Quality of Life Improved in GPP in Effisayil 2 Trial

Alice B. Gottlieb, MD, PhD ©https://profiles.mountsinai.org/

A poster presented at the 2024 Society of Dermatology Physician Assistant Annual Summer Dermatology Conference found spesolimab improved quality of life in patients with generalized pustular psoriasis (GPP).¹

The poster detailed the further analysis of the Effisayil 2 Trial (NCT04399837), which found spesolimab 300 mg subcutaneously every 4 weeks following a 600 mg subcutaneous loading dose significantly reduced the risk of GPP flare-ups by 84%. The study included patients (N= 123) between 12 and 75 years old who experienced flare-ups but had clear or almost clear skinupon study initiation.² Mean age among the placebo and active groups was approximately 40 years and more than half of the patients were female. Patient race was Asian or White, with slightly more Asian patients in the spesolimab than in the placebo group. Mean BMI was similar; 25.6 and 26.9 in the active and placebo groups, respectively.

At baseline, generalized pustular psoriasis area and severity index (GPPASI) was 3.92 and 3.11 for spesolimab and placebo, respectively. About 90% of patients in both groups had a generalized pustular psoriasis physician global assessment (GPPGA) score of 1; 10% of those in the active treatment group and 13% of those in the placebo group had a score of 0. Both groups had similar number of historical flares (2.4) per year at baseline. Total Dermatology Life Quality Index (DLQI) score was 11.1 and 7.2 for spesolimab and placebo, respectively.

During the 16-month multicenter, randomized, parallel group, double blind, placebo controlled, phase IIb study, participants received monthly injections of spesolimab or placebo for the first 11 months. Patients were examined during each monthly visit to ascertain if they were experiencing GPP flares and general health. Any patient with a GPP flare received get a dose of spesolimab as an infusion into a vein. Patients were also able to come in at any time to confirm flare-ups.

In the follow-up analysis, Alice B. Gottlieb, MD, PhD, clinical professor and medical director at the Ichan School of Medicine at Mount Sinai in New York, New York, and colleagues examined the responses from the DLQI, which was administered during the monthly visits at weeks 4, 8, 12, 24, 36, and 48 (which was the conclusion of the study) in both the placebo and spesolimab groups. Gottlieb et al looked for a minimum of a 4-point reduction in the baseline DLQI score, which indicated a clinically important improvement.

Gottlieb et al reported that of the patients without flares, more patients receiving spesolimab than those receiving placebo showed an improvement in the DLQI scores. Specifically, 34.48% vs 9.68% of patients achieved a 4 point reduction in the spesolimab and placebo groups, respectively, at week 4. At week 48, 37.93% and 25.81% of patients on the spesolimab and placebo groups, respectively. Similarly, a larger percentage of patients in the active agent group (24.1%) had a DLQI score of 0 or 1 vs the placebo group (3.2%).

First published in 1994, the DLQI consists of 10 questions to quantify the impact of dermatological disease burden on patients aged 16 years and older. It covers various domains: symptoms and feelings, treatment, leisure, work and school, daily activities, and personal relationships; scores range from 0 (no effect on patient’s life) to 30 (large impact on patient’s life). Each domain is scored as follows:

0, which means not relevant or not at all;

1, which means a little;

2, which means a lot;

3, which means very much

“Patients treated with spesolimab (300 mg SC q4w*) rapidly gained improvements in DLQI scores compared with placebo, which were sustained through to Week 48,” Gottlieb and colleagues concluded.

Do you have clinical pearls in addressing GPP? If you are interested in writing case discussions or clinical reviews, email DTEditor@mmhgroup.com.

References

1. Gottlieb AB, Strober B, Kokolakis G, 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. Poster presented at: 2024 SDPA Annual Summer Dermatology Conference; June 5- 9, 2024; San Diego, California.

2. A Study to Test Whether BI 655130 (Spesolimab) Prevents Flare-ups in Patients With Generalized Pustular Psoriasis. ClinicalTrials.gov. Last updated December 14, 2023. Accessed June 6, 2024. https://classic.clinicaltrials.gov/ct2/show/NCT04399837