Rituximab Holds Promise for Treating Sjogren's Syndrome

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Rituximab Holds Promise for Treating Sjogren's Syndrome

By Matas A. Loewy

VIENNA (Reuters Health) Jun 13 - Anti-CD20 monoclonal antibody

rituximab (Rituxan), currently approved for non-Hodgkin's lymphoma, may

be useful in treating patients with primary Sjogren's syndrome, the

results of two small, open-label phase II studies suggest.

In the first trial, Dr. Valrie Devauchelle-Pensec and colleagues from

the Centre Hospitalier Universitaire, in Brest, France, treated 16

primary Sjogren's syndrome patients with rituximab infusions (375

mg/m2) at week 0 and week 1, with follow-up at 12 weeks. All patients

fulfilled the new American-European consensus group criteria for the

syndrome, had active disease and did not receive corticosteroid drugs

as adjuvant treatment.

The treatment achieved a complete depletion of CD20 levels by week 12

and it was in general " well tolerated, " the researchers reported here

last Friday at the Annual European Congress of Rheumatology.

The investigators were unable to prove an objective reduction of

dryness by means of conventional methods, such as the Shirmer test. But

Doppler waveform analysis of salivary glands showed significant

improvements and " patients had a statistically significant favorable

response in subjective criteria such as fatigue and dryness, " they

said.

According to Dr. Devauchelle-Pensec, the results are encouraging, but

larger placebo-controlled studies are needed. " Now we plan to study 150

patients with recent onset of the disease, as those suffering from

long-standing Sjogren's syndrome have a lesser response rate, " she told

Reuters Health.

In a related phase II, open-label trial, researchers from the

University Medical Centre of Groningen in the Netherlands tested

rituximab in eight patients with early Sjgren's syndrome and in seven

patients who also had lymphoma (MALT-type). Four once-a-week infusions

of rituximab (375 mg/m2) were administered, with prednisone and

clemastine given as premedication.

The investigative team led by Dr. Jan Pijpe observed " significant

improvement " in subjective symptoms, along with increase in salivary

gland function in five of the eight patients with early Sjogren's

syndrome and in two of the seven patients with Sjogren's and MALT with

residual salivary gland function.

However, because three patients with early Sjogren's syndrome developed

a " clinical picture compatible with serum sickness, " the researchers

suggest that higher dose of prednisone or other concurrent

immunosuppressive therapy may be necessary when using rituximab in

patients with active Sjogren's syndrome.