BACKGROUND: Dose escalations of biologic agents may be attempted in the management of moderate-to-severe psoriasis. This has implications for the real-world cost of treatment.

Compared with PsO- and PsA-free controls, moderate-to-severe PsO patients were more likely to have selected comorbidities and higher health care utilization and costs.

Background Numerous inclusion and exclusion criteria are involved in phase III moderate to severe psoriasis trials investigating the safety and efficacy of biologics. This questions the generalization of results. Methods In this cohort study, we applied inclusion/exclusion criteria for phase III trials from original protocols (adalimumab – REVEAL, ustekinumab – PHOENIX, brodalumab – AMAGINE, secukinumab FIXTURE) to all patients enrolled in the PsoBioTeq prospective registry who received a biological agent for the first time between July 2012 and November 2017. We then compared the efficacy, drug survival and occurrence of adverse events between patients who satisfied/did not satisfy the eligibility criteria for these phase III trials. Results A total of 1267 patients were enrolled, of whom 993 (78.4%) were not eligible for at least one RCT (randomized controlled trial) and 251 (19.1%) did not meet the PASI/PGA severity requirements. Apart from disease severity, the most frequent criteria resulting in exclusion were as follows: non‐plaque psoriasis (12.6%), significant cardiac disease (8.4%), significant liver disease (7.3%), elevated liver enzymes (4.9–9.6%) and personal history of diabetes (9.2%). There was no difference in drug survival between the two groups. The incidence ratio of adverse events was significantly lower in eligible versus non‐eligible patients [0.78 (95% CI 0.62–0.97) (P = 0.03)]. Conclusion The majority of patients treated with biologics in the PsoBioTeq real‐life registry would not have been eligible for phase III moderate to severe psoriasis trials. Patients not eligible for psoriasis phase III clinical trials have a higher incidence of adverse events.

ObjectiveTo compare the prevalence of comorbidities, health care utilization, and costs between moderate‐to‐severe psoriasis (PsO) patients with comorbid psoriatic arthritis (PsA) and matched controls.MethodsAdults ages 18–64 years with concomitant diagnoses of PsO and PsA (PsO+PsA) were identified in the OptumHealth Reporting and Insights claims database between January 2007 and March 2012. Moderate‐to‐severe PsO was defined based on the use of at least one systemic or phototherapy during the 12‐month study period after the index date (randomly selected date after the first PsO diagnosis). Control patients without PsO and PsA were demographically matched 1:1 with PsO+PsA patients. Multivariate regressions were employed to examine PsO/PsA‐related comorbidities, medications, health care utilization, and costs between PsO+PsA patients and controls, adjusting for demographics, index year, insurance type, and non–PsO/PsA‐related comorbidities.ResultsAmong 1,230 matched pairs of PsO+PsA patients and controls, PsO+PsA patients had significantly more PsO/PsA‐related comorbidities, with the top 3 most common in both groups being hypertension (35.8% versus 23.5%), hyperlipidemia (34.6% versus 28.5%), and diabetes mellitus (15.9% versus 10.0%). Compared with controls, PsO+PsA patients had a higher number of distinct prescriptions filled (incidence rate ratio 2.3, P < 0.05); were more likely to have inpatient admissions (odds ratio [OR] 1.6), emergency room visits (OR 1.3), and outpatient visits (OR 62.7) (all P < 0.05); and incurred significantly higher total, pharmacy, and medical costs (adjusted annual cost differences per patient $23,160, $17,696, and $5,077, respectively; all P < 0.01).ConclusionCompared with matched PsO‐ and PsA‐free controls, moderate‐to‐severe PsO patients with comorbid PsA had higher comorbidity and health care utilization and costs.