European Commission approves SPEVIGO® for new and expanded indications in generalized pustular psoriasis
Boehringer Ingelheim announced today that The European Commission (EC) approved a new indication of SPEVIGO® (spesolimab) injection for the prevention of generalized pustular psoriasis (GPP) flares in adults and adolescents from 12 years of age, as well as an extension of the approved indication for SPEVIGO® infusion for the treatment of generalized pustular psoriasis (GPP) flares in adults and adolescents from 12 years of age as monotherapy.
- The approval is based on the EFFISAYIL® 2 trial.1–3
- The trial showed that no flares were observed after week 4 of SPEVIGO® administered subcutaneously2
During the 48-week trial, an 84% reduction of the risk of GPP flares was observed.1 - The trial also showed a similar incidence of patients with adverse events across the spesolimab and placebo treatment arms.4
“We are increasingly gathering momentum towards a future where people with this rare and often unpredictable disease receive the care they need,” said Shashank Deshpande, Member of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim. “The European Commission's approval means that more people will be able to access a treatment option, with the potential to both prevent and alleviate the chronic, unpredictable symptoms of this devastating disease.”
Why it matters?
- GPP is a rare, chronic, heterogenous, inflammatory neutrophilic disease associated with painful skin manifestations and systemic symptoms, such as fever, pain, and fatigue.5
- GPP varies widely between individuals living with the condition, with symptoms presenting both above and below the skin.6
- Uncontrolled GPP may require emergency care and can lead to life-threatening complications, such as multi-organ failure and sepsis.7
- GPP’s unpredictable nature can potentially have significant long-term impacts on quality of life for people living with it and leads to fear and anxiety over the disease course.8
- SPEVIGO® is currently approved in 519 countries for the treatment of GPP flares, and the European Commission’s decision follows similar approvals for expanded and new indications in the US and China.10 Collectively these approvals help address a significant unmet need and could help improve the lives of many people living with GPP.
About SPEVIGO®
SPEVIGO® is a novel, humanized, selective antibody that specifically blocks the activation of the IL-36R, a signaling pathway within the immune system shown to be involved in the pathogenesis of several autoinflammatory diseases, including GPP. It is the first targeted therapy for the treatment of GPP and has been evaluated in the largest clinical program specifically for the treatment of patients with GPP.2,11,12
About generalized pustular psoriasis (GPP)
GPP is a chronic, heterogenous, neutrophilic inflammatory disease associated with skin and systemic symptoms that is distinct from plaque psoriasis. GPP is recognized as a separate clinical entity from other forms of psoriasis, with the IL-36 pathway being a key driver of GPP and triggering response to treatment.5
Prevalence of GPP varies considerably across geographical regions, ranging from 1.76 to 124 patients per million persons.7 GPP can become life-threatening (mortality rates ranging from 2% to 16%) due to severe complications, such as multisystem organ failure and sepsis requiring urgent hospital care; many GPP patients also suffer from various comorbidities, which contribute to the ongoing burden for the patient and healthcare systems.7,13 GPP symptoms appear unpredictable and present on a continuum, which greatly impacts a patient’s quality of life, and may cause fear and anxiety over the disease course, as well as long-term impacts on quality of life related to work/school, emotional health, social activities, and finances.6–8
About the EFFISAYIL® clinical trial program
The EFFISAYIL® clinical trial program evaluated the largest and broadest population of GPP patients in trials of a therapy specifically targeting the IL-36 pathway for GPP.2
- EFFISAYIL® 1: A Phase II study that demonstrated treatment with a single intravenous dose of spesolimab significantly improved signs and symptoms of GPP in patients experiencing a flare, including rapid pustular and skin clearance. These results supported the approval of spesolimab as the first specific treatment for GPP flares in adults in major markets.1
- EFFISAYIL® 2: A Phase IIb study that showed subcutaneous spesolimab significantly reduced the risk of GPP flares by 84% over 48 weeks compared to placebo. In the trial with 123 patients, no flares were observed after week 4 of spesolimab SC treatment in the high-dose group (n=30).1–3
- EFFISAYIL® ON: An open-label extension study to evaluate the long-term safety and efficacy of spesolimab in patients with GPP who have completed previous spesolimab trials.14
- EFFISAYIL® REP (ongoing): An open-label, single-arm, Phase IIIb/IV trial to evaluate the efficacy, safety, and the impact of immunogenicity in the treatment of patients with GPP presenting with a recurrent flare following their initial GPP flare treatment with spesolimab IV.15
About Boehringer Ingelheim
Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry’s top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. More than 53,500 employees serve over 130 markets to build a healthier, more sustainable, and equitable tomorrow. Learn more at https://www.boehringer-ingelheim.com/.
References:
1 Boehringer Ingelheim. Spesolimab prevented generalized pustular psoriasis flares in Effisayil™ 2 trial. 2023. https://www.boehringer-ingelheim.com/human-health/skin-and-inflammatory-diseases/gpp/spesolimab-prevents-gpp-flares (Accessed 22 July 2024).
2 Morita A, Strober B, Burden AD, et al. Efficacy and safety of subcutaneous spesolimab for the prevention of generalised pustular psoriasis flares (Effisayil 2): an international, multicentre, randomised, placebo-controlled trial. Lancet. 2023;402:1541–1551.
3 Gordon KB, Lebwohl M, Barker J, et al. Effect of spesolimab on achieving sustained disease remission in patients with generalized pustular psoriasis: Results from the Effisayil 2 study. European Academy of Dermatology & Venereology Congress; 2023; Berlin, Germany. Abstract P0731.
4 Lebwohl M et al. Spesolimab for the prevention of generalized pustular psoriasis (GPP) flares: Results from the randomized, placebo-controlled trial Effisayil 2. Abstract presented at the 25th World Congress of Dermatology July 2023, Singapore.
5 Marrakchi S, Puig L. Pathophysiology of generalized pustular psoriasis. Am J Clin Dermatol. 2022;23:13–19.
6 Gooderham MJ, Van Voorhees AS, Lebwohl MG. An update on generalized pustular psoriasis. Expert Rev Clin Immunol. 2019;15:907–919.
7 Prinz JC, Choon SE, Griffiths CEM, et al. Prevalence, comorbidities and mortality of generalized pustular psoriasis: A literature review. J Eur Acad Dermatol Venereol. 2023;37:256–273.
8 Reisner DV, Johnsson FD, Kotowsky N, et al. Impact of generalized pustular psoriasis from the perspective of people living with the condition: Results of an online survey. Am J Clin Dermatol. 2022;23:65–71.
9 Record on file.
10 Boehringer Ingelheim. SPEVIGO® approved for expanded indications in China and the US. 2024. https://www.boehringer-ingelheim.com/human-health/skin-and-inflammatory-diseases/gpp/spevigo-approved-expanded-indications-china-us-0 (Accessed 13 September 2024).
11 Choon SE, Lebwohl MG, Marrakchi S, et al. Study protocol of the global Effisayil 1 Phase II, multicentre, randomised, double-blind, placebo-controlled trial of spesolimab in patients with generalized pustular psoriasis presenting with an acute flare. BMJ Open. 2021;11:e043666.
12 Bachelez H, Choon SE, Marrakchi S, et al. Trial of spesolimab for generalized pustular psoriasis. N Engl J Med. 2021;385:2431–2440.
13 Choon SE, Navarini AA, Pinter A. Clinical course and characteristics of generalized pustular psoriasis. Am J Clin Dermatol. 2022;23:21–29.
14 Effisayil™ ON: A study to test long-term treatment with spesolimab in people with generalized pustular psoriasis who took part in a previous study. https://clinicaltrials.gov/study/NCT03886246. (Accessed 22 July 2024).
15 Effisayil™ REP: A study to test whether spesolimab helps people with generalized pustular psoriasis (GPP) who need treatment for repeated flares. https://clinicaltrials.gov/study/NCT06013969. (Accessed 22 July 2024).
