PMID- 21110526
OWN - NLM
STAT- MEDLINE
DCOM- 20110315
LR  - 20160707
IS  - 1179-1888 (Electronic)
IS  - 1175-0561 (Linking)
VI  - 12
IP  - 1
DP  - 2011 Feb 1
TI  - Efficacy and safety of adalimumab among patients with moderate to severe 
      psoriasis with co-morbidities: Subanalysis of results from a randomized, 
      double-blind, placebo-controlled, phase III trial.
PG  - 51-62
LID - 10.2165/11530640-000000000-00000 [doi]
AB  - BACKGROUND: Psoriasis is associated with a variety of major physical and mental 
      co-morbidities. OBJECTIVE: To assess the incremental burden of co-morbidities on 
      patient-reported outcomes and evaluate the efficacy and safety of adalimumab in 
      psoriasis patients with co-morbidities. STUDY DESIGN: Data were obtained from the 
      initial 16-week, double-blind treatment period of REVEAL (Randomized controlled 
      EValuation of adalimumab Every other week dosing in moderate to severe psoriasis 
      triAL), a randomized, multicenter, phase III clinical trial. INTERVENTION: 
      Patients with moderate to severe psoriasis were randomized in a 2 : 1 ratio to 
      receive adalimumab 80 mg (two 40 mg injections administered subcutaneously) at 
      baseline followed by one 40 mg injection every other week from week 1 to week 15 
      or placebo. MAIN OUTCOME MEASURES: Clinical severity (Psoriasis Area and Severity 
      Index [PASI]) and patient-reported outcomes (Dermatology Life Quality Index 
      [DLQI], Short Form 36 [SF-36] health survey, Work Productivity and Activity 
      Impairment [WPAI] questionnaire) were assessed during the trial. The effect of 
      selected co-morbidities (i.e. hypertension, psoriatic arthritis, hyperlipidemia, 
      obesity, depression, other forms of arthritis, diabetes mellitus, and other 
      cardiovascular diseases) on patient-reported outcomes was evaluated using 
      multivariate analysis of covariance models. Subgroup analyses were performed by 
      co-morbidity type to statistically compare the clinical efficacy, 
      patient-reported outcome benefits, and safety of adalimumab with placebo in the 
      presence of these conditions. RESULTS: Study co-morbidities were each 
      independently associated with significantly greater impairment on at least one 
      general patient-reported outcome measured at baseline (all p < 0.05), with the 
      exception of hyperlipidemia. During the 16-week study, adalimumab patients 
      demonstrated significantly greater PASI 75 response rates (defined as a reduction 
      of at least 75% in PASI scores from baseline) compared with placebo patients for 
      all co-morbidity subgroups. Adalimumab provided consistent improvements in DLQI, 
      SF-36 Physical Component Summary and Mental Component Summary scores, and WPAI 
      total scores from baseline to week 16 within co-morbidity subgroups. Rates of 
      serious adverse events (AEs), serious infectious AEs, and AEs leading to 
      discontinuation were comparable between adalimumab and placebo for patients with 
      co-morbidities. CONCLUSIONS: Co-morbidities were associated with additionally 
      impaired health-related quality of life and work productivity in patients with 
      psoriasis. Adalimumab significantly improved efficacy and patient-reported 
      outcomes and was well tolerated in patients with co-morbidities.
FAU - Kimball, Alexa B
AU  - Kimball AB
AD  - Harvard Medical School, Boston, Massachusetts 02114, USA. 
      harvardskinstudies@partners.org
FAU - Bensimon, Arielle G
AU  - Bensimon AG
FAU - Guerin, Annie
AU  - Guerin A
FAU - Yu, Andrew P
AU  - Yu AP
FAU - Wu, Eric Q
AU  - Wu EQ
FAU - Okun, Martin M
AU  - Okun MM
FAU - Bao, Yanjun
AU  - Bao Y
FAU - Gupta, Shiraz R
AU  - Gupta SR
FAU - Mulani, Parvez M
AU  - Mulani PM
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - New Zealand
TA  - Am J Clin Dermatol
JT  - American journal of clinical dermatology
JID - 100895290
RN  - 0 (Anti-Inflammatory Agents)
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - FYS6T7F842 (Adalimumab)
SB  - IM
MH  - Adalimumab
MH  - Adult
MH  - Anti-Inflammatory Agents/adverse effects/*therapeutic use
MH  - Antibodies, Monoclonal/adverse effects/*therapeutic use
MH  - Antibodies, Monoclonal, Humanized
MH  - Comorbidity
MH  - Double-Blind Method
MH  - Efficiency
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Multivariate Analysis
MH  - Psoriasis/*drug therapy/epidemiology/pathology
MH  - Quality of Life
MH  - Severity of Illness Index
MH  - Treatment Outcome
EDAT- 2010/11/30 06:00
MHDA- 2011/03/16 06:00
CRDT- 2010/11/30 06:00
PHST- 2010/11/30 06:00 [entrez]
PHST- 2010/11/30 06:00 [pubmed]
PHST- 2011/03/16 06:00 [medline]
AID - 4 [pii]
AID - 10.2165/11530640-000000000-00000 [doi]
PST - ppublish
SO  - Am J Clin Dermatol. 2011 Feb 1;12(1):51-62. doi: 
      10.2165/11530640-000000000-00000.