Table 2.
mAbs authorized for the treatment of RA or IBD (CD and UC) in the US (up until September 2022): administration routes, dosing regimens and product presentations (adult indications)
| Indication | mAb | Administration route and dosing regimena | IV product presentationsa | SC product presentationsa | |
|---|---|---|---|---|---|
| IV | SC | ||||
| RA | Rituximab | 2*1000 mg separated by 2 weeks (one course) every 24 weeks or based on clinical evaluation (not sooner than every 16 weeks) | -b | 100 mg/10 mL, 500 mg/50 mL in single-dose vials | -b |
| Tocilizumab | 4 mg/kg q4w followed by 8 mg/kg q4w based on clinical response |
Patients < 100 kg: 162 mg q2w, followed by increase to q1w based on clinical response Patients ≥ 100 kg: 162 mg q1w |
80 mg/4 mL, 200 mg/10 mL, 400 mg/20 mL in single-dose vials | 162 mg/0.9 mL in single-dose prefilled syringe or single-dose prefilled autoinjector | |
| Sarilumab | - | 200 mg q2w | - | 150 mg/1.14 mL or 200 mg/1.14 mL solution in single-dose prefilled syringe or prefilled pen | |
| IBD | Ustekinumab |
Induction: < 55 kg: 260 mg > 55 kg to 85 kg: 390 mg > 85 kg: 520 mg Maintenance: 90 mg 8 weeks after the initial dose, then q8w (SC) |
90 mg 8 weeks after the initial IV induction dose, then q8w | 130 mg/26 mL solution in single-dose vial |
45 mg/0.5 mL or 90 mg/mL solution in single-dose prefilled syringe 45 mg/0.5 mL in single-dose vial |
| Vedolizumab | 300 mg at weeks 0, 2 and 6, then q8w | -c | 300 mg of lyophilized powder in single-use 20 mL vial | -c | |
| Natalizumab | 300 mg q4w | -d | 300 mg/15 mL solution in single-dose vial | -d | |
| RA & IBD | Infliximab |
RA: 3 mg/kg at weeks 0, 2 and 6, then q8w (may be increased to 10 mg/kg q8w or to dosing frequency of q4w) CD: 5 mg/kg at weeks 0, 2 and 6, then q8w (may be increased to 10 mg/kg q8w if loss of response) UC: 5 mg/kg at weeks 0, 2 and 6, then q8w |
-e | 100 mg of lyophilized powder in single-dose vial | -e |
| Adalimumab | - |
RA: 40 mg q2w (some patients not receiving methotrexate may benefit from dose increase to 40 mg q1w or 80 mg q2w) CD: 160 mg on day 1 (given in one day or split over two consecutive days); 80 mg on day 15 and 40 mg q2w starting on Day 29 UC: 160 mg on day 1 (given in one day or split over two consecutive days); 80 mg on day 15 and 40 mg q2w starting on Day 29 |
- |
80 mg/0.8 mL, 40 mg/0.8 mL, and 40 mg/0.4 mL in single-dose prefilled pen 80 mg/0.8 mL, 40 mg/0.8 mL, 40 mg/0.4 mL, 20 mg/0.4 mL, 20 mg/0.2 mL, 10 mg/0.2 mL, 10 mg/0.1 mL in single-dose prefilled glass syringe 40 mg/0.8 mL in single-dose glass vial for institutional use only |
|
| Golimumab |
RA: 2 mg/kg at weeks 0 and 4, then q8w |
RA: 50 mg q1m UC: 200 mg at week 0, 100 mg at week 2 and then 100 mg q4w |
50 mg/4 mL solution in single-dose vial |
50 mg/0.5 mL in single-dose prefilled syringe or single-dose prefilled autoinjector 100 mg/1.0 mL in single-dose prefilled syringe or single-dose prefilled autoinjector |
|
| Certolizumab pegol | - |
RA: 400 mg initially and at weeks 2 and 4, followed by 200 mg q2w; for maintenance dosing, 400 mg q4w can be considered CD: 400 mg initially and at weeks 2 and 4. If response occurs, 400 mg q4w |
- |
200 mg lyophilized powder in single-dose vial 200 mg/mL solution in single-dose prefilled syringe |
CD Crohn’s disease, IV intravenous, mg milligram, mL milliliter, qXd every X day, qXm every X month, qXw every X week, RA rheumatoid arthritis, SC subcutaneous, UC ulcerative colitis
aThis table lists FDA-approved products; deviations with EMA-approved product presentations or other indications are indicated as a footnote
bA SC formulation for rituximab is approved in oncology indications
cA SC formulation for vedolizumab is approved in IBD in the EU
dA SC formulation for natalizumab is approved in MS in the EU
eBiosimilar infliximab (Remsima®) is approved for subcutaneous administration in the EU