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

Spesolimab for patients with generalized pustular psoriasis flares: Real-world experience in China. (PubMed, Chin Med J (Engl)) - No abstract available

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

Spesolimab Treatment in GPP: Impact of IL-36RN Mutations and Concomitant Plaque Psoriasis. (PubMed, Clin Cosmet Investig Dermatol) - "Two patients with concomitant plaque psoriasis, despite initially poor responses to spesolimab, achieved resolution of pustules after switching their therapy to ixekizumab or secukinumab. These findings suggest that spesolimab can effectively treat GPP, regardless of IL-36RN gene mutation status. However, its therapeutic efficacy may be suboptimal in patients with concomitant plaque psoriasis, indicating the need for further investigation to optimize treatment outcomes in this subgroup."

Journal • Dermatology • Immunology • Psoriasis • Pustular Psoriasis

Randomised Phase 3 trial of spesolimab in patients with ulcerative pyoderma gangrenosum: A study protocol (EADV 2025) - No abstract available

Clinical • P3 data • Pyoderma Gangrenosum

The impact of spesolimab on health-related quality of life (HRQoL) measured by the short form-36 (SF-36) among patients with generalized pustular psoriasis (GPP): Results from the EFFISAYIL® 2 trial (EADV 2025) - No abstract available

Clinical • HEOR • Dermatology • Immunology • Psoriasis • Pustular Psoriasis

A case of generalized pustular psoriasis with capillary leak syndrome successfully treated with spesolimab (EADV 2025) - No abstract available

Clinical • Dermatology • Immunology • Psoriasis • Pustular Psoriasis

Spesolimab impact on health status among patients with generalized pustular psoriasis (GPP) measured by EQ-5D-5L: Results from the EFFISAYIL® 2 trial (EADV 2025) - No abstract available

Clinical • Dermatology • Immunology • Psoriasis • Pustular Psoriasis

Real-World Experience with Spesolimab for Generalized Pustular Psoriasis: A Four-Case Series (EADV 2025) - No abstract available

Clinical • Real-world • Real-world evidence • Dermatology • Immunology • Psoriasis • Pustular Psoriasis

Spesolimab improves Generalized Pustular Psoriasis Physicians Global Assessment (GPPGA), affected body surface area (BSA), and quality of life (QoL) in generalized pustular psoriasis (GPP): EFFISAYIL® 2 trial analyses (EADV 2025) - No abstract available

Clinical • HEOR • Dermatology • Immunology • Psoriasis • Pustular Psoriasis

Long-term management of chronic generalized pustular psoriasis with subcutaneous spesolimab: A case report (EADV 2025) - No abstract available

Case report • Clinical • Dermatology • Immunology • Psoriasis • Pustular Psoriasis

Spesolimab as treatment option for refractory Acrodermatitis Continua of Hallopeau (EADV 2025) - No abstract available

Dermatitis • Dermatology • Immunology

Spesolimab for the treatment of generalised pustular psoriasis flares: Preliminary analysis of the EFFISAYIL REP study (EADV 2025) - No abstract available

Dermatology • Immunology • Psoriasis • Pustular Psoriasis

Heterogeneous Response to Spesolimab in Pyoderma Gangrenosum Depends on Underlying Myeloid Disorders. (PubMed, J Am Acad Dermatol) - No abstract available

Heterogeneity • Journal • Hematological Malignancies • Pyoderma Gangrenosum

Real-world treatment patterns in patients with generalized pustular psoriasis (GPP). (PubMed, J Am Acad Dermatol) - "Corticosteroids were frequently prescribed, despite published reports of GPP flare following withdrawal, and fewer GPP-only than GPP+PsO patients received biologics, consistent with the lack of FDA-approved targeted therapies for GPP during the study."

HEOR • Journal • Real-world evidence • Dermatology • Immunology • Inflammation • 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

Pediatric Generalized Pustular Psoriasis Responsive to Colchicine: A Cost-Effective Alternative to Biologics. (PubMed, Pediatr Dermatol) - "While many drugs like oral retinoids, cyclosporine, methotrexate, and spesolimab are used, colchicine is a safe and underutilized drug that acts by inhibition of neutrophils and the TNF-α-NF-kβ pathway. We report a case of a 10-year-old with generalized pustular psoriasis refractory to cyclosporine and methotrexate who achieved complete remission within 6 weeks of colchicine monotherapy."

HEOR • Journal • Dermatology • Immunology • Pediatrics • Psoriasis • Pustular Psoriasis • TNFA

MicroRNA-223 expression during flares in patients with generalized pustular psoriasis is regulated by spesolimab treatment. (PubMed, J Invest Dermatol) - No abstract available

Journal • Dermatology • Immunology • Psoriasis • Pustular Psoriasis • MIR223

Outcomes of Spesolimab Treatment of Generalized Pustular Psoriasis and Psoriasis with Pustules for 12 Weeks: A Prospective Cohort Study from China. (PubMed, J Am Acad Dermatol) - No abstract available

Journal • Dermatology • Immunology • Psoriasis • Pustular Psoriasis

A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Netherton Syndrome (clinicaltrials.gov) - P2/3 | N=43 | Completed | Sponsor: Boehringer Ingelheim | Active, not recruiting ➔ Completed

Trial completion • Dermatology

“Extension application to add a new strength of 300 mg (150 mg/ml) for solution for injection in a pre-filled syringe. The RMP (version 3.0) is updated in accordance. In addition, the applicant has updated SmPC (Annex I) and Package Leaflet (Annex IIIB) for both 450 mg concentrate for solution for infusion and 150 mg and 300 mg solution for injection in line with the new excipient guideline” (European Medicines Agency) - Pharmacovigilance Risk Assessment Committee (PRAC) Minutes of meeting on 2 – 5 Jun 2025

PRAC • Hidradenitis Suppurativa

Real-world effectiveness of spesolimab in Acrodermatitis continua of hallopeau: A multicenter retrospective study (ChiCTR) - P4 | N=15 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Chongqing Medical University; The First Affiliated Hospital of Chongqing Medical University

New P4 trial • Real-world evidence • Dermatitis • Dermatology • Immunology • CD123 • CXCL8 • IL4 • IL5

Achieving Therapeutic Success with Spesolimab: Two Cases of Drug-Induced Generalized Pustular Psoriasis Initially Mimicking Acute Generalized Exanthematous Pustulosis. (PubMed, J Inflamm Res) - "Both patients received systemic glucocorticoids and cyclosporine yet exhibited recurrent pustular flares with lakes of pus and a prolonged disease course exceeding two months. In patients with first-onset drug-induced pustulosis resembling AGEP, the presence of lakes of pus, prolonged duration, and recurrent flares despite conventional therapies should be diagnosed as GPP promptly. Early intervention with spesolimab demonstrates efficacy in controlling disease activity and improving outcomes."

Journal • Dermatology • Immunology • Psoriasis • Pustular Psoriasis

Boehringer Ingelheim and LEO Pharma enter partnership to commercialize and further develop SPEVIGO (spesolimab) (LEO Pharma Press Release) - "Boehringer Ingelheim and LEO Pharma today announced an exclusive global license and transfer agreement to commercialize and advance the development of SPEVIGO (spesolimab)...Under the terms of the agreement, LEO Pharma will be responsible for commercialization and further development of SPEVIGO leveraging its global commercial platform within medical dermatology to raise disease awareness and secure access for patients with GPP."

Licensing / partnership • Dermatology • Immunology

Targeting the IL-36 receptor with spesolimab mitigates residual inflammation and prevents generalized pustular psoriasis flares. (PubMed, J Clin Invest) - No abstract available

Journal • Dermatology • Immunology • Inflammation • Psoriasis • Pustular Psoriasis

Spesolimab for treatment of severe hidradenitis suppurativa in the real world. (PubMed, Indian J Dermatol Venereol Leprol) - No abstract available

Journal • Real-world evidence • Dermatology • Hidradenitis Suppurativa • Immunology

Spesolimab for generalised pustular psoriasis. (PubMed, Aust Prescr) - No abstract available

Journal • Review • Dermatology • Immunology • Psoriasis • Pustular Psoriasis