PMID- 31058469 OWN - NLM STAT- MEDLINE DCOM- 20201002 LR - 20201002 IS - 2151-4658 (Electronic) IS - 2151-464X (Linking) VI - 72 IP - 7 DP - 2020 Jul TI - Meta-Analysis of Treatment for Primary Sjogren's Syndrome. PG - 1011-1021 LID - 10.1002/acr.23917 [doi] AB - OBJECTIVE: The current focus of treatment in primary Sjogren's syndrome (SS) is symptom management. Since SS is an autoimmune disease with multisystem involvement, systemic immunosuppression may have a role in improving signs and symptoms and preventing progression. We undertook this review to assess the efficacy and safety of immunomodulation on primary SS from randomized clinical trials (RCTs). METHODS: Five electronic databases (Medline, Embase, Central, ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform) were searched to include RCTs for the treatment of SS. Primary outcome measures included ocular dryness, oral dryness, tear production, and salivary function. Serious adverse events (AEs) and withdrawals due to AEs were also assessed. RESULTS: The search yielded 32 trials evaluating 19 different medications. The average duration of diagnosis was long (up to 9.2 years). Twenty-two trials examined ocular and oral dryness, for which only 2 and 4 trials showed statistically significant improvements, respectively. No studies found a benefit for tear production; few studies found improvements for unstimulated salivary flow (3 of 16 RCTs) and stimulated salivary flow (2 of 14 RCTs). Meta-analysis at 6 months found improvements as compared to placebo for unstimulated salivary flow (P = 0.003) and a decrease in the erythrocyte sedimentation rate (P = 0.007). No differences were seen for serious AEs, but there were increased withdrawals from AEs (risk ratio 2.33; P = 0.03). CONCLUSION: Reducing inflammation potentially improves salivary gland function. No individual immunomodulatory drug demonstrated a consistent benefit in xerostomia and xerophthalmia. Further work is needed to identify SS patients with an ability to improve and with outcomes that are valid and sensitive to change within clinical trials. Tradeoffs in the future between benefit and safety may also be important, because more withdrawals occurred with active treatment. CI - (c) 2019, American College of Rheumatology. FAU - Chu, Lucy L AU - Chu LL AD - Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada. FAU - Cui, Kangping AU - Cui K AD - Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada. FAU - Pope, Janet E AU - Pope JE AUID- ORCID: 0000-0003-1479-5302 AD - Schulich School of Medicine and Dentistry, Western University, and St. Joseph's Health Care, London, Ontario, Canada. LA - eng PT - Journal Article PT - Meta-Analysis DEP - 20200607 PL - United States TA - Arthritis Care Res (Hoboken) JT - Arthritis care & research JID - 101518086 RN - 0 (Immunosuppressive Agents) SB - IM MH - Humans MH - Immunomodulation MH - Immunosuppressive Agents/*therapeutic use MH - Sjogren's Syndrome/complications/*drug therapy MH - Treatment Outcome MH - Xerophthalmia/drug therapy/etiology MH - Xerostomia/drug therapy/etiology EDAT- 2019/05/07 06:00 MHDA- 2020/10/03 06:00 CRDT- 2019/05/07 06:00 PHST- 2018/12/26 00:00 [received] PHST- 2019/04/30 00:00 [accepted] PHST- 2019/05/07 06:00 [pubmed] PHST- 2020/10/03 06:00 [medline] PHST- 2019/05/07 06:00 [entrez] AID - 10.1002/acr.23917 [doi] PST - ppublish SO - Arthritis Care Res (Hoboken). 2020 Jul;72(7):1011-1021. doi: 10.1002/acr.23917. Epub 2020 Jun 7.