Safety Outcomes Associated With Apremilast Use in Psoriasis

Plaque Psoriasis
Plaque Psoriasis
Investigators examined long-term safety during weeks 16 to 52 of apremilast in patients with psoriasis.

In patients with psoriasis who were treated with apremilast, the percentage of adverse events (AEs) decreased during weeks 16 to 52 of therapy, suggesting that physicians should consider encouraging these individuals to tolerate AEs during the first 16 weeks of treatment, according to published in the British Journal of Dermatology.

A multicenter retrospective chart review of apremilast-treated patients with psoriasis was conducted at 2 academic hospitals in Toronto, Canada. The investigators sought to report on long-term safety data in a cohort of apremilast-treated patients over 16 to 52 weeks and to assess trends in the development of AEs. Charts included in the analysis were identified by generating a list of all individuals who were ever prescribed apremilast via use of the electronic health record database at both institutions. Eligible participants with psoriasis were age ≥18 and had been treated with apremilast for ≥16 weeks. Those individuals who discontinued apremilast during weeks 0 to 16 of treatment or were lost to follow-up were excluded from the study.

Reported AEs (ie, safety trends) were recorded from weeks 0 to 16 and from weeks 16 to 52 of treatment. New-onset AEs (those occurring after week 16) were reported during the 16-52-week time period. Ongoing AEs that began in the 0- to16-week time period and continued beyond week 16 were not included again in the 16- to 52-week time frame.

A total of 131 patients were included in the review. The mean patient age was 50.6±11.3 years; 60.3% of the participants were men. Mean duration of psoriasis in the patients was 18.2±11.8 years. Of the 131 individuals enrolled in the study, 30.5% reported AEs during weeks 16 to 52, which was significantly lower than the 53.4% AEs rate reported by patients during weeks 0 to 16 (P <.001). Moreover, the average number of AEs reported per patient was significantly lower during long-term treatment beyond 16 weeks (weeks 0 to 16: 1.2±1.5 vs weeks 16 to 52: 0.4±0.8; P <.001). 

Some of the commonly reported AEs in weeks 16 to 52 were headache, nausea, diarrhea, non-specific gastrointestinal symptoms, weight loss, and loose stool.

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The investigators concluded that the decrease in AEs reported during weeks 16 to 52 can be explained in part by patients who discontinued treatment due to AEs during weeks 16 to 52 possibly experiencing additional AEs during follow-up that were not registered.

This real-world study of apremilast therapy in patients with psoriasis suggests that AEs experienced by patients during the first 16 weeks of therapy may resolve over time.


Ighani A, Georgakopoulos JR, Shear NH, Walsh S, Yeung J. Long-term 52-week trends in apremilast safety outcomes for treatment of psoriasis in clinical practice: a multicentre, retrospective case series [published online August 18, 2018]. Br J Dermatol