Τίτλος:
Efficacy and safety of topical and systemic medications: A systematic literature review informing the EULAR recommendations for the management of Sjögren's syndrome
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
Objective To evaluate current evidence on the efficacy and safety of topical and systemic medications in patients with primary Sjögren syndrome (SjS) to inform European League Against Rheumatism treatment recommendations. Methods The MEDLINE, EMBASE and Cochrane databases were searched for case-control/prospective cohort studies, randomised controlled trials (RCTs) and systematic reviews. Results Current evidence in primary SjS patients fulfilling the 2002 criteria is based on the data from 9 RCTs, 18 prospective cohort studies and 5 case-control studies. Two Cochrane systematic literature reviews (SLRs) have reported that topical treatments for dry mouth and dry eye are safe and effective. Ocular cyclosporine A was safe and effective in two RCTs including 1039 patients with dry eye syndrome. Two Cochrane SLRs on serum tear drops and plugs showed inconsistency in possible benefits, both for symptoms and objective measures. Five RCTs reported significant improvements in oral dryness and salivary flow rates for pilocarpine and cevimeline. An RCT showed no significant placebo-differences for hydroxychloroquine 400 mg/day for the primary outcome (visual analogue scale (VAS) composite of dryness, fatigue and pain). We identified seven RCTs carried out in primary SjS patients. RCTs using infliximab, anakinra and baminercept found no placebo-differences for the primary outcomes. The two largest RCTs randomised 255 patients to receive rituximab or placebo and reported no significant results in the primary outcome (VAS composite), while prospective studies suggested efficacy in systemic disease. Conclusion The current evidence supporting the use of the main topical therapeutic options of primary SjS is solid, while limited data from RCTs are available to guide systemic therapies. © 2019 Author(s).
Συγγραφείς:
Brito-Zerón, P.
Retamozo, S.
Kostov, B.
Baldini, C.
Bootsma, H.
De Vita, S.
Dörner, T.
Gottenberg, J.-E.
Kruize, A.A.
Mandl, T.
Ng, W.-F.
Seror, R.
Tzioufas, A.G.
Vitali, C.
Bowman, S.
Mariette, X.
Ramos-Casals, M.
Περιοδικό:
RMD Open: Rheumatic & Musculoskeletal Diseases
Εκδότης:
BMJ Publishing Group
Λέξεις-κλειδιά:
abatacept; alpha interferon; anakinra; artificial tear; baminercept; belimumab; cevimeline; cyclosporine; diquafosol; epratuzumab; etanercept; glucocorticoid; hydroxychloroquine; infliximab; nonsteroid antiinflammatory agent; pilocarpine; rituximab; saliva substitute; serum tear; tacrolimus; unclassified drug, biological therapy; drug efficacy; drug safety; dry eye; human; immunosuppressive treatment; lacrimal gland; meta analysis; randomized controlled trial (topic); Review; salivation; Sjoegren syndrome; systematic review; systemic therapy; topical treatment; visual analog scale; xerostomia; adverse event; clinical trial (topic); disease management; multimodality cancer therapy; procedures; Sjoegren syndrome; treatment outcome, Clinical Trials as Topic; Combined Modality Therapy; Disease Management; Humans; Sjogren's Syndrome; Treatment Outcome
DOI:
10.1136/rmdopen-2019-001064
