Table 2.
Statements from guidelines and consensus statements for different auto-inflammatory disorders on issues related to the use of infliximab: dosage regimen, induction therapy, loss of response, loss of response and the use of concomitant medication
| Indication | Study, year (reference) | Dosage (mg kg−1) | Induction therapy (weeks) | Maintenance intervals (in weeks) | Determination of (non) response* | Advice regarding loss of response in patients who initially responded to IFX | Recommended co-medication |
|---|---|---|---|---|---|---|---|
| CD | Centocor, 2009 [61] | 5 | 0,2,6 | 8 | Active Crohn's disease: after two doses Fistulizing disease: after three doses | Some patients may regain response with dose escalation. | NA |
| ECCO, 2006 [6] | 5 | NA | 8 | NA | Most try increasing the dose to 10 mg kg−1 | AZA, MP or MTX | |
| AGA, 2007 [4] | 5 | 0,2,6 | 8 | After two doses | Patients who have attenuated response may be given - higher dose infusions up to 10 mg kg−1 at 8-week intervals, or - 5 mg kg−1 at shortened intervals as frequently as every 4 weeks. | Initiated in advance of biologic therapy | |
| Hommes et al., 2006 [7] | 5 | 0,2,6 | 8 | 4 weeks after the second infusion | Increase to 10 mg kg−1 on strict verified indication. | Use of an immunosuppressant. | |
| Panaccione et al., 2004 [8] | 5 | 0,2,6 | 8 | After three doses | Dosage increasement to 10 mg kg−1 or shortening of infusion intervals | Concomitant immunosuppressive therapy (eg, 6-MP, AZA or MTX) | |
| UC | Centocor, 2009 [61] | 5 | 0,2,6 | 8 | After three doses | NA | NA |
| AGA, 2007 [4]*** | |||||||
| RA | Centocor, 2009 [61] | 3 | 0,2,6 | 8 | 12 weeks | Options: - Increase the dose step-wise by approximately 1.5 mg kg−1, up to a maximum of 7.5 mg kg−1 every 8 weeks or - Administration of 3 mg kg−1 as often as every 4 weeks may be considered. | MTX |
| Furst et al., 2008 [9] | NA | NA | NA | Within 12–24 weeks | Increasing the dose or reducing the dosing intervals may provide additional benefit in RA, as may the addition or substitution of other DMARDs. | MTX | |
| NICE, 2007 [11] | 3 | 0,2,6 | 8 | 6 months | Options: - Increase the dose step-wise by approximately 1.5 mg kg−1, up to a maximum of 7.5 mg kg−1 every 8 weeks or - Administration of 3 mg kg−1 as often as every 4 weeks may be considered. | MTX | |
| NVR, 2003 [12] | NA | NA | NA | 12 weeks | Increasing dose or reducing the infusion intervals | NA | |
| FSR, 2007 [13] | 3 | 0,2,6 | 8 | 12 weeks | Changes can be made in the dosing interval (every 6 to 8 weeks) or dosage (3 to 5 mg kg−1), or the patient can be switched to another TNFα antagonist | MTX or another DMARD | |
| JCR, 2007 [14] | 3 | 0,2,6 | 8 | NA | Increment of dosage or shortening of interval is not allowed | MTX at a dose of 6–8mg week−1 | |
| ACR, 2008 [17] | NA | NA | NA | NA | NA | MTX | |
| BSR, 2005 [16] | NA | NA | NA | 3 months | NA | MTX | |
| AS | Centocor, 2009 [61] | 5 | 0,2,6 | 6 to 8 | After two doses | NA | NA |
| Furst et al., 2008 [9] | 5 | 0,2,6 | 6 to 8 | 6–12 weeks | NA | None | |
| NICE, 2008 [23] | Infliximab is not recommended for the treatment of ankylosing spondylitis | ||||||
| FSR, 2007 [22] | NA | NA | NA | 6–12 weeks | Changes in dosage or dosing interval or the the patient can be switched to another TNFα antagonist | None | |
| Braun et al., 2006 [18] | 5 | NA | 6 to 8 | 6–12 weeks | NA | None | |
| BSR, 2005 [21] | 5 | 0,2,6 | 6 to 8 | 12 weeks and every 3 months thereafter | NA | NA | |
| NVR, 2005 [19] | 5 | 0,2,6 | 6 | 6–12 weeks and every 6 months thereafter | NA | None | |
| CRA, 2002 [57] | 5 | 0,2,6 | 8 | NA | NA | None | |
| PsA | Centocor, 2009 [61] | 5 | 0,2,6 | 8 | NA | NA | MTX |
| AAD, 2008 [60] | 5 | 0,2,6 | 6 to 8 | NA | Dose and interval of infusion may be adjusted as needed. | NA | |
| FSR, 2007 [22] | NA | NA | NA | 6–12 weeks | Changes in dosage or dosing interval or the the patient can be switched to another TNFα antagonist | None | |
| NICE, 2007 [24] | 5 | 0,2,6 | 8 | 12 weeks | NA | MTX**** | |
| Furst et al., 2008 [9] | NA | NA | NA | NA | NA | NA | |
| Ps | Centocor, 2009 [61] | 5 | 0,2,6 | 8 | 14 weeks (four doses) | NA | None |
| Reich et al., 2008 [25] | 5 | 0,2,6 | 8 | 12 weeks (or three doses) | Decreasing the interval between infusions (e.g. from every 8 weeks to every 6 weeks), increasing the dose of drug administered and/or introducing a supplementary therapy such as a topical treatment or MTX. | None | |
| BAD, 2005 [26] | 5 | 0,2,6 | 8 | NA | NA | ***** | |
| NVDV, 2005 [27] | 3–10 mg kg−1** | 0,2,6 | 8 | 8 weeks | NA | None | |
| AAD, 2008 [36] | 5 | 0,2,6 | 6 to 8 | NA | Dose and interval of infusion may be adjusted as needed. | NA | |
| Sterry et al. 2004 [58] | 5 or 10 | 0,2,6 | NA | NA | NA | NA | |
| NICE, 2008 [59] | 5 | 0,2,6 | 8 | 10 weeks | NA | NA | |
*
Period after which treatment with IFX should be stopped in case of non-response.
**
A definitive recommended dose has not been determined yet.
***
See section on Crohn's disease. No distinction is made in the AGA consensus statement between Crohn's disease and ulcerative colitis.
****
Following the Summary of Product Characteristics.
*****
Concomitant systemic therapies may be indicated for some patients with very severe unstable psoriasis, although doses of these should be minimized. AZA, azathioprine; MP, mercaptopurine; MTX, methotrexate; NA, no advice given.