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RESEARCH - Adverse events and factors associated with toxicity in patients with early RA treated with MTX tight-control therapy: CAMERA

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Ann Rheum Dis. Published Online First: 5 July 2009. doi:10.1136/ard.2008.106617

BMJ Publishing Group Ltd & European League Against Rheumatism.

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Extended Report

Adverse events and factors associated with toxicity in patients with

early rheumatoid arthritis treated with methotrexate tight control

therapy (the CAMERA study)

S M M Verstappen 1, M F Bakker 1, A H M Heurkens 2, M J van der Veen

3, A A Kruize 1, M A W Geurts 4, J W J Bijlsma 1 and J W G s 1*

1 University Medical Center Utrecht, Utrecht, Netherlands

2 Meander Medical Center, Amersfoort, Netherlands

3 St Jansdal Hospital, Harderwijk, Netherlands

4 St Antonius Hospital, Nieuwegein, Netherlands

Abstract

Objective: To evaluate toxicity profiles in patients with rheumatoid

arthritis (RA) treated either according to an intensive or a

conventional treatment strategy approach with methotrexate (MTX) and

to study factors associated with MTX related toxicity.

Methods: Data were used from the CAMERA study in which clinical

efficacy of an intensive treatment strategy with MTX was more

beneficial compared to a conventional treatment strategy approach. In

the present study, data on adverse events were compared between the

two treatment groups. Logistic regression analyses were used to

identify possible associations between factors assessed at baseline

and withdrawal due to MTX related adverse events or liver toxicity at

follow-up.

Results: Although significantly more patients in the intensive

treatment group experienced MTX related adverse events compared to the

conventional treatment group, all recorded adverse events were

relatively mild. A higher Body Mass Index (BMI) was significantly

associated with withdrawal due to MTX related adverse events in the

multiple regression analyses. There was a trend towards an association

between diminished creatinine clearance and MTX withdrawal. For liver

toxicity, increased serum liver enzymes at baseline were associated

with liver toxicity during follow-up.

Conclusion: Although the occurrence of adverse events in the intensive

treatment group was higher than in the conventional treatment group,

the previously observed clinical efficacy of an intensive treatment

strategy seems to outweigh the observed toxicity profiles. When

starting MTX, attention should be given to patients with a high BMI

and those with increased levels of liver enzymes and decreased renal

function.

http://ard.bmj.com/cgi/content/abstract/ard.2008.106617v1?papetoc

Not an MD

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