Research Progress on Spesolimab Injection in the Treatment of Generalized Pustular Psoriasis
Objective To provide a reference for the application of Spesolimab Injection in the treatment of generalized pustular psoriasis(GPP).Methods The literature related to spesolimab injection in the PubMed,ENPS,and the Clinical Trails.gov were searched from their inception and May 6,2023,and its pharmacokinetics,clinical efficacy,safety,special population and applicable population were summarized.Results Spesolimab Injection could inhibit interleukin-36 signaling by specifically binding to the interleukin-36 receptor,and has been marketed in multiple countries/regions including the United States of American(USA),European Union,Japan,and China.After a single intravenous dose of 900 mg of Spesolimab Injection to patients with GPP,the area under the blood concentration time curve(AUC)and peak concentration(Cmax)in anti-drug antibody-negative patients were 4 750[95%CI(4 510,4 970)](µg·d)/mL and 238[95%CI(218,256)]µg/mL,respectively.The apparent volume of distribution was 6.4 L,and the terminal half-life was 25.5 d.After one week of medication,the proportion of the patients with GPP Physician Overall Assessment(GPPGA)pustular single score of 0 point and the proportion of the patients with GPPGA overall score of 0-1 point in the Spesolimab Injection group were significantly higher than that in the placebo group(54.29%vs.5.56%,42.86%vs.11.11%,P<0.05).After 12 weeks of medication,most patients receiving Spesolimab Injection had GPPGA pustular single score of 0 point(60.0%)and GPPGA overall score of 0-1 point(60.0%).No serious adverse events occurred,with most adverse events being mild or moderate.Spesolimab Injection was suitable for improving symptoms in adult patients with GPP during acute attacks,and should be used with caution during pregnancy,lactation,infancy,and elderly patients.Conclusion Spesolimab Injection in the treatment of patients with GPP is rapid,effective,and well tolerated by patients.
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