BackgroundApremilast, an oral, small‐molecule phosphodiesterase 4 inhibitor, has demonstrated efficacy in patients with moderate‐to‐severe psoriasis.ObjectiveEvaluate efficacy and safety of apremilast vs. placebo in biologic‐naive patients with moderate‐to‐severe plaque psoriasis and safety of switching from etanercept to apremilast in a phase IIIb, randomized, double‐blind, placebo‐controlled study (NCT01690299).MethodsTwo hundred and fifty patients were randomized to placebo (n = 84), apremilast 30 mg BID (n = 83) or etanercept 50 mg QW (n = 83) through Week 16; thereafter, all patients continued or switched to apremilast through Week 104. The primary efficacy endpoint was achievement of PASI‐75 at Week 16 with apremilast vs. placebo. Secondary endpoints included achievement of PASI‐75 at Week 16 with etanercept vs. placebo and improvements in other clinical endpoints vs. placebo at Week 16. Outcomes were assessed through Week 52. This study was not designed for apremilast vs. etanercept comparisons.ResultsAt Week 16, PASI‐75 achievement was greater with apremilast (39.8%) vs. placebo (11.9%; P < 0.0001); 48.2% of patients achieved PASI‐75 with etanercept (P < 0.0001 vs. placebo). PASI‐75 response was maintained in 47.3% (apremilast/apremilast), 49.4% (etanercept/apremilast) and 47.9% (placebo/apremilast) of patients at Week 52. Most common adverse events (≥5%) with apremilast, including nausea, diarrhoea, upper respiratory tract infection, nasopharyngitis, tension headache and headache, were mild or moderate in severity; diarrhoea and nausea generally resolved in the first month. No new safety or tolerability issues were observed through Week 52 with apremilast.ConclusionApremilast demonstrated significant efficacy vs. placebo at Week 16 in biologic‐naive patients with psoriasis, which was sustained over 52 weeks, and demonstrated safety consistent with the known safety profile of apremilast. Switching from etanercept to apremilast did not result in any new or clinically significant safety findings, and efficacy was maintained with apremilast through Week 52.

Apremilast demonstrated clinical improvements in PsA for up to 52 weeks, including signs and symptoms, physical function, and psoriasis. No new safety signals were observed. ClinicalTrials.gov identifier: NCT01212757.

Apremilast demonstrated an acceptable safety profile and was generally well tolerated for ≥156 weeks.

Comorbidity rates align with those described in the literature and support the concept that psoriasis patients have high rates of cardiometabolic comorbidities. This analysis highlights the potential utility of very large insurance databases for determining comorbidity prevalence in psoriasis, which may aid health care providers in managing psoriasis.

ObjectivesWe assessed comorbidities associated with psoriatic arthritis in a broad cohort of US-insured adult patients using the Truven Health Analytics MarketScan Database.MethodsPrevalence and incidence rates were assessed for 28 comorbid conditions among adult patients in the MarketScan database with a diagnosis of psoriatic arthritis and having two or more health claims for psoriatic arthritis between 1 July 2008 and 31 July 2015. Findings were compared with those of a similar, previously published analysis of patients with psoriasis.ResultsAmong a total of 186 552 patients with a diagnosis of psoriatic arthritis, 94 302 had two or more health claims for psoriatic arthritis during the study period and were included in the comorbidity analysis. The prevalence and incidence rates of the most common comorbidities were 47.5% and 35.0% for hyperlipidaemia, respectively; 47.3% and 31.3% for hypertension; 21.2% and 15.4% for depression; 20.2% and 13.5% for type 2 diabetes mellitus; and 16.6% and 12.4% for fibromyalgia. Patients with psoriatic arthritis had notably higher incidence rates of uveitis, fibromyalgia, osteoporosis, Crohn’s disease and non-alcoholic liver disease than patients with psoriasis.ConclusionThis observational retrospective analysis using the MarketScan database provides real-world health claims data on the prevalence and incidence of comorbidities in a large US patient population with psoriatic arthritis. The observed high cardiometabolic comorbidity rates align with those reported in the literature and may help healthcare providers in the comprehensive management of patients with psoriatic arthritis.