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Review
. 2015 Jul 14;7(6):CD001555.
doi: 10.1002/14651858.CD001555.pub5.

Treatment for inclusion body myositis

Michael R Rose  1 , Katherine Jones  1 , Kevin Leong  2 , Maggie C Walter  3 , James Miller  4 , Marinos C Dalakas  5 , Ruth Brassington  6 , Robert Griggs  7
Affiliations
Review

Treatment for inclusion body myositis

Michael R Rose et al. Cochrane Database Syst Rev. .

Abstract
in English, Spanish

Background: Inclusion body myositis (IBM) is a late-onset inflammatory muscle disease (myopathy) associated with progressive proximal and distal limb muscle atrophy and weakness. Treatment options have attempted to target inflammatory and atrophic features of this condition (for example with immunosuppressive and immunomodulating drugs, anabolic steroids, and antioxidant treatments), although as yet there is no known effective treatment for reversing or minimising the progression of inclusion body myositis. In this review we have considered the benefits, adverse effects, and costs of treatment in targeting cardinal effects of the condition, namely muscle atrophy, weakness, and functional impairment.

Objectives: To assess the effects of treatment for IBM.

Search methods: On 7 October 2014 we searched the Cochrane Neuromuscular Disease Group Specialized Register, the Cochrane Central Register for Controlled Trials (CENTRAL), MEDLINE, and EMBASE. Additionally in November 2014 we searched clinical trials registries for ongoing or completed but unpublished trials.

Selection criteria: We considered randomised or quasi-randomised trials, including cross-over trials, of treatment for IBM in adults compared to placebo or any other treatment for inclusion in the review. We specifically excluded people with familial IBM and hereditary inclusion body myopathy, but we included people who had connective tissue and autoimmune diseases associated with IBM, which may or may not be identified in trials. We did not include studies of exercise therapy or dysphagia management, which are topics of other Cochrane systematic reviews.

Data collection and analysis: We used standard Cochrane methodological procedures.

Main results: The review included 10 trials (249 participants) using different treatment regimens. Seven of the 10 trials assessed single agents, and 3 assessed combined agents. Many of the studies did not present adequate data for the reporting of the primary outcome of the review, which was the percentage change in muscle strength score at six months. Pooled data from two trials of interferon beta-1a (n = 58) identified no important difference in normalised manual muscle strength sum scores from baseline to six months (mean difference (MD) -0.06, 95% CI -0.15 to 0.03) between IFN beta-1a and placebo (moderate-quality evidence). A single trial of methotrexate (MTX) (n = 44) provided moderate-quality evidence that MTX did not arrest or slow disease progression, based on reported percentage change in manual muscle strength sum scores at 12 months. None of the fully published trials were adequately powered to detect a treatment effect. We assessed six of the nine fully published trials as providing very low-quality evidence in relation to the primary outcome measure. Three trials (n = 78) compared intravenous immunoglobulin (combined in one trial with prednisone) to a placebo, but we were unable to perform meta-analysis because of variations in study analysis and presentation of trial data, with no access to the primary data for re-analysis. Other comparisons were also reported in single trials. An open trial of anti-T lymphocyte immunoglobulin (ATG) combined with MTX versus MTX provided very low-quality evidence in favour of the combined therapy, based on percentage change in quantitative muscle strength sum scores at 12 months (MD 12.50%, 95% CI 2.43 to 22.57). Data from trials of oxandrolone versus placebo, azathioprine (AZA) combined with MTX versus MTX, and arimoclomol versus placebo did not allow us to report either normalised or percentage change in muscle strength sum scores. A complete analysis of the effects of arimoclomol is pending data publication. Studies of simvastatin and bimagrumab (BYM338) are ongoing. All analysed trials reported adverse events. Only 1 of the 10 trials interpreted these for statistical significance. None of the trials included prespecified criteria for significant adverse events.

Authors' conclusions: Trials of interferon beta-1a and MTX provided moderate-quality evidence of having no effect on the progression of IBM. Overall trial design limitations including risk of bias, low numbers of participants, and short duration make it difficult to say whether or not any of the drug treatments included in this review were effective. An open trial of ATG combined with MTX versus MTX provided very low-quality evidence in favour of the combined therapy based on the percentage change data given. We were unable to draw conclusions from trials of IVIg, oxandrolone, and AZA plus MTX versus MTX. We need more randomised controlled trials that are larger, of longer duration, and that use fully validated, standardised, and responsive outcome measures.

Antecedentes: La miositis por cuerpos de inclusión (MCI) es una enfermedad muscular inflamatoria (miopatía) de aparición tardía asociada con atrofia muscular y debilidad progresivas de los miembros proximales y distales. Las opciones de tratamiento se han intentado dirigir a las características inflamatorias y atróficas de esta afección (por ejemplo, con fármacos inmunosupresores e inmunomoduladores, esteroides anabólicos y tratamientos antioxidantes), aunque hasta ahora no hay un tratamiento eficaz conocido para la reversión o la reducción de la progresión de la miositis por cuerpos de inclusión. En esta revisión se han considerado los efectos beneficiosos, los efectos adversos y los costos del tratamiento dirigido a los efectos fundamentales de la afección, a saber, la atrofia muscular, la debilidad y el deterioro funcional.

Objetivos: Evaluar los efectos del tratamiento para la MCI. MÉTODOS DE BÚSQUEDA: El 7 octubre 2014, se hicieron búsquedas en el registro especializado del Grupo Cochrane de Enfermedades Neuromusculares (Cochrane Neuromuscular Disease Group), en el Registro Cochrane Central de Ensayos Controlados (Cochrane Central Register of Controlled Trials) (CENTRAL), MEDLINE y en EMBASE. Además, en noviembre 2014 se realizaron búsquedas de ensayos en curso o terminadas pero no publicados en los registros de ensayos clínicos. CRITERIOS DE SELECCIÓN: Se consideraron para inclusión en la revisión los ensayos aleatorios o cuasialeatorios, incluidos los ensayos cruzados (crossover), del tratamiento para la MCI en adultos en comparación con placebo u otro tratamiento. Se excluyeron específicamente los pacientes con MCI familiar y miopatía por cuerpos de inclusión hereditaria, pero se incluyeron los pacientes con enfermedades del tejido conjuntivo y autoinmunitarias asociadas con MCI, que pueden o no identificarse en los ensayos. No se incluyeron los estudios de terapia con ejercicios o tratamiento de la disfagia, que son los temas de otras revisiones sistemáticas Cochrane. OBTENCIÓN Y ANÁLISIS DE LOS DATOS: Se utilizaron procedimientos metodológicos Cochrane estándar.

Resultados principales: La revisión incluyó diez ensayos (249 participantes) que utilizaron diferentes regímenes de tratamiento. Siete de los diez ensayos evaluaron agentes únicos y tres evaluaron agentes combinados. Muchos de los estudios no presentaron datos suficientes para el informe del resultado primario de la revisión, que fue el cambio porcentual en la puntuación de fuerza muscular a los seis meses. Los datos agrupados de dos ensayos de interferón beta‐1a (n = 58) no identificaron diferencias importantes en las puntuaciones normalizadas de la suma de la fuerza muscular manual desde el inicio hasta los seis meses (diferencia de medias [DM] ‐0,06; IC del 95%: ‐0,15 a 0,03) entre IFN beta‐1a y placebo (pruebas de calidad moderada). Un único ensayo de metotrexato (MTX) (n = 44) proporcionó pruebas de calidad moderada de que el MTX no detuvo ni enlenteció la progresión de la enfermedad, sobre la base del cambio porcentual informado en las puntuaciones de la suma de la fuerza muscular manual a los 12 meses. Ninguno de los ensayos publicados completamente tuvo poder estadístico suficiente para detectar un efecto del tratamiento. Se consideró que seis de los nueve ensayos publicados completamente aportaron pruebas de calidad muy baja con respecto a la medida de resultado primaria. Tres ensayos (n = 78) compararon la inmunoglobulina intravenosa (combinada en un ensayo con prednisona) con placebo, pero no fue posible realizar el metanálisis debido a las variaciones en el análisis de los estudios y a la presentación de los datos del ensayo, sin acceso a los datos primarios para el reanálisis. Otras comparaciones también se informaron en ensayos individuales. Un ensayo abierto de inmunoglobulina anti‐linfocitos T (IgAT) combinada con MTX versus MTX proporcionó pruebas de calidad muy baja a favor del tratamiento combinado, sobre la base del cambio porcentual en las puntuaciones cuantitativas de la suma de la fuerza muscular a los 12 meses (DM 12,50%; IC del 95%: 2,43 a 22,57). Los datos de los ensayos de oxandrolona versus placebo, azatioprina (AZA) combinada con MTX versus MTX y arimoclomol versus placebo no permitieron informar sobre el cambio porcentual o normalizado en las puntuaciones de la suma de la fuerza muscular. Un análisis completo de los efectos del arimoclomol está pendiente de la publicación de los datos. Están en curso estudios de simvastatina y bimagrumab (BYM338). Todos los ensayos analizados informaron eventos adversos. Solamente uno de los diez ensayos interpretó la significación estadística de los eventos adversos. Ninguno de los ensayos incluyó criterios preespecificados para los eventos adversos significativos.

Conclusiones de los autores: Los ensayos de interferón beta‐1a y MTX proporcionaron pruebas de calidad moderada de que no tienen efectos sobre la progresión de la MCI. Las limitaciones generales del diseño de los ensayos, que incluyen el riesgo de sesgo, los escasos números de participantes y la corta duración, hacen difícil determinar si alguno de los tratamientos farmacológicos incluidos en esta revisión fue eficaz. Un ensayo abierto de ATG combinada con MTX versus MTX aportó pruebas de calidad muy baja a favor del tratamiento combinado sobre la base de los datos de cambio porcentual facilitados. No fue posible establecer conclusiones de los ensayos de IgIV, oxandrolona y AZA más MTX versus MTX. Se necesitan más ensayos controlados aleatorios de mayor tamaño, con una duración más prolongada y que utilicen medidas de resultado completamente validadas, estandarizadas y de interés.

PubMed Disclaimer

Conflict of interest statement

MR is a member of the Muscle Study Group that published the two trials of IFN beta‐1a for IBM. These trials were grant funded with a proportion of those funds paid to my institution for the conduct of the trial only and with no personal financial benefit ensuing. For these trials the drug (Avonex) and matching placebo were supplied free of charge by the manufacturer Biogen. The trial protocols, data entry, data analysis, and publications were in the hands of the investigators with no input from Biogen.

KJ's research contribution has been paid for by a grant from the Association Française contre les Myopathies.

KL has no known financial conflicts of interest.

MW has published one randomised trial of IVIg in IBM. She contributed to the Novartis EU Local Advisory Board Meeting (IBM BYM338 trial) on 15 April 2013.

JM has been a member of advisory boards for CSL Behring, Octapharma, and Grifols, companies that produce IVIg. He received meeting expenses to attend Peripheral Nerve Society meetings in 2011, 2012, and 2013 from Baxter and CSL Behring, which produce IVIg products. He is a local principal investigator for the RESILIENT study, an ongoing study of bimagrumab in sporadic IBM sponsored by Novartis.

MD has published three randomised trials of IVIg in IBM. He has accepted institutional grants unrelated to the present review from: CSL, Genesis, Merck, Novartis, and Genzyme. He has also received personal compensation for lectures or consultancies from Novartis, Dysimmune Diseases Foundation, Therapath, Genzyme, Octapharma, and Baxter.

RB has no known financial conflicts of interest. She is Managing Editor of the Cochrane Neuromuscular Disease Group.

RG is a member of the Muscle Study Group that published two trials of IFN beta‐1a for IBM. He has no other known conflicts of interest.

Figures

1
1
Risk of bias summary: review authors' judgements about each risk of bias item for each included study. Red (‐) = high risk of bias, yellow (?) = unclear risk of bias and green (+) = low risk of bias.
2
2
Forest plot of comparison: 1 Interferon beta‐1a versus placebo, outcome: 1.1 Normalised change in muscle strength over baseline at 6 months.
3
3
Forest plot of comparison: 1 Interferon beta‐1a versus placebo, outcome: 1.2 Percentage change over baseline in muscle mass at 6 months.
1.1
1.1. Analysis
Comparison 1 Interferon beta‐1a versus placebo, Outcome 1 Normalised change in muscle strength over baseline at 6 months.
1.2
1.2. Analysis
Comparison 1 Interferon beta‐1a versus placebo, Outcome 2 Percentage change over baseline in muscle mass at 6 months.
2.1
2.1. Analysis
Comparison 2 Methotrexate versus placebo, Outcome 1 Significant adverse events.
3.1
3.1. Analysis
Comparison 3 Anti‐T lymphocyte + methotrexate versus methotrexate, Outcome 1 Percentage change from baseline (QMT) at 12 months.
See this image and copyright information in PMC

Update of

References

References to studies included in this review

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Machado 2013 {published and unpublished data}
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ACTRN12614000082606 {published data only}
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NCT00079768 {published data only}
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NCT00917956 {published data only}
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EUCTR2007‐004359‐12‐IT {published data only}
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NCT01423110 {published data only}
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