Infliximab in patients with primary Sj�gren's syndrome: A pilot study

Steinfeld, Serge; Demols, Paul; Salmon, Isabelle; Kiss, Róbert; Appelboom, Thierry

doi:10.1002/1529-0131(200110)44:10<2371::aid-art401>3.0.co;2-w

Cited by 143 publications

(63 citation statements)

References 17 publications

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“…However, few of the patients treated with other TNF␣ antagonists that develop anti-DNA antibodies display clinical SLE, and this generally does not involve major organs (10). In another pilot trial in SS patients, the TNF␣ antagonist infliximab was not associated with development of features of clinical SLE, nor with prominent rashes and peripheral neuropathy, as seen in our patients receiving thalidomide (11). In addition, thalidomide has been used in chronic cutaneous lupus with fewer problems in the same dosage range as that planned for our patients.…”

Section: Lettermentioning

confidence: 53%

Prominent adverse effects of thalidomide in primary Sjögren's syndrome

Pillemer¹,

Leakan²,

Sankar³

et al. 2004

Arthritis & Rheumatism

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Section: Lettermentioning

confidence: 53%

Prominent adverse effects of thalidomide in primary Sjögren's syndrome

Pillemer¹,

Leakan²,

Sankar³

et al. 2004

Arthritis & Rheumatism

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“…Steinfeld et al treated 16 patients with primary SS with infliximab, another chimeric monoclonal antibody (42). Infliximab was well tolerated, and all patients completed the study.…”

Section: Discussionmentioning

confidence: 99%

Rituximab treatment in patients with primary Sjögren's syndrome: An open‐label phase II study

Pijpe

Imhoff²,

Spijkervet

et al. 2005

Arthritis & Rheumatism

447

300

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Objective. To investigate the safety and efficacy of B cell depletion treatment of patients with active primary Sjögren's syndrome of short duration (early primary SS) and patients with primary SS and mucosaassociated lymphoid tissue (MALT)-type lymphoma (MALT/primary SS).Methods. Fifteen patients with primary SS were included in this phase II trial. Inclusion criteria for the early primary SS group were B cell hyperactivity (IgG >15 gm/liter), presence of autoantibodies (IgM rheumatoid factor, anti-SSA/SSB), and short disease duration (<4 years). Inclusion criteria for the MALT/ primary SS group were primary SS and an associated MALT-type lymphoma (Ann Arbor stage IE) localized in the parotid gland. Patients were treated with 4 infusions of rituximab (375 mg/m 2 ) given weekly after pretreatment with prednisone (25 mg) and clemastine. Patients were evaluated, using immunologic, salivary/ lacrimal function, and subjective parameters, at baseline and at 5 and 12 weeks after the first infusion.Results. Significant improvement of subjective symptoms and an increase in salivary gland function was observed in patients with residual salivary gland function. Immunologic analysis showed a rapid decrease of peripheral B cells and stable levels of IgG. Human antichimeric antibodies (HACAs) developed in 4 of 15 patients (27%), all with early primary SS. Three of these patients developed a serum sickness-like disorder. Of the 7 patients with MALT/primary SS, complete remission was achieved in 3, and disease was stable in 3 and progressive in 1.Conclusion. Findings of this phase II study suggest that rituximab is effective in the treatment of primary SS. The high incidence of HACAs and associated side effects observed in this study needs further evaluation.

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“…Results of recent open-label studies of a related biologic agent, infliximab, have shown significant improvement in measures of disease activity in SS (15,16). The results of our trial of a TNF␣ blocker differ from those reported by Steinfeld et al for infliximab, a monoclonal antibody directed against this cytokine.…”

Section: Discussionmentioning

confidence: 99%

“…However, clinical trials directed at the autoimmune and inflammatory components of SS have been mostly uncontrolled and of insufficient sample size to draw any definitive conclusions regarding the efficacy of such agents (14). A small, uncontrolled, open-label trial of an anti-TNF␣ antibody, infliximab, given for 3 months to patients with primary SS was reported to be safe and beneficial (15). A 1-year uncontrolled followup study (16) confirmed these initial observations.…”

mentioning

confidence: 93%

Etanercept in Sjögren's syndrome: A twelve‐week randomized, double‐blind, placebo‐controlled pilot clinical trial

Sankar

Brennan

Kok

et al. 2004

Arthritis & Rheumatism

269

107

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Objective. To assess the safety and potential efficacy of etanercept in the treatment of Sjögren's syndrome (SS).Methods. This pilot study was a 12-week randomized, double-blind, placebo-controlled trial of etanercept, with 14 subjects in each group. Patients received 25 mg of etanercept or placebo (vehicle) by twice-weekly subcutaneous injection. Patients met the AmericanEuropean Consensus Group criteria for SS. The primary outcome required at least 20% improvement from baseline values for at least 2 of the following 3 domains: subjective or objective measures of dry mouth, subjective or objective measures of dry eyes, and IgG level or erythrocyte sedimentation rate (ESR).Results. Of the 14 patients taking etanercept, 11 had primary SS and 3 had SS secondary to rheumatoid arthritis. Baseline measures did not differ between the 2 groups. Three etanercept-treated patients and 1 placebo-treated patient did not complete the trial. Five etanercept-treated patients and 3 placebo-treated patients showed improvement from baseline in the primary outcome variable at 12 weeks, but the difference was not statistically significant. There were no significant differences between the groups for changes in subjective measures of oral or ocular symptoms (by visual analog scale), the IgG level, Schirmer I test result, van Bijsterveld score, or salivary flow. At 12 weeks, the ESR had decreased in the etanercept group compared with baseline (P ‫؍‬ 0.004); however, the mean reduction was only 18.6%.Conclusion. We found no evidence to suggest that treatment with etanercept at a dosage of 25 mg twice weekly for 12 weeks was clinically efficacious in SS. A larger trial will be necessary to definitively address the efficacy of etanercept in the treatment of SS.

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Infliximab in patients with primary Sj�gren's syndrome: A pilot study

Cited by 143 publications

References 17 publications

Prominent adverse effects of thalidomide in primary Sjögren's syndrome

Prominent adverse effects of thalidomide in primary Sjögren's syndrome

Rituximab treatment in patients with primary Sjögren's syndrome: An open‐label phase II study

Etanercept in Sjögren's syndrome: A twelve‐week randomized, double‐blind, placebo‐controlled pilot clinical trial

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