Certolizumab Dosing for Rheumatoid Arthritis
For rheumatoid arthritis, certolizumab pegol (Cimzia) should be dosed at 400 mg (given as two 200 mg subcutaneous injections) at weeks 0,2, and 4, followed by 200 mg every 2 weeks for maintenance, with an alternative maintenance option of 400 mg every 4 weeks. 1
Loading Dose Regimen
- Initial loading consists of 400 mg administered as two separate 200 mg subcutaneous injections at weeks 0,2, and 4 1
- The two 200 mg injections should be given at separate sites in the thigh or abdomen when the 400 mg dose is needed 1
- Injection sites must be rotated and should not be given into areas where skin is tender, bruised, red, or hard 1
Maintenance Dosing Options
Two evidence-based maintenance regimens are available:
- Primary maintenance: 200 mg every 2 weeks (every other week) starting at week 6 1
- Alternative maintenance: 400 mg every 4 weeks can be considered for ongoing treatment 1
Both maintenance regimens demonstrated comparable efficacy in clinical trials, with ACR20 response rates of 67.1% for 200 mg every 2 weeks versus 65.2% for 400 mg every 4 weeks at week 34 2
Combination Therapy Requirement
- Certolizumab should be used in combination with methotrexate for optimal efficacy in rheumatoid arthritis 3, 4
- The EULAR guidelines specifically recommend that TNF inhibitors including certolizumab be used with methotrexate in patients who have responded insufficiently to methotrexate and/or other conventional synthetic DMARDs 3
- Concomitant methotrexate use is essential to meet medical necessity criteria according to treatment guidelines 4
Clinical Efficacy Timeline
- Improvements in ACR response rates are evident as early as week 1 and sustained through week 52 5, 6
- Significant ACR20 response rates at week 24 were 57-61% with certolizumab plus methotrexate versus 9-14% with placebo plus methotrexate 7, 6
- Radiographic progression is significantly inhibited, with mean changes in modified Total Sharp Score of 0.2-0.4 units with certolizumab versus 1.2-2.8 units with placebo at weeks 24-52 7, 6
Administration Considerations
- The solution should be clear to opalescent, colorless to yellow, essentially free from particulates 1
- Do not use if cloudy or if foreign particulate matter is present 1
- Cimzia contains no preservatives; unused portions must be discarded 1
- If refrigerated, allow vials to reach room temperature for 30 minutes before reconstituting (for lyophilized powder formulation) 1
Common Pitfall to Avoid
Do not use certolizumab as monotherapy when methotrexate can be tolerated. If oral methotrexate causes gastrointestinal side effects, subcutaneous methotrexate administration should be attempted before abandoning methotrexate altogether, as subcutaneous administration has higher bioavailability and potentially fewer gastrointestinal adverse effects 3, 4