Metotreksat ve Biyolojik Naif veya 6 ay Metotreksat Tedavisi Almayan Romatoid Artritli Hastalarında Tocilizumab Monoterapisinin 5 Yıllık Etkinliği ve Güvenliği: AMBITION Çalışması
Results from the AMBITION study (Actemra versus Methotrexate double-Blind Investigate Trial In mONotherapy), showed the continuing efficacy and safety of tocilizumab up to 264 weeks.
AMBITION was a 24-week randomised controlled trial in patients with active RA who were either MTX-naïve or MTX-free for 6 months prior to study entry. Patients received TCZ 8 mg/kg IV Q4W or oral MTX weekly (7.5 mg dose escalating to 20 mg). For those patients who then entered the long-term extension (LTE) study (N=134), long-term efficacy and safety was assessed from their first dose of TCZ 8 mg/kg IV Q4W to 264 weeks (5 years). MTX or another allowable DMARD could be added if ≥50% improvement in TJC and SJC was not achieved from the core study baseline.
Time to maximum response (according to remission criteria: DAS28 <2.6, CDAI ≤2.8, SDAI ≤3.3) was 130 weeks; this was maintained through Week 264. No trends were seen in SAE type reported over time. The most common SAE for monotherapy patients was infection; risk for serious infection remained stable over time.
The findings presented are consistent with the efficacy and safety results of seven other TCZ monotherapy studies, and suggest a sustained effect even in the absence of MTX. Long-term treatment of RA with TCZ monotherapy is an important option for patients who are unable to tolerate MTX or for whom MTX is otherwise inappropriate.