SEMIRA Study: Best to Continue Low Dose Steroids in RA Save
The SEMIRA trial studied the tapering vs continuing oral glucocorticoids in rheumatoid arthritis (RA) patients who achieved a low disease activity state (with tocilizumab) were more likely to show safety and better disease control with continuing steroids - even though two-thirds of patients were able to safely taper their glucocorticoid dose.
The Steroid EliMination In Rheumatoid Arthritis (SEMIRA) trial was a multicentre, randomised controlled trial of adult RA patients who were given tocilizumab (SC 162 mg q 8 wk or IV 8 mg/kg with or without csDMARDs) and prednisone 5–15 mg per day for 24 weeks. Thereafter, if they had stable low disease activity (by DAS28-ESR < 3.2) and were on prednisone 5 mg per day for 4 weeks or more, they were randomized to either blindly continue prednisone 5 mg per day or to taper prednisone reaching 0 mg per day by week 16. maintained at stable doses during the entire 24-week study. The primary outcome was the DAS28-ESR change at week 24.
A total of 421 RA patients were enrolled. At week 24 the change in DAS-28-ESR was
- Continued steroid (N=128) −0·08 (–0·27 to 0·12)
- Tapered steroid (N=131): 0·54 (95% CI 0·35–0·73) (difference 0·61 [0·35–0·88]; p<0·0001)
The results favored continuing prednisone 5 mg per day group. Successful treatment (LDAS, no flare) at week 24 was achieved in 77% of the continued-prednisone group and 65% of the tapered-prednisone group (relative risk 0·83; 95% CI 0·71–0·97).
Serious adverse events were similar between groups (5% vs 3%) and no one developed adrenal insufficiency.