Pioneering novel approaches to unlock the full potential of IL-1β

Interleukin-1 beta (IL-1β) is a pro-inflammatory cytokine that plays a central role in the pathogenesis of a wide range of human diseases.1 It activates immune cells that generate proinflammatory cytokines, including IL-6, TNF-α, and IL-17. Dysregulated IL-1β signaling is a major driver of inflammation, contributing to the progression of autoimmune disorders.

IL-1β inhibition has proven effective in multiple immune mediated inflammatory diseases.1-3 It also has a well-established class safety and tolerability profile supported by:4-7

  • ILARIS (canakinumab), an IL-1β blocker approved in multiple indications
  • Data from >7,500 clinical trial participants
  • >15 years of real-world experience
References: 1. Dinarello CA. Immunol Rev. 2018;281(1):8-27. 2. Kany S et al. Int J Mol Sci. 2019;20(23):6008. 3. Kimball AB et al. Presented at: American Academy of Dermatology; March 8-12, 2024; San Diego, CA. 4. ILARIS Prescribing Information.https://www.novartis.com/us-en/sites/novartis_us/files/ilaris.pdf 5. Ridker PM et al. N Engl J Med. 2017;377(12):1119-1131. 6. Everett BM et al. Circulation. 2019;139(10):1289-1299. 7. Schieker M et al. Ann Intern Med. 2020;173(7):509-515.

IL-1β in HS

Hidradenitis suppurativa (HS) is a chronic, progressive inflammatory skin disease that causes painful nodules, abscesses, and tunnels to be formed under the skin.1-4 If not adequately and promptly treated, the chronic inflammation characteristic of HS may progress to tissue destruction and permanent scarring.1-3,5

There is a substantial unmet need for more effective and durable treatment options

Currently approved biologics for HS (adalimumab [anti-TNF-α], secukinumab [anti-IL-17A], and bimekizumab [dual anti-IL-17A/F]) achieve HiSCR50 (an efficacy measure) only ~50% of the time, with more stringent thresholds (HiSCR75/90) achieved in even fewer individuals.6-9 Long-term disease control remains a challenge with established biologics and an area of uncertainty with newer agents (secukinumab and bimekizumab), as data on sustained efficacy are still emerging.6-9 In addition, people with HS often have comorbidities that can limit access to current treatment options.

IL-Iβ dominates the pathophysiology of HS2,10,11

Key clinical evidence supporting IL-1 inhibition as an approach to treating HS

In a Phase 2 trial with lutikizumab (an IL-1α/β bispecific), participants receiving lutikizumab achieved a treatment effect comparable to other HS therapies, despite the fact that the trial evaluated a more severe patient population.12 In addition, MAS825 (an IL-1β/IL-18 bispecific) showed positive results in a Phase 2 randomized controlled study in HS.13-16

References: 1. Diaz MJ et al. Curr Iss Mol Bio. 2023;45:4400-4415. 2. Agnese ER et al. Cureus. 2023;15(11):e49390. 3. de Oliveira ASLE et al. Biomolecules. 2022;12(10):1371. 4. Sabat R et al. Lancet. 2025;405(10476):420-438. 5. Caccavale S et al. Life (Basel). 2023;13(1):189. 6. Vradeli G et al. J Am Acad Dermatol. 2025:92(6):1389-1390. 7. Zouboulis CC et al. J Am Acad Dermatol. 2019;80(1):60-69. 8. Kimball AB et al. Br J Dermatol. 2025;192(4):629-640. 9. Zouboulis CC et al. J Dermatol Venerol. 2025;15(1):29-39. 10. Vossen ARJV et al. J Invest Dermatol. 2020;140(7):1463-1466. 11. Kelly G et al. Br J Dermatol. 2015;173(6):1431-1439. 12. Alavi A et al. Br J Dermatol. 2024;191(4):508-518. 13. Ingram JR et al. J Eur Acad Dermatol Venereol. 2022;36(9):1597-1605. 14. Kimball AB et al. Dermatol Ther (Heidelb). 2024;14(1):83-98. 15. ClinicalTrials.gov identifier: NCT03827798. Updated January 21, 2023. Accessed March 24, 2024. https://clinicaltrials.gov/search?term=NCT03827798 16. Kimball AB et al. Presented at: American Academy of Dermatology; March 8-12, 2024; San Diego, CA.