PMID- 20533545
OWN - NLM
STAT- MEDLINE
DCOM- 20101123
LR  - 20220311
IS  - 1529-0131 (Electronic)
IS  - 0004-3591 (Linking)
VI  - 62
IP  - 10
DP  - 2010 Oct
TI  - The efficacy and safety of abatacept in patients with non-life-threatening 
      manifestations of systemic lupus erythematosus: results of a twelve-month, 
      multicenter, exploratory, phase IIb, randomized, double-blind, placebo-controlled 
      trial.
PG  - 3077-87
LID - 10.1002/art.27601 [doi]
AB  - OBJECTIVE: To evaluate abatacept therapy in patients with non-life-threatening 
      systemic lupus erythematosus (SLE) and polyarthritis, discoid lesions, or 
      pleuritis and/or pericarditis. METHODS: In a 12-month, multicenter, exploratory, 
      phase IIb randomized, double-blind, placebo-controlled trial, SLE patients with 
      polyarthritis, discoid lesions, or pleuritis and/or pericarditis were randomized 
      at a ratio of 2:1 to receive abatacept ( approximately 10 mg/kg of body weight) or placebo. 
      Prednisone (30 mg/day or equivalent) was given for 1 month, and then the dosage 
      was tapered. The primary end point was the proportion of patients with new flare 
      (adjudicated) according to a score of A/B on the British Isles Lupus Assessment 
      Group (BILAG) index after the start of the steroid taper. RESULTS: A total of 118 
      patients were randomized to receive abatacept and 57 to receive placebo. The 
      baseline characteristics were similar in the 2 groups. The proportion of new 
      BILAG A/B flares over 12 months was 79.7% (95% confidence interval [95% CI] 72.4, 
      86.9) in the abatacept group and 82.5% (95% CI 72.6, 92.3) in the placebo group 
      (treatment difference -3.5 [95% CI -15.3, 8.3]). Other prespecified flare end 
      points were not met. In post hoc analyses, the proportions of abatacept-treated 
      and placebo-treated patients with a BILAG A flare were 40.7% (95% CI 31.8, 49.5) 
      versus 54.4% (95% CI 41.5, 67.3), and the proportions with physician-assessed 
      flare were 63.6% (95% CI 54.9, 72.2) and 82.5% (95% CI 72.6, 92.3), respectively; 
      treatment differences were greatest in the polyarthritis group. Prespecified 
      exploratory patient-reported outcomes (Short Form 36 health survey, sleep 
      problems, fatigue) demonstrated a treatment effect with abatacept. The frequency 
      of adverse events (AEs) was comparable in the abatacept and placebo groups (90.9% 
      versus 91.5%), but serious AEs (SAEs) were higher in the abatacept group (19.8 
      versus 6.8%). Most SAEs were single, disease-related events occurring during the 
      first 6 months of the study (including the steroid taper period). CONCLUSION: 
      Although the primary/secondary end points were not met in this study, 
      improvements in certain exploratory measures suggest some abatacept efficacy in 
      patients with non-life-threatening manifestations of SLE. The increased rate of 
      SAEs requires further assessment.
FAU - Merrill, J T
AU  - Merrill JT
AD  - Oklahoma Medical Research Foundation, Oklahoma City, OK 73104, USA. 
      joan-merrill@omrf.org
FAU - Burgos-Vargas, R
AU  - Burgos-Vargas R
FAU - Westhovens, R
AU  - Westhovens R
FAU - Chalmers, A
AU  - Chalmers A
FAU - D'Cruz, D
AU  - D'Cruz D
FAU - Wallace, D J
AU  - Wallace DJ
FAU - Bae, S C
AU  - Bae SC
FAU - Sigal, L
AU  - Sigal L
FAU - Becker, J-C
AU  - Becker JC
FAU - Kelly, S
AU  - Kelly S
FAU - Raghupathi, K
AU  - Raghupathi K
FAU - Li, T
AU  - Li T
FAU - Peng, Y
AU  - Peng Y
FAU - Kinaszczuk, M
AU  - Kinaszczuk M
FAU - Nash, P
AU  - Nash P
LA  - eng
SI  - ClinicalTrials.gov/NCT00119678
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Arthritis Rheum
JT  - Arthritis and rheumatism
JID - 0370605
RN  - 0 (Immunoconjugates)
RN  - 0 (Placebos)
RN  - 7D0YB67S97 (Abatacept)
SB  - IM
CIN - Arthritis Rheum. 2011 Apr;63(4):1157-8; author reply 1158. PMID: 21452333
MH  - Abatacept
MH  - Adult
MH  - Disease Progression
MH  - Female
MH  - Humans
MH  - Immunoconjugates/*therapeutic use
MH  - Intention to Treat Analysis
MH  - Lupus Erythematosus, Systemic/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Placebos
EDAT- 2010/06/10 06:00
MHDA- 2010/12/14 06:00
CRDT- 2010/06/10 06:00
PHST- 2010/06/10 06:00 [entrez]
PHST- 2010/06/10 06:00 [pubmed]
PHST- 2010/12/14 06:00 [medline]
AID - 10.1002/art.27601 [doi]
PST - ppublish
SO  - Arthritis Rheum. 2010 Oct;62(10):3077-87. doi: 10.1002/art.27601.