PMID- 17021768
OWN - NLM
STAT- MEDLINE
DCOM- 20070815
LR  - 20191210
IS  - 0340-3696 (Print)
IS  - 1432-069X (Electronic)
IS  - 0340-3696 (Linking)
VI  - 298
IP  - 7
DP  - 2006 Dec
TI  - The incidence of arthropathy adverse events in efalizumab-treated patients is low 
      and similar to placebo and does not increase with long-term treatment: pooled 
      analysis of data from Phase III clinical trials of efalizumab.
PG  - 329-38
AB  - A large-scale, pooled analysis of safety data from five Phase III clinical trials 
      (including open-label extensions of two of these studies) and two Phase III 
      open-label clinical trials of efalizumab was conducted to explore whether 
      arthropathy adverse events (AEs) were associated with efalizumab treatment in 
      patients with moderate-to-severe chronic plaque psoriasis. Data from patients who 
      received subcutaneous injections of efalizumab or placebo were stratified for 
      analysis into phases according to the nature and duration of treatment. These 
      included: the 'first treatment' phase (0-12-week data from patients who received 
      either efalizumab, 1 mg/kg once weekly, or placebo in the five placebo-controlled 
      studies); the 'extended treatment' phase (13-24-week data from seven trials for 
      all efalizumab-treated patients); and the 'long-term treatment' phase (data from 
      efalizumab-treated patients who received treatment for up to 36 months in two 
      long-term trials). Descriptive statistics were performed and the incidence of 
      arthropathy AEs per patient-year was calculated using 95% confidence intervals 
      (CIs). During the first treatment phase, a similar proportion of patients had an 
      arthropathy AE in the efalizumab group (3.3%; 58/1740 patients) compared with the 
      placebo group (3.5%; 34/979 patients); the incidence of arthropathy AEs per 
      patient-year was 0.15 in the efalizumab group (95% CI 0.11-0.19) and 0.16 in the 
      placebo group (95% CI 0.11-0.22). Analysis of first treatment phase data from one 
      study (n = 793) showed that the incidence of psoriatic arthropathy per 
      patient-year was lower in efalizumab-treated patients (0.10; 95% CI 0.05-0.18) 
      than in those given placebo (0.17; 95% CI 0.08-0.30). During the extended 
      treatment phase, the incidence of arthropathy remained low (0.17; 95% CI 
      0.14-0.22). Data from two long-term studies showed that there was no increase in 
      the incidence of arthropathy AEs over time in patients treated with efalizumab 
      for up to 36 months. Patients who had an arthropathy AE during treatment with 
      efalizumab appeared to be more likely to have a history of arthropathy prior to 
      treatment. Efalizumab does not appear to increase the risk of arthropathy AEs 
      compared with placebo.
FAU - Pincelli, Carlo
AU  - Pincelli C
AD  - Department of Medicine, Institute of Dermatology, University of Modena and Reggio 
      Emilia, Modena, Italy. carlo@unimo.it
FAU - Henninger, Eric
AU  - Henninger E
FAU - Casset-Semanaz, Florence
AU  - Casset-Semanaz F
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20060921
PL  - Germany
TA  - Arch Dermatol Res
JT  - Archives of dermatological research
JID - 8000462
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - XX2MN88N5D (efalizumab)
SB  - IM
MH  - Adult
MH  - Antibodies, Monoclonal/*adverse effects/*therapeutic use
MH  - Antibodies, Monoclonal, Humanized
MH  - Dose-Response Relationship, Drug
MH  - Drug-Related Side Effects and Adverse Reactions
MH  - Humans
MH  - Incidence
MH  - Joint Diseases/*chemically induced/epidemiology
MH  - Middle Aged
MH  - Psoriasis/*drug therapy/pathology
MH  - Risk Factors
MH  - Severity of Illness Index
MH  - Time Factors
PMC - PMC1705535
EDAT- 2006/10/06 09:00
MHDA- 2007/08/19 09:00
PMCR- 2006/12/18
CRDT- 2006/10/06 09:00
PHST- 2006/05/11 00:00 [received]
PHST- 2006/08/17 00:00 [accepted]
PHST- 2006/08/08 00:00 [revised]
PHST- 2006/10/06 09:00 [pubmed]
PHST- 2007/08/19 09:00 [medline]
PHST- 2006/10/06 09:00 [entrez]
PHST- 2006/12/18 00:00 [pmc-release]
AID - 694 [pii]
AID - 10.1007/s00403-006-0694-9 [doi]
PST - ppublish
SO  - Arch Dermatol Res. 2006 Dec;298(7):329-38. doi: 10.1007/s00403-006-0694-9. Epub 
      2006 Sep 21.