Ustekinumab Treatment and Improvement of Physical Function and Health-Related Quality of Life in Patients With Psoriatic Arthritis

Abstract

Objective: To examine the effects of ustekinumab on patient-reported outcomes (PROs) in PSUMMIT 1 and PSUMMIT 2 patients with active psoriatic arthritis (PsA) who were methotrexate (MTX) naive, MTX experienced, or anti-tumor necrosis factor (TNF) experienced.

Methods: Patients in the phase 3, PSUMMIT 1 (n = 615) and PSUMMIT 2 (n = 312) studies randomly (1:1:1) received placebo, ustekinumab 45-mg, or ustekinumab 90-mg subcutaneous injections at weeks 0, 4, 16, 28, 40, and 52. The PROs (Health Assessment Questionnaire [HAQ] disability index [DI], Dermatology Life Quality Index [DLQI], 36-Item Short Form [SF-36] health survey physical (PCS) and mental component summary scores, patient assessments of pain and disease activity, and impact of disease on productivity) were assessed at weeks 0, 24, and 52. In these post hoc analyses, outcomes were compared between the ustekinumab and placebo groups for 3 mutually exclusive antecedent-exposure populations from the combined studies: MTX/anti-TNF naive (placebo, n = 56; 45 mg, n = 58; and 90 mg, n = 66), MTX experienced, biologic agent naive (placebo, n = 192; 45 mg, n = 190; and 90 mg, n = 185), and anti-TNF experienced with or without MTX (placebo, n = 62; 45 mg, n = 60; and 90 mg, n = 58).

Results: At week 24, mean improvements from baseline in HAQ DI, DLQI, and SF-36 PCS scores were significantly greater in both ustekinumab groups versus placebo across antecedent-exposure groups. Greater proportions of ustekinumab-treated than placebo-treated patients (all P < 0.05) had clinically meaningful improvements in HAQ DI (≥0.3), DLQI (≥5), and SF-36 (≥5) scores at week 24, irrespective of drug exposure. Improvements in pain, disease activity, and impact of disease on productivity were similar, and benefits were maintained through week 52.

Conclusion: Significant improvements in PROs with ustekinumab versus placebo were observed in 3 antecedent-exposure populations of PsA patients, including those with prior MTX and anti-TNF use.

Trial registration: ClinicalTrials.gov NCT01009086 NCT01077362.

© 2016, The Authors. Arthritis Care & Research published by Wiley Periodicals, Inc. on behalf of the American College of Rheumatology.

Figures

Figure 1

Mean change from baseline in the Health Assessment Questionnaire (HAQ) disability index (DI) score (A), the proportion of patients with an improvement in HAQ DI score ≥0.3 (B) at week 24, and the proportion of patients with a HAQ DI score ≤0.5 at week 24 among patients with baseline HAQ DI score >0.5 (C). * = P < 0.001; † = P < 0.01; ‡ = P < 0.05; MTX = methotrexate; TNF = tumor necrosis factor.

Figure 2

Mean change from baseline in Dermatology Life Quality Index (DLQI) score (A), the proportion of patients with an improvement in DLQI score ≥5 (B), and the proportion of patients with a DLQI score = 0 or 1 (C) at week 24. Note that DLQI was assessed in patients with ≥3% body surface area affected by psoriasis at baseline. * = P < 0.001; † = P < 0.01; MTX = methotrexate; TNF = tumor necrosis factor.