Inefficacy of Remicade in primary Sjogren's syndrome

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Arthritis Rheum. 2004 Apr;50(4):1270-6.

Inefficacy of infliximab in primary Sjogren's syndrome: results of the

randomized, controlled Trial of Remicade in Primary Sjogren's Syndrome

(TRIPSS).

Mariette X, Ravaud P, Steinfeld S, Baron G, Goetz J, Hachulla E, Combe

B, Puechal X, Pennec Y, Sauvezie B, Perdriger A, Hayem G, Janin A,

Sibilia J.

Service de Rhumatologie, Hopital de Bicetre AP-HP, and Universite

Paris-Sud, Le Kremlin Bicetre, France.

xavier.mariette@...

OBJECTIVE: There is no effective treatment for patients with primary

Sjogren's syndrome (SS). Since tumor necrosis factor alpha (TNF alpha)

could be a key element in the pathogenesis of primary SS, we conducted a

multicenter, randomized, double-blind, placebo-controlled trial to

evaluate the effect of infliximab in primary SS. METHODS: A total of 103

patients with primary SS were randomly assigned to receive infliximab

infusions (5 mg/kg) or placebo at weeks 0, 2, and 6 and were followed up

for 22 weeks. All patients fulfilled the new American-European Consensus

Group criteria for SS and had active disease as assessed by values >50

mm on 2 of 3 visual analog scales (VAS) (0-100 mm) that evaluated joint

pain, fatigue, and buccal, ocular, skin, vaginal, or bronchial dryness.

A favorable overall response was defined as the patient having > or =30%

improvement between weeks 0 and 10 in the values on 2 of the 3 VAS.

Secondary end points were values on each VAS separately, the number of

tender and swollen joints, the basal salivary flow rate, results of the

Schirmer test for lacrimal gland function, the focus score on labial

salivary gland biopsy, the level of C-reactive protein, and the

erythrocyte sedimentation rate evaluated at weeks 0, 10, and 22, as well

as quality of life evaluated by use of the generic Short Form 36

questionnaire administered at weeks 0, 10, and 22. RESULTS: At week 10,

26.5% of patients receiving placebo and 27.8% of patients treated with

infliximab had a favorable overall response (P = 0.89), and at week 22,

20.4% of the placebo group and 16.7% of the infliximab group had a

favorable response (P = 0.62). In addition, the 2 groups did not differ

in any of the secondary end points over the 22 weeks of the trial.

Severe adverse events reported in the infliximab group did not differ

from those observed in previous studies.

CONCLUSION: This randomized, double-blind, placebo-controlled study of

an anti-TNF agent did not show any evidence of efficacy of infliximab in

primary SS.

PMID: 15077311

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