ABSTRACT
OBJECTIVES: To study the effects of abatacept on disease activity and on muscle biopsy features of adult patients with dermatomyositis (DM) or polymyositis (PM). METHODS: Twenty patients with DM (n=9) or PM (n=11) with refractory disease were enrolled in a randomised treatment delayed-start trial to receive either immediate active treatment with intravenous abatacept or a 3 month delayed-start. The primary endpoint was number of responders, defined by the International Myositis Assessment and Clinical Studies Group definition of improvement (DOI), after 6 months of treatment. Secondary endpoints included number of responders in the early treatment arm compared with the delayed treatment arm at 3 months. Repeated muscle biopsies were investigated for cellular markers and cytokines. RESULTS: 8/19 patients included in the analyses achieved the DOI at 6 months. At 3 months of study, five (50%) patients were responders after active treatment but only one (11%) patient in the delayed treatment arm. Eight adverse events (AEs) were regarded as related to the drug, four mild and four moderate, and three serious AEs, none related to the drug. There was a significant increase in regulatory T cells (Tregs), whereas other markers were unchanged in repeated muscle biopsies. CONCLUSIONS: In this pilot study, treatment of patients with DM and PM with abatacept resulted in lower disease activity in nearly half of the patients. In patients with repeat muscle biopsies, an increased frequency of Foxp3+ Tregs suggests a positive effect of treatment in muscle tissue.
Subject(s)
Abatacept/administration & dosage , Dermatomyositis/drug therapy , Immunosuppressive Agents/administration & dosage , Polymyositis/drug therapy , Adult , Drug Administration Schedule , Female , Humans , Male , Middle Aged , Pilot Projects , Treatment OutcomeABSTRACT
The aim of the study was to evaluate whether topical application of 0.2% glyceryl trinitrate ointment could reduce post-haemorrhoidectomy healing time and pain both at rest and during defecation. Thirty patients with grade III and IV haemorrhoids were included in the study and divided into two groups. All patients underwent Milligan-Morgan haemorrhoidectomy, and anorectal manometry was performed before surgery and after 5 and 30 days. In one group a placebo ointment was applied to the perianal wounds, while in the other group a 0.2% glyceryl trinitrate ointment was used. Maximum resting pressure was reduced in the glyceryl trinitrate group and increased in the placebo group after 5 days. Postoperative pain both at rest and during defecation, and the time to healing and return to normal activity were significantly reduced in the glyceryl trinitrate group, whilst analgesic consumption was similar. An elevated incidence of headache was observed In the glyceryl trinitrate group. Topical application of glyceryl trinitrate was effective in reducing postoperative pain and healing time, but the substantial incidence of side effects may limit its extensive use.
