Gaze into My Crystal Ball (Predictors of Composite Response)
Composite response (CR) was defined as what?
Minimum 2 point reduction on MG-ADL and Minimum 3 point reduction on QMG
What is MWPI? (What does it stand for and what is the minimum point improvement from baseline in Neuro-QoL Fatigue scores?)
Meaningful Within Person Improvement, ≥6.7 point-improvement
What is the difference between unanchored MAIC and PCB-anchored Butcher ITC?
MAIC adjust for patient characteristics using individual patient data for NIPO and aggregate data for comparators; Butcher ITC uses aggregate published data with no adjustment
What was the rate of SAEs in the DB Phase vs OLE and how many discontinuations due to SAEs were there in both?
14.3% PBO v 9.2% NIPO DB; 23.9% PBO/NIPO vs 28.4% NIPO/NIPO OLE
What proportion of patients had MCI in MG-ADL at W48?
84.6% NIPO/NIPO and 63.3% PBO/NIPO
Independent of treatment, what were the 3 predictors of achieving Composite Response (CR)?
Early response, higher baseline bulbar and limb weakness on QMG
What were the primary findings in the Vissing et al. Fatigue poster?
A higher proportion of NIPO patients had MWPI in Neuro-QoL Fatigue than PBO and NIPO patients had greater improvements in Fatigue scores as early as Week 2 and sustained through Week 24
What subgroups/populations were compared for the comparative analyses for NIPO vs EFGART and NIPO vs ROZA?
Vs EFGART: AChR+; vs ROZA: AChR+ and MuSK+
How many deaths were there in the DB phase and the OLE and what were they?
3 DB; 4 OLE
What proportion of patients achieved MSE in DB phase and OLE phase? How did MSE compare between DB Week 24 NIPO and OLE Week 24 PBO/NIPO?
18.4% DB, 26.9% OLE NIPO/NIPO; 44.3% OLE PBO/NIPO
Across all timepoints, a significantly higher proportion of NIPO-treated patients achieved CR than PBO (about twice as many). We also assessed the liklihood of achieving CR at timepoints from Week 2 to Week 24. At week 24, how many times more likely were NIPO patients to acheive CR than PBO?
4-fold greater odds
NIPO-treated patients demonstrated improvements in Neuro-QoL Fatigue Score as early as Week ______ compared with PBO.
Week 2
At what timepoint is NIPO favored over EFGART and over ROZA?
EFGART: Week 8-24; ROZA: Week 10-14
Describe the results for lipids in the DB phase and how these data correlate with blood pressure and/or cardiovascular risk?
Mild increases in total cholesterol, HDL, and LDL; total chol/HDL ratio remained under 4; no difference in rates of MACE events or CV risk for patients with lipid changes; mean systolic BP was lower than baseline in DB and OLE
What were mean MG-ADL scores at OLE Week 24 (Study Week 48)?
-5.19 NIPO/NIPO, -2.68 PBO/NIPO
At Week 2, nipocalimab-group patients had nearly _____ greater odds of achieving CR vs placebo-group patients
5-fold
NIPO-treated patients were approximately how much more likely to have MWPI sustained for greater than 8, 12, 16, or 20 weeks?
Twice as likely
Decribe the results for the standardized mean AUC MG-ADL for nipocalimab vs other FcRn blockers.
Cumulative effect over time was greater with NIPO vs other FcRns
Describe the muscle spasms and peripheral edema observed in the trial? (rates for DB and OLE, severity, changes in rates over time)
DB: 12.2% for each; OLE 6.8% muscle spasms, 5.1% peripheral edema; all mild to moderate
What were mean QMG scores at OLE Week 24 (Study Week 48)?
-4.73 NIPO/NIPO, -3.24 PBO/NIPO