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• At Month 6, the geometric mean UPCR ratio relative to baseline was 0.70 (95% CI: 0.57, 0.85) and 1.08 (95% CI: 0.88, 1.31) in the FABHALTA and placebo groups, respectively¹

The treatment effect of FABHALTA on UPCR at Month 6 was generally consistent across subgroups, including age, sex, race, baseline disease characteristics (such as baseline proteinuria and eGFR levels), and use of immunosuppressive therapies.¹

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After the initial 6-month treatment period, all patients received FABHALTA for an additional 6 months.¹

In patients initially randomized to FABHALTA, the reduction in 24-hour UPCR seen at Month 6 was maintained at Month 12. In patients who switched from placebo to FABHALTA, the reduction in 24-hour UPCR from Month 6 to Month 12 was similar to the reduction seen in patients initially randomized to FABHALTA.¹

In a supplemental analysis of geometric mean UPCR first morning void ratio relative to baseline at Month 6²:

• FABHALTA arm: 0.68 (95% CI: 0.52, 0.87) 

• Placebo arm: 1.00 (95% CI: 0.77, 1.31) 

• The relative reduction at Month 6 was 33% between FABHALTA and placebo

While more FABHALTA-treated patients (30%) compared to placebo (6%) achieved a ≥50% reduction in 24-hour UPCR compared to baseline, there was no difference between FABHALTA and placebo in the proportion of patients with stable or improved eGFR compared to baseline at Month 6 (90% in FABHALTA vs 89% in placebo)¹

Composite renal end point was defined as:

A ≥50% reduction in 24-hour UPCR compared to baseline + stable or improved eGFR compared to baseline (≤15% reduction in eGFR)¹

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Following the 6-month treatment period, all patients were treated with FABHALTA for an additional 6-month open-label period. Results from the open-label period are descriptive in nature. No statistical hypothesis testing was done. Data should be interpreted with caution, and no formal conclusions can be made.

• At Month 12, composite renal end point was met by 44.1% of FABHALTA-treated patients and 24.0% of those who switched to FABHALTA from placebo²

  • ≥50% proteinuria reduction²: 45.9% (FABHALTA) and 29.4% (FABHALTA switch)

  • Stable or improved eGFR²: 84.2% (FABHALTA) and 88.2% (FABHALTA switch)

A separate secondary end point analyzing the change in eGFR from baseline to Month 6 was studied.²

• No statistically significant difference in eGFR was seen between FABHALTA and placebo at Month 6 (+1.3 mL/min/1.73 m² with FABHALTA and -0.9 mL/min/1.73 m² with placebo).² Since the threshold for statistical significance was not met, any numerical difference could be due to chance

Results presented below are from the open-label period which are descriptive in nature. No statistical hypothesis testing was done. Data should be interpreted with caution, and no formal conclusions can be made.

• Exploratory end point²: In patients initially randomized to FABHALTA, the mean change from baseline in eGFR at Month 12 was +0.44 mL/min/1.73 m²

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Following the 6-month treatment period, all patients were treated with FABHALTA for an additional 6-month open-label period. Results from the open-label period are descriptive in nature. No statistical hypothesis testing was done. Data should be interpreted with caution, and no formal conclusions can be made.

• The proportion of participants with different levels of proteinuria at Month 12²:

  • FABHALTA: 23.7% (<1 g/g), 36.8% (1 to <3 g/g), 36.8% (≥3 g/g), 2.6% (missing)

  • FABHALTA SWITCH from placebo: 13.9% (<1 g/g), 52.8% (1 to <3 g/g), 27.8% (≥3 g/g), 5.6% (missing)