Minimal Disease Activity and Patient-Acceptable Symptom State in Psoriatic Arthritis: A Real-World Evidence Study...

Ustekinumab (UST) is a fully human immunoglobulin G1 monoclonal antibody approved for treating moderate to severe psoriasis and, more recently, psoriatic arthritis (PsA) as well. However, information regarding its clinical usefulness in a real-world setting is scarce. We aimed to evaluate the effectiveness and safety of UST in a real-world clinical setting.

This single-center observational study included PsA outpatients (n = 50) treated with UST from March 2015 to March 2017. Only patients who used at least 3 doses of UST were analyzed. The percentage of patients who achieved a minimal disease activity (MDA) response was collected. The impact of the disease was also evaluated according to the recently developed Psoriatic Arthritis Impact of Disease (PsAID) questionnaire. A binary logistic regression multivariate model was performed to look for variables predicting MDA.

Twenty-seven patients (54%) reached an MDA state. Mean PsAID in MDA group was 3.5 ± 2.9 versus 6.8 ± 5.1 in non-MDA patients (p < 0.001). Among the patients who achieved MDA, 19 (70.4%) had a patient-acceptable symptom state according to the PsAID, whereas only 5 (21.7%) of the 23 patients who did not reach an MDA achieved a patient-acceptable symptom state (p < 0.001). Higher basal Psoriasis Area and Severity Index decreased the odds of achieving MDA (odds ratio [OR], 0.80; 95% CI, 0.65-0.99; p = 0.038), whereas a longer use of UST (OR, 1.52; 95% CI, 1.13-2.06; p = 0.015) and a previous failure to 1 anti-tumor necrosis factor α (OR, 18; 95% CI, 2.52-128.63; p = 0.004) increased this odds. We found no major safety problems.

Ustekinumab was effective and safe in this PsA population. Minimal disease activity and PsAID may be useful tools in the evaluation of PsA therapeutic interventions in routine clinical practice.