RESEARCH - Humira/MTX better than either alone for early, aggressive RA

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Adalimumab/MTX better than either alone for early, aggressive RA

Rheumawire

Jan 19, 2006

Janis

Leiden, the Netherlands - Results from the PREMIER study show that early

combination treatment with adalimumab (Humira, Abbott Laboratories) plus

methotrexate (MTX) is more effective than either drug used alone for

patients with early, aggressive rheumatoid arthritis (RA) [1]. The

combination is significantly better at improving RA signs and symptoms,

slowing radiographic progression, and inducing clinical remission, Dr

Ferdinand C Breedveld (Leiden University Medical Center, the Netherlands)

reports in the January 2006 issue of Arthritis & Rheumatism.

" A reasonable and probably cost-effective approach [to initial treatment of

early, aggressive RA] would then be to start with a cheap combination

therapy, which is methotrexate and corticosteroids in low and decreasing

dosages. If methotrexate alone cannot achieve low disease activity or

remission, the next step should be the combination of a TNF antagonist and

methotrexate. Trying another DMARD would be a waste of time with

irreversible destruction coming in, " Breedveld told rheumawire.

Study compared combination with monotherapy in MTX-naive patients

The PREMIER study, sponsored by Abbott Laboratories, randomized 799 RA

patients with active disease of less than three years' duration who had

never been treated with MTX. Inclusion criteria included >8 swollen joints,

>10 tender joints, an erythrocyte sedimentation rate (ESR) of >28 mm/hr or

C-reactive protein (CRP) concentration of >1.5 mg/dL, and either rheumatoid

factor (RF) positivity or at least one joint erosion. Those who had been

treated with MTX, cyclophosphamide, cyclosporine, azathioprine, or more than

two other DMARDs were excluded.

Patients were assigned to adalimumab (40 mg sc every other week) plus oral

MTX (initial dose 7.5 mg/wk), to oral MTX plus placebo sc injection, or to

adalimumab plus oral placebo.

Remission now seen as a " realistic goal "

The key PREMIER findings were that patients treated with adalimumab/MTX:

Were more likely to have ACR50 response.

Had significantly less radiographic disease progression.

Had less change in joint-space narrowing scores.

Were twice as likely to have no radiographic progression.

Were twice as likely to have DAS28 clinical remission, defined as a score of

<2.6.

Were more likely to maintain ACR70 response for at least six months.

" Remission is now a realistic goal, " Breedveld said.

Early treatment was also considered in the Dutch Behandel Strategieen (BeSt)

study of early RA, for which Breedveld was also lead investigator.

" Both studies show that low disease activity and progression can be achieved

in the majority of early-RA patients. The results shown are completely

different from the cohorts followed a decade ago. Both PREMIER and BeSt show

that combination therapy in early RA is effective and not toxic and that it

is superior to monotherapy. Around 30% of early RA patients can be

controlled by methotrexate monotherapy, but it is not possible to identify

them up front, " Breedveld said.

Source

1. Breedveld FC, Weisman MH, Kavanaugh AF, et al. The PREMIER

Study. A multicenter, randomized, double-blind clinical trial of combination

therapy with adalimumab plus methotrexate versus methotrexate alone or

adalimumab alone in patients with early, aggressive rheumatoid arthritis who

had not had previous methotrexate therapy. Arthritis Rheum 2006; 54:26-37.

Not an MD

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org