ADORE data support switching to etanercept alone in MTX-resistant RA

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ADORE data support switching to etanercept alone in MTX-resistant RA



Mar 7, 2006



Janis

Nijmegen, the Netherlands - Investigators from the Add Enbrel or

Replace Methotrexate (ADORE) study of rheumatoid arthritis (RA)

patients who have inadequate responses to methotrexate (MTX)

monotherapy report that adding etanercept (Enbrel, Amgen/Wyeth) to

ongoing MTX provides no benefit beyond a simple switch to etanercept

alone [1]. Dr Piet LCM van Riel (University Medical Center Nijmegen,

the Netherlands) reports on behalf of the ADORE researchers in ls

of the Rheumatic Diseases, published online February 7, 2006.

" Our main findings were that combination etanercept/MTX and

etanercept alone had similar efficacy, that discontinuing MTX did not

reduce the clinical response to etanercept, and that stopping MTX did

not result in a flare of disease, which means that MTX was indeed not

effective in these patients, " van Riel told rheumawire.

Randomized, open-label study, without radiography



Stopping MTX did not result in a flare of disease, which means that

MTX was indeed not effective in these patients.



The ADORE trial was a 16-week, randomized, open-label study of

patients with active RA despite taking MTX of 12.5 mg/week or more

for at least three months. Patients were randomized either to

etanercept (25 mg sc twice weekly) added to their baseline MTX dose

(n=155) or to etanercept alone (n=160). The primary end point was

DAS28 (4) improvement of >1.2 units.

Van Riel reports data for 136 patients in the etanercept group and

125 patients in the etanercept/MTX group. The analysis shows no

significant difference between the groups in:

Proportion of patients with a DAS28 (4) improvement of >1.2 units at

week 16.

Proportion of patients with a DAS28 (3) improvement of >1.2 units.

Mean improvement in DAS28 (4) scores from baseline to week 16.

Median time to achieve DAS28 (4) improvement >1.2 units.

The risk of flare, defined as a worsening of DAS28 (4) score of >0.6

units, after discontinuation of MTX was a concern but was not

observed in any patients switched from MTX to etanercept.



For the RA patient with an inadequate response to MTX, the first

action would be to replace MTX with etanercept.



" For the RA patient with an inadequate response to MTX, the first

action would be to replace MTX with etanercept. In an individual

case, it is always possible that there might be a need to add MTX

again later if the response to etanercept alone is insufficient. The

TEMPO study has shown that MTX and etanercept can act

synergistically, but in patients with no response to MTX, there is no

(or only very minor) additional effect from the combination, " van

Riel said.

The authors expect their study to have " practical implications for

physicians who are confronted with a patient who has an inadequate

response to MTX, a situation that occurs frequently in clinical

practice, " but they offer several caveats. The most important are

that the ADORE trial was a brief, open-label study, without

radiographic data. " Although there was a decrease in the erythrocyte

sedimentation rate (ESR) in both treatment groups in the current

study, this improvement was significantly greater in the combination

group. This leaves open the possibility that the combination group

may have experienced less radiographic progression over time, as a

higher ESR may indicate continued underlying joint inflammation and

joint damage, " they write.



Van Riel PLCM, Taggart AJ, Sany J, et al. Efficacy and safety of

combination etanercept and methotrexate versus etanercept alone in

patients with rheumatoid arthritis with an inadequate response to

methotrexate: the ADORE study. Ann Rheum Dis 2006; DOI:10.1136/ard.

2005.043299. Available at http://ard.bmjjournals.com.

http://www.jointandbone.org/viewArticle.do?primaryKey=659691