Safety follow-up analysis1
- Patients may have received multiple biologic DMARDs in follow-up.
- Two patients in each group subsequently received a TNF inhibitor.
- Three patients received tocilizumab and 2 received experimental drug.
- Patients receiving Rituxan plus methotrexate within an international clinical trial program entered safety follow-up. Peripheral B-cell counts were monitored for ≥48 weeks. Patients were permitted to receive biologic DMARDs. All serious adverse events or infections that required IV antibiotics were collected.
Median time to subsequent treatment post Rituxan: 8 months (range 0.1 month to 52 months).1
- Defined as the period following receipt of first dose of Rituxan.
- Adapted from ACR 2010.1
- The rates of serious infections in patients who received their first subsequent biologic DMARD <6 months (n=87) and ≥6 months (n=196) after their last Rituxan dose were 5.04 and 4.94 events per 100 patient-years, respectively
- 83% of patients had peripheral B-cell levels below the lower limit of normal at time of subsequent treatment1
- Limited data are available on the safety of the use of biologic agents or DMARDs other than methotrexate in patients exhibiting peripheral B-cell depletion following treatment with rituximab
- Observe patients closely for signs of infection if biologic agents and/or DMARDs are used concomitantly
Safety of biologics in B-cell depleted patients
Dr. Daniel Furst hosts a video presentation on the safety of biologics used after Rituxan, from findings by Dr. Mark Genovese and Colleagues.
- Genovese MC, Breedveld F, Emery P, et al. Rate of serious infections in RA patients who subsequently receive other biologic therapies after discontinuing rituximab treatment. Presented at the Annual Scientific Meeting of the American College of Rheumatology. November 6-11, 2010, Atlanta, GA. Poster 403.