BACKGROUND/PURPOSE: Fatigue is highly important to patients (pts) with psoriatic arthritis (PsA). Secukinumab, an anti-interleukin-17A monoclonal antibody, significantly improved the signs and symptoms of active PsA in the phase 3 FUTURE 2 study (NCT01752634).1Here we present the results of a post-hoc analysis assessing the impact of secukinumab on fatigue according to prior anti-tumor necrosis factor (anti-TNF) therapy status. The relationship between fatigue and baseline disease characteristics, as well as to other assessments of PsA response to therapy, are also presented.
METHODS: Pts with active PsA were randomized to receive subcutaneous (s.c.) secukinumab (300 mg, 150 mg, or 75 mg) or placebo (PBO) at baseline, Wks 1, 2, 3, and 4, and every 4 wks thereafter. Fatigue was assessed at baseline and Wks 4, 8, 12, 16, and 24 using the Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F) scale. Mean change in FACIT-F score from baseline up to Wk 24 was assessed using mixed model repeated measures analysis with visit, weight, and baseline FACIT-F score as covariates. A minimum clinically important difference (MCID) >4 was used to define fatigue response. A logistic regression model was used to investigate baseline predictors of FACIT-F improvement at Wk 16. The relationship between FACIT-F and ACR 20, PASI 75, PASI 90, DAS28-CRP low disease activity (LDA; = 3.2) and remission (< 2.6), and Psoriatic Arthritis Response Criteria (PsARC) was assessed at Wks 8 and 16. The secukinumab 75 mg s.c. group was excluded from this analysis as it did not meet any pre-defined secondary endpoints.
RESULTS: Of 298 pts included in this analysis, 193 were anti–TNF-naive and 105 anti–TNF-inadequate responders (IR). Mean changes from baseline in FACIT-F were improved with secukinumab 150 and 300 mg vs. placebo in both anti-TNF-naïve and anti-TNF-IR populations at the majority of timepoints up to Wk 24 with mean changes exceeding the MCID at all timepoints (Table). In a logistic regression model of FACIT-F response at Wk 16, age was the only baseline factor found to be a significant covariate (P<0.05). ACR 20 responses correlated with improvements in FACIT-F at Wk 16; no relationship was seen between FACIT-F and PASI 75, PASI 90, DAS28-CRP, LDA and remission criteria, or PsARC.
CONCLUSION: Secukinumab improved fatigue in patients with active PsA regardless of prior anti-TNF therapy. A relationship between improvement in fatigue and improvements in the signs and symptoms of PsA was only shown for ACR 20 response and not for other assessments of disease. These results suggest that fatigue in PsA is not strongly related to disease activity but was still improved by secukinumab.
