Table 2.
Study completion, reasons for withdrawal, and treatment history
| Study completion, reasons for withdrawal, and treatment history | Dupilumab 300 mg qw/q2w (N = 2677) |
|---|---|
| OLE study completion status | |
| Completed up to week 52 | 2207 (82.4) |
| Completed up to week 100 | 1065 (39.8) |
| Completed up to week 148 | 557 (20.8) |
| Completed up to week 204 | 352 (13.1) |
| Completed up to week 244 | 202 (7.5) |
| Completed studya | 1114 (41.6) |
| Patients ongoing | 201 (7.5) |
| Withdrawn from study | 1362 (50.9) |
| Study terminated by sponsor (regulatory approval/commercialization) | 810 (30.3) |
| Withdrawal by patientb | 238 (8.9) |
| AEc | 114 (4.3) |
| Lost to follow-up | 69 (2.6) |
| Lack of efficacy | 58 (2.2) |
| Protocol deviation | 36 (1.3) |
| Pregnancy | 20 (0.7) |
| Physician decisiond | 12 (0.4) |
| Unknown | 4 (0.1) |
| Covid-19 travel restriction | 1 (<0.1) |
| Concomitant topical treatment for AD during the study | |
| Patients who used TCSs | 1427 (53.3) |
| Patients who used TCIs | 436 (16.3) |
| Patients who used TCSs or TCIs | 1498 (56.0) |
| Patients who used TCSs and TCIs | 365 (13.6) |
| Rescue medication | |
| Patients who used rescue treatment for AD | 47 (1.8) |
| Corticosteroids for systemic use | 44 (1.6) |
| Cyclosporine | 3 (0.1) |
| Phototherapy | 2 (<0.1) |
Data are expressed as n (%) unless otherwise specified
AD atopic dermatitis, AE adverse event, OLE open-label extension, q2w every 2 weeks, qw weekly, TCI topical calcineurin inhibitor, TCS topical corticosteroid
aThese patients completed the treatment and end-of-study periods
bIncludes reasons of relocation, desire for pregnancy, did not want to discontinue treatment for 12 weeks during the follow-up period, work/school conflict, and personal reasons not specified. Further details for patient withdrawal because of personal reasons were not captured
cIncludes both those on treatment at the time of withdrawal and those not on treatment during the safety follow-up period. Further details on the AE are not provided as with a formally reported clinical safety event
dIncludes decisions because of alcohol abuse, AD worsening during follow-up period (n = 2), multiple complex medical issues that outweighed study benefits, principal investigator decision, positive result of hepatitis B core antibody test, resignation of the investigator, site closing, patient could not commit to scheduled study visits (n = 2), patient’s declining health, and medical monitor decision to discontinue because of a serious AE (no further details provided by the investigator) causing the patient to discontinue dupilumab for 6 months