RESEARCH - Comparison of efficacy and safety of subcutaneous versus oral administration of MTX in patients with active RA

[Guest guest]

Arthritis Rheum. 2007 Dec 28;58(1):73-81 [Epub ahead of print]

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;

MCâ€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 >/=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 >/=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/sites/entrez?cmd=Retrieve & db=PubMed & list_uids=181635\

21 & dopt=AbstractPlus

Not an MD