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Abstract Number: 5L

Rapamycin Vs. Placebo for the Treatment of Inclusion Body Myositis: Improvement of the 6 Min Walking Distance, a Functional Scale, the FVC and Muscle Quantitative MRI

Olivier Benveniste1, Jean-Yves Hogrel2, Melanie Annoussamy2, Damien Bachasson2, Aude Rigolet3, Laurent Servais2, Joe-Elie Salem4, Baptiste Hervier3, Oceane Landon Cardinal5, Kuberaka Mariampillai1, Jean-Sebastien hulot4, Pierre Carlier2 and Yves Allenbach6, 1Assistance Publique - Hôpitaux de Paris, Pitié-Salpêtrière University Hospital, Department of Internal Medicine and Clinical Immunology, Hospital University Department: inflammation, immunopathology and biotherapy (DHU i2B), Paris, France, Paris, France, 2Institute of Myology, Paris, France, 3Internal Medicine, Pitié-Salpêtrière University Hospital, Paris, France, 4INSERM, CIC-1421, Paris, France, 5Internal Medicine, Assistance Public - Hopitaux de Paris, Pitié-Salpêtrire University Hospital, Paris, France, 6Internal Medicine, Assistance Public - Hopitaux de Paris, Pitié-Salpêtrière University Hospital, Paris, France

Meeting: 2017 ACR/ARHP Annual Meeting

Date of first publication: October 19, 2017

Keywords: Late-Breaking 2017, Myositis

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Session Information

Date: Tuesday, November 7, 2017

Session Title: ACR Late-Breaking Abstract Session

Session Type: ACR Late-breaking Abstract Session

Session Time: 4:30PM-6:00PM

Background/Purpose:

Inclusion body Myositis (IBM) is the most frequent myositis in patients over 50 years old. Conventional immunosuppressive drugs are today ineffective or even aggravate muscle deficits. Rapamycin is a mTOR inhibitor used in organ transplantation. Potentially, rapamycin can deplete T effector cells, preserve T regulatory cells and induce autophagy (protein degradation), all parameters impaired during IBM.

Methods:

RAPAMI is a prospective, randomized, controlled, double blind, monocentric, phase IIb trial evaluating the efficacy of rapamycin against placebo (NCT02481453). The primary endpoint was stabilization of maximal voluntary quadriceps isometric strength assessed with a dynamometer (Biodex System3 pro). Secondary endpoints included safety, other muscle groups strength, distance walked in 6 minutes (6MWD), pulmonary functional tests, functional scales, and muscle quality assessed by quantitative nuclear resonance magnetic exams (NRM).

Results:

Forty-four patients were treated by oral rapamycin (2 mg/d, n=22) or placebo (n=22) during 12 months (M12). Twelve months after the initiation of the treatment, the quadriceps strength decreased significantly and similarly in both groups (mean relative change: -11.07% vs. -12.36 %). Nevertheless, in comparison to the placebo group, 6MWD was unchanged (mean change: -4.1 m vs. -38.5 m, p=0.035), IBM weakness composite index was less degraded (11.91% vs. 24.26%, p=0.038) and forced vital capacity significantly improved (mean relative change: +12.3% vs. 1.6%, p=0.016). Additionally, NRM showed significant less fat muscle replacement (difference between M12 and baseline in %) in quadriceps (1.7 vs. 4.4, p=0.025) or hamstrings (0.9 vs. 7.3, p=0.027). Finally in NRM, the loss between M12 and baseline of contractile cross-sectional area (mm²) was less pronounced in quadriceps (-3.7 vs. -10.7, p=0.005).

Conclusion: Even if the primary endpoint was not reached, these first results showed coherent data in favor of rapamycin. Notably for the first time in a RCT, an improvement of the 6MWD is observed during IBM.


Disclosure: O. Benveniste, None; J. Y. Hogrel, None; M. Annoussamy, None; D. Bachasson, None; A. Rigolet, None; L. Servais, None; J. E. Salem, None; B. Hervier, None; O. Landon Cardinal, None; K. Mariampillai, None; J. S. hulot, None; P. Carlier, None; Y. Allenbach, None.

To cite this abstract in AMA style:

Benveniste O, Hogrel JY, Annoussamy M, Bachasson D, Rigolet A, Servais L, Salem JE, Hervier B, Landon Cardinal O, Mariampillai K, hulot JS, Carlier P, Allenbach Y. Rapamycin Vs. Placebo for the Treatment of Inclusion Body Myositis: Improvement of the 6 Min Walking Distance, a Functional Scale, the FVC and Muscle Quantitative MRI [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/rapamycin-vs-placebo-for-the-treatment-of-inclusion-body-myositis-improvement-of-the-6-min-walking-distance-a-functional-scale-the-fvc-and-muscle-quantitative-mri/. Accessed March 1, 2021.
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