ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1987

Dramatic Efficacy of Tocilizumab As First Line Therapy in Patients with Recent Polymyalgia Rheumatica (PMR): Results of the First Longitudinal Prospective Study

Valerie Devauchelle1, Alain Saraux2, Jean-Marie Berthelot3, Divi Cornec4, Yves Renaudineau5, Sandrine Jousse-Joulin1, Thierry Marhadour6, Solene Querellou7, Florent Garrigues8, Michel De Bandt9 and Maelenn Gouillou10, 1Rheumatology, Brest university medical school, EA 2216, UBO and CHU de la Cavale Blanche,, Brest, France, 2Rheumatology Department, CHU de la Cavale Blanche, Brest Cedex, France, 3Rheumatology, University Hospital, Nantes, France, 4Department of rheumatology, Brest Occidentale University, Brest, France, 5Immunology, Brest University Medical School Hospital, Brest, France, 6CHU La Cavale Blanche, Brest, France, 7Nuclear Medicine Department, Morvan University Hospital, Brest, France, 8Radiology department, Cavale Blanche Hospital and Brest Occidentale University, Brest, France, 9Rheumatology department, CHU Fort de France, Fort de France, France, 10Clinical Investigation Centre (CIC) 1412, CHU Cavale Blanche- Institut National de la Santé et de la Recherche Médicale (INSERM), Brest, France

Meeting: 2015 ACR/ARHP Annual Meeting

Date of first publication: September 29, 2015

Keywords: , , ,

Session Information

Date: Monday, November 9, 2015

Title: Vasculitis Poster II

Session Type: ACR Poster Session B

Session Time: 9:00AM-11:00AM

Background/Purpose: Glucocorticoids (GCs) are the cornerstone treatment of polymyalgia rheumatica (PMR) but induce several adverse events.

Methods:

Objectives: To evaluate efficacy and safety of tocilizumab as first line therapy in PMR.

Design: Prospective open label study (ClinicalTrials.gov: NCT01713842).

Setting: 2 university hospitals in France.

Patients: 20 glucocorticoids (GCs) naives patients with recent PMR fulfilling the Chuang criteria, with a disease duration of less than 12 months and an active disease ((PMR-AS)> 10) were included. Patients with suspected giant cell arteritis were excluded.

Intervention: All patients received tocilizumab infusions (week 0, 4 and 8) without GCs (period 1) and then oral GCs from week 12 to week 24 according to the PMR-AS at week 12 (patients with PMR-AS£10 were treated by 0.15mg/kg whereas those with PMR-AS>10 received 0.30 mg/kg).  The primary endpoint was the response to tocilizumab based on PMR-AS£ 10 at week 12. Secondary endpoints were the PMR-AS response at weeks 2,4,8,12,16, 20 and 24 and the GCs sparing effect.

Results:

At inclusion, median PMR-AS was 36.6 (IQR: 30.4-43.8). At week 12, all patients reached the primary end point and were included in the low dose corticosteroid group. Median PMR-AS at week 12 and 24 were respectively 4.5 (IQR: 3.2-6.8) p< 0.001 and 0.95 (IQR: 0.4-2) p<0.001. No treatment rescue was necessary. Improvement was moderate by ultrasound, MRI and TEP-CT. The infusions of tocilizumab induced a GCs sparing effect of 70.2%. The sensitivity analysis based on a determined dosage of GC of 15mg/day without taking account of the patient’s weight found similar results. Most frequent adverse events were transient neutropenia and leucopenia reported in 3 and 5 patients. One patient received only one infusion of tocilizumab due to adverse event.Limitations:Infusions were done every 4 weeks and not every 2 weeks as in systemic disease. This could explain a slower response than supposed with GCs.

Conclusion:

Monotherapy with Tocilizumab has a major efficacy in recent PMR and allows a sparing corticosteroid effect.

Disclosure: V. Devauchelle, None; A. Saraux, None; J. M. Berthelot, None; D. Cornec, None; Y. Renaudineau, None; S. Jousse-Joulin, None; T. Marhadour, None; S. Querellou, None; F. Garrigues, None; M. De Bandt, None; M. Gouillou, None.

To cite this abstract in AMA style:

Devauchelle V, Saraux A, Berthelot JM, Cornec D, Renaudineau Y, Jousse-Joulin S, Marhadour T, Querellou S, Garrigues F, De Bandt M, Gouillou M. Dramatic Efficacy of Tocilizumab As First Line Therapy in Patients with Recent Polymyalgia Rheumatica (PMR): Results of the First Longitudinal Prospective Study [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/dramatic-efficacy-of-tocilizumab-as-first-line-therapy-in-patients-with-recent-polymyalgia-rheumatica-pmr-results-of-the-first-longitudinal-prospective-study/. Accessed .

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