Low-dose methotrexate with leucovorin (folinic acid) in the management of RA

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Arthritis Rheum. 1993 Jun;36(6):795-803.

Comment in:

ACP J Club. 1994 Jan-Feb;120 Suppl 1:14.

Arthritis Rheum. 1994 Mar;37(3):444-5.

Low-dose methotrexate with leucovorin (folinic acid) in the management

of rheumatoid arthritis. Results of a multicenter randomized,

double-blind, placebo-controlled trial.

Shiroky JB, Neville C, Esdaile JM, Choquette D, Zummer M, Hazeltine M,

Bykerk V, Kanji M, St-Pierre A, Robidoux L, et al.

Division of Rheumatology, Montreal General Hospital, Quebec, Canada.

OBJECTIVE. To determine whether the side effects of methotrexate can be

decreased by the concurrent use of leucovorin, without affecting the

efficacy of the methotrexate. METHODS. We conducted a multicenter

randomized, double-blind, placebo-controlled trial of leucovorin

administration, 2.5-5.0 mg orally, to be given 24 hours after the

single, weekly, oral dose of methotrexate. Every 3 weeks for 52 weeks,

patients were evaluated for rheumatic disease activity and side effects.

Dosage adjustments for both methotrexate and leucovorin were made as

needed, according to a defined protocol. The primary outcome evaluated

was the frequency of study withdrawals because of side effects and/or

inefficacy. Secondary outcomes evaluated included the frequency of side

effects and the relative efficacy of methotrexate in the leucovorin and

placebo treatment groups. RESULTS. Ninety-two evaluable patients were

analyzed (44 took leucovorin and 48 placebo). Twenty-two patients

withdrew early because of side effects unresponsive to our protocol, and

1 because of inefficacy; 17 had been taking placebo and 6 had been

taking leucovorin (35% versus 14%, P < 0.02). The number of visits

during which side effects were reported was reduced by almost 50% in the

leucovorin treatment group (P < 0.001). There were significant

reductions in the frequencies of all common side effects. At 52 weeks,

disease activity was similar in both patient groups.

CONCLUSION. The methotrexate-leucovorin protocol used significantly

reduces common side effects of methotrexate therapy without

significantly altering efficacy.

PMID: 8507221

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