Table 5b.
Interim flares by baseline disease severity
| Treatment | Baseline disease severity | Total person–years | All flares* | Rate of all flares | p† | Severe flares* | Rate of severe flares | p† |
|---|---|---|---|---|---|---|---|---|
| MMF | No A | 11.7 | 12 | 1.03 | Reference | 4 | 0.34 | Reference |
| ≥1 A | 19.3 | 46 | 2.39 | 0.01 | 36 | 1.87 | 0.0013 | |
| AZA | No A | 19.5 | 23 | 1.18 | Reference | 9 | 0.46 | Reference |
| ≥1 A | 16.8 | 22 | 1.31 | 0.72 | 15 | 0.90 | 0.12 | |
| MTX | No A | 17.5 | 11 | 0.63 | Reference | 7 | 0.40 | Reference |
| ≥1 A | 15.0 | 35 | 2.33 | 0.0002 | 32 | 2.13 | <0.0001 | |
| NIS | No A | 11.4 | 10 | 0.88 | Reference | 5 | 0.44 | Reference |
| ≥1 A | 19.5 | 15 | 0.77 | 0.75 | 12 | 0.62 | 0.52 |
AZA: azathioprine; MMF: mycophenolate mofetil; MTX: methotrexate; NIS: no immunosuppressant
Response Definition: Non-nephritis trials: all baseline British Isles Lupus Assessment Group (BILAG) severe or moderate (A or B) scores improved by at least 1 step with no new A or 2+ new B scores.
*
All flares defined as ≥1 new BILAG A or ≥2 new B scores any new A or ≥2 new Bs since the last visit. Severe flare defined as ≥1 new BILAG A since last visit.
†
By fitting a Poisson regression model to the total number of flares and the total person–years for each background drug group.