Real-world safety of spesolimab in generalized pustular psoriasis: Evidence from an expanded access program in Argentina

Main Article Content

María Laura Galimberti
María Lapadula
Rosana Veira
Nichiren Pillai
Rafael Sani Simões
Ana Rodriguez Castelli
Natalia Dominguez
Glenda Vilchez
Lucas Sheridan
Amy Weatherill
Xuemei Ding

Keywords

generalized pustular psoriasis, spesolimab, real-world evidence

Abstract

Introduction: Generalized pustular psoriasis (GPP) is a heterogeneous, systemic, neutrophilic, inflammatory disease associated with chronic symptoms and periods of flaring. Spesolimab is an anti-interleukin-36 receptor monoclonal antibody approved for the treatment of flares in adult patients with GPP in Argentina (17 Aug 2023).1 Here, we present safety data from a real-world expanded access program (EAP: 22 Feb 2023–10 Jan 2024) in Argentina which provided early access to spesolimab intravenous (IV) for GPP patients presenting with a flare with no other treatment options.
Methods: Patients (18–75 years old) diagnosed with GPP received a 900mg dose of spesolimab IV for flare treatment, with an optional second dose after 1 week for persistent flare symptoms. Adverse events (AEs), serious AEs (SAEs), and AEs of special interest (AESIs) were recorded for up to 16 weeks after the last spesolimab infusion.
Results: Six female patients were treated with spesolimab IV (1 dose, n=2; 2 doses, n=4).Mean (standard deviation [SD]) age: 49.3 (11.5) years (range: 30–60 years), mean (SD) body mass index: 28.1 (5.8) kg/m2, and mean (SD) follow-up: 3.85 (0.11) months. At baseline, GPP had been diagnosed within ≤1 year (n=2), >1–≤5 years (n=1), and >10 years (n=3). Reported flare triggers were stress (n=2), treatment withdrawal (n=1), heat (n=1), lack of current treatment efficacy (n=1), and unknown (n=1). At baseline, 4 patients had ≥1 comorbidity, including hypertension (n=2), tachycardia, hypothyroidism, chronic gastritis, arthritis, and epilepsy (each n=1). Five patients reported use of ≥1 concomitant medication (including immunosuppressants and corticosteroids) during the EAP; 1 patient had discontinued ustekinumab (biologic). Three patients had signs of plaque psoriasis within the past year and had received treatment for plaque psoriasis; 1 patient had ongoing plaque psoriasis. In total, 4 patients had any AEs (all 4 patients had mild AEs [influenza, catarrh, pruritis, rash, pain] and 1 of these patients also had a moderate AE [headache]). Two drug-related AEs (pruritus and rash) were reported in 1 patient. The hypersensitivity event (rash) was non-serious. There were no reports of SAEs, AESIs, or AEs that led to discontinuation/death.


Conclusion: Spesolimab showed a favorable safety profile in patients with GPP, including patients with comorbidities and those taking concomitant medication. Findings were comparable with a Phase 2a randomized controlled trial in patients with GPP flares (EFFISAYIL 1).

References

1. Rivera-Díaz R, et al. Dermatol Ther (Heidelb) 2023;13:673–88;

2. Puig L, et al. J Eur Acad Dermatol Venereol 2023;37:37–52;

3. Bhutani T, Farberg AS. Dermatol Ther (Heidelb) 2024;14:341–60;

4. Marrakchi S, Puig L. Am J Clin Dermatol 2022;23(Suppl 1):13–19;

5. Johnston A, et al. J Allergy Clin Immunol 2017;140:109–20;

6. Hawkes JE, et al. Front Immunol 2023;14:1292941;

7. Farag A, et al. J Invest Dermatol 2024 (Online ahead of print);

8. Bachelez H, et al. N Engl J Med 2021;385:2431–40;

9. Spesolimab [prescribing information]. Boehringer Ingelheim, Argentina: August 2023.