P101 Baseline characteristics and cardiovascular risk of adults with plaque psoriasis treated with apremilast in UK clinical practice: a retrospective analysis of the British Association of Dermatologists Biologics and Immunomodulators Register

Abstract

Abstract Apremilast is approved for use in moderate-to-severe plaque psoriasis (PsO) in adults not responding to or unsuitable for systemic therapy, with tolerability and efficacy demonstrated in randomized controlled clinical trials {Paul C, Cather J, Gooderham M et al. Efficacy and safety of apremilast, an oral phosphodiesterase 4 inhibitor, in patients with moderate-to-severe plaque psoriasis over 52 weeks: a phase III, randomized controlled trial (ESTEEM 2). Br J Dermatol 2015; 173:1387–99; Papp K, Reich K, Leonardi CL et al. Apremilast, an oral phosphodiesterase 4 (PDE4) inhibitor, in patients with moderate to severe plaque psoriasis: results of a phase III, randomized, controlled trial [Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis (ESTEEM) 1]. J Am Acad Dermatol 2015; 73:37–49}. However, clinical trial populations are not always representative of the wider patient population treated in clinical practice. Our retrospective database analysis (funded by Amgen) assessed the characteristics of patients initiating apremilast in UK clinical practice and their risk of cardiovascular disease (CVD). From the British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR), we included patients with a diagnosis of plaque PsO, aged ≥ 18 years, initiating apremilast between October 2015 and March 2021. Outcomes included Psoriasis Severity Index (PASI), Dermatology Life Quality Index (DLQI), EuroQol-5D questionnaire (EQ-5D), time from PsO diagnosis to apremilast initiation, previous treatments and future risk of CVD (Framingham Risk Score). We identified 265 eligible patients {47.5% (n = 126) female; median age at PsO diagnosis 23 years [interquartile range (IQR) 16–37]; median time from PsO diagnosis to apremilast initiation, 19.1 years (IQR 11.0–30.4); mean (SD) number of prior psoriasis therapies 1.6 (1.0), most frequently methotrexate (30%) and acitretin (28%)}. Adverse events were the most common reason for discontinuing prior treatments (33%). The median PASI score was 12.7 (IQR 10.4–17.0). Over half (59%) of all patients had a DLQI of > 10 (median 15; IQR 9–20). Approximately half (46%) reported a family history of PsO. The most common PsO manifestations were scalp (76%) and nails (53%); 18% of patients had comorbid psoriatic arthritis. Other common comorbidities were hypertension (23%), depression (22%) and dyslipidaemia (10%). The median body mass index was 29.9 kg m−2 (IQR 26.0–35.3); 21% of patients were current smokers and 11% were harmful/hazardous drinkers (CAGE questionnaire). Approximately one-third (32%) felt moderately anxious or depressed (EQ-5D). Over half (57%) reported moderate-to-extreme pain (EQ-5D). Ten (3.8%) patients had pre-existing CVD, four (1.5%) had angina pectoris, two (0.8%) had a history of myocardial infarction (0.8%) and four (1.5%) had history of stroke or transient ischaemic attack. Of 186 patients aged 30–74 years without pre-existing CVD, approximately two-thirds (61%) were at moderate or high risk (Framingham Risk Score ≥ 10) of developing CVD within 10 years. In conclusion, patients initiating apremilast in UK clinical practice had moderate-to-severe psoriasis, which affected their quality of life, specifically, pain, anxiety and depression. Cardiometabolic and psychiatric comorbidities were prevalent, with a high proportion of patients having a moderate-to-high risk of CVD.