RESEARCH - Comparison of efficacy and safety of subcutaneous versus oral MTX

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Arthritis Rheum. 2008 Jan;58(1):73-81.

Comparison of the clinical efficacy and safety of subcutaneous versus

oral administration of methotrexate in patients with active rheumatoid

arthritis: results of a six-month, multicenter, randomized,

double-blind, controlled, phase IV trial.

Braun J, Kästner P, Flaxenberg P, Währisch J, Hanke P, Demary W, von

Hinüber U, Rockwitz K, Heitz W, Pichlmeier U, Guimbal-Schmolck C,

Brandt A; MC-MTX.6/RH Study Group.

Rheumazentrum Ruhrgebiet, Herne, Germany.

OBJECTIVE: To compare the efficacy and safety of subcutaneous (SC)

versus oral administration of methotrexate (MTX) in patients with

active rheumatoid arthritis (RA). METHODS: MTX-naive patients with

active RA (Disease Activity Score in 28 joints >or= 4) were eligible

for the study if they had not previously taken biologic agents and had

not taken disease-modifying antirheumatic drugs for 2 weeks prior to

randomization. Patients were randomly assigned to receive 15 mg/week

of MTX either orally (2 7.5-mg tablets plus a dummy prefilled syringe;

n=187 patients) or SC (prefilled syringe containing 10 mg/ml plus 2

dummy tablets; n=188 patients) for 24 weeks. At week 16, patients who

did not meet the American College of Rheumatology criteria for 20%

improvement (ACR20) were switched from 15 mg of oral MTX to 15 mg of

SC MTX and from 15 mg of SC MTX to 20 mg of SC MTX for the remaining 8

weeks, still in a blinded manner. The primary outcome was an ACR20

response at 24 weeks. RESULTS: At week 24, significantly more patients

treated with SC MTX than with oral MTX showed ACR20 (78% versus 70%)

and ACR70 (41% versus 33%) responses. Patients with a disease duration

>or= 12 months had even higher ACR20 response rates (89% for SC

administration and 63% for oral). In 52 of the ACR20 nonresponders

(14%), treatment was switched at week 16. Changing from oral to SC MTX

and from 15 mg to 20 mg of SC MTX resulted in 30% and 23% ACR20

response rates, respectively, in these patients. MTX was well

tolerated. The rate of adverse events was similar in all groups.

CONCLUSION: This 6-month prospective, randomized, controlled trial is

the first to examine oral versus SC administration of MTX. We found

that SC administration was significantly more effective than oral

administration of the same MTX dosage. There was no difference in

tolerability.

PMID: 18163521

http://www.ncbi.nlm.nih.gov/pubmed/18163521

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