A prospective, open-label, non-comparative study of ambrisentan with anti-fibrotic agent combination therapy in the treatment of diffuse systemic sclerosis.

BACKGROUND: Systemic Sclerosis is a multifactorial autoimmune rheumatic disease characterized by inflammation, fibrosis, immune dysregulation and vascular dysfunction. METHODS: An open label, prospective, non-comparative study evaluating ambrisentan with an antifibrotic agent in diffuse cutaneous systemic sclerosis (dcSSc). Recruited 15 consecutive patients with dcSSc who were already on a stable dose of an antifibrotic agent and if they met inclusion criteria they were initiated on ambrisentan 5 mg/day for 12 months. Primary outcome measure was the modified Rodnan skin score (mRSS) while secondary measures were the short form 36 (SF-36) questionnaire, the Medsger severity score and pulmonary function studies. RESULTS: Fifteen patients were recruited and ten patients completed all 12 months of the study. An intention to treat was used to analyze the data. There was statistical improvement of the mean mRSS and the perceived change in health component of the SF-36. The Medsger severity score and pulmonary function studies remained unchanged over the course of the study. CONCLUSION: Patients who tolerated the combination of an antifibrotic with ambrisentan had an improvement of their mRSS over the course of the study as well as an improvement of their perceived health. TRIAL REGISTRATION: Clinicaltrials.gov, NCT01093885; March 2010.

Can Probiotic Supplements Improve Outcomes in Rheumatoid Arthritis?

PURPOSE OF REVIEW: The purpose of this review is to frame the discussion of the potential use of probiotics for the management of rheumatoid arthritis (RA) in the historical and scientific context linking the human microbiota to the etiology, pathogenesis, and treatment of RA. Given this context, the review then details the clinical trials that have been carried out so far that have tried to address the question. RECENT FINDINGS: A variety of laboratory and clinical observations link the flora of the oral cavity and lower gastrointestinal tract with citrullination, as well as immunological alterations that may contribute to the risk of developing RA. Clinical trials to date have been small and mostly short term. Statistically significant change in certain disparate clinical endpoints has been reported, but these endpoints have varied from study to study and have been of limited clinical significance. No consistent, robust impact on patient reported, or laboratory outcome measures has emerged from clinical trials so far. There remain theoretical reasons to further investigate the use of probiotics as adjunctive therapies for autoimmune disease, but changes in trial design may be needed to reveal the benefit of this intervention.