Key Insights from Novartis at AAD and AAAAI: Flexibility and Personalization in Dermatology Treatment

At both the American Academy of Dermatology (AAD) and American Academy of Allergy, Asthma, and Immunology Annual Meetings, Novartis shared pivotal findings regarding the flexibility of secukinumab (Cosentyx) for hidradenitis suppurativa (HS) and remibrutinib as an effective treatment for chronic spontaneous urticaria (CSU).¹

These findings reflect a broader shift towards personalized, adaptable treatment regimens in dermatology, where therapies are tailored to meet the unique needs of individual patients.

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Cosentyx for Hidradenitis Suppurativa: A Flexible Treatment Option

Anthony Yadao, MD, vice president and head of immunology at Novartis, discussed new post-hoc analysis data from the phase 3 SUNSHINE (NCT03713619)² and SUNRISE (NCT03713632)³ extension trials, which focused on secukinumab in HS.

Key findings from these studies revealed that for patients who did not respond to a 4-week dosing schedule, increasing the dosing frequency to every 2 weeks resulted in significant improvements in reducing inflammatory nodules and abscesses. This flexible dosing schedule offers a critical advantage, allowing clinicians to adjust treatment to better match a patient's response.

“We recognize that HS affects everyone differently, and treatment needs to be tailored to each patient,” Yadao said. “These findings highlight the importance of flexibility in managing HS. Cosentyx can offer the ability to adjust dosing frequency, meaning if a patient isn’t responding to the standard 4-week schedule, they have the option to switch to every 2 weeks. This personalized approach helps ensure patients get the best possible outcomes based on their individual needs.”

These insights reinforce the role of Cosentyx as a flexible treatment for moderate to severe HS, allowing for personalized care and ensuring better management of symptoms based on patient-specific needs.

Remibrutinib and the Future of CSU

The latest findings from the phase 3 REMIX-1 and REMIX-2 trials highlight the potential of remibrutinib, an oral Bruton’s tyrosine kinase inhibitor, as a promising treatment for patients withCSU.

Published in the New England Journal of Medicine⁴ and presented at the AAD Annual Meeting, the results offer an update on this investigational therapy.

Both the REMIX-1 (NCT05030311)⁵ and REMIX-2 trials met their primary endpoints, demonstrating that remibrutinib significantly improved CSU symptoms compared to a placebo.

Specifically, the treatment resulted in a greater improvement in the composite score of itching and hives (UAS7) and its individual components, the itch severity score, and hive severity score, over 12 weeks. This effect was not only significant at 12 weeks but was sustained throughout the 24-week study period.

The findings revealed that patients receiving remibrutinib experienced early symptom improvement, with significant reductions in bothhives and itching observed as early as week 1. This early relief was maintained through week 24, with more patients on remibrutinib achieving a UAS7 score of ≤6 (indicating low disease activity) and even complete resolution (UAS7=0) compared to those on placebo.

Importantly, remibrutinib demonstrated a safety profile comparable to placebo, with overall adverse event rates being minimal.

Robert Snyder, MD, a study investigator from Riverchase Dermatology, provided additional insights into the long-term data presented for remibrutinib, particularly regarding its impact on sleep quality and daily functioning.

According to Snyder, the phase 3data highlighted the significant benefits of remibrutinib, which were observable as early as week 1 and persisted through week 52.

"A greater proportion of patients taking remibrutinib reported fewer disruptions to sleep and daily life compared to those on placebo," he noted.

This was particularly important given the severe impact of CSU on patients' quality of life.

By the 1-year mark, 60.6% of patients in REMIX-1 and 64.7% in REMIX-2 who received remibrutinib reported no CSU-related impairments in sleep or daily activities. This aligns with the study's broader conclusions, emphasizing that remibrutinib is not only effective in reducing the physical symptoms of CSU but also improves the overall quality of life for patients.

Snyder also discussed how the findings contribute to understanding CSU treatment, noting that many patients struggle with inadequate control even after initial antihistamine therapy.

"The REMIX-1 and REMIX-2 trials show the potential for remibrutinib as an oral treatment for people with CSU whose symptoms are inadequately controlled by H1-antihistamines," he remarked.

What’s Next for CSU Treatment?

Snyder further discussed the implications of these findings for clinical decision-making, stating that there is a growing need for more effective oral treatments.

“The data showed that remibrutinib reduced the impact of CSU on sleep and daily activity as early as week 1,” he explained. “This early response could be meaningful for those who have been dealing with unpredictable and persistent symptoms for years.”

As the next steps, the data from these phase 3 studies will be used to support regulatory submissions in the first half of 2025.

References

1. Novartis data presentations at AAAAI and AAD underscore commitment to advancing treatment of hidradenitis suppurativa (HS) and chronic spontaneous urticaria (CSU). Novartis. Published February 27, 2025. Accessed March 14, 2025. https://www.novartis.com/news/media-releases/novartis-data-presentations-aaaai-and-aad-underscore-commitment-advancing-treatment-hidradenitis-suppurativa-hs-and-chronic-spontaneous-urticaria-csu
2. A study of the efficacy and safety of remibrutinib in chronic spontaneous urticaria (REMIX-1) (NCT03713619). ClinicalTrials.gov. Updated February 20, 2025. Accessed March 14, 2025. https://clinicaltrials.gov/study/NCT03713619
3. A study of the efficacy and safety of remibrutinib in chronic spontaneous urticaria (REMIX-2) (NCT03713632). ClinicalTrials.gov. Updated February 20, 2025. Accessed March 14, 2025. https://clinicaltrials.gov/study/NCT03713632
4. Metz M, Giménez-Arnau A, Hide M, et al. Remibrutinib in chronic spontaneous urticaria. N Engl J Med. 2025;392(10):984-994. doi:10.1056/NEJMoa2408792
5. A study of remibrutinib in patients with chronic spontaneous urticaria (REMIX-1) (NCT05030311). ClinicalTrials.gov. Updated February 20, 2025. Accessed March 14, 2025. https://clinicaltrials.gov/study/NCT05030311