AB0509 SUSPENSIVE EFFICACY OF TOCILIZUMAB IN TREATMENT-NAÏVE PATIENTS WITH TAKAYASU ARTERITIS: TOCITAKA FRENCH PROSPECTIVE MULTICENTER OPEN-LABELLED TRIAL. (13th June 2020)
- Record Type:
- Journal Article
- Title:
- AB0509 SUSPENSIVE EFFICACY OF TOCILIZUMAB IN TREATMENT-NAÏVE PATIENTS WITH TAKAYASU ARTERITIS: TOCITAKA FRENCH PROSPECTIVE MULTICENTER OPEN-LABELLED TRIAL. (13th June 2020)
- Main Title:
- AB0509 SUSPENSIVE EFFICACY OF TOCILIZUMAB IN TREATMENT-NAÏVE PATIENTS WITH TAKAYASU ARTERITIS: TOCITAKA FRENCH PROSPECTIVE MULTICENTER OPEN-LABELLED TRIAL.
- Authors:
- Mekinian, A.
Saadoun, D.
Jerome.Connault@chu-Nantes.Fr, J. C. N. F.
I-Quere@chu-Montpellier.Fr, I. Q. M. F.
Jégo, P.
Nicolas.Limal@aphp.Fr, N. L. F.
Wxv, W.
Gottenberg, J. E.
Vautier, M.
Lea.Savey@aphp.Fr, L. S. F.
Cacoub, P.
Fain, O. - Abstract:
- Abstract : Objectives: To assess long term efficacy of tocilizumab in treatment-naive patients with Takayasu arteritis (TAK). Methods: In this multicenter, prospective, open-labelled trial, we aim to evaluate the benefit of adding tocilizumab to steroids in treatment-naïve patients with TAK, on discontinuation of steroids after 6 months of tocilizumab treatment, and to assess relapse-free survival following tocilizumab discontinuation. Results: Thirteen patients with TAK were included, with a median age of 32 years [19-45] and 12 (92%) females. Six (54%) patients met the primary end-point. Among 11 (85%) patients which achieved remission at 6 months, 6 (54%) have reached primary endpoint.. Among the 5 remaining patients which continued steroids, 3 had a prednisone-equivalent dosage < 5mg/day. A significant decrease of disease activity was observed after 6 months of tocilizumab therapy: decrease of median NIH scale (3 [3-4] at baseline, versus 1 [0-2] after 6 months; p <0.001), ITAS-2010 score (5 [2-7] versus 3 [0-8]; p = 0.002), and ITAS-A score (7 [4-10] versus 4 [1-15]; p = 0.0001)]. All patients discontinued tocilizumab after 7 infusions, and no other immunosuppressive drugs was introduced, except for 1 patient which received methotrexate. After 9 and 12 months, respectively 7 (54%) and 6 (50%) patients achieved remission with less than 7.5 mg/day of prednisone, and 9 (69%) and 9 (75%) with doses <10 mg/day. During the 12 months follow-up after tocilizumabAbstract : Objectives: To assess long term efficacy of tocilizumab in treatment-naive patients with Takayasu arteritis (TAK). Methods: In this multicenter, prospective, open-labelled trial, we aim to evaluate the benefit of adding tocilizumab to steroids in treatment-naïve patients with TAK, on discontinuation of steroids after 6 months of tocilizumab treatment, and to assess relapse-free survival following tocilizumab discontinuation. Results: Thirteen patients with TAK were included, with a median age of 32 years [19-45] and 12 (92%) females. Six (54%) patients met the primary end-point. Among 11 (85%) patients which achieved remission at 6 months, 6 (54%) have reached primary endpoint.. Among the 5 remaining patients which continued steroids, 3 had a prednisone-equivalent dosage < 5mg/day. A significant decrease of disease activity was observed after 6 months of tocilizumab therapy: decrease of median NIH scale (3 [3-4] at baseline, versus 1 [0-2] after 6 months; p <0.001), ITAS-2010 score (5 [2-7] versus 3 [0-8]; p = 0.002), and ITAS-A score (7 [4-10] versus 4 [1-15]; p = 0.0001)]. All patients discontinued tocilizumab after 7 infusions, and no other immunosuppressive drugs was introduced, except for 1 patient which received methotrexate. After 9 and 12 months, respectively 7 (54%) and 6 (50%) patients achieved remission with less than 7.5 mg/day of prednisone, and 9 (69%) and 9 (75%) with doses <10 mg/day. During the 12 months follow-up after tocilizumab discontinuation, a relapse occurred among 5 patients (45%) out of 11 in which achieved remission after 6 months of tocilizumab. No severe AEs were considered related to study treatment and none required tocilizumab interruption or dose reduction. No deaths have occurred during the study period. Conclusion: Tocilizumab seems an effective steroid sparing therapy in TAK but its effect appears to be suspensive. Disclosure of Interests: Arsene Mekinian: None declared, david Saadoun: None declared, jerome.connault@chu-nantes.fr jerome.connault@chu-nantes.fr: None declared, i-quere@chu-montpellier.fr i-quere@chu-montpellier.fr: None declared, Patrick Jégo: None declared, nicolas.limal@aphp.fr nicolas.limal@aphp.fr: None declared, wxv wxv: None declared, Jacques-Eric Gottenberg Grant/research support from: BMS, Pfizer, Consultant of: BMS, Sanofi-Genzyme, UCB, Speakers bureau: Abbvie, Eli Lilly and Co., Roche, Sanofi-Genzyme, UCB, Mathieu Vautier: None declared, lea.savey@aphp.fr>; lea.savey@aphp.fr>;: None declared, Patrice cacoub: None declared, olivier fain: None declared … (more)
- Is Part Of:
- Annals of the rheumatic diseases. Volume 79(2020)Supplement 1
- Journal:
- Annals of the rheumatic diseases
- Issue:
- Volume 79(2020)Supplement 1
- Issue Display:
- Volume 79, Issue 1 (2020)
- Year:
- 2020
- Volume:
- 79
- Issue:
- 1
- Issue Sort Value:
- 2020-0079-0001-0000
- Page Start:
- 1552
- Page End:
- 1552
- Publication Date:
- 2020-06-13
- Subjects:
- Rheumatism -- Periodicals
616.723005 - Journal URLs:
- http://ard.bmjjournals.com/ ↗
http://www.pubmedcentral.nih.gov/tocrender.fcgi?journal=149&action=archive ↗
http://www.bmj.com/archive ↗
http://gateway.ovid.com/server3/ovidweb.cgi?T=JS&MODE=ovid&D=ovft&PAGE=titles&SEARCH=annals+of+the+rheumatic+diseases.tj&NEWS=N ↗ - DOI:
- 10.1136/annrheumdis-2020-eular.4592 ↗
- Languages:
- English
- ISSNs:
- 0003-4967
- Deposit Type:
- Legaldeposit
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- Available online (eLD content is only available in our Reading Rooms) ↗
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- British Library DSC - BLDSS-3PM
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