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Medscape
22-05-2025
- Health
- Medscape
Secukinumab Cuts Chronic Pain in Hidradenitis Suppurativa
Compared with placebo, secukinumab demonstrated superior pain reduction in moderate to severe hidradenitis suppurativa in two phase 3 trials. Improvements in pain were sustained through week 52 and were associated with better quality of life outcomes. METHODOLOGY: Researchers analysed 1084 patients with moderate to severe hidradenitis suppurativa from two phase 3 trials (SUNSHINE and SUNRISE) and randomly assigned them to receive secukinumab 300 mg subcutaneously every 2 weeks (SECQ2W) or every 4 weeks (SECQ4W) or placebo until week 16. At week 16, patients randomly assigned to receive placebo switched to receive SECQ2W (placebo-SECQ2W) or SECQ4W (placebo-SECQ4W) until week 52, whereas those originally randomly assigned to receive SECQ2W or SECQ4W continued this treatment until week 52. Pain was assessed using the Patient's Global Assessment of Skin Pain on a continuous numeric rating scale (NRS) through week 52; the severity of pain was categorised into quartiles on the basis of baseline scores (NRS ≤ 3.3, NRS > 3.3 to ≤ 5.4, NRS > 5.4 to ≤ 7.2, and NRS > 7.2). This post hoc analysis of pooled data from the two trials evaluated the effect of secukinumab on multiple aspects of pain and in different subgroups of patients with hidradenitis suppurativa. TAKEAWAY: At week 16, a greater mean absolute change from baseline in skin pain was observed with secukinumab treatment (SECQ2W: mean difference, −1.35; SECQ4W: mean difference, −1.05) than with placebo (mean difference, −0.47). Reductions in skin pain in the secukinumab groups at week 16 were sustained, with a trend for improvement through week 52. Similar improvements were observed in placebo-SECQ2W and placebo-SECQ4W groups. Among patients with severe baseline pain (NRS > 7.2), 20.0% in the SECQ2W group and 12.7% in the SECQ4W group achieved significant pain reduction (NRS ≤ 3.3) at week 16. Patients achieving lower pain scores (NRS ≤ 3.3) experienced better quality of life outcomes. In the secukinumab groups, the proportion of patients requiring pain medication decreased at weeks 16 and 52 compared with baseline. IN PRACTICE: "This post hoc analysis of the SUNSHINE and SUNRISE phase 3 trials highlights the benefits of secukinumab in reducing skin pain in patients with moderate to severe HS [hidradenitis suppurativa], seen within a few weeks of treatment initiation, and sustained, with a trend for improvement, through week 52," the authors wrote. "Importantly, improvements in disease-related pain were associated with improvements in QoL [quality of life] of patients, as well as a decrease in the proportion of patients taking pain medication," they added. SOURCE: This study was led by John R. Ingram, Department of Dermatology & Academic Wound Healing, Division of Infection and Immunity, Cardiff University, Cardiff, Wales. It was published online on May 15, 2025, in Dermatology and Therapy . LIMITATIONS: Changes in skin pain observed may have been influenced by the use of concomitant medications and cannot be fully attributed to the study treatment alone. The cutoffs used for assessing skin pain categories were based on baseline NRS quartiles due to the absence of validated cutoffs for the hidradenitis suppurativa population. Additionally, the study population predominantly consisted of self-reported White participants, with a relatively low proportion of Black patients potentially limiting the generalisability of the findings to the broader global population. DISCLOSURES: This study was funded by Novartis Pharma AG, Basel, Switzerland. One author declared being an employee and stockholder at Novartis Ireland Limited, Dublin, Ireland. Four authors declared being employees of Novartis Pharma AG, Basel, Switzerland. One author declared being an employee of Novartis Pharmaceuticals, East Hanover, New Jersey, United States, at the time of the study. Several authors reported receiving consulting fees and having other ties with various sources.
Yahoo
28-02-2025
- Business
- Yahoo
Novartis data presentations at AAAAI and AAD underscore commitment to advancing treatment of hidradenitis suppurativa (HS) and chronic spontaneous urticaria (CSU)
Two-year efficacy and safety data analyses from Phase III SUNSHINE and SUNRISE trials of continuous Cosentyx® (secukinumab) treatment in HS to be presented New analyses of 52-week data from Phase III REMIX pivotal trials of investigational remibrutinib, demonstrating impact in key clinical outcomes for patients with CSU also to be presented Regulatory submissions for remibrutinib as a treatment for CSU on track for filing in 1H 2025 EAST HANOVER, N.J., Feb. 28, 2025 /PRNewswire/ -- Novartis announced today it will present data from 17 abstracts, including investigator-initiated trials, across its immunology portfolio at the 2025 American Academy of Allergy Asthma and Immunology (AAAAI) and World Allergy Organization (WAO) Joint Congress and the 2025 American Academy of Dermatology (AAD) Annual Meeting. Data presented at the congresses include long-term urticaria control, sleep, and activity analyses from the Phase III REMIX-1 and REMIX-2 studies evaluating investigational remibrutinib for the treatment of chronic spontaneous urticaria (CSU). Additionally, long-term data from the Cosentyx® (secukinumab) Phase III SUNSHINE and SUNRISE trials in patients with hidradenitis suppurativa (HS) and patient-reported outcomes from a Phase II trial evaluating remibrutinib in HS will be presented. "Conditions like CSU and HS are more than just skin deep, often having a profound impact on patients' daily lives and activities," said Angelika Jahreis, Global Head, Development, Immunology, Novartis. "These data at AAAAI and AAD highlight our continued commitment to reimagine medicine and address treatment gaps for people with immune-mediated diseases. We are particularly excited about the potential for remibrutinib as a novel oral treatment for patients with CSU who remain symptomatic on antihistamines." These CSU data will support regulatory submissions in the first half of 2025. In addition to CSU, remibrutinib is being investigated in other immune-mediated conditions, including chronic inducible urticaria (CIndU), HS, and food allergy. Key abstracts accepted by AAAAI include: Abstract Title Abstract Number/ Presentation Details Remibrutinib The Impact of Remibrutinib on Urticaria Control in Patients with Chronic Spontaneous Urticaria: Long-term Results from the REMIX-1/-2 Phase 3 Trials Abstract #598Oral PresentationSaturday, March 12:35 – 2:45 PM PST Remibrutinib Treatment Has No Clinical Impact on Mean Blood Cell Counts in Patients With Chronic Spontaneous Urticaria: Pooled Safety Analysis From REMIX-1 and REMIX-2 Studies Abstract #592Poster PresentationSunday, March 29:45 – 10:45 AM PST Key abstracts accepted by AAD include: Abstract Title Abstract Number/ Presentation Details Remibrutinib Effect of Remibrutinib on Sleep and Daily Activities in Patients With Chronic Spontaneous Urticaria (CSU) up to Week 52 in the REMIX-1/-2 studies Abstract #62278e-Poster with Oral PresentationFriday, March 74:55 – 5:00 PM EST Improvements in Itch and Hive Symptoms With Remibrutinib as Early as Week 1 in Patients With Chronic Spontaneous Urticaria (CSU) in REMIX-1/-2 Abstract #P62280e-Poster Presentation Effects of Remibrutinib Treatment on Ambulatory Blood Pressure in Adult Patients With Chronic Spontaneous Urticaria (CSU) Abstract #62284e-Poster Presentation Remibrutinib in patients with moderate to severe hidradenitis suppurativa: Patient reported outcomes from a randomized, phase 2, double-blind, placebo-controlled platform study Abstract #62279e-Poster Presentation Cosentyx The impact of continuous secukinumab treatment between weeks 52–104 on draining tunnels in patients with moderate to severe hidradenitis suppurativa: A post hoc analysis of the SUNSHINE and SUNRISE extension trial Abstract #63334e-Poster Presentation The impact of continuous secukinumab treatment between weeks 52–104 on HiSCR75, HiSCR90, and HiSCR100 in patients with moderate to severe hidradenitis suppurativa: A post hoc analysis of the SUNSHINE and SUNRISE extension trial Abstract #62149e-Poster Presentation Efficacy of secukinumab uptitration from every 4 weeks to every 2 weeks dosing between weeks 52-104 in week 52 HiSCR non-responder patients with moderate to severe hidradenitis suppurativa: A post hoc analysis of the SUNSHINE and SUNRISE extension trial Abstract #63451e-Poster Presentation The impact of continuous secukinumab treatment through week 104 on efficacy outcomes in patients with moderate to severe hidradenitis suppurativa: A post hoc analysis of the SUNSHINE and SUNRISE core and extension trials Abstract #64857e-Poster Presentation The impact of continuous secukinumab treatment through week 104 on patient reported outcomes in patients with moderate to severe hidradenitis suppurativa: A post hoc analysis of the SUNSHINE and SUNRISE core and extension trials Abstract #64674e-Poster Presentation Product InformationFor full prescribing information, including approved indications and important safety information about marketed products, please visit DisclaimerThis press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. 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