Developmental status of new biologicals for RA treatment
| Target | Agent | Developmental status |
|---|---|---|
| IL-6 | Sarilumab (human mAb against IL-6Rα) | Phase II, phase III published26 27; several phase II and III trials ongoing (clinicaltrials.gov)(some presented with abstracts)28–30 |
| Sirukumab (human mAb against IL-6) | Phase II published;31 some of phase II presented with abstracts;70–72 several phase III trials ongoing (clinicaltrials.gov) | |
| Olokizumab (human mAb against IL-6) | Phase IIb published;32 3 phase II trials completed (no results posted)73–75 | |
| Clazakizumab (human mAb against IL-6) | Phase II trial published;33 1 phase IIb trial abstract presented;34 1 phase IIb trial, active not recruiting76 | |
| ALX-0061 (monovalent IL-6R targeting nanobody) | Phase I/II study abstract presented35 1 phase II combination therapy77 and 1 phase IIb monotherapy trials recruiting78 | |
| B cells | Ofatumumab (human mAb against CD20) | Phase I/II studies and phase III trial published39–41 |
| Tabalumab (human mAb against BAFF) | Phase II trials published;42–44 several phase III trials ongoing, no results posted (clinicaltrials.gov), however some presented with abstracts45–47 | |
| IL-17 | Ixekizumab (human mAb against IL-17) | Phase I, phase II published48 49 |
| Secukinumab (human mAb against IL-17) | Phase II published;50 several phase III trials ongoing (clinicaltrials.gov) | |
| Brodalumab (human mAb against IL-17R) | Phase Ib published;51 1 phase II published;52 1 phase II terminated for lack of efficacy in RA79 | |
| IL-12/23 | Ustekinumab (human mAb against IL-12/23 p40) | Phase II completed, has results57 |
| CNTO 1959 (human mAb against IL23p19) | Phase II completed, has results57 | |
| GM-CSF | MOR103 (human mAb against, GM-CSF) | Phase Ib/IIa published56 |
| Mavrilimumab (human mAb against GM-CSFR) | Phase I and phase IIa published;53 54 phase IIb abstract presented;55 one phase II trial completed, no results posted;80 1 phase II trial recruiting81 | |
| IL-21 | NNC114-006 (NN8828) (human mAb against IL-21) | 2 phase I completed, no results posted;59 60 phase II completed, no results posted61 |
| IL-20 | NNC109-0012 (human mAb against IL-20) | 2 phase I abstracts presented;63 64 phase IIa abstracts presented;65 66 2 phase II trials terminated, no results posted;67 68 1 phase II trial withdrawn, no results posted69 |
BAFF, B cell-activating factor; GM-CSF, granulocyte–macrophage colony-stimulating factor; GM-CSFR, GM-CSF receptor; IL-6R, interleukin 6 receptor; mAb, monoclonal antibody; RA, rheumatoid arthritis.