Spesolimab Rapidly Improves QoL in Generalized Pustular Psoriasis

Bruce Strober, MD, PhD

Credit: Central Connecticut Dermatology

Patients with generalized pustular psoriasis receiving 300 mg of subcutaneous spesolimab every 4 weeks (Q4W)—following a 600 mg loading dose—exhibited an 84% reduction in flare risk compared with the placebo group, according to data presented at the SDPA Annual Summer Dermatology Conference.¹

The spesolimab-sbzo (Spevigo) injection, a novel humanized selective IgG1 antibody designed to impact the interleukin-36 receptor (IL-36R), was recently approved by the US Food and Drug Administration (FDA) for generalized pustular psoriasis treatment of patients aged 12 years and older weighing ≥ 40 kg.²

“Until now, people living with generalized pustular psoriasishave not had any approved options to treat their disease,” Bruce Strober, MD, PhD, clinical professor of dermatology at Yale University and Central Connecticut Dermatology, said in a statement.² “(Spesolimab) has the potential to redefine the treatment options for the patients we serve.”

Generalized pustular psoriasis is a heterogeneous inflammatory neutrophilic disorder which is chronic and characterized by patients having painful symptoms on their skin as well as systemic manifestations such as fever and pain. The condition can appear persistent or relapsing courses.²

According to a recent interview with Tina Bhutani, MD, J. Scott Boswell, MD, and Kanya Oul, RN, managing the condition requires a continuous treatment approach, with a watchful eye for flare-ups. A quick diagnosis is crucial to avoid mistaking generalized pustular psoriasis for other conditions, preventing worsening symptoms and complications.³

The Effisayil 2 trial was a 48-week study in which 92 individuals were placed in the treatment arm (30 in the high dose group [300 mg], 31 in medium dose, and 31 in low dose) and 31 individuals were placed in the placebo arm.²

Participants completed the Dermatology Life Quality Index (DLQI) questionnaire, a 10-question quality of life questionnaire that covers topics including work and school, treatment, personal relationship, daily activities, and leisure, at weeks 4, 8, 12, 24, 36, and 48. The questionnaire scores range from 0 (no effect on quality of life) to 3 (extremely effected). Patients were randomized either spesolimab or placebo. A 4-point change from baseline was categorized as clinically important.¹

At baseline, patient characteristics were similar, although patients in the spesolimab group had a higher DLQI score compared with placebo (11.1 vs 7.2, respectively). In the spesolimab group, the mean age was 40.2 years, 60% (n = 18) were female, and 70% (n = 20) were Asian. In the placebo group, the mean age was 39.5 years, 58% (n = 18) were female, and 55% (n = 17) were Asian.¹

Patients in the spesolimab cohort demonstrated rapid improvements in DLQI scores compared with placebo, which were maintained through week 48. A higher proportion of patients treated with spesolimab exhibited clinically meaningful ≥ 4-point improvement in DLQI scores combined with no flare compared with those in the placebo group from baseline until week 48.¹

More patients in the 300 mg subcutaneous Q4W cohort obtained a DLQI of 0 or 1 at all visits up to week 48. A smaller number of patients treated with spesolimab reported a disease flare from week 4 to week 48 compared with placebo (3/29 vs 16/31, respectively).¹

References

1. ^{Gottlieb AB, Strober B, Kokolakis G, Merola JF, et al. Spesolimab rapidly improves quality of life in patients with generalized pustular psoriasis, as per Dermatology Life Quality Index scores: Data from the Effisayil® 2 trial. Presented at: SDPA Annual Summer Dermatology Conference. San Diego, CA. June 5 – 9, 2024.}
2. ^{Smith T. Spesolimab approved in US, China for generalized pustular psoriasis in patients 12 and older. HCP Live. March 19, 2024. Accessed June 14, 2024. https://www.hcplive.com/view/spesolimab-approved-in-us-china-for-generalized-pustular-psoriasis-in-patients-12-and-older.}
3. ^{Tina Bhutani M, J. Scott Boswell M, Kanya Oul R. Treatment of generalized pustular psoriasis (GPP). HCP Live. April 12, 2024. Accessed June 14, 2024. https://www.hcplive.com/view/treatment-of-generalized-pustular-psoriasis-gpp-.}