RESEARCH - The PREMIER study: Humira + MTX vs. Humira alone or MTX alone

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Arthritis Rheum. 2005 Dec 29;54(1):26-37 [Epub ahead of print]

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 treatment.

Breedveld FC, Weisman MH, Kavanaugh AF, Cohen SB, Pavelka K, Vollenhoven RV,

Sharp J, JL, Spencer-Green GT.

Leiden University Medical Center, Leiden, The Netherlands.

OBJECTIVE: To compare the efficacy and safety of adalimumab plus

methotrexate (MTX) versus MTX monotherapy or adalimumab monotherapy in

patients with early, aggressive rheumatoid arthritis (RA) who had not

previously received MTX treatment. METHODS: This was a 2-year, multicenter,

double-blind, active comparator-controlled study of 799 RA patients with

active disease of <3 years' duration who had never been treated with MTX.

Treatments included adalimumab 40 mg subcutaneously every other week plus

oral MTX, adalimumab 40 mg subcutaneously every other week, or weekly oral

MTX. Co-primary end points at year 1 were American College of Rheumatology

50% improvement (ACR50) and mean change from baseline in the modified total

Sharp score. RESULTS: Combination therapy was superior to both MTX and

adalimumab monotherapy in all outcomes measured. At year 1, more patients

receiving combination therapy exhibited an ACR50 response (62%) than did

patients who received MTX or adalimumab monotherapy (46% and 41%,

respectively; both P < 0.001). Similar superiority of combination therapy

was seen in ACR20, ACR70, and ACR90 response rates at 1 and 2 years. There

was significantly less radiographic progression (P </= 0.002) among patients

in the combination treatment arm at both year 1 and year 2 (1.3 and 1.9

Sharp units, respectively) than in patients in the MTX arm (5.7 and 10.4

Sharp units) or the adalimumab arm (3.0 and 5.5 Sharp units). After 2 years

of treatment, 49% of patients receiving combination therapy exhibited

disease remission (28-joint Disease Activity Score <2.6), and 49% exhibited

a major clinical response (ACR70 response for at least 6 continuous months),

rates approximately twice those found among patients receiving either

monotherapy. The adverse event profiles were comparable in all 3 groups.

CONCLUSION: In this population of patients with early, aggressive RA,

combination therapy with adalimumab plus MTX was significantly superior to

either MTX alone or adalimumab alone in improving signs and symptoms of

disease, inhibiting radiographic progression, and effecting clinical

remission.

PMID: 16385520

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve & db=pubmed & dopt=Abstra\

ct & list_uids=16385520 & itool=iconabstr & query_hl=13 & itool=pubmed_docsum

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Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

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