PMID- 20933301
OWN - NLM
STAT- MEDLINE
DCOM- 20101228
LR  - 20151119
IS  - 1097-6787 (Electronic)
IS  - 0190-9622 (Linking)
VI  - 63
IP  - 6
DP  - 2010 Dec
TI  - Benefit-risk analysis of adalimumab versus methotrexate and placebo in the 
      treatment of moderate to severe psoriasis: comparison of adverse event-free 
      response days in the CHAMPION trial.
PG  - 1011-8
LID - 10.1016/j.jaad.2009.12.029 [doi]
AB  - BACKGROUND: The Comparative Study of Humira versus Methotrexate (MTX) versus 
      Placebo in Psoriasis Patients (CHAMPION) demonstrated superior efficacy of 
      biologic over conventional systemic immunosuppressant therapy in psoriasis. 
      OBJECTIVE: We sought to compare the risk-benefit profile of adalimumab (ADA), 
      MTX, and placebo using data from CHAMPION. METHODS: Patients randomized to ADA (n 
      = 107), MTX (n = 110), or placebo (n = 53) were followed up for 16 weeks. 
      Response (>/=75% improvement in Psoriasis Area and Severity Index), days free of 
      adverse events (AEs), moderate to severe AEs, infection-related AEs, and study 
      drug-related AEs were analyzed. RESULTS: ADA treatment was associated with 
      substantially more days (SD) of AE-free response compared with MTX or placebo 
      treatment, respectively: 36.9 (31.1) versus 8.3 (15.9) or 6.7 (18.1) days of 
      response free of any AEs, 43.8 (31.9) versus 11.1 (19.9) or 7.9 (19.9) days of 
      response free of moderate to severe AEs, 48.5 (29.2) versus 12.4 (21.7) or 9.2 
      (21.8) days of response free of infection-related AEs, and 44.6 (31.4) versus 
      11.8 (21.1) or 10.0 (24.0) days free of study drug-related AEs (all P < .0001 for 
      ADA vs MTX or placebo). LIMITATIONS: This clinical trial-based analysis may not 
      have captured the full spectrum of AEs in the actual clinical setting. The short 
      (16-week) duration of the trial limited the ability to capture some important but 
      uncommon AEs associated with long-term ADA or MTX use. CONCLUSION: With 4 times 
      as many AE-free response days, ADA demonstrated a superior benefit-risk profile.
CI  - Copyright (c) 2010 American Academy of Dermatology, Inc. Published by Mosby, Inc. 
      All rights reserved.
FAU - Reich, Kristian
AU  - Reich K
AD  - Dermatologikum Hamburg, Hamburg, Germany. reich@dermatologikum.de
FAU - Signorovitch, James
AU  - Signorovitch J
FAU - Ramakrishnan, Karthik
AU  - Ramakrishnan K
FAU - Yu, Andrew P
AU  - Yu AP
FAU - Wu, Eric Q
AU  - Wu EQ
FAU - Gupta, Shiraz R
AU  - Gupta SR
FAU - Bao, Yanjun
AU  - Bao Y
FAU - Mulani, Parvez M
AU  - Mulani PM
LA  - eng
PT  - Comparative Study
PT  - Journal Article
DEP - 20101008
PL  - United States
TA  - J Am Acad Dermatol
JT  - Journal of the American Academy of Dermatology
JID - 7907132
RN  - 0 (Anti-Inflammatory Agents)
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Immunosuppressive Agents)
RN  - 0 (Placebos)
RN  - FYS6T7F842 (Adalimumab)
RN  - YL5FZ2Y5U1 (Methotrexate)
SB  - IM
MH  - Adalimumab
MH  - Adult
MH  - Anti-Inflammatory Agents/administration & dosage/adverse effects
MH  - Antibodies, Monoclonal/*administration & dosage/adverse effects
MH  - Antibodies, Monoclonal, Humanized
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Immunosuppressive Agents/administration & dosage/adverse effects
MH  - Male
MH  - Methotrexate/*administration & dosage/adverse effects
MH  - Middle Aged
MH  - Placebos
MH  - Psoriasis/*drug therapy/*epidemiology
MH  - Randomized Controlled Trials as Topic/*statistics & numerical data
MH  - Risk Assessment/statistics & numerical data
MH  - Risk Factors
MH  - Severity of Illness Index
MH  - Treatment Outcome
EDAT- 2010/10/12 06:00
MHDA- 2010/12/29 06:00
CRDT- 2010/10/12 06:00
PHST- 2009/07/15 00:00 [received]
PHST- 2009/11/17 00:00 [revised]
PHST- 2009/12/01 00:00 [accepted]
PHST- 2010/10/12 06:00 [entrez]
PHST- 2010/10/12 06:00 [pubmed]
PHST- 2010/12/29 06:00 [medline]
AID - S0190-9622(09)02310-X [pii]
AID - 10.1016/j.jaad.2009.12.029 [doi]
PST - ppublish
SO  - J Am Acad Dermatol. 2010 Dec;63(6):1011-8. doi: 10.1016/j.jaad.2009.12.029. Epub 
      2010 Oct 8.