RESEARCH - Patient-reported outcomes in the TEMPO trial

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Ann Rheum Dis. 2005 Aug 3; [Epub ahead of print]

Patient-reported outcomes in a trial of combination therapy with etanercept

and methotrexate for rheumatoid arthritis: the TEMPO trial.

van der Heijde D, Klareskog L, Singh A, Tornero J, Melo-Gomes J, Codreanu C,

Pedersen R, Freundlich B, Fatenejad S.

University Hospital Maastricht, Netherlands.

OBJECTIVE: To compare patient-reported measures of function, health-related

quality of life (QoL), and satisfaction with medication among rheumatoid

arthritis patients treated with methotrexate (MTX), etanercept or both for

up to one year. METHODS: In a 52-week double-blind clinical trial, patients

with active RA were randomised to receive etanercept 25 mg twice weekly,

methotrexate up to 20 mg weekly, or combination therapy. The Health

Assessment Questionnaire disability index (HAQ), EuroQoL health status

visual analogue scale (EQ-5D VAS), patient global assessment and patient

general health VAS were administered at baseline and weeks 2, 4, 8, 12, 16,

20, 24, 32, 40, 48 and 52. Satisfaction with medication was compared at 52

weeks. RESULTS: Of 682 enrolled patients, 522 completed 52 weeks of

treatment. Mean improvement from baseline in HAQ score was 0.65, 0.70, and

1.0 for MTX, etanercept and combination, respectively. The mean percentage

and absolute improvement in HAQ was significantly higher (P<0.01) for

combination therapy than either monotherapy. Combination therapy produced

significantly more rapid achievement of HAQ </= 0.5 and sustained for 6

months than either monotherapy (P<0.01). Compared with monotherapy

recipients, patients receiving combination therapy achieved significantly

better (P<0.05) health state as measured by EQ-5D VAS (63.7 & [plusmn]3.2,

66.8+/-3.2, 72.7+/-3.1 for MTX, etanercept, and combination, respectively).

Results were similar for other assessments (P<0.01). Patients in combination

and etanercept groups were significantly more likely (P<0.0001 and P=0.0009,

respectively) to report satisfaction with medication.

CONCLUSIONS: Combination therapy with etanercept and methotrexate improved

function, QoL and satisfaction with medication significantly better than

monotherapy.

PMID: 16079172

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve & db=PubMed & list_uids=1\

6079172 & dopt=Abstract

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