Table 1.

Asthma Outcome Domain Definitions and Timing of Pre- and Postbiologic Assessment

Outcome	Definition	Prebiologic	Postbiologic
Annualized exacerbation rate	•Asthma-related hospital attendance/admission, AND/OR •Asthma-related ER attendance, AND/OR •Acute OCS course ⩾3 d	1 yr before biologic initiation (or 48 wk minimum)	Annualized after biologic initiation (number of events assessed for a minimum of 48 wk and a maximum of 80 wk after biologic initiation)
Asthma control*	•GINA control test (1), OR •ACT Test (48), OR •ACQ (49)	At biologic initiation (or assessment closest to biologic initiation up to a maximum of 1 yr before biologic initiation)	Closest to 1 yr after biologic initiation (24 wk minimum and 80 wk maximum)
Daily LTOCS dose†	•Continuous OCS use ⩾3 mo duration •Daily LTOCS (prednisolone equivalent) dose (mg)	At biologic initiation	Closest to 1 yr after biologic initiation (24 wk minimum and 80 wk maximum)
Lung function‡	•ppFEV1	At biologic initiation (or assessment closest to biologic initiation up to a maximum of 1 yr before biologic initiation)	Closest to 1 yr after biologic initiation (24 wk minimum and 80 wk maximum)

Definition of abbreviations: ACQ = Asthma Control Questionnaire; ACT = Asthma Control Test; ER = emergency room; GINA = Global Initiative for Asthma; LTOCS = long-term oral corticosteroid; OCS = oral corticosteroid; ppFEV₁ = percent predicted FEV₁.

^*Some countries use ACQ and/or ACT to assess control. In these instances, ACQ and/or ACT control categories were fitted to GINA 2020 control categories as follows: Mean ACQ: well controlled (⩽0.75), partly controlled (>0.75 to <1.5), uncontrolled (⩾1.5). Total ACT: well controlled (>19), partly controlled (>15 to ⩽19), uncontrolled (⩽15). A summary of control test used by each country is provided in the online supplement (Table E2).

^† In cases when there were different periods with different doses before biologic initiation, the most recent dose (i.e., closest to biologic initiation) was used. For postbiologic dose and if changed from prebiologic dose, the new dose closest to 1 year after biologic initiation (minimum 24 wk, maximum 80 wk) was used and the date of change used to calculate the follow-up time.

^‡ Postbronchodilator used if available and prebronchodilator used otherwise, while ensuring that pre- and postbiologic measures were both either pre- or post-bronchodilator. Post-bronchodilator measurements were used for 61.6% of patients with available prebiologic ppFEV₁ (n = 2,705). The remaining 38.4% of patients were all treated with inhaled corticosteroid/long-acting β₂-agonist (i.e., bronchodilator not specifically withheld).