Efficacy and Safety of Apremilast in the Treatment of Moderate-to-severe Plaque Psoriasis ：a Meta-analysis / 中国药房

ABSTRACT

OBJECTIVE： To evaluate the efficacy and safety of apremilast in the treatment of moderate-to-severe plaque psoriasis systematically. METHODS： Retrieved from PubMed， Embase， Cochrane Library， VIP， CNKI and CBM， RCTs about apremilast or apremilast combined with other drugs （trial group） versus placebo （control group） in the treatment of moderate- to-severe plaque psoriasis were collected. Meta-analysis was conducted by using Rev Man 5.3 statistical software after literature screening， data extraction and quality evaluation with bias risk evaluation tool of Cochrane System Evaluator Manual 5.1.0. RESULTS： Totally 7 studies were included， involving 2 332 patients. Results of Meta-analysis showed that case number of psoriasis assessment and severity index （PASI） decreased by 75％ （PASI 75％） [OR＝6.44，95％CI（4.90，8.45），P＜0.000 01]， PASI 90％ [OR＝8.13， 95％CI（4.65， 14.22）， P＜0.000 01] and sPGA 0 or 1 [OR＝3.89，95％CI（3.00，5.05），P＜0.000 01]， the incidence of ADR [OR＝1.87，95％CI（1.44，2.43）， P＜0.000 01] in trial group were significantly more or higher than control group. Subgroup analysis by apremilast dose showed that case number of 20 mg PASI 75％ [OR＝4.72，95％CI（2.77，8.05），P＜0.000 01]， 30 mg PASI 75％ [OR＝7.05，95％CI（5.13，9.69），P＜0.000 01]， 20 mg PASI 90％ [OR＝4.27，95％CI（1.80，10.09），P＝0.001]， 30 mg PASI 90％ [OR＝11.11，95％CI（5.27，23.43），P＜0.000 01]， 20 mg sPGA 0 or 1 [OR＝2.82，95％CI（1.51，5.26），P＝0.001]， 30 mg sPGA 0 or 1 [OR＝4.13，95％CI（3.10，5.50），P＜0.000 01]， the incidence of 30 mg ADR [OR＝1.94，95％CI（1.51，2.49），P＜0.000 01] in trial group were significantly more or higher than control group. There was no statistical significance in the incidence of serious ADR [OR＝1.27，95％CI（0.77，2.07），P＝0.35] or case number of ADR leading to withdrawal [OR＝1.48，95％CI（1.00，2.20），P＝0.05] between 2 groups. CONCLUSIONS： Apremilast is effective for moderate-to-severe plaque psoriasis in dose-dependent manner and improve the quality of life， but increase the incidence of ADR.