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Visual Abstract | Efficacy and safety of spesolimab in the prevention of generalized pustular psoriasis flares: Effisayil 2
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Dysregulation of interleukin 36 plays a key role in the pathogenesis of generalized pustular psoriasis (GPP), which has a highly unpredictable clinical course. Spesolimab, an anti-interleukin-36 receptor antibody, is approved for the treatment of flares in adult patients with GPP; however, there are currently no optimal treatments for the prevention of GPP flares.
The Psoriasis and Psoriatic Arthritis Hub has previously reported safety results from Effisayil 1 (NCT03782792) assessing spesolimab in patients with GPP presenting with an acute flare. More recently, Morita et al.1 published an article in Lancet reporting results from Effisayil 2 (NCT04399837) evaluating the efficacy and safety of subcutaneous spesolimab for the prevention of flares in patients with GPP. Here, we are pleased to present a visual abstract summarizing the key findings.
Key baseline patient characteristics are shown in Table 1.
Table 1. Baseline patient characteristics*
|
Characteristic, % (unless otherwise stated) |
Spesolimab (N = 92) |
Placebo (n = 31) |
||
|---|---|---|---|---|
|
|
Low (n = 31) |
Medium (n = 31) |
High (n = 30) |
|
|
Mean age, years |
38.9 |
42.9 |
40.2 |
39.5 |
|
Sex |
|
|
|
|
|
Female |
65 |
65 |
60 |
58 |
|
Male |
35 |
35 |
40 |
42 |
|
Mean GPPASI total score |
3.03 |
3.12 |
3.92 |
3.11 |
|
GPPGA total score |
|
|
|
|
|
0 |
6 |
26 |
10 |
13 |
|
1 |
94 |
74 |
90 |
87 |
|
Mean PSS total core |
4.1 |
3.9 |
5.3 |
3.6 |
|
Mean DLQI total score |
7.6 |
6.6 |
11.1 |
7.2 |
|
Concurrent plaque psoriasis† |
32 |
23 |
23 |
32 |
|
Use of at least one systemic medication (discontinued at randomization) |
81 |
74 |
73 |
71 |
|
Mean number of previous flares/year |
2.7 |
1.9 |
2.4 |
2.4 |
|
Time since first diagnosis |
|
|
|
|
|
≤1 year |
16 |
13 |
13 |
10 |
|
>1 to ≤5 years |
19 |
29 |
30 |
32 |
|
>5 to ≤10 years |
19 |
26 |
27 |
23 |
|
>10 years |
45 |
32 |
30 |
35 |
|
DLQI, Dermatology Life Quality Index; GPPASI, Generalized Pustular Psoriasis Area and Severity Index; GPPGA, Generalized Pustular Psoriasis Physician Global Assessment; PSS, Psoriasis Symptom Scale. |
||||
The results from this study demonstrated that high-dose spesolimab was superior to placebo and significantly reduced the risk of a GPP flare over 48 weeks. Spesolimab has the potential to shift the clinical management of GPP, leading to improvement in patient’s quality of life.
- Morita A, Strober B, Burden AD, et al. Efficacy and safety of subcutaneous spesolimab for the prevention of generalised pustular psoriasis flares (Effisayil 2): an international, multicentre, randomised, placebo-controlled trial. Lancet. 2023;402(10412):1541-1551. DOI: 1016/S0140-6736(23)01378-8
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