title: Patient-reported Health-related Quality of Life with apremilast for psoriatic arthritis: a phase II, randomized, controlled study.
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 Questionnaire-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.
  
  
  CONCLUSIONS
  Apremilast resulted in statistically significant and clinically meaningful improvements in HRQOL, pain and global VAS, and FACIT-F scores.
authors.affiliation: Division of Immunology and Rheumatology, Stanford University School of Medicine, Palo Alto, California 94028, USA. vstrand@stanford.edu
authors.forename: Vibeke
authors.initials: V
authors.lastname: Strand
authors.forename: Georg
authors.initials: G
authors.lastname: Schett
authors.forename: Chiachi
authors.initials: C
authors.lastname: Hu
authors.forename: Randall M
authors.initials: RM
authors.lastname: Stevens
mesh_terms: D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D015535:Arthritis, Psoriatic / Q000188:drug therapy* / Q000523:psychology; D004185:Disability Evaluation; D005221:Fatigue; D005260:Female; D006304:Health Status; D006801:Humans; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D017060:Patient Satisfaction; D011788:Quality of Life / Q000523:psychology*; D011795:Surveys and Questionnaires; D013792:Thalidomide / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D013792:Thalidomide; C505730:apremilast
keywords: CLINICAL TRIALS; PSORIATIC ARTHRITIS; QUALITY OF LIFE; SPONDYLOARTHROPATHY; VISUAL ANALOG SCALE