Effect of ustekinumab on physical function and health-related quality of life in patients with psoriatic arthritis: a randomized, placebo-controlled, phase II trial

Abstract

Objective:

To use data from a phase II clinical trial to evaluate the effect of ustekinumab, a human immunoglobulin monoclonal antibody that binds with high affinity to the shared p40 subunit of human interleukins-12 and -23, on physical disability and health-related quality of life (HRQoL) in patients with psoriatic arthritis (PsA).

Methods:

In this multicenter, double-blind, placebo-controlled, crossover study of ustekinumab, patients with active PsA were randomized (1:1 ratio) to receive either ustekinumab at weeks 0, 1, 2, and 3 and placebo at weeks 12 and 16 (n = 76) or placebo at weeks 0, 1, 2, and 3 and ustekinumab at weeks 12 and 16 (n = 70). Physical function was assessed using the disability index from the Health Assessment Questionnaire-Disability Index (HAQ-DI) in all randomized patients. HRQoL was evaluated using the Dermatology Life Quality Index (DLQI) in a subset of patients (84.9%) with at least 3% body surface area (BSA) psoriasis involvement at baseline.

Results:

At baseline, overall mean HAQ-DI and DLQI scores were 0.9 and 11.5, respectively, indicating impaired physical function and moderate effect on HRQoL. At week 12, ustekinumab patients had significantly more improvement (decrease) in the mean HAQ-DI (−0.31) and DLQI (−8.6) scores versus placebo (−0.04 and −0.8, respectively; p < 0.001 for both comparisons). At week 12, 58.7% (37/63) of ustekinumab-treated patients had a DLQI score of 0 or 1 (no negative effect of disease or treatment on HRQoL) versus 5.5% (3/55) for placebo (p < 0.001). The results also indicated a positive but weak correlation between improvement in physical function and HRQoL, pain, and skin response as well as between improvement in joint and skin responses in patients receiving ustekinumab or placebo. Potential limitations of the study include the short duration of the placebo-controlled period and the relatively small patient population.

Conclusion:

Ustekinumab significantly improved physical function and HRQoL in patients with PsA and psoriasis involving at least 3% BSA.

Keywords::

• DLQI
• HAQ
• Health-related quality of life
• Patient-reported outcomes
• Physical function
• Psoriatic arthritis
• Ustekinumab

Transparency

Declaration of funding

Centocor Research & Development, Inc., Malvern, PA funded this study.

Declaration of financial/other relationships

A.K. has received funding for clinical research from Abbott, Amgen, Centocor, and UCB. A.B.G. is principal investigator on grants paid to Tufts Medical Center for clinical research from Abbott, Amgen, Celgene, Centocor, Immune Control, Incyte, and Wyeth. A. Menter has received funding for clinical research from Abbot, Amgen, Astellas, Centocor, Genentech, Warner Chilcott, and Wyeth. A. Mendelsohn is an employee of Centocor Research & Development, Inc. Y-K.S. is an employee of Johnson & Johnson Pharmaceutical Research and Development. S.L. is an employee of Johnson & Johnson Pharmaceutical Services, LLC. A. Mendelsohn, S.L., and Y-K.S. own stock in Johnson & Johnson, of which Centocor Research & Development, Inc. is a subsidiary. Peer reviewers may receive honoraria from CMRO for their review work. The peer reviewers have disclosed no relevant financial relationships.

Acknowledgments

The authors wish to thank Cynthia Arnold of Centocor Ortho Biotech, Inc. for her editorial assistance and writing support.

Portions of these data have been presented at the Canadian Dermatology Association, Vancouver, BC, Canada, July 1–5, 2009; American College of Rheumatology, San Francisco, CA, USA, October 24–29, 2008; European Academy of Dermatology and Venereology, Paris, France, September 17–21, 2008; Summer American Academy of Dermatology, Chicago, IL, USA, July 30–August 3, 2008; and the European League Against Rheumatism, Paris, France, June 11–14, 2008.