persistent patient-level effect of guselkumab at consecutive 8-week dosing visits and over time in patients with active psoriatic arthritis: Post hoc analysis of a 2-year, phase 3, randomized, controlled study. ACR Open Rheumatol. Published online October 4, 2024. Source

 

 

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Key clinical point: In biologic-naive patients with active psoriatic arthritis (PsA), guselkumab administered every 8 weeks (Q8W) led to consistent patient-level improvements in joint disease activity, which persisted for 2 years.

Major finding: Guselkumab maintained high rates of minimal clinically important improvements (MCII) in the clinical Disease Activity Index for PsA (cDAPSA; 94%-99%), with improvements of ≥ 5.7 from baseline through week 52 with a dosing of 100 mg guselkumab Q8W. Among those achieving MCII by week 24, maintenance rates were 69.2% for the cDAPSA and 89.0% for the Psoriatic Arthritis Disease Activity Score at 100 weeks post-achievement.

Study details: This post hoc analysis of the phase 3 DISCOVER-2 trial included 248 biologic-naive patients with active PsA who received 100 mg guselkumab Q8W for 100 weeks.

Disclosures: This study was supported by Janssen Research & Development, LLC. Several authors disclosed holding stock or stock options; receiving grants, payment, honoraria, or consulting fees; or having other ties with various sources, including Janssen.

Source: Mease PJ, Baraliakos X, Chandran V, et al. Persistent patient-level effect of guselkumab at consecutive 8-week dosing visits and over time in patients with active psoriatic arthritis: Post hoc analysis of a 2-year, phase 3, randomized, controlled study. ACR Open Rheumatol. Published online October 4, 2024. Source

 

 

Key clinical point: In biologic-naive patients with active psoriatic arthritis (PsA), guselkumab administered every 8 weeks (Q8W) led to consistent patient-level improvements in joint disease activity, which persisted for 2 years.

Major finding: Guselkumab maintained high rates of minimal clinically important improvements (MCII) in the clinical Disease Activity Index for PsA (cDAPSA; 94%-99%), with improvements of ≥ 5.7 from baseline through week 52 with a dosing of 100 mg guselkumab Q8W. Among those achieving MCII by week 24, maintenance rates were 69.2% for the cDAPSA and 89.0% for the Psoriatic Arthritis Disease Activity Score at 100 weeks post-achievement.

Study details: This post hoc analysis of the phase 3 DISCOVER-2 trial included 248 biologic-naive patients with active PsA who received 100 mg guselkumab Q8W for 100 weeks.

Disclosures: This study was supported by Janssen Research & Development, LLC. Several authors disclosed holding stock or stock options; receiving grants, payment, honoraria, or consulting fees; or having other ties with various sources, including Janssen.

Source: Mease PJ, Baraliakos X, Chandran V, et al. Persistent patient-level effect of guselkumab at consecutive 8-week dosing visits and over time in patients with active psoriatic arthritis: Post hoc analysis of a 2-year, phase 3, randomized, controlled study. ACR Open Rheumatol. Published online October 4, 2024. Source

 

 

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Secukinumab Promotes Long-Term Disease Control in PsA

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Mon, 10/21/2024 - 11:17

Key clinical point: Secukinumab led to clinical improvements across all psoriatic arthritis (PsA) domains, achieving minimal disease activity and demonstrating a favorable 4-year safety profile in biologic-naive patients, those with previous treatment failure, and those with or without comorbidities.

Major finding: During the 48-month follow-up, secukinumab significantly reduced the proportion of patients with active tender joints, swollen joints, enthesitis, and dactylitis (all P < .01). Overall, 50% of patients achieved remission or low disease activity in PsA, with higher rates of minimal disease activity in biologic-naive vs non-naive patients (76.9% vs 66.2%; P < .01) and in those without comorbidities vs those with over three comorbidities (78.8% vs 48.7%; P < .001). Only 5.9% of patients discontinued treatment due to adverse events.

Study details: This 4-year prospective observational study included 685 patients with PsA who received secukinumab; 32.9% were biologic-naive and 74.2% had at least one comorbidity.

Disclosures: This study did not receive financial support from any pharmaceutical company. The authors declared no conflicts of interest.

Source: Ramonda R, Lorenzin M, Chimenti MS, et al. Four-year effectiveness, safety and drug retention rate of secukinumab in psoriatic arthritis: A real-life Italian multicenter cohort. Arthritis Res Ther. 2024;26:172. Source

 

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Key clinical point: Secukinumab led to clinical improvements across all psoriatic arthritis (PsA) domains, achieving minimal disease activity and demonstrating a favorable 4-year safety profile in biologic-naive patients, those with previous treatment failure, and those with or without comorbidities.

Major finding: During the 48-month follow-up, secukinumab significantly reduced the proportion of patients with active tender joints, swollen joints, enthesitis, and dactylitis (all P < .01). Overall, 50% of patients achieved remission or low disease activity in PsA, with higher rates of minimal disease activity in biologic-naive vs non-naive patients (76.9% vs 66.2%; P < .01) and in those without comorbidities vs those with over three comorbidities (78.8% vs 48.7%; P < .001). Only 5.9% of patients discontinued treatment due to adverse events.

Study details: This 4-year prospective observational study included 685 patients with PsA who received secukinumab; 32.9% were biologic-naive and 74.2% had at least one comorbidity.

Disclosures: This study did not receive financial support from any pharmaceutical company. The authors declared no conflicts of interest.

Source: Ramonda R, Lorenzin M, Chimenti MS, et al. Four-year effectiveness, safety and drug retention rate of secukinumab in psoriatic arthritis: A real-life Italian multicenter cohort. Arthritis Res Ther. 2024;26:172. Source

 

Key clinical point: Secukinumab led to clinical improvements across all psoriatic arthritis (PsA) domains, achieving minimal disease activity and demonstrating a favorable 4-year safety profile in biologic-naive patients, those with previous treatment failure, and those with or without comorbidities.

Major finding: During the 48-month follow-up, secukinumab significantly reduced the proportion of patients with active tender joints, swollen joints, enthesitis, and dactylitis (all P < .01). Overall, 50% of patients achieved remission or low disease activity in PsA, with higher rates of minimal disease activity in biologic-naive vs non-naive patients (76.9% vs 66.2%; P < .01) and in those without comorbidities vs those with over three comorbidities (78.8% vs 48.7%; P < .001). Only 5.9% of patients discontinued treatment due to adverse events.

Study details: This 4-year prospective observational study included 685 patients with PsA who received secukinumab; 32.9% were biologic-naive and 74.2% had at least one comorbidity.

Disclosures: This study did not receive financial support from any pharmaceutical company. The authors declared no conflicts of interest.

Source: Ramonda R, Lorenzin M, Chimenti MS, et al. Four-year effectiveness, safety and drug retention rate of secukinumab in psoriatic arthritis: A real-life Italian multicenter cohort. Arthritis Res Ther. 2024;26:172. Source

 

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New Cosmeceutical as Effective as Cysteamine for Facial Melasma

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Mon, 10/21/2024 - 11:21

A new serum containing 2-mercaptonicotinoyl glycine (Melasyl) as its main ingredient was at least as good as, if not better than, cysteamine 5% cream in treating facial melasma in a randomized controlled study presented at the European Academy of Dermatology and Venereology (EADV) 2024 Congress.

“Melasyl is a new potent melanogenesis inhibitor that exhibits a unique mode of action while preserving melanocyte integrity,” Mukta Sachdev, MD, head of the Department of Dermatology at Manipal Hospital in Bangalore, India, said at a late-breaking news session.

Both the serum and the cysteamine cream lightened participants’ skin to a similar extent, according to the modified Melasma Area and Severity Index (mMASI), with respective reductions of 4.19 and 3.81 points over a period of 4 months from baseline values of 11.15 and 10.93. 

Toa55/iStock/Getty Images

The mMASI score ranges from 0 to 24, with the lowest score representing the least and the highest score the most severe hyperpigmentation of the skin.

But the serum performed better than the cream by another measure. Judged by investigators blinded to which preparation study participants had been using, there was a significantly higher reduction in the Investigator Global Assessment (IGA) score from baseline among those treated with the serum than among those treated with the cream (−51.85% vs −39.06%; P = .0163). 

Moreover, after 4 months of treatment, there were significantly more participants with clear or almost clear skin with the serum than with the cream (17.46% vs 7.81%; P = .0163), Sachdev reported.

Other skin parameters relative to melasma, such as the brightness of skin tone and evenness of the improvement, improved more in the participants using the serum vs cream, she said. 

With “no side effects, no local skin reactions,” Sachdev said, “quality of life improved significantly and similarly, and almost all subjects in both groups were very satisfied with their treatment options.”
 

Active Ingredients

Margarida Gonçalo, MD, PhD, professor of dermatology at the University of Coimbra, in Portugal, who co-chaired the late-breaking news session, commented: “It’s really nice to have new products to treat such a devastating disease.”

Session co-chair, Lidia Rudnicka, MD, head of the Department of Dermatology, Medical University of Warsaw, in Poland, and president of the Polish Dermatological Society, wanted to know more about the active ingredients of the serum and the study’s design. 

Sachdev replied that the serum also contains other ingredients that provide “antioxidant protection” and moisturization. These include retinyl palmitate, which works on the dermal-epidermal junction, and hyaluronic acid, as well as “soothing agents,” such as the medicinal herb Centella asiatica, she said.
 

Study Design

Conducted at a single center in India, the study involved 127 adults aged 20-50 years with melasma. For inclusion, the participants had to have facial epidermal or mixed melasma (phototypes III-V) for more than 1 year; those with dermal melasma were excluded. 

Participants were randomly allocated to receive either the serum, which was applied topically to the areas of interest twice a day in the morning and then at bedtime (n = 63), or cysteamine cream (n = 64), which was applied once a day in addition to a neutral moisturizer. Treatment was for 4 months, with an on-site visit every month. 

All participants were supplied with the same sunscreen/ultraviolet protector applied twice a day (once in the morning and again at midday) and a neutral hydrating cleanser that was used in the morning and evening. 
 

 

 

Practical Implications

Over 4 months, both products showed significant improvement in melasma without reaching a plateau, Sachdev reported, with the serum demonstrating superior efficacy and tolerability, as judged by the investigators. 

The study suggests that the serum is a promising non-hydroquinone treatment for melasma, she said. Hydroquinone-containing topical preparations are used to depigment the skin, but their long-term use can be limited for safety reasons. 

“When products like this demonstrate improvement, it is something for the dermatologist to think about because we now have newer ingredients, which are safer and well tolerated,” she continued, noting that there appeared to be no risk for exogenous ochronosis, which can occur with long-term application of hydroquinone.

“So, I think the armamentarium of non-hydroquinone products for the treatment of melasma is rapidly expanding, and there are studies now with clinically proven efficacy,” Sachdev concluded. 

The study was supported by L’Oréal France La Roche-Posay, which launched Melasyl in March 2024. Sachdev reported receipt of research support and honoraria from the company. Gonçalo and Rudnicka were not involved in the study and had no relevant conflicts of interest to report. 
 

A version of this article appeared on Medscape.com.

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A new serum containing 2-mercaptonicotinoyl glycine (Melasyl) as its main ingredient was at least as good as, if not better than, cysteamine 5% cream in treating facial melasma in a randomized controlled study presented at the European Academy of Dermatology and Venereology (EADV) 2024 Congress.

“Melasyl is a new potent melanogenesis inhibitor that exhibits a unique mode of action while preserving melanocyte integrity,” Mukta Sachdev, MD, head of the Department of Dermatology at Manipal Hospital in Bangalore, India, said at a late-breaking news session.

Both the serum and the cysteamine cream lightened participants’ skin to a similar extent, according to the modified Melasma Area and Severity Index (mMASI), with respective reductions of 4.19 and 3.81 points over a period of 4 months from baseline values of 11.15 and 10.93. 

Toa55/iStock/Getty Images

The mMASI score ranges from 0 to 24, with the lowest score representing the least and the highest score the most severe hyperpigmentation of the skin.

But the serum performed better than the cream by another measure. Judged by investigators blinded to which preparation study participants had been using, there was a significantly higher reduction in the Investigator Global Assessment (IGA) score from baseline among those treated with the serum than among those treated with the cream (−51.85% vs −39.06%; P = .0163). 

Moreover, after 4 months of treatment, there were significantly more participants with clear or almost clear skin with the serum than with the cream (17.46% vs 7.81%; P = .0163), Sachdev reported.

Other skin parameters relative to melasma, such as the brightness of skin tone and evenness of the improvement, improved more in the participants using the serum vs cream, she said. 

With “no side effects, no local skin reactions,” Sachdev said, “quality of life improved significantly and similarly, and almost all subjects in both groups were very satisfied with their treatment options.”
 

Active Ingredients

Margarida Gonçalo, MD, PhD, professor of dermatology at the University of Coimbra, in Portugal, who co-chaired the late-breaking news session, commented: “It’s really nice to have new products to treat such a devastating disease.”

Session co-chair, Lidia Rudnicka, MD, head of the Department of Dermatology, Medical University of Warsaw, in Poland, and president of the Polish Dermatological Society, wanted to know more about the active ingredients of the serum and the study’s design. 

Sachdev replied that the serum also contains other ingredients that provide “antioxidant protection” and moisturization. These include retinyl palmitate, which works on the dermal-epidermal junction, and hyaluronic acid, as well as “soothing agents,” such as the medicinal herb Centella asiatica, she said.
 

Study Design

Conducted at a single center in India, the study involved 127 adults aged 20-50 years with melasma. For inclusion, the participants had to have facial epidermal or mixed melasma (phototypes III-V) for more than 1 year; those with dermal melasma were excluded. 

Participants were randomly allocated to receive either the serum, which was applied topically to the areas of interest twice a day in the morning and then at bedtime (n = 63), or cysteamine cream (n = 64), which was applied once a day in addition to a neutral moisturizer. Treatment was for 4 months, with an on-site visit every month. 

All participants were supplied with the same sunscreen/ultraviolet protector applied twice a day (once in the morning and again at midday) and a neutral hydrating cleanser that was used in the morning and evening. 
 

 

 

Practical Implications

Over 4 months, both products showed significant improvement in melasma without reaching a plateau, Sachdev reported, with the serum demonstrating superior efficacy and tolerability, as judged by the investigators. 

The study suggests that the serum is a promising non-hydroquinone treatment for melasma, she said. Hydroquinone-containing topical preparations are used to depigment the skin, but their long-term use can be limited for safety reasons. 

“When products like this demonstrate improvement, it is something for the dermatologist to think about because we now have newer ingredients, which are safer and well tolerated,” she continued, noting that there appeared to be no risk for exogenous ochronosis, which can occur with long-term application of hydroquinone.

“So, I think the armamentarium of non-hydroquinone products for the treatment of melasma is rapidly expanding, and there are studies now with clinically proven efficacy,” Sachdev concluded. 

The study was supported by L’Oréal France La Roche-Posay, which launched Melasyl in March 2024. Sachdev reported receipt of research support and honoraria from the company. Gonçalo and Rudnicka were not involved in the study and had no relevant conflicts of interest to report. 
 

A version of this article appeared on Medscape.com.

A new serum containing 2-mercaptonicotinoyl glycine (Melasyl) as its main ingredient was at least as good as, if not better than, cysteamine 5% cream in treating facial melasma in a randomized controlled study presented at the European Academy of Dermatology and Venereology (EADV) 2024 Congress.

“Melasyl is a new potent melanogenesis inhibitor that exhibits a unique mode of action while preserving melanocyte integrity,” Mukta Sachdev, MD, head of the Department of Dermatology at Manipal Hospital in Bangalore, India, said at a late-breaking news session.

Both the serum and the cysteamine cream lightened participants’ skin to a similar extent, according to the modified Melasma Area and Severity Index (mMASI), with respective reductions of 4.19 and 3.81 points over a period of 4 months from baseline values of 11.15 and 10.93. 

Toa55/iStock/Getty Images

The mMASI score ranges from 0 to 24, with the lowest score representing the least and the highest score the most severe hyperpigmentation of the skin.

But the serum performed better than the cream by another measure. Judged by investigators blinded to which preparation study participants had been using, there was a significantly higher reduction in the Investigator Global Assessment (IGA) score from baseline among those treated with the serum than among those treated with the cream (−51.85% vs −39.06%; P = .0163). 

Moreover, after 4 months of treatment, there were significantly more participants with clear or almost clear skin with the serum than with the cream (17.46% vs 7.81%; P = .0163), Sachdev reported.

Other skin parameters relative to melasma, such as the brightness of skin tone and evenness of the improvement, improved more in the participants using the serum vs cream, she said. 

With “no side effects, no local skin reactions,” Sachdev said, “quality of life improved significantly and similarly, and almost all subjects in both groups were very satisfied with their treatment options.”
 

Active Ingredients

Margarida Gonçalo, MD, PhD, professor of dermatology at the University of Coimbra, in Portugal, who co-chaired the late-breaking news session, commented: “It’s really nice to have new products to treat such a devastating disease.”

Session co-chair, Lidia Rudnicka, MD, head of the Department of Dermatology, Medical University of Warsaw, in Poland, and president of the Polish Dermatological Society, wanted to know more about the active ingredients of the serum and the study’s design. 

Sachdev replied that the serum also contains other ingredients that provide “antioxidant protection” and moisturization. These include retinyl palmitate, which works on the dermal-epidermal junction, and hyaluronic acid, as well as “soothing agents,” such as the medicinal herb Centella asiatica, she said.
 

Study Design

Conducted at a single center in India, the study involved 127 adults aged 20-50 years with melasma. For inclusion, the participants had to have facial epidermal or mixed melasma (phototypes III-V) for more than 1 year; those with dermal melasma were excluded. 

Participants were randomly allocated to receive either the serum, which was applied topically to the areas of interest twice a day in the morning and then at bedtime (n = 63), or cysteamine cream (n = 64), which was applied once a day in addition to a neutral moisturizer. Treatment was for 4 months, with an on-site visit every month. 

All participants were supplied with the same sunscreen/ultraviolet protector applied twice a day (once in the morning and again at midday) and a neutral hydrating cleanser that was used in the morning and evening. 
 

 

 

Practical Implications

Over 4 months, both products showed significant improvement in melasma without reaching a plateau, Sachdev reported, with the serum demonstrating superior efficacy and tolerability, as judged by the investigators. 

The study suggests that the serum is a promising non-hydroquinone treatment for melasma, she said. Hydroquinone-containing topical preparations are used to depigment the skin, but their long-term use can be limited for safety reasons. 

“When products like this demonstrate improvement, it is something for the dermatologist to think about because we now have newer ingredients, which are safer and well tolerated,” she continued, noting that there appeared to be no risk for exogenous ochronosis, which can occur with long-term application of hydroquinone.

“So, I think the armamentarium of non-hydroquinone products for the treatment of melasma is rapidly expanding, and there are studies now with clinically proven efficacy,” Sachdev concluded. 

The study was supported by L’Oréal France La Roche-Posay, which launched Melasyl in March 2024. Sachdev reported receipt of research support and honoraria from the company. Gonçalo and Rudnicka were not involved in the study and had no relevant conflicts of interest to report. 
 

A version of this article appeared on Medscape.com.

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Comparative Performance of Adalimumab and Secukinumab in PsA

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Key clinical point: Adalimumab and secukinumab showed comparable efficacy in patients with psoriatic arthritis (PsA); however, secukinumab was more effective for skin improvement and adalimumab was superior in alleviating ultrasound-confirmed synovitis.

Major finding: At week 12, there was no significant difference between adalimumab and secukinumab in achieving a 20% improvement in the American College of Rheumatology response (odds ratio [OR], 0.59; P = .22). Secukinumab showed higher efficacy than adalimumab in achieving a 90% improvement in the Psoriasis Area and Severity Index (OR, 2.25; P = .03). At week 52, adalimumab achieved greater improvements in the ultrasound synovitis count (β, 0.94; P = .03) and synovitis power Doppler signal (β = 0.20; P = .02) than secukinumab.

Study details: This prospective real-world study included 116 patients with PsA (age, 18 years) who received secukinumab or adalimumab (both n = 58).

Disclosures: This study did not receive any specific funding. No conflicts of interest were reported.

Source: Wang Y, Xiao Y, Zhang L, et al. Superior effect of adalimumab versus secukinumab on ultrasound-confirmed synovitis in psoriatic arthritis: Comprehensive evidence from musculoskeletal ultrasound and clinical assessments. J Dermatolog Treat. 2024;35:2411849. Source

 

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Key clinical point: Adalimumab and secukinumab showed comparable efficacy in patients with psoriatic arthritis (PsA); however, secukinumab was more effective for skin improvement and adalimumab was superior in alleviating ultrasound-confirmed synovitis.

Major finding: At week 12, there was no significant difference between adalimumab and secukinumab in achieving a 20% improvement in the American College of Rheumatology response (odds ratio [OR], 0.59; P = .22). Secukinumab showed higher efficacy than adalimumab in achieving a 90% improvement in the Psoriasis Area and Severity Index (OR, 2.25; P = .03). At week 52, adalimumab achieved greater improvements in the ultrasound synovitis count (β, 0.94; P = .03) and synovitis power Doppler signal (β = 0.20; P = .02) than secukinumab.

Study details: This prospective real-world study included 116 patients with PsA (age, 18 years) who received secukinumab or adalimumab (both n = 58).

Disclosures: This study did not receive any specific funding. No conflicts of interest were reported.

Source: Wang Y, Xiao Y, Zhang L, et al. Superior effect of adalimumab versus secukinumab on ultrasound-confirmed synovitis in psoriatic arthritis: Comprehensive evidence from musculoskeletal ultrasound and clinical assessments. J Dermatolog Treat. 2024;35:2411849. Source

 

Key clinical point: Adalimumab and secukinumab showed comparable efficacy in patients with psoriatic arthritis (PsA); however, secukinumab was more effective for skin improvement and adalimumab was superior in alleviating ultrasound-confirmed synovitis.

Major finding: At week 12, there was no significant difference between adalimumab and secukinumab in achieving a 20% improvement in the American College of Rheumatology response (odds ratio [OR], 0.59; P = .22). Secukinumab showed higher efficacy than adalimumab in achieving a 90% improvement in the Psoriasis Area and Severity Index (OR, 2.25; P = .03). At week 52, adalimumab achieved greater improvements in the ultrasound synovitis count (β, 0.94; P = .03) and synovitis power Doppler signal (β = 0.20; P = .02) than secukinumab.

Study details: This prospective real-world study included 116 patients with PsA (age, 18 years) who received secukinumab or adalimumab (both n = 58).

Disclosures: This study did not receive any specific funding. No conflicts of interest were reported.

Source: Wang Y, Xiao Y, Zhang L, et al. Superior effect of adalimumab versus secukinumab on ultrasound-confirmed synovitis in psoriatic arthritis: Comprehensive evidence from musculoskeletal ultrasound and clinical assessments. J Dermatolog Treat. 2024;35:2411849. Source

 

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Weather Has a Limited Effect on PsA Symptoms

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Key clinical point: In patients with psoriatic arthritis (PsA), disease activity was significantly lower in winter than in summer; however, the correlation between patient-reported outcomes (PROs) and weather-related factors lacked clinical significance.

Major finding: Disease activity scores, including the Clinical Disease Activity Index (mean, 8.2 vs 8.8; P < .001) and Simplified Disease Activity Index (mean, 8.6 vs 9.5; P < .001) scores, were significantly lower in winter than in summer. However, the association between weather-related factors and various PROs, including pain and fatigue measures, was not clinically significant (Pearson correlation coefficient, < 0.7).

Study details: In this study, 2665 PROs from 858 patients with PsA were analyzed and hourly measurements of temperature, relative humidity, and pressure were matched with disease activity and PROs in winter and summer.

Disclosures: The lead author received funding through the Canadian Association of Psoriasis Patients and the Canadian Institute of Health Research Institute of Musculoskeletal Health and Arthritis for this study. Some authors declared having ties with various sources.

Source: Joly-Chevrier M, Coupal L, Sauvageau LC, Movahedi M, Choquette D. A real-world analysis on weather variation disease activity and patient reported outcomes in psoriatic arthritis. J Rheumatol. Published online September 15, 2024. Source

 

 

 

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Key clinical point: In patients with psoriatic arthritis (PsA), disease activity was significantly lower in winter than in summer; however, the correlation between patient-reported outcomes (PROs) and weather-related factors lacked clinical significance.

Major finding: Disease activity scores, including the Clinical Disease Activity Index (mean, 8.2 vs 8.8; P < .001) and Simplified Disease Activity Index (mean, 8.6 vs 9.5; P < .001) scores, were significantly lower in winter than in summer. However, the association between weather-related factors and various PROs, including pain and fatigue measures, was not clinically significant (Pearson correlation coefficient, < 0.7).

Study details: In this study, 2665 PROs from 858 patients with PsA were analyzed and hourly measurements of temperature, relative humidity, and pressure were matched with disease activity and PROs in winter and summer.

Disclosures: The lead author received funding through the Canadian Association of Psoriasis Patients and the Canadian Institute of Health Research Institute of Musculoskeletal Health and Arthritis for this study. Some authors declared having ties with various sources.

Source: Joly-Chevrier M, Coupal L, Sauvageau LC, Movahedi M, Choquette D. A real-world analysis on weather variation disease activity and patient reported outcomes in psoriatic arthritis. J Rheumatol. Published online September 15, 2024. Source

 

 

 

Key clinical point: In patients with psoriatic arthritis (PsA), disease activity was significantly lower in winter than in summer; however, the correlation between patient-reported outcomes (PROs) and weather-related factors lacked clinical significance.

Major finding: Disease activity scores, including the Clinical Disease Activity Index (mean, 8.2 vs 8.8; P < .001) and Simplified Disease Activity Index (mean, 8.6 vs 9.5; P < .001) scores, were significantly lower in winter than in summer. However, the association between weather-related factors and various PROs, including pain and fatigue measures, was not clinically significant (Pearson correlation coefficient, < 0.7).

Study details: In this study, 2665 PROs from 858 patients with PsA were analyzed and hourly measurements of temperature, relative humidity, and pressure were matched with disease activity and PROs in winter and summer.

Disclosures: The lead author received funding through the Canadian Association of Psoriasis Patients and the Canadian Institute of Health Research Institute of Musculoskeletal Health and Arthritis for this study. Some authors declared having ties with various sources.

Source: Joly-Chevrier M, Coupal L, Sauvageau LC, Movahedi M, Choquette D. A real-world analysis on weather variation disease activity and patient reported outcomes in psoriatic arthritis. J Rheumatol. Published online September 15, 2024. Source

 

 

 

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