PMID- 23588944
OWN - NLM
STAT- MEDLINE
DCOM- 20140207
LR  - 20220409
IS  - 1499-2752 (Electronic)
IS  - 0315-162X (Linking)
VI  - 40
IP  - 7
DP  - 2013 Jul
TI  - Patient-reported Health-related Quality of Life with apremilast for psoriatic 
      arthritis: a phase II, randomized, controlled study.
PG  - 1158-65
LID - 10.3899/jrheum.121200 [doi]
AB  - 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. CONCLUSION: 
      Apremilast resulted in statistically significant and clinically meaningful 
      improvements in HRQOL, pain and global VAS, and FACIT-F scores.
FAU - Strand, Vibeke
AU  - Strand V
AD  - Division of Immunology and Rheumatology, Stanford University School of Medicine, 
      Palo Alto, California 94028, USA. vstrand@stanford.edu
FAU - Schett, Georg
AU  - Schett G
FAU - Hu, Chiachi
AU  - Hu C
FAU - Stevens, Randall M
AU  - Stevens RM
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20130415
PL  - Canada
TA  - J Rheumatol
JT  - The Journal of rheumatology
JID - 7501984
RN  - 0 (Anti-Inflammatory Agents, Non-Steroidal)
RN  - 4Z8R6ORS6L (Thalidomide)
RN  - UP7QBP99PN (apremilast)
SB  - IM
MH  - Adult
MH  - Anti-Inflammatory Agents, Non-Steroidal/*therapeutic use
MH  - Arthritis, Psoriatic/*drug therapy/psychology
MH  - Disability Evaluation
MH  - Fatigue
MH  - Female
MH  - Health Status
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Pain Measurement
MH  - Patient Satisfaction
MH  - Quality of Life/*psychology
MH  - Surveys and Questionnaires
MH  - Thalidomide/*analogs & derivatives/therapeutic use
MH  - Treatment Outcome
OTO - NOTNLM
OT  - CLINICAL TRIALS
OT  - PSORIATIC ARTHRITIS
OT  - QUALITY OF LIFE
OT  - SPONDYLOARTHROPATHY
OT  - VISUAL ANALOG SCALE
EDAT- 2013/04/17 06:00
MHDA- 2014/02/08 06:00
CRDT- 2013/04/17 06:00
PHST- 2013/04/17 06:00 [entrez]
PHST- 2013/04/17 06:00 [pubmed]
PHST- 2014/02/08 06:00 [medline]
AID - jrheum.121200 [pii]
AID - 10.3899/jrheum.121200 [doi]
PST - ppublish
SO  - J Rheumatol. 2013 Jul;40(7):1158-65. doi: 10.3899/jrheum.121200. Epub 2013 Apr 
      15.