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Introduction: Patients with serious comorbidities are traditionally excluded from clinical trials. Apremilast is not contraindicated in active infections, malignancy and serious hepatic or renal impairment, but real-life data is needed to support this recommendation. Objectives: The aim of this paper is to present our personal as well as literature-sourced real-world evidenced on apremilast use in psoriasis patients with serious baseline comorbidities. Methods: A case-series and systematic literature review were performed. The psoriasis archives of a tertiary-care hospital, four electronic databases (MEDLINE, ScienceDirect, Cochrane Library, Google scholar) and other sources were searched (2014 – July 2021). Identified records were considered eligible, if they reported on the use of apremilast monotherapy in psoriasis patients with chronic infections, history of malignancy, serious liver, renal, psychiatric, or other disease(s). Results: At least 841 psoriasis patients with serious baseline diseases received apremilast. Only 3 cases of cancer progression and no infection reactivations or worsening of other diseases were documented. No increased frequency / severity of adverse events or reduced drug efficacy were noted. Main limitations of this study are the exclusion of a few reports due to inappropriately documented data and the fact that at least some patients might have been counted more than once. Conclusions: Apremilast is a safe and adequately efficacious option for psoriasis that cannot be treated / is challenging to treat with classic systemic agents and/or biologics.

Introduction: Pain is experienced by most patients with hidradenitis suppurativa (HS) and has a severe impact on their quality of life. Its management still presents a challenge. Adalimumab, a TNF-a antagonist, has shown promising results in HS-related pain reduction. Objectives: To aggregate and synthesize all existing evidence regarding the effect of adalimumab on HS-associated skin pain. Methods: We identified original controlled and uncontrolled studies with participants receiving adalimumab, which included change in pain score post-treatment comparing to baseline as an endpoint. We searched MEDLINE, ScienceDirect, the Cochrane Library, ClinicalTrials.gov and International Clinical Trials Registry Platform. The primary endpoint of our study was mean change (continuous variable) of pain scores at week 12 comparing to baseline. Results: We performed a meta-analysis of four randomized controlled trials (282 patients in the intervention group and 266 patients in the control group). Adalimumab brought about a 0.418 reduction in mean pain score at its worst with 95%CI [-0.588, -0.248] and p = 0.000 at 12 weeks after treatment commencement. Four more studies were included in a qualitative synthesis, two of which reported statistically significant reduction in pain scores at week 12. Conclusions: Adalimumab could be prescribed more readily in cases of hidradenitis associated with significant skin pain.

Introduction: Drug survival is an indirect measure of efficacy and safety and its post-marketing assessment using real-life data is invaluable. Objectives: To investigate the survival of apremilast in a cohort of psoriasis patients treated with apremilast in a Greek hospital. Methods: A retrospective cross-sectional study examined adult psoriasis patients receiving apremilast (March 2016 to January 2021). Primary endpoint was the cumulative survival probability at 52 weeks. Kaplan-Meier analysis was used to calculate survival probability. Cox regression analysis was performed to investigate potential risk factors for apremilast discontinuation. Results: 102 patients (29.4% females) with a mean age of 55.94 years (Standard Deviation 15.21) were included. 65 patients (63.7%) had discontinued treatment by lock date: 19 (18.6%) due to lack of efficacy, 24 (23.5%) due to loss of efficacy, 15 (14.7%) due to adverse reactions, and 7 (6.86%) due to other reasons. Cumulative survival probability at 52 weeks was 52.1%. Median survival time for all reasons for discontinuation was 58 weeks 95%Confidence Interval (40.02, 75.98). Conclusions: Approximately half of patients remained on apremilast after a year of treatment. Secondary drug failure was the most common reason for discontinuation.