(P-309) Psoriasis Risk After Betablockers Exposure: Analysis of French Pharmacovigilance Data

Background: While there are convincing individual case reports on the association between beta-blocker (BB) use and psoriasis provocation, epidemiological studies yielded conflicting results.

Objectives: In this context, we aimed to investigate French pharmacovigilance data.

Methods: We reviewed spontaneous reports recorded in the French national Pharmacovigilance Database (FPVD) between 1985 and 2019. The association between BB exposure and risk of psoriasis was assessed using the case/non-case method. Cases were reports of “psoriatic conditions” (High Level Term). Non cases were all other cutaneous ADRs except psoriasis. For each BB, Reporting Odds Ratio (ROR) and its 95% confidence interval (95%CI) were calculated.

Results: During the study period, 203 152 spontaneous reports of cutaneous ADRs were registered in the FPVD. Two hundred twenty-five reports were “psoriatic conditions” cases with BBs. The average age was 64 +/- 14 years (range 6 to 92 years); the male/female ratio was 1.4. Forty one percent of reports were serious. Seventy four percent of reports were De Novo cases. Psoriatic manifestations were: “plaque psoriasis” (n=123), “psoriasiform dermatitis” (n=88), “pustular psoriasis” (n=10), “erythrodermic psoriasis” (n=3) and “psoriatic arthritis” (n=1). BBs were mainly used in hypertension management. Time to onset (when given) ranged from 1 day to 22 years but most often less than 1 year. Outcome was favorable after BB discontinuation in 68% of reports. The ROR for psoriasis with BBs was 8.95 (95%CI 7.75 – 10.33). The ROR with BBs used for cardiovascular conditions was 9.20 (7.94 – 10.66): ROR with β1 selective blockers was 10.39 (95%CI 8.90 – 12.14); with non-β1 selective blockers was 5.98 (4.17 – 8.56). The ROR with BBs used for glaucoma was 4.09 (2.66 – 6.28). The highest values of ROR were obtained with acebutolol (n= 32; ROR= 12.16; 95%CI= 8.39 – 17.60), celiprolol (n=16; ROR= 12.12; 95%CI= 7.19 – 20.43), atenolol (n=45; ROR= 11.57; 95%CI= 8.47 – 15.81), betaxolol (n=5; ROR= 10.55; 95%CI= 4.19 – 26.61) and bisoprolol (n=71; ROR= 8.91. 95%CI= 6.96 – 11.41).

Conclusions: We highlighted a statistically significant disproportionality which constitutes a potential safety signal. Psoriasis risk after BB exposure is a class effect. Both, systemic and topical, cardioselective and non-cardioselective BBs are involved. Increasing awareness during the 1st year of BB exposure is needed. Further large population studies are mandatory to conclude on this possible association.