OP0027 TIME TO FLARE AND GLUCOCORTICOID EXPOSURE IN PATIENTS WITH NEW-ONSET VERSUS RELAPSING GIANT CELL ARTERITIS TREATED WITH TOCILIZUMAB OR PLACEBO PLUS PREDNISONE TAPERING: 3-YEAR RESULTS FROM A RANDOMIZED CONTROLLED PHASE 3 TRIAL
| العنوان: | OP0027 TIME TO FLARE AND GLUCOCORTICOID EXPOSURE IN PATIENTS WITH NEW-ONSET VERSUS RELAPSING GIANT CELL ARTERITIS TREATED WITH TOCILIZUMAB OR PLACEBO PLUS PREDNISONE TAPERING: 3-YEAR RESULTS FROM A RANDOMIZED CONTROLLED PHASE 3 TRIAL |
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| المؤلفون: | Martin Aringer, Robert Spiera, Bhaskar Dasgupta, Daniel Engelbert Blockmans, Min Bao, Elisabeth Brouwer, M. C. Cid, Sebastian Unizony, Carlo Salvarani, Helen Spotswood, John H. Stone, Jürgen Rech |
| المصدر: | Annals of the Rheumatic Diseases. 79:20.1-20 |
| بيانات النشر: | BMJ, 2020. |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | medicine.medical_specialty, education.field_of_study, business.industry, Immunology, Population, medicine.disease, Placebo, General Biochemistry, Genetics and Molecular Biology, New onset, Giant cell arteritis, chemistry.chemical_compound, Tocilizumab, Rheumatology, chemistry, Prednisone, Internal medicine, Immunology and Allergy, Medicine, In patient, business, education, Glucocorticoid, medicine.drug |
| الوصف: | Background:In part 1 of the 52-week, double-blind GiACTA trial, tocilizumab (TCZ) every week (QW) or every other week (Q2W) + prednisone tapering reduced the risk for flare versus placebo (PBO) + 26-week prednisone tapering among patients with new-onset giant cell arteritis (GCA) at baseline. Among patients with relapsing GCA, TCZ QW but not Q2W + prednisone reduced the risk for flare versus both PBO groups, and there was separation in the time to flare between the TCZ QW and Q2W groups.1Objectives:To report time to first flare and potential cumulative glucocorticoid (GC) sparing over 3 years of the GiACTA trial (part 1 + 2-year open-label part 2) among patients with new-onset or relapsing GCA.Methods:At the end of part 1, patients entered open-label part 2, in which GCA therapy (including initiation/termination of open-label TCZ and/or GCs) was given at the investigator’s discretion according to disease status. Time to first GCA flare during the 3-year study period was assessed using Kaplan-Meier analysis for patients in the intention-to-treat population according to disease onset status at baseline (new-onset/relapsing) based on their originally assigned treatment groups: TCZ QW, TCZ Q2W, or pooled PBO (PBO+26-week and PBO+52-week prednisone taper).Results:Among patients randomly assigned in part 1, 47 of 100 (47%) in the TCZ QW group, 26 of 49 (53%) in the TCZ Q2W group, and 46 of 101 (46%) in the pooled PBO group had new-onset GCA at baseline; the rest had relapsing GCA. Median time to first flare over 3 years was longer for patients assigned to TCZ treatment in part 1 than for patients assigned to PBO; Kaplan-Meier analysis showed a clear separation between the TCZ QW and the pooled PBO groups over 3 years for patients with new-onset and relapsing GCA (Figure 1A). Separation between the TCZ QW and TCZ Q2W groups was also observed over 3 years in patients with new-onset and relapsing GCA, although this was more evident in patients with relapsing GCA (Figure 1B). Higher proportions of patients in the TCZ QW group (new-onset, 49%; relapsing, 47%) than the pooled PBO group (new-onset, 28%; relapsing, 31%) and the TCZ Q2W group (new-onset, 27%; relapsing, 35%) remained flare-free during their entire treatment period. Cumulative prednisone dose over 3 years was lower for patients originally assigned to TCZ QW versus those originally assigned to PBO for patients with new-onset GCA and those with relapsing GCA at baseline (Figure 2).Conclusion:In this 3-year analysis of GiACTA parts 1 and 2, time to first flare favored TCZ QW over TCZ Q2W in patients with new-onset and relapsing GCA. TCZ QW delayed time to first flare and resulted in lower cumulative GC exposure compared with PBO in patients with new-onset and relapsing GCA, supporting TCZ QW dosing in patients with GCA regardless of disease onset.References:[1]Stone JH et al. N Engl J Med 2017;377:317-28.Disclosure of Interests:John H. Stone Grant/research support from: Roche, Consultant of: Roche, Helen Spotswood Shareholder of: Roche Products Ltd, Employee of: Roche Products Ltd, Sebastian Unizony Grant/research support from: Genentech, Inc., Martin Aringer Consultant of: Boehringer Ingelheim, Roche, Speakers bureau: Boehringer Ingelheim, Roche, Daniel Blockmans Consultant of: yes, Speakers bureau: yes, Elisabeth Brouwer Consultant of: Roche (consultancy fee 2017 and 2018 paid to the UMCG), Speakers bureau: Roche (2017 and 2018 paid to the UMCG), Maria C. Cid Speakers bureau: Roche, Bhaskar Dasgupta Grant/research support from: Roche, Consultant of: Roche, Sanofi, GSK, BMS, AbbVie, Speakers bureau: Roche, Jürgen Rech Consultant of: BMS, Celgene, Novartis, Roche, Chugai, Speakers bureau: AbbVie, Biogen, BMS, Celgene, MSD, Novartis, Roche, Chugai, Pfizer, Lilly, Carlo Salvarani: None declared, Robert Spiera Grant/research support from: Roche-Genetech, GSK, Boehringer Ingelheim, Chemocentryx, Corbus, Forbius, Sanofi, Inflarx, Consultant of: Roche-Genetech, GSK, CSL Behring, Sanofi, Janssen, Chemocentryx, Forbius, Mistubishi Tanabe, Min Bao Shareholder of: Roche, Employee of: Genentech |
| تدمد: | 1468-2060 0003-4967 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_________::cd88ce962f86a4d64bf5386b7188ce52 https://doi.org/10.1136/annrheumdis-2020-eular.1538 |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi...........cd88ce962f86a4d64bf5386b7188ce52 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 14682060 00034967 |
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