Etanercept in Sjögren's syndrome: a pilot-randomized, double-blind, placebo-controlled clinical trial

Abstract

ObjectiveTo assess the safety and potential efficacy of etanercept in the treatment of Sjögren's syndrome (SS).Study designThis pilot study was a 12-week, randomized, placebo-controlled, double-blind trial of etanercept with 14 subjects in each group. Patients received 25 mg of etanercept or placebo by twice weekly subcutaneous injections. Patients met American-European classification criteria for SS. The primary outcome required at least 20% improvement from baseline values for at least 2 of 3 of the following: 1) subjective or objective measures of dry mouth; 2) subjective or objective measures of dry eyes; 3) IgG or ESR.ResultsOf the 14 subjects on etanercept, 11 had primary SS and 3 had SS secondary to RA. Mean baseline measures did not differ between groups. Three etanercept and 1 placebo patient did not complete the trial. Five etanercept and 3 placebo subjects showed improvement at 12 weeks compared with baseline in the primary outcome, which was not significant (P = .2). No significant differences occurred between the groups for changes over the trial in subjective oral or ocular measures (visual analog scales), IgG, Schirmer I test, Van Bijsterveld scores, or salivary flow. ESR decreased in the etanercept group after adjusting for baseline levels (P = .0147). However, the level of improvement was not clinically meaningful (18.6%).Conclusions1) Treatment with etanercept 25 mg twice weekly for 12-weeks was not beneficial in SS. 2) No clinically meaningful improvement was noted for any outcomes. ObjectiveTo assess the safety and potential efficacy of etanercept in the treatment of Sjögren's syndrome (SS). To assess the safety and potential efficacy of etanercept in the treatment of Sjögren's syndrome (SS). Study designThis pilot study was a 12-week, randomized, placebo-controlled, double-blind trial of etanercept with 14 subjects in each group. Patients received 25 mg of etanercept or placebo by twice weekly subcutaneous injections. Patients met American-European classification criteria for SS. The primary outcome required at least 20% improvement from baseline values for at least 2 of 3 of the following: 1) subjective or objective measures of dry mouth; 2) subjective or objective measures of dry eyes; 3) IgG or ESR. This pilot study was a 12-week, randomized, placebo-controlled, double-blind trial of etanercept with 14 subjects in each group. Patients received 25 mg of etanercept or placebo by twice weekly subcutaneous injections. Patients met American-European classification criteria for SS. The primary outcome required at least 20% improvement from baseline values for at least 2 of 3 of the following: 1) subjective or objective measures of dry mouth; 2) subjective or objective measures of dry eyes; 3) IgG or ESR. ResultsOf the 14 subjects on etanercept, 11 had primary SS and 3 had SS secondary to RA. Mean baseline measures did not differ between groups. Three etanercept and 1 placebo patient did not complete the trial. Five etanercept and 3 placebo subjects showed improvement at 12 weeks compared with baseline in the primary outcome, which was not significant (P = .2). No significant differences occurred between the groups for changes over the trial in subjective oral or ocular measures (visual analog scales), IgG, Schirmer I test, Van Bijsterveld scores, or salivary flow. ESR decreased in the etanercept group after adjusting for baseline levels (P = .0147). However, the level of improvement was not clinically meaningful (18.6%). Of the 14 subjects on etanercept, 11 had primary SS and 3 had SS secondary to RA. Mean baseline measures did not differ between groups. Three etanercept and 1 placebo patient did not complete the trial. Five etanercept and 3 placebo subjects showed improvement at 12 weeks compared with baseline in the primary outcome, which was not significant (P = .2). No significant differences occurred between the groups for changes over the trial in subjective oral or ocular measures (visual analog scales), IgG, Schirmer I test, Van Bijsterveld scores, or salivary flow. ESR decreased in the etanercept group after adjusting for baseline levels (P = .0147). However, the level of improvement was not clinically meaningful (18.6%). Conclusions1) Treatment with etanercept 25 mg twice weekly for 12-weeks was not beneficial in SS. 2) No clinically meaningful improvement was noted for any outcomes. 1) Treatment with etanercept 25 mg twice weekly for 12-weeks was not beneficial in SS. 2) No clinically meaningful improvement was noted for any outcomes.