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: Disease Activity, glucocorticoids, polymyalgia rheumatica, tocilizumab and treatment

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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