Spevigo (spesolimab-sbzo) / Boehringer Ingelheim, LEO Pharma - LARVOL DELTA

Spesolimab Rapidly Resolved Capillary Leak Syndrome Associated with Generalized Pustular Psoriasis. (PubMed, Acta Derm Venereol) - No abstract available

Journal • Dermatology • Immunology • Psoriasis • Pustular Psoriasis

P099 Spesolimab use in effective treatment of generalized pustular psoriasis: a case report. (PubMed, Br J Dermatol) - "He was managed as an inpatient with topical treatment and oral prednisolone...He received oral methotrexate therapy but upon readmission with pustulation flare, diagnosis of GPP was confirmed and acitretin commenced...The patient then experienced widespread desquamative eruption and incipient pustulation, and as it was not possible to secure further compassionate funding for spesolimab as maintenance therapy, he commenced secukinumab therapy...In our patient with GPP spesolimab was a highly effective treatment modality, leading to lasting skin clearance when used as monotherapy from its induction, but unavailable for maintenance therapy. We await NICE appraisal, due March 2025, to consider its use within NHS care."

Journal • Dermatology • Gastroenterology • Hepatology • Immunology • Keratitis • Pancreatitis • 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 | Initiation date: Nov 2025 ➔ Feb 2026

Trial initiation date • Dermatology • Immunology • Psoriasis • Pustular Psoriasis

Generalized pustular psoriasis: review and consensus of the Psoriasis Group of the Spanish Academy of Dermatology and Venereology. (PubMed, Actas Dermosifiliogr) - "Spesolimab (Spevigo®) is the only drug approved for treatment and prevention of GPP flares, and there are uncertainties that justify the development by the Psoriasis Group (GPs) of the Spanish Academy of Dermatology and Venereology (AEDV) of a Delphi consensus on the diagnosis and treatment of this rare disease...Following two rounds, between October 2024 and January 2025, agreement (≥80% of participants) was reached on 50 out of of 70 statements, including the definition of GPP outbreak, infection screening, medium- and long-term treatment goals, and criteria for initiation of maintenance treatment. This Delphi consensus is intended to support clinicians in the diagnosis and treatment of patients with PPG in our setting."

Clinical guideline • Journal • Dermatology • Immunology • Infectious Disease • Inflammation • Psoriasis • Pustular Psoriasis • Rare Diseases

Efficacy and Safety of All Monoclonal Antibodies in Moderate-to-Severe Atopic Dermatitis: A Systematic Review and Network Meta-Analysis. (PubMed, Pharmacoepidemiol Drug Saf) - "Through the analysis of the primary efficacy indicators, this network meta-analysis (NMA) study indicated that all monoclonal antibodies performed better than placebo. Based on the results of this study, Spesolimab, Rademikibart, Dupilumab, Amlitelimab were recommended treatment options with relatively good efficacy and safety."

Clinical • Journal • Retrospective data • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus

A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Netherton Syndrome (clinicaltrials.gov) - P2/3 | N=43 | Terminated | Sponsor: Boehringer Ingelheim | Completed ➔ Terminated; Sponsor decision

Trial termination • Dermatology

Sequential Treatment of Generalized Pustular Psoriasis Combined with Bullous Pemphigoid Using Spesolimab and Dupilumab: A Case Report and Literature Review. (PubMed, Case Rep Dermatol) - "Initial acitretin therapy resolved pustules but not bullae. This case highlights the potential of sequential spesolimab and dupilumab therapy as an effective and safe approach for managing GPP coexisting with BP. Targeting distinct inflammatory pathways may provide a new treatment option for complex dermatological comorbidities."

Journal • Bullous Pemphigoid • Dermatology • Dermatopathology • Immunology • Inflammation • Psoriasis • Pustular Psoriasis • IL13 • IL4

Long-term disease control with subcutaneous spesolimab in GPP patients with or without IL-36RN mutation. Results from the EFFISAYIL ON study (ISDS 2025) - P2 | "Safety data are consistent with the known safety profile of spesolimab. Long-term SC spesolimab treatment is effective in preventing or reducing the cumulative number of flares in patients with GPP with or without IL36RN mutation, with an unchanged safety profile."

Clinical • Dermatology • Immunology • Psoriasis • Pustular Psoriasis

Randomized Phase 3 trial of spesolimab in patients with ulcerative pyoderma gangrenosum: A study protocol (ISDS 2025) - P3 | "These results will provide safety and efficacy data on spesolimab as a potential treatment for ulcerative PG. Acknowledgments: Study supported and funded by Boehringer Ingelheim. Eleanor James, BSc, (Ashfield MedComms, an Inizio company) provided medical writing support (contracted and funded by Boehringer Ingelheim)."

Clinical • P3 data • Dermatology • Pyoderma Gangrenosum

Cross-spectrum efficacy of spesolimab in IL-36-mediated dermatoses: a 'case study. (PubMed, J Dermatolog Treat) - "A 15-year-old female with ERASPEN-confirmed GPP developed hydroxychloroquine-induced AGEP (EuroSCAR score = 7) despite wild-type IL36RN and CARD14...Acitretin provided no benefit, and cyclosporine (150 mg/day) produced only transient improvement before relapse...Spesolimab produced rapid and durable control of IL-36-driven AGEP independent of IL36RN mutation status. These findings support IL-36 receptor blockade as a targeted therapeutic option for refractory AGEP and further position AGEP and GPP along a shared IL-36-mediated disease spectrum."

Journal • Dermatology • Immunology • Psoriasis • Pustular Psoriasis

Long-term control of refractory acrodermatitis continua of Hallopeau with subcutaneous spesolimab: A case report. (PubMed, JAAD Case Rep) - No abstract available

Journal • Dermatitis • Dermatology • Immunology

Biologic Therapy for Generalized Pustular Psoriasis: Real-World Comparative Effectiveness in a Single-Center. (PubMed, J Am Acad Dermatol) - No abstract available

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

Amoxicillin-Triggered Flare of Generalized Pustular Psoriasis in a Patient With Homozygous IL36RN Pathogenic Variant Treated With Spesolimab and Cyclosporin A. (PubMed, J Dermatol) - No abstract available

Journal • Dermatology • Immunology • Psoriasis • Pustular Psoriasis

Highlights of the Brazilian Society of Dermatology's Brazilian Consensus on Psoriasis. (PubMed, An Bras Dermatol) - "The updated treatment algorithm used experts' responses through the Delphi method and, among other modifications, removed acitretin from the plaque psoriasis treatment sequence, defined treatment lines for choosing immunobiologicals in both adult and pediatric populations, and included spesolimab and cyclosporine as first-line treatments for generalized pustular psoriasis. Finally, the new Consensus addresses the place of small molecule inhibitors in the algorithm and discusses future treatment options for plaque psoriasis."

Journal • Dermatology • Immunology • Pediatrics • Psoriasis • Pustular Psoriasis • Rheumatology

Inefficiencies of Off-Label Therapy in the Prevention of Generalized Pustular Psoriasis (GPP) Flares: Real-World Evidence From Europe (ISPOR-EU 2025) - "GPP is largely managed off-label using therapies for plaque psoriasis, despite being a distinct disease and the approval of targeted treatment (i.e., spesolimab) in 2022...Of 183 eligible patients, 103 patients had 475 prescriptions for off-label preventive therapy, including: retinoid (18.1%), methotrexate (16.4%), TNF biologic (13.3%), topical corticosteroid (11.6%), IL-17 biologic (9.3%), and oral corticosteroid (8.7%)...Termination due to "adverse events" occurred most often with retinoid (22.7% [15/66]), cyclosporin (15.4% [4/26]), and PDE 4 inhibitor (66.7% [2/3])... Long-term GPP management with off-label therapies involves frequent dose adjustment, and discontinuations due to lack of efficacy and adverse events, that potentially negatively impact patient outcome. These findings highlight the need for targeted GPP therapy."

Clinical • HEOR • Real-world • Real-world evidence • Dermatology • Immunology • Inflammation • Psoriasis • Pustular Psoriasis • IL17A • IL23A

Successful treatment of refractory and recurrent pyoderma gangrenosum with pustules and ulcers using spesolimab. (PubMed, Clin Exp Dermatol) - No abstract available

Journal • Pyoderma Gangrenosum

Sweet Syndrome in a Patient with Common Variable Immunodeficiency (ACAAI 2025) - "Case Description A 24-year-old female with medical history including CVID on IVIG along with TNF associated periodic fever syndrome (TRAPs) on Anakinra presented with recurrent abscesses of left postauricular region and sternocleidomastoid, arthralgias and fevers...Patient was successfully treated with high-dose steroids and Tacrolimus, then transitioned to Spesolimab monotherapy...Due to her immunodeficiency, the patient was suspected of having recurrent abscesses which failed invasive procedures and extensive antibiotics prior to confirmed diagnosis of Sweet Syndrome. This highlights the diagnostic complexity of cases that present with both features of immunodeficiency and immune dysregulation."

Clinical • Dermatology • Infectious Disease • Musculoskeletal Pain • Primary Immunodeficiency

Rapid Resolution of Pediatric Acrodermatitis Continua of Hallopeau With Spesolimab. (PubMed, Pediatrics) - "No treatment-related adverse events occurred during therapy or follow-up. Our case report presents the successful application of spesolimab in a 7-year-old child with ACH, thus further supporting the potential of this targeted biologic agent in pediatric ACH treatment."

Journal • Dermatitis • Dermatology • Immunology • Infectious Disease • Inflammation • Mood Disorders • Pediatrics • Psoriasis • Pustular Psoriasis

Infliximab-Induced Synovitis, Acne, Pustulosis, Hyperostosis, Osteitis (SAPHO) Syndrome (ACG 2025) - "Dermatology evaluation with a biopsy of the lesions favored Infliximab-induced pustular psoriasis, and the patient was transitioned to Upadacitinib...She failed a trial of Risankizumab and cyclosporine but later switched to Spesolimab and methotrexate with rapid improvement in her cutaneous symptoms...Furthermore, our patient responded favorably to Spesolimab, an FDA-approved anti-IL36R used to treat pustular psoriasis. Taken together, this suggests that SAPHO syndrome may be an autoimmune process defined by two distinct pathophysiologies."

Acne Vulgaris • Alopecia • CNS Disorders • Crohn's disease • Dermatology • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Immunology • Inflammatory Arthritis • Inflammatory Bowel Disease • Insomnia • Musculoskeletal Diseases • Musculoskeletal Pain • Neutropenia • Orthopedics • Psoriasis • Psoriatic Arthritis • Pustular Psoriasis • Rheumatology • Seronegative Spondyloarthropathies • Sleep Disorder

Spesolimab for acute-flare generalized pustular psoriasis with severe erythema and plaques: A case report. (PubMed, Medicine (Baltimore)) - "This case demonstrates that spesolimab is highly effective not only for pustules in GPP but also promotes excellent regression of erythema and plaques."

Journal • Dermatology • Diabetes • Immunology • Inflammatory Arthritis • Metabolic Disorders • Psoriasis • Psoriatic Arthritis • Pustular Psoriasis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Type 2 Diabetes Mellitus

Key data to be presented at the 2025 Fall Clinical Dermatology Conference by LEO Pharma include (Businesswire) - "The first U.S. prevalence data on CHE, based on a survey of more than 10,000 people. The CHECK study includes findings on demographics, disease severity, healthcare resource utilization, and ability to work among CHE patients; New health economics and outcomes data that explores the burden of CHE in the U.S. and analyzes the potential financial impact of ANZUPGO (delgocitinib) cream on a U.S. Commercial Health plan; Real-world ADBRY (tralokinumab-ldrm) data, evaluating the safety and effectiveness of up to 12 months of treatment for patients with moderate to severe AD; New findings examining the burden of GPP in the U.S., as well as the effect of treatments such as SPEVIGO (spesolimab)."

Clinical data • Atopic Dermatitis • Pustular Psoriasis

Spatiotemporal transcriptomics deciphered neutrophil activated IL-36 as driver and effective therapeutic target in Sweet syndrome. (PubMed, Br J Dermatol) - "We applied anti-IL-36R monoclonal antibody, Spesolimab, to treat two SS patients and achieved favorable outcomes, however, the molecular mechanism is unproved...Overall, a forward loop consisting of keratinocytes, heterogenous maturation neutrophils and CD8+ T cells was constructed to decipher the potential pathogenesis of SS, and IL-36 activated by neutrophil elastase released from heterogenous maturation neutrophils was one of the drivers of the loop. Moreover, IL-36 signaling was confirmed as a novel and effective treatment target for SS, which may be served as an alternative option for corticosteroid-resistant cases as well as patients with contraindications."

Journal • Dermatology • Immunology • Infectious Disease • Inflammation • Mood Disorders • Pain • CD8 • ELANE

A Study in Patients With Atopic Eczema to Test How Effective BI 655130 is and How Well it is Tolerated (clinicaltrials.gov) - P2 | N=51 | Completed | Sponsor: Boehringer Ingelheim | Phase classification: P2a ➔ P2

Phase classification • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

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

Trial completion • Dermatology • Immunology • Psoriasis • Pustular Psoriasis

A Study to Test How Effective and Safe Different Doses of BI 655130 Are in Patients With a Moderate to Severe Form of the Skin Disease Palmoplantar Pustulosis (clinicaltrials.gov) - P2 | N=152 | Completed | Sponsor: Boehringer Ingelheim | Phase classification: P2b ➔ P2

Phase classification • Dermatology • Immunology • Psoriasis