Table 1.
Approved and investigational uses of rituximab for treating autoimmune disorders.
| Disease | Description | Phase | Status or outcome |
|---|---|---|---|
| Rheumatoid arthritis | Anti-TNF inadequate responders (IR) | Phase II | Effective [30] |
| Anti-TNF IR (DANCER) | Phase IIB | Effective [7] | |
| Anti-TNF IR (REFLEX) | Phase III | Approved [8] | |
| Early RA | Phase I/II | Ongoing | |
| MTX IR (RUMBA) | Phase II | Ongoing | |
| MTX IR, rituximab plus anti-TNF | Phase II | Ongoing | |
| MTX IR (SCORE, SERENE) | Phase III | Ongoing | |
| MTX naive | Phase III | Ongoing | |
| Non-biological DMARD IR (SUNDIAL) | Phase III | Ongoing | |
| SLE | Non-renal disease (EXPLORER) | Phase II | Not effective [36] |
| Lupus nephritis (LUNAR) | Phase II | Not effective | |
| Lupus nephritis | Phase II | Ongoing | |
| ITP | Chronic ITP | Phase II | Effective [39] |
| Acute adult ITP | Phase II | Ongoing | |
| Chronic ITP | Phase II | Ongoing | |
| Untreated, adult ITP | Phase III | Completed | |
| Chronic ITP | Phase III | Ongoing | |
| Pemphigus | Refractory; > 30% BSA | Phase II | Effective [40] |
| Refractory or steroid-dependent | Phase II/III | Effective [41] | |
| Severe pemphigus | Phase III | Ongoing | |
| Sjögren's syndrome (SS) | Primary SS (pSS) | Phases I/II | Effective [43] |
| pSS | Phase II | Ongoing | |
| pSS, early, active disease (TEARS) | Phases II/III | Ongoing | |
| Myositis | Refractory polmyositis | Phase II | Ongoing |
| Adult dermatomyositis | |||
| Refractory juvenile dermatomyositis | |||
| Graves' disease | Mild relapsing | Phase II | Effective [55] |
| New onset and relapsing disease | Phases I/II | Effective [54] | |
| Graves' opthalmopathy | Phases II/III | Ongoing | |
| Myasthenia gravis | Refractory myasthenia gravis | Phases I/II | Ongoing |
| Refractory myasthenia gravis | Phase II | Ongoing | |
| Multiple sclerosis | Relapsing–remitting MS | Phase II | Effective [60] |
| Relapsing–remitting MS | Phase II | Effective [61] | |
| Primary progressive MS | Phases II/III | Ongoing | |
| ANCA-associated vasculitis | Churg–Strauss syndrome | Phases II/III | Ongoing |
| Wegener's granulomatosis | Phases II/III | Ongoing | |
| Microscopic polyangiitis (RAVE) | |||
| Maintenance versus azathioprine | Phase III | Ongoing |
TNF, tumour necrosis factor; RA, rheumatoid arthritis; SLE, systemic lupus erthematosus; MTX, methotrexate; DMARD, disease modifying anti-rheumatic drug; ITP, immune thrombocytopenic purpura; MS, multiple sclerosis; ANCA, anti-neutrophil cytoplasmic antibody.