Open-label pilot trial of imatinib mesylate (Gleevec) in the treatment of systemic sclerosis- associated active interstitial lung disease (SSc-ILD)
Arthritis & Rheumatism, 07/21/2011
Clinical Article
Khanna D et al. – Use of high-dose daily (600 mg/day) imatinib in SSc-ILD was associated with a large number of AEs. Our AE experience suggests that doses lower than 600 mg/day imatinib may be appropriate and that further doseranging is needed to understand the therapeutic index of imatinib in SSc.
Methods- Recruited 20 SSc patients with FVC<85% predicted, dyspnea on exertion, and presence of ground glass appearance on HRCT
- Patients received oral imatinib therapy (up to 600 mg/day) for 1 year
- AEs, pulmonary function tests, and modified Rodnan skin score (MRSS) captured every 3 months
- Course of lungfunction, HAQ-DI and MRSS were modeled over length of study to explore efficacy
- Majority of patients were female (65%), Caucasian (75%) and had diffuse SSc (70%)
- Thebaseline mean (SD) FVC%predicted was 65.2 (14.0) and MRSS was 18.7 (10.1)
- Mean (SD) imatinib dose was 445 (125) mg/day
- Of 20 patients, 12 completed study, 7 discontinued due to AEs, and 1 patient was lost to follow-up
- Common AEs (≥ 20%) included fatigue, facial/ lower extremity edema, nausea and vomiting, diarrhea, generalized rash, and new onset proteinuria
- Treatment with imatinib showed trend towards improvement of FVC%predicted of 1.74% (p>0.05) and MRSS of 3.9 units (p< 0.001)



