Table 1.
Patient | Age/gender | Time to quiescence* (wk) |
Concomitant ISM at baseline |
Able to decrease other ISM (ISM at 26 wk, 48 wk) |
Number of infliximab infusions |
ISM grade (based on mg/kg dose) |
Adverse events | |
---|---|---|---|---|---|---|---|---|
Pre-infliximab | At 48 wk | |||||||
1 | 43/Male | 2 | Prednisone 16mg | Yes (prednisone 2 mg, prednisone 2 mg) | 11 | 2 | 1 | None |
2 | 28/Female | 6 | Prednisone 50 mg | Yes (prednisone 2.5, none) | 11 | 5 | 0 | None |
3 | 21/Female | 2 | Prednisone 30 mg | Yes (none, none) | 11 | 3 | 0 | Ear infection with transient decreased hearing, UTI, lower RTI, and facial rash |
4 | 55/Female | 10 | Prednisone 17.5 mg | Yes (prednisone 12.5, prednisone 10 mg) | 12† | 2 | 1 | UTI, diarrhea, upper RTI, nasal congestion and headache, mouth sores, head tremor, occasional numbness and tingling in extremities |
5 | 34/Male | 2 | Prednisone 20 mg, Methotrexate 17.5 mg | No (failed after 26 wk; terminated) |
8‡ | 7 | n/a | None |
Primary outcome: quiescence in 14 wk.
Escalated dose at week 34 visit.
Terminated from study (secondary to treatment failure) after week 26 visit.
Note: Prednisone expressed in daily doses. ISM, immunosuppressive medications; UTI, urinary tract infection; RTI, respiratory tract infection; n/a, not applicable.