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Intravenous cyclophosphamide is more effective than other immunosuppressive drugs in interstitial lung disease associated with myositis
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A comparison of the efficacy of cyclophosphamide as first-line therapy versus other immunosuppressive therapies (azathioprine, glucocorticoids, mycophenolate mofetil, calcineurin inhibitors, rituximab) was performed in 47 patients with interstitial lung disease associated with myositis (excluding anti-MDA5 dermatomyositis):
- 22 were on cyclophosphamide, 25 on other immunosuppressive therapy;
- 64% of the participants on cyclophosphamide (compared to 32% for the others) had an improvement in their vital capacity of more than 10% on this treatment, the primary endpoint of the study;
- no participant on cyclophosphamide had a deterioration in vital capacity compared to six (24%) on another immunosuppressive drug;
- there was no significant difference in carbon monoxide diffusing capacity (DLCO) or number of deaths between the two groups.
Taking into account a probable potentiating effect of mycophenolate mofetil allowing to decrease the doses of corticosteroids, the authors conclude to the interest of using cyclophosphamide in association with mycophenolate mofetil as a first line treatment of interstitial lung disease in myositis.
It should be noted that a phase IIIAu cours d’un essai clinique de phase III, un médicament, pour lequel on a déterminé lors d’essais antérieurs l’innocuité et le dosage optimum (essais de phase I et II), est administré à un grand groupe de malades, sur une longue durée, dans le but d’évaluer son efficacité thérapeutique en la comparant à celle d’un traitement de référence ou un placebo. Il permet aussi de mettre en évidence les interactions indésirables et les effets secondaires du traitement à moyen terme. Au terme de cet essai, le médicament peut obtenir une autorisation de mise sur le marché. trial underway in France aims to compare the efficacy of cyclophosphamide followed by azathioprine to that of tacrolimus in diffuse infiltrative lung disease related to antisynthetase syndrome (Catr-Pat trial, in French).