Spevigo (spesolimab-sbzo) / Boehringer Ingelheim - LARVOL DELTA

Effective Spesolimab Treatment for Generalized Pustular Psoriasis Masquerading as Acute Generalized Exanthematous Pustulosis: A Case Report. (PubMed, Cureus) - "Spesolimab, a monoclonal antibody targeting the interleukin 36 (IL-36) receptor, provides rapid symptom relief for GPP flares, but real-world data remain limited. We report a case of GPP complicated by overlapping features with AGEP, highlighting the importance of precise diagnosis and the efficacy of spesolimab."

Journal • Dermatology • Immunology • Psoriasis • Pustular Psoriasis

The role of interleukin inhibitors in the treatment of hidradenitis suppurativa; a systematic review of clinical trials. (PubMed, Autoimmun Rev) - "Secukinumab showed sustained hidradenitis Suppurativa Clinical Response (HiSCR) improvements, particularly in biologic-naïve patients with common adverse events (AEs). Bimekizumab was effective with biweekly dosing, while the four-week regimen had inconsistent results, with rare reports of AEs. Brodalumab and bermekimab provided rapid and sustained HiSCR responses with lesion reductions, which were well tolerated. Guselkumab and ustekinumab showed promising but statistically nonsignificant improvements with mild AEs. Risankizumab did not significantly improve HiSCR rates but showed Dermatology Life Quality Index (DLQI) benefits. Anakinra offered moderate efficacy with prolonged exacerbation-free periods but led to some treatment discontinuations. Spesolimab reduced inflammatory lesions and draining tunnels while maintaining a favorable safety profile. IL inhibitors, especially IL-17 inhibitors, have demonstrated efficacy in treating moderate-to-severe HS, while..."

Journal • Review • Dermatology • Hidradenitis Suppurativa • Immunology • Inflammation • IL17A • IL23A

Case Report: Spesolimab for pyoderma gangrenosum in an undifferentiated oligoarthritis patient receiving anti-IL-17 therapy. (PubMed, Front Immunol) - "The patient was diagnosed with pyoderma gangrenosum (PG) and achieved remission after receiving three doses of 900 mg intravenous Spesolimab every 4 weeks, along with discontinuation of Ixekizumab. The case highlights the successful use of Spesolimab (anti-IL36R) in treating PG and explores the potential "paradoxical phenomenon" linked to anti-IL-17 therapy, providing novel insights into immune dysregulation and therapeutic strategies."

Journal • Dermatology • Immunology • Infectious Disease • Inflammatory Arthritis • Pyoderma Gangrenosum • IL17A

Assessment of Conditional Listing for Highly Uncertain and High-Priced Drugs in Taiwan (ISPOR 2025) - "The review and assessment process were conducted independently by two researchers. A total of 12 drugs were considered for conditional listing between 2022 and 2024, which included Pemazyre, Tepmetko, Qarziba, Kymriah, Vitrakvi, Blincyto, Vydamax, Takhzyro, Polivy, Velexbru, Spevigo, and Koselugo. The conditional listing opens up new opportunities for high-priced drugs. However, the 2-year real-world evidence for Pemazyre remains insufficient for the government to make a final reimbursement decision. Consequently, the results of the HTA will pose challenges in the future in Taiwan."

Specific drugs for rare diseases in a province of eastern China under catalog management: from 2021 to 2023. (PubMed, Front Pharmacol) - "Spesolimab, Sodium Phenylbutyrate, Nitisinone and Emapalumab are currently in short supply, and the delivery rate of 16 drugs such as Selumetinib, Sirolimus (tablet), Octreotide, Dimethyl Fumarate and Lanreotide is below 80%...This indicates a generally high level of accessibility to drugs for rare diseases in China. However, attention should be given to improving the supply capacity for drugs that are in short supply and have a low delivery rate."

Journal • Rare Diseases

Spesolimab for the Treatment of Generalized Pustular Psoriasis Flares: An Observational, Retrospective, and Multicenter Study of Effectiveness and Safety in Real-World Clinical Practice. (PubMed, Int J Dermatol) - No abstract available

Clinical • Journal • Real-world evidence • Retrospective data • Dermatology • Immunology • Inflammation • Psoriasis • Pustular Psoriasis

Diseases of the interleukin-36 pathway. (PubMed, J Allergy Clin Immunol) - No abstract available

Journal • Dermatology • Immunology • Psoriasis • Pustular Psoriasis

Real-World Evidence on the Effectiveness and Safety of Spesolimab in the Treatment of Generalized Pustular Psoriasis Flares: A Case Series. (PubMed, BioDrugs) - No abstract available

HEOR • Journal • Real-world evidence • Dermatology • Immunology • Psoriasis • Pustular Psoriasis

Clinical Responses and Transcriptomic Analysis of Spesolimab in a Girl With Severe Dermatitis, Multiple Allergies and Metabolic Wasting Syndrome. (PubMed, Exp Dermatol) - "Previous studies have demonstrated that acitretin and systemic biologics targeting IL-17, IL-12/IL-23, and IL-4 are effective in treating SAM syndrome. This case highlights the therapeutic potential of targeting the IL-36 pathway in SAM syndrome and supports the use of skin RNA-seq for personalised selection of anti-inflammatory biologics in rare dermatological disorders. This report marks the first clinical application of Spesolimab in SAM syndrome, offering a novel therapeutic approach."

Journal • Allergy • Cachexia • Dermatitis • Dermatology • Genetic Disorders • Immunology • Infectious Disease • Psoriasis • Pustular Psoriasis • IL12A • IL17A • IL23A • IL4

Viral Injury to Clad Derived Lung Parenchymal Epithelial Cells (PECs) Exhibit Upregulation of Markers of Senescence and IL-36 Gamma (IL-36γ) (ISHLT 2025) - "The role of IL-36 as a mediator of the inflammatory response and its association with senescence requires further investigation. Inhibition of IL-36 (with Spesolimab) or senescence pathways may offer novel treatment targets."

Fibrosis • Infectious Disease • Inflammation • Respiratory Diseases • CDKN1A • IL6

Successful Management of Refractory Generalized Pustular Psoriasis With Spesolimab. (PubMed, Am J Ther) - No abstract available

Journal • Dermatology • Immunology • Psoriasis • Pustular Psoriasis

Lunsayil 1: A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Hidradenitis Suppurativa (clinicaltrials.gov) - P2/3 | N=209 | Completed | Sponsor: Boehringer Ingelheim | Active, not recruiting ➔ Completed

Trial completion • Dermatology • Hidradenitis Suppurativa • Immunology

Efficacy and safety of spesolimab in the treatment of generalized pustular psoriasis in elderly patients. (PubMed, Ann Dermatol Venereol) - No abstract available

Journal • Dermatology • Immunology • Psoriasis • Pustular Psoriasis

Generalized Pustular Psoriasis with Breast Cancer Successfully Treated with Spesolimab Causing Neutrophilia: A Case Report. (PubMed, Acta Derm Venereol) - No abstract available

Journal • Breast Cancer • Dermatology • Immunology • Oncology • Psoriasis • Pustular Psoriasis • Solid Tumor

Multi-Criteria Decision Analysis for Evaluating Spesolimab in Generalized Pustular Psoriasis in Brazil (ISPOR 2025) - "This MCDA exercise established a robust framework for evaluating and prioritizing key criteria in the context of GPP treatment, emphasizing the therapeutic benefits of spesolimab. The significant weighting of health-related criteria underlines the urgency for effective interventions and supports timely access to novel treatments within the Brazilian healthcare system. Future efforts should incorporate economic assessments as more robust economic burden data becomes available, enabling a more comprehensive analysis."

Dermatology • Immunology • Inflammation • Psoriasis • Pustular Psoriasis

An updated safety review of hidradenitis suppurativa treatment options. (PubMed, Expert Opin Drug Saf) - "Emerging therapies such as IL-17 inhibitors (bimekizumab), IL-36 inhibitors (spesolimab), and small molecules like the JAK inhibitor povorcitinib provide promising alternatives for patients unresponsive to conventional treatments. Challenges remain, including diagnostic delays, economic barriers, and the need for real-world evidence to validate long-term safety and efficacy. Advancing precision medicine, improving early diagnosis, and adopting comprehensive care models will enhance HS management and patients' quality of life."

Adverse events • Journal • Review • Dermatology • Gastrointestinal Disorder • Hidradenitis Suppurativa • Immunology • Infectious Disease • IL17A

From the Masterclasses in Dermatology 2024 Meeting: Updates in Psoriasis Treatments. (PubMed, J Clin Aesthet Dermatol) - "An IL-36 receptor antibody, spesolimab, demonstrates efficacy in generalized pustular psoriasis...Deucravacitinib, a tyrosine kinase (TYK) 2 inhibitor, is highly selective, effective, and safe. Additionally, JNJ-77242113, an investigational IL-23 receptor antagonist, constitutes an orally administered, targeted biologic therapy. Together, these developments are shaping the future for patients with PsO. It is our goal to simplify the complexities of emerging treatment options, offering clinicians a concise and useful guide for patient management."

Journal • Review • Dermatology • Immunology • Inflammation • Inflammatory Arthritis • Oncology • Psoriasis • Psoriatic Arthritis • Pustular Psoriasis • Rheumatology • Seronegative Spondyloarthropathies • IL12A • IL17A • IL23A

Successful treatment of generalized pustular psoriasis during pregnancy with secukinumab in a patient hypersensitive to spesolimab: a case report. (PubMed, J Dermatolog Treat) - "A healthy boy was delivered vaginally at term. Our findings provide evidence that secukinumab is an effective and safe treatment option for GPP during pregnancy."

Journal • Dermatology • Immunology • Inflammation • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics • Pain • Psoriasis • Pustular Psoriasis

Spesolimab Post-marketing Surveillance in Korean Patients With Flares With Generalized Pustular Psoriasis (clinicaltrials.gov) - P=N/A | N=21 | Not yet recruiting | Sponsor: Boehringer Ingelheim

New trial • Dermatology • Immunology • Psoriasis • Pustular Psoriasis

PMS of Spesolimab I.V. in GPP Patients With Acute Symptoms (clinicaltrials.gov) - P=N/A | N=52 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Recruiting ➔ Active, not recruiting | N=40 ➔ 52

Enrollment change • Enrollment closed • Dermatology • Immunology • Psoriasis • Pustular Psoriasis

Initial Dosing of BI 655130 in Palmoplantar Pustulosis Patients (clinicaltrials.gov) - P2 | N=59 | Completed | Sponsor: Boehringer Ingelheim | Phase classification: P2a ➔ P2

Biomarker • Phase classification • Dermatology • Immunology • Psoriasis

spesolimab (Spevigo) is not recommended for use within NHSScotland (Scottish Medicines Consortium) - "Indication under review: for the treatment of flares in adult patients with generalised pustular psoriasis (GPP) as monotherapy. In a double-blind, phase II study, spesolimab, compared with placebo, significantly increased the proportion of adults with a moderate-to-severe flare of GPP who achieved pustular clearance. The submitting company did not present a sufficiently robust clinical and economic analysis to gain acceptance by SMC. This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting."

Reimbursement • Pustular Psoriasis

Acrodermatitis continua of Hallopeau successfully treated with spesolimab. (PubMed, Ann Dermatol Venereol) - No abstract available

Journal • Dermatitis • Dermatology • Immunology

Effect of spesolimab on sustained disease control in patients with generalized pustular psoriasis: Post hoc analysis of the EFFISAYIL 2 study. (PubMed, J Am Acad Dermatol) - P2 | "Spesolimab 600 mg SC LD followed by 300 mg SC q4w provides sustained improvement of skin symptoms and QoL burden in a substantially higher proportion of patients with GPP versus placebo."

Journal • Retrospective data • Dermatology • Immunology • Inflammation • Psoriasis • Pustular Psoriasis

Flare burden in generalized pustular psoriasis (GPP): analysis of pre-trial historical experience of patients enrolled in EFFISAYIL® 2 (AAD 2025) - "In the EFFISAYIL® 2 trial [1], the IL-36 receptor inhibitor spesolimab (600 mg subcutaneous [SC] loading dose; 300 mg SC q4w) significantly reduced GPP flare risk over 48 weeks... Patients with GPP have a high burden of disease. New treatments are needed to provide long-term disease control."

Clinical • Dermatology • Fatigue • Immunology • Inflammation • Pain • Psoriasis • Pustular Psoriasis