The study’s secondary endpoints were a 75% reduction in the Psoriasis Area and Severity Index (PASI75) and ACR50 responses, as well as change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI), improvement in enthesitis (Leeds Enthesitis Index) and dactylitis score (a 0–3 scoring system) at Week 24, as well as ACR20 response at Week 16. At Week 24, GUS treatment led to significantly greater improvements in dactylitis, enthesitis and health-related quality of life as measured by the Short Form Health Survey (SF-36 physical and mental component summary scores) compared with placebo-treated patients. In addition, at Week 24, minimal disease activity was attained by a higher percentage of GUS-treated patients compared with placebo-treated patients (23% vs. 2%; P=0.001). “It is difficult to compare guselkumab with other existing therapies for PsA, since no head-to-head studies have been done,” says Dr. Deodhar. “However, the improvements seen with guselkumab in the various manifestations of psoriatic arthritis and patient-reported outcomes are very promising.”
GUS was well tolerated with no unexpected safety findings. Both the treatment and control groups had comparable numbers of adverse events through Week 24 (placebo: 33%; GUS: 36.0%). The most common adverse event was infection, which occurred in 20% of placebo-treated patients and 17% of GUS-treated patients.
FX006 Promising for Knee OA
A new drug application has been submitted to the FDA for FX006 (Zilretta), a long-acting steroid injection for knee OA.2 The treatment combines triamcinolone acetonide (TCA) in a polymer to provide longer lasting pain relief.
In a Phase 3 trial, patients who received FX006 reported about half of the pain level on average compared with placebo-treated patients through 12 weeks.2 This study was a Phase 3, randomized, double-blind, placebo-controlled, active-comparator trial. Efficacy was assessed in 484 patients at four-week intervals over 24 weeks. The primary trial endpoint was pain reduction assessed by the weekly mean of the average pain score for active comparator compared with placebo, which was achieved by FX006 (P<0.0001).
‘It is encouraging to see how well patients responded to guselkumab with respect to improvements in signs & symptoms of psoriatic arthritis as early as Week 4.’ —Dr. Deodhar
The treatment also achieved statistically significant improvements in WOMAC A (pain), B (stiffness) and C (function) at Weeks 4, 8 and 12 compared with placebo and immediate-release TCA (P<0.05). Efficacy by Knee Injury and Osteoarthritis Outcome Score quality of life at four-week intervals over 24 weeks was also achieved by FX006.
