Patients failing a DMARD: to switch to sulfasalazine or to add sulfasalazine to ongoing leflunomide - results from the 12-month relief study

[Guest guest]

Ann Rheum Dis. 2004 Jul 22

Patients failing a DMARD: to switch to sulfasalazine or to add

sulfasalazine to ongoing leflunomide - results from the 12-month relief

study.

Dougados M, Emery P, Lemmel E, Zerbini C, Brin S, Van Riel P.

Hopital Cochin, Paris, France.

OBJECTIVE: To evaluate the efficacy and safety of adding sulfasalazine

to leflunomide treatment versus switching to sulfasalazine alone in

rheumatoid arthritis (RA) patients with an inadequate response to

leflunomide monotherapy. METHODS: Patients with active RA (Disease Activity

Score 28 [DAS 28] >3.2) enrolled in the first open-label phase of the RELIEF

study received leflunomide for 24 weeks. Inadequate responders then entered

the double-blind phase and received a further 24 weeks' treatment with

leflunomide (20 mg once-daily [QD]) plus sulfasalazine (final dose 2 g QD),

or placebo plus sulfasalazine (dose as above). The primary efficacy variable

was the DAS 28 response rate, and secondary efficacy outcomes were American

College of Rheumatology (ACR) 20%, 50% and 70% response rates. Adverse

events, including standard laboratory tests, were recorded. RESULTS: A total

of 106 inadequate responders entered the double-blind phase; 56 received

leflunomide plus sulfasalazine, and 50 received placebo plus sulfasalazine.

In the intent-to-treat population, more patients receiving leflunomide plus

sulfasalazine (44.6%) achieved a DAS 28 response at endpoint versus those

receiving placebo plus sulfasalazine (34.0%) (p=0.179). In the week 24

completers, more patients receiving leflunomide plus sulfasalazine (30.4%)

were DAS 28 responders versus those receiving placebo plus sulfasalazine

(20.0%) (p=0.081). Comparable numbers of patients in each treatment group

were ACR 20% responders; however, the ACR50% response rate was significantly

higher in the leflunomide plus sulfasalazine group (8.9%) versus the placebo

plus sulfasalazine group (0%) (p=0.038). The safety profiles of both

treatment groups were comparable. CONCLUSION: Although small patient numbers

do not allow firm conclusions, these results indicate a favorable, but not

statistically significant benefit for combining leflunomide with

sulfasalazine over switching to sulfasalazine alone in RA patients

inadequately responding to leflunomide.

PMID: 15271770 [PubMed - as supplied by publisher]