The study did not meet the primary endpoint in change from baseline in mean daily OCS dose at week 48.
52.6% of patients treated with 5.0 mg/kg efzofitimod achieved complete steroid withdrawal at week 48 vs 40.2% on placebo (p=0.0919).
Clinical improvement in KSQ-Lung score at week 48 observed in the 5.0 mg/kg efzofitimod treatment group vs placebo (p=0.0479).
Greater proportion of patients achieved complete steroid withdrawal at week 48 with a KSQ-Lung score improvement in the 5.0 mg/kg efzofitimod treatment group (29.5%) vs placebo (14.4%) (p=0.0199).
Lung function as measured by forced vital capacity (FVC) at week 48 was maintained.
Primary Endpoint Missed
Study did not meet the primary endpoint in change from baseline in mean daily OCS dose at week 48.
Steroid Withdrawal Rate
52.6% of patients achieved complete steroid withdrawal with 5.0 mg/kg efzofitimod at week 48, outperforming placebo.
Clinical Improvement
Clinical improvement in KSQ-Lung score observed in the 5.0 mg/kg treatment group.
Safety Profile
Efzofitimod was well-tolerated at both 3.0 mg/kg and 5.0 mg/kg doses, consistent with previous safety observations in all trials.
- The study results indicate promising outcomes with efzofitimod in pulmonary sarcoidosis, despite missing the primary endpoint.
- Higher steroid withdrawal rates and clinical improvements in lung scores show potential benefits of the treatment.
- Maintained lung function measured by FVC is a positive indicator of efzofitimod's efficacy and patient outcomes.
While the Phase 3 EFZO-FIT™ study did not meet its primary endpoint, the performance of efzofitimod in achieving steroid withdrawal and clinical improvements is significant. The maintained lung function and favorable safety profile highlight the potential of efzofitimod in treating pulmonary sarcoidosis.