Academic Journal
OP0162 ABATACEPT TREATMENT FOR PATIENTS WITH EARLY ACTIVE PRIMARY SJÖGREN’S SYNDROME: OPEN-LABEL EXTENSION PHASE OF A RANDOMIZED CONTROLLED PHASE III TRIAL
| العنوان: | OP0162 ABATACEPT TREATMENT FOR PATIENTS WITH EARLY ACTIVE PRIMARY SJÖGREN’S SYNDROME: OPEN-LABEL EXTENSION PHASE OF A RANDOMIZED CONTROLLED PHASE III TRIAL |
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| المؤلفون: | Arends, S., Van Nimwegen, J. F., Mossel, E., Van Zuiden, G. S., Delli, K., Stel, A. J., Van der Vegt, B., Haacke, E. A., Olie, L., Los, L., Verstappen, G. M., Pringle, S. A., Spijkervet, F. K. L., Kroese, F. G. M., Vissink, A., Bootsma, H. |
| المصدر: | Annals of the Rheumatic Diseases ; volume 79, issue Suppl 1, page 102.2-102 ; ISSN 0003-4967 1468-2060 |
| بيانات النشر: | BMJ |
| سنة النشر: | 2020 |
| الوصف: | Background: Abatacept (CTLA-4-Ig) targets the CD80/CD86:CD28 co-stimulatory pathway required for full T-cell activation and T-cell dependent activation of B-cells. The Abatacept Sjögren Active Patients phase III (ASAPIII) trial is a mono-center, investigator-initiated, placebo controlled study with an open-label extension phase ( NCT02067910 ), which assessed the efficacy and safety of weekly subcutaneous abatacept (125mg) in patients with early active primary Sjögren’s syndrome (pSS). Previous analyses of the double blind phase showed no significant effect of abatacept treatment compared to placebo on the primary endpoint, difference in EULAR Sjögren’s syndrome disease activity index (ESSDAI) at week 24. 1 Objectives: To evaluate the efficacy and safety of extended (48 weeks) open label abatacept treatment in pSS patients. Methods: Included patients had biopsy-proven pSS, fulfilled the AECG and ACR-EULAR criteria, had disease duration ≤7 years (median 2 years), ESSDAI ≥5, and 89% were anti–SSA positive. All 40 patients who received abatacept (ABA) in week 0-24 were subsequently treated with abatacept from week 24-48. Of the 40 patients who received placebo (PLB) in week 0-24, 2 were lost to follow up, and 38 were treated with abatacept from week 24-48. Systemic disease activity (ESSDAI), patient reported symptoms (ESSPRI), serological outcomes (RF and IgG), ocular staining score (OSS) and unstimulated whole salivary flow (UWS) were assessed. We evaluated whether outcomes improved within treatment groups, from week 0 to subsequent visits and from week 24 to subsequent visits: 1.Within ABA→ABA treated patients: a. Week 0-48 to assess overall efficacy. b. Week 24-48 to assess additional efficacy of long term treatment. 2.Within PLB→ABA treated patients: a. Week 0-24 to assess whether a placebo effect occurred. b. Week 24-48 to assess short-term efficacy of open label ABA. GEE modeling was used to test significance of changes over time. Missing data were not imputed. Results: ESSDAI and ESSPRI were improved within ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| DOI: | 10.1136/annrheumdis-2020-eular.4439 |
| الاتاحة: | http://dx.doi.org/10.1136/annrheumdis-2020-eular.4439 https://syndication.highwire.org/content/doi/10.1136/annrheumdis-2020-eular.4439 |
| رقم الانضمام: | edsbas.F5D740B0 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1136/annrheumdis-2020-eular.4439 |
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