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Leflunomide improves symptoms of dactylitis, fatigue, skin disease among patients with PsA, researchers report

Monday, June 18 2007 | Comments

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What's This? Leflunomide is effective and well tolerated in the treatment of psoriatic arthritis in daily clinical practice, with benefits in dactylitis, fatigue, and skin disease, according to study findings.

"We've heard a lot of data on the anti-TNF [agents]; we have excellent evidence for these drugs, but these are second-line," said Dr. Frank Behrens, the lead researcher who presented the data. "What we are missing is evidence for our first-line treatments, like methotrexate [and other] traditional [disease-modifying antirheumatic drugs] ...."

To evaluate the effectiveness and safety of leflunomide in the treatment of PsA in daily clinical practice, researchers conducted a prospective 24-week observational study of 330 adults with active PsA who were treated with leflunomide. All patients received a loading dose of leflunomide 100 mg/day for 3 days, followed by leflunomide 20 mg/d thereafter. Patients who were already receiving methotrexate received leflunomide as an add-on therapy.

Response according to Psoriatic Arthritis Response Criteria (PsARC) served as the primary efficacy measure; secondary measures included the proportion of patients with improvement in pain (as measured by the 5-point Likert scale), dactylitis, fatigue, and skin disease (as evaluated using physician's assessment of skin status).

Among the 315 patients with sufficient data available, 78.1% (95% CI, 73.1%-82.5%) achieved PsARC at 24 weeks.

Compared with baseline, significant improvements in dactylitis (P<.0001) were observed among 49.7% of patients.

"We thought that conventional DMARDs have no effect on dactylitis ... but at the end of the study, nearly 70% have no signs of dactylitis," said Dr. Behrens.

Skin evaluations also improved among patients, with 57.7% achieving "very good" status.

"Only 3% of patients included in the study had 'very good' skin status at the start of the therapy, and at the end, 75% of the patients had 'very good' or 'good' [status] ...," Dr. Behrens noted.

Further, 84.2% of patients experienced significant improvements in pain from baseline (P<.0001), and 64.7% experienced significant improvements in fatigue (P<.0001).

Forty-five patients (13.6%) experienced a total of 71 adverse events. The most common adverse events included diarrhea--which made up 16.9% of all adverse reactions--alopecia (11.3%), and pruritus (5.6%). Two patients had a total of 3 serious adverse events, including increased serum glutamic pyruvic transaminase, hypertensive crisis, and increased transaminases. Not one of these events was fatal.

"Interestingly, we have no higher amount of side effects ... in combination methotrexate and leflunomide," Dr. Behrens said.

"So, in conclusion, we think that we can use leflunomide as a first-line treatment option in patients with active PsA and arthritis," Dr. Behrens said. "The effect is not only on peripheral arthritis, but also on dactylitis, fatigue, and skin disease." (Behrens F, et al. Abstract #OP0149.)

This information may concern a use that has not been approved by the Food and Drug Administration.

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