Alternative assessments of biologic outcomes
The GETE used in OMA (Figure 2a) captured all modalities of response. It
captured all (100%, 32/32) patients who had an improvement of AHE
status (≥1 AHE to 0 AHE), all (100%, 75/75) patients who had an
OCS/Exacerbation response (≥50% reduction in mOCS dose or
exacerbations) and 97.8%, (48/49) of patients who had an ACQ response
(≥the minimally important difference [MID] of 0.5).
In comparison, in MEPO, 16.7%, (6/36) patients who had an ACQ response
and 18.2%, (4/22) patients who had an AQLQ response (≥MID of 0.5) were
not deemed responders based on NICE criteria (Figure 2b). Similarly,
30%, (3/10) subjects who had an improvement of AHE status were not
deemed responders using conventional criteria. Additionally, NICE
criteria did not capture three patients who responded in two separate
domains (ACQ & AQLQ: 2, AHE & ACQ:1). Conversely, some MEPO responders
did not show ACQ (21.0%, 8/38) nor AQLQ (30.8%, 8/26) responses.