1158 Strand, et al: HRQOL with apremilast Personal non-commercial use only. The Journal of Rheumatology Copyright © 2013. All rights reserved. Patient-reported Health-related Quality of Life with Apremilast for Psoriatic Arthritis: A Phase II, Randomized, Controlled Study Vibeke Strand, Georg Schett, ChiaChi Hu, and Randall M. Stevens ABSTRACT. Objective. Apremilast, a specific inhibitor of phosphodiesterase 4, modulates proinflammatory and antiinflammatory cytokine production. A phase IIb randomized, controlled trial (RCT) evaluated the effect of apremilast on patient-reported outcomes (PRO) in psoriatic arthritis (PsA). Methods. In this 12-week RCT, patients with active disease (duration > 6 mo, ≥ 3 swollen and ≥ 3 tender joints) received apremilast (20 mg BID or 40 mg QD) or placebo. PRO included pain and global assessment of disease activity [visual analog scale (VAS)], Health Assessment Question- naire-Disability Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), and Medical Outcomes Study Short-Form 36 Health Survey (SF-36) assessing health-related quality of life (HRQOL). Percentages of patients reporting improvements ≥ minimum clinically important differences (MCID) and correlations between SF-36 domains and pain VAS, HAQ-DI, and FACIT-F were determined. Results. Among the 204 randomized patients (52.5% men; mean age 50.6 yrs), baseline SF-36 scores reflected large impairments in HRQOL. Apremilast 20 mg BID resulted in statistically significant and clinically meaningful improvements in physical and mental component summary scores and 7 and 6 SF-36 domains, respectively, compared with no change/deterioration in placebo group. Patients receiving apremilast 20 mg BID and 40 mg QD reported significant improvements ≥ MCID in global VAS scores and FACIT-F versus placebo, and significant improvements in pain VAS scores. Moderate-high, significant correlations were evident between SF-36 domains and other PRO. Conclusion. Apremilast resulted in statistically significant and clinically meaningful improvements in HRQOL, pain and global VAS, and FACIT-F scores. (First Release April 15 2013; J Rheumatol 2013;40:1158–65; doi:10.3899/jrheum.121200) Key Indexing Terms: CLINICAL TRIALS PSORIATIC ARTHRITIS QUALITY OF LIFE SPONDYLOARTHROPATHY VISUAL ANALOG SCALE From the Division of Immunology and Rheumatology, Stanford University School of Medicine, Palo Alto, California, USA; University Erlangen-Nuremberg, Erlangen, Germany; and Celgene Corporation, Summit, New Jersey, USA. Sponsored by Celgene Corporation. V. Strand, MD, Adjunct Clinical Professor, Division of Immunology and Rheumatology, Stanford University School of Medicine; G. Schett, MD, University Erlangen-Nuremberg; C. Hu, EdM, MS; R.M. Stevens, MD, Celgene Corporation. Address correspondence to Dr. V. Strand, Division of Immunology and Rheumatology, Stanford University School of Medicine, 306 Ramona Road, Portola Valley, CA 94028, USA. E-mail: vstrand@stanford.edu Accepted for publication February 4, 2013. Psoriatic arthritis (PsA) is a chronic inflammatory arthritis associated with psoriasis 1 . An estimated 40% of patients with psoriasis develop PsA 1,2 , with a prevalence in the general US population between 0.3% and 1.0% 1 . PsA is associated with poor health-related quality of life (HRQOL), including general health, bodily pain, and physical functioning, well below that of age- and sex-matched US norms 3,4 , and longterm work disability 4,5,6 . In a survey conducted by the National Psoriasis Foundation, 44% of patients with PsA who were not working reported this was partially or entirely due to their PsA 2 . The presence of both PsA and psoriasis may further influence HRQOL, with larger impairments than those seen with psoriasis alone 7,8,9 . Understanding the effect of new treatments on patient-reported outcomes (PRO) is important when assessing their overall clinical value. The effect on HRQOL may be influenced by treatment-related factors, such as efficacy, tolerability, adverse events, safety, and treatment regimen (e.g., dosing frequency, route of administration, cost). Effective treatment of patients with PsA, including use of disease-modifying antirheumatic drugs (DMARD), has been shown to significantly improve PRO, including HRQOL 10,11 . However, these benefits differ among agents, with methotrexate (MTX) having a lesser effect on PRO than tumor necrosis factor (TNF) inhibitors 9,12 . In addition, treatment of patients with traditional and biologic DMARD therapy may be compromised by adverse events, poor toler- ability, inconvenient route of administration, and/or injection/infusion reactions 13,14,15,16 . No oral DMARD therapy is currently approved by the US Food and Drug www.jrheum.org Downloaded on August 15, 2022 from