Table 6

Summary of additional clinical and research aspects for future consideration

Future clinical and research agenda
SafetyRituximab in the context of concomitant
 Milder congestive heart failure (NYHA I–III)
 Demyelinating disorders (efficacy seen in phase I–II studies of MS/NMO)
 New-onset malignancy
Registry data
 tuberculosis reactivation
 Rare serious AE (PML)
 Parameters associated with infection risk (Ig)
 Vaccination—minimal interval between vaccine and RTX administration
Efficacy
 Disease groupsConnective tissue disorders
RA/vasculitis; overlap syndromes
 Dosage regimenDose, dosage schedule
Different induction and maintenance regimens?
Impact of different dosage regimens on structural progression
 Concomitant medicationAlternative DMARD to MTX
Timing and initiation of DMARD
Combination RTX with other biological agent
 Flare and retreatmentEarly signs of flare/reactivation
Long-term impact of re-treatment/repeat multiple cycles
 Translational researchMechanism of action of RTX
Biomarkers of response
Indicators of re-treatment (B cell/subsets)
Switching biological therapiesMerit of RTX following initial TNF-i failure compared to alternative TNF-i or other biological agent
Pharmacoeconomic analyses
  • DMARD, disease-modifying antirheumatic drug; MS, multiple sclerosis; MTX, methotrexate; NMO, neuromyelitis optica; NYHA, New York Heart Association; PML, progressive multifocal leukoencephalopathy; RA, rheumatoid arthritis; RTX, rituximab; TB, tuberculosis; TNF-i, tumour necrosis factor inhibitor.