Background/Purpose: To evaluate the effect of guselkumab (GUS) on Health-Related Quality of Life (HRQOL) and correlate changes of HRQOL and disease activity in patients with psoriatic arthritis (PsA).

Methods: Patients from the Phase 2a, multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of guselkumab in the treatment of patients with active PsA were analyzed. Patients with active PsA and ≥3% body surface area (BSA) of plaque psoriasis despite current or previous treatment with standard-of-care therapies, including those previously exposed to anti-TNFα agents, were randomized 2:1 to receive GUS 100mg subcutaneously or placebo (PBO) at wks0, 4, and every 8wks (q8w) thereafter through wk44. At wk16, pts from either group with <5% improvement from baseline in both swollen and tender joint counts were eligible for early escape to open-label ustekinumab. At wk24, all remaining PBO pts crossed-over to receive GUS 100 mg, and then received GUS at wk28, and q8w thereafter through wk44. HRQOL was assessed using 36-Item Short Form Health Survey (SF-36) which assesses general health from 8 functional areas. A physical and mental component summary scores (PCS and MCS) were derived from 8 scale scores. A change of ≥5 points from the baseline in PCS or MCS was defined as clinically meaningful. Correlations of changes in SF-36 PCS and MCS with changes in Disease Activity in Psoriatic Arthritis (DAPSA) were evaluated using Spearman correlation at Week 24.

Results: The mean (SD) of SF-36 PCS and MCS at the baseline was 33.8 (7.4), 44.2 (11.9), respectively, which were significant below the US population norm (50 +/-10). At wk24, patients in the GUS group achieved statistically greater mean improvement in SF-36 PCS (6.6) and MCS (4.7) than PBO group (0.5 in PCS, -0.1 in MCS) (all p<0.01); and greater proportions of patients in GUS group achieved a clinically meaningful improvement in PCS (55%) and MCS (47%) than patients in PBO group (22.5% in PCS, p<0.001; 26.5% in MCS, p=0.017). Additionally, greater mean improvements in all SF-36 scales score in GUS group than PBO group were observed. At wk44, patients randomized to PBO at the baseline and crossed over to GUS at wk24 achieved improvements in SF-36 PCS (8.0) or MCS (5.5). The magnitude of these changes was similar to patients randomized to GUS at baseline (8.3 in PCS, 5.6 in MCS). Change in DAPSA score at wk24 was significantly correlated with change in PCS (r=-0.57, p<0.001) and MCS (r=-0.45, p<0.001).

Conclusion: GUS-treated PsA patients demonstrated significant improvement in HRQOL and in all subscales of SF-36, indicating patient-perceived improvements in health status. Improvement in SF-36 was highly correlated with reduction in PsA disease activity.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/clinically-meaningful-improvement-in-health-related-quality-of-life-and-the-association-with-disease-activity-in-psoriatic-arthritis-after-treatment-with-guselkumab-results-from-a-randomized-placebo/