Table 1.
Drug studied | Number of patients Drug/Placebo | Background therapy | Change in FVC % predicted | Prednisone Taper | Change in Quality of Life | Comments |
---|---|---|---|---|---|---|
Methotrexate 27 | 9 Methotrexate; 6 Placebo |
Prednisone | 11% | Significant prednisone tapering |
Not reported | No significant change in FVC absolute value. Excluded from analysis 7 patients treated started on methotrexate and withdrew from study |
Fluticasone 28 | 10 Fluticasone; 12 Placebo |
Prednisone | No significant change | No significant difference | No difference in SF-36 | Less cough reported with fluticasone. No objective measurement reported. |
Pentoxifylline 29 | 12 Pentoxifylline; 13 Placebo |
Prednisone | No significant difference | yes | Not reported | Significant steroid sparing only at 8 and 10 months; Significantly less flares with prednisone tapering; Did not report FVC results |
Golimumab 30 | 42 Golimumab; 44 Placebo |
Prednisone plus other agents | -0.87% | no change in prednisone | No significant changes | Same placebo patients for golimumab and ustekinumab trial |
Ustekinumab 30 | 46 Ustekinumab; 44 Placebo | Prednisone plus other agents | -2.17% | no change in prednisone | No significant changes | Same placebo patients for golimumab and ustekinumab trial |
Efzofitimod 31 | 27 Efzofitimod; 12 Placebo; |
Prednisone plus other agents | 2.81 % at 3 mg/kg; 3.30 at 5 mg/kg | Dose response effect seen for prednisone tapering | Statistically significant (p value <0.05) improvement in KSQ Lung, KSQ GH and FAS |
Underpowered to demonstrate significant changes in FVC |