The Rheumatoid Arthritis and MUScle (RAMUS) Study: Protocol for an observational single-arm study of skeletal muscle in patients with rheumatoid arthritis receiving tofacitinib

Journal of Frailty, Sarcopenia and Falls

article

Joshua L. Bennett¹  Maha Egail¹  Amy E. Anderson¹  Richard Dodds¹  Catherine Feeney³  Gráinne S. Gorman³  Arthur G. Pratt¹  Avan A. Sayer¹  Kieren G. Hollingsworth¹  John D. Isaacs¹ 

[1] Newcastle University Institute for Translational and Clinical Research;NIHR Newcastle Biomedical Research Centre, Newcastle University and Newcastle upon Tyne NHS Foundation Trust;Wellcome centre for Mitochondrial Research, Newcastle University

关键词: Body composition;    Magnetic resonance imaging;    Rheumatoid arthritis;    Sarcopenia;    Tofacitinib Abstract People with rheumatoid arthritis (RA) are disproportionately affected by sarcopenia;    the generalised loss of muscle strength and mass;    consequently facing an increased risk of falls;    functional decline and death. Currently;    there are no approved pharmacological treatments for sarcopenia. RA patients who start tofacitinib (a Janus kinase inhibitor) develop small increases in serum creatinine that are not explained by renal function changes and could reflect sarcopenia improvement. The RAMUS Study is a proof of concept;    single-arm observational study in which patients with RA who commence tofacitinib according to routine care will be offered participation according to eligibility criteria. Participants will undergo lower limb quantitative magnetic resonance imaging;    whole-body dual energy x-ray absorptiometry;    joint examination;    muscle function testing and blood tests at three time points: prior to starting tofacitinib and 1 and 6 months afterwards. Muscle biopsy will be performed before and 6 months after starting tofacitinib. The primary outcome will be lower limb muscle volume changes following treatment initiation. The RAMUS Study will investigate whether muscle health improves following tofacitinib treatment for RA. Identifying a potential pharmacological treatment for sarcopenia could have important implications for individuals with RA and for older people in general.ISRCTN registry ID: 13364395.;   

DOI  :  10.22540/JFSF-08-053

学科分类：内科医学

来源: Hylonome Publications

【 摘 要 】

People with rheumatoid arthritis (RA) are disproportionately affected by sarcopenia, the generalised loss of muscle strength and mass, consequently facing an increased risk of falls, functional decline and death. Currently, there are no approved pharmacological treatments for sarcopenia. RA patients who start tofacitinib (a Janus kinase inhibitor) develop small increases in serum creatinine that are not explained by renal function changes and could reflect sarcopenia improvement. The RAMUS Study is a proof of concept, single-arm observational study in which patients with RA who commence tofacitinib according to routine care will be offered participation according to eligibility criteria. Participants will undergo lower limb quantitative magnetic resonance imaging, whole-body dual energy x-ray absorptiometry, joint examination, muscle function testing and blood tests at three time points: prior to starting tofacitinib and 1 and 6 months afterwards. Muscle biopsy will be performed before and 6 months after starting tofacitinib. The primary outcome will be lower limb muscle volume changes following treatment initiation. The RAMUS Study will investigate whether muscle health improves following tofacitinib treatment for RA. Identifying a potential pharmacological treatment for sarcopenia could have important implications for individuals with RA and for older people in general.ISRCTN registry ID: 13364395.

【 授权许可】

CC BY-NC-SA