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Infliximab Ineffective In Treating Primary Sjögren's Syndrome: Presented at EULAR
By Adrian Burton
LISBON, PORTUGAL -- June 20, 2003 -- Infliximab is not effective in the treatment of primary Sjögren's syndrome (pSS), say researchers.
"pSS is an autoimmune disease that affects some 0.2% of the population and is the second most common inflammatory rheumatism after rheumatoid arthritis - and to date there is no treatment," explained Dr. Xavier Mariette, Professor of Rheumatology at the Hôpital Le Bicêtre, Le-Kremlin Bicêtre, Paris, France. He made his comments here in Lisbon yesterday at the Annual European Congress of Rheumatology
Suggestions have been made, however, that tumour necrosis factor (TNF) may play a role in the development of pSS, an idea supported by the results of a recent pilot trial of infliximab, a monoclonal antibody raised against TNF. In that trial, the antibody appeared to greatly improve the fatigue, joint pain and sicca symptoms of pSS patients.
New research presented yesterday, however, suggests that infliximab is no better than placebo. In a double-blind trial, 103 patients with pSS were enrolled and randomised to receive either infliximab infusions (5 mg/kg at week 0, 2 and 6; n=54) or placebo (n=49). For inclusion, all patients had to score over 50 mm (max. 100 mm) on any 2 of 3 visual analogue scales for joint pain, fatigue and dryness of the mouth, eyes, skin, bronchi or vagina.
At baseline, there were no statistical differences between the two groups in terms of age, pain score, fatigue score, sicca score, salivary flow, Schirmer test score or swollen or tender joint counts etc.
Responders were defined as those who achieved a 30% or greater improvement on the visual analogue scale scores at week 10.
Unfortunately, rather than confirming the promising results of the pilot study, no significant differences were found between the two groups, in terms of number of responders, for any of the parameters measured. For example, 30.6% of patients from the placebo group and 31.5% from the infliximab group were responders (P=0.92), while 22.5% of the former group and 22.2% of the latter were responders in terms of sicca improvement (P=0.98). Other results were similar.
"Infliximab does not appear to be efficient in controlling the clinical or histological signs of this disease," concluded Dr. Mariette.
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