Rodriguez PC, et al. - This study was performed on patients with active RA previously treated with DMARD therapy. Researchers assessed the safety and clinical response for a longer treatment of 12 itolizumab intravenous doses in these subjects. Clinical response was observed from the beginning of the treatment, which sustained for over 24 weeks. Efficacy of 12-week versus 6-week treatment (assessed in the previous study) was found to be similar. Findings strengthened the safety profile of itolizumab and offered further evidence on the clinical benefit from the use of this anti-CD6 monoclonal antibody (mAb) in RA patients.

Methods

• In this study, 21 subjects were enrolled in four dose groups (0.1, 0.2, 0.4 and 0.8 mg/kg).
• Researchers monitored efficacy endpoints including American College of Rheumatology (ACR)20, ACR50 and ACR70 response rates and Disease Activity Score in 28 joints (DAS28) at baseline and at specific time points over a 10-week follow-up period.

Results

• Findings revealed that itolizumab was well tolerated up to the highest tested dose.
• Researchers reported no related serious adverse events and most adverse events were mild.
• They also noted that itolizumab treatment did not produce lymphopenia and, therefore, was not associated with infections.
• In addition, data reported that all patients achieved a clinical response (ACR20) at least once during the study.
• It was found that 11 subjects (55%) achieved at least a 20% improvement in ACR just one week after the first itolizumab administration.