Visual Abstract | Efficacy and safety of spesolimab in the prevention of generalized pustular psoriasis flares: Effisayil 2

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*

DLQI, Dermatology Life Quality Index; GPPASI, Generalized Pustular Psoriasis Area and Severity Index; GPPGA, Generalized Pustular Psoriasis Physician Global Assessment; PSS, Psoriasis Symptom Scale. *Adapted from Morita, et al.1 †Based on investigator’s clinical investigation at enrolment.
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

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.