LIBERTY AD OLE is an ongoing, multicenter, open-label trial in adults with moderate-to-severe AD (NCT01949311). The protocol is provided in electronic supplementary material 1. The detailed study design and data (cut-off date April 2016) have been previously reported [13 (link)]. We report results with a cut-off date of 1 December 2018 (database lock 13 February 2019), at which time approximately 550 sites in 28 countries in North America, Europe, and Asia–Pacific had participated.
Patients were included if they participated in previous phase I–III dupilumab studies (including patients in the placebo groups) [10 (link)–12 (link), 14 (link)–21 (link)] and adequately completed the required parent study assessments or were screened for phase III studies (NCT02277743/NCT02277769) [12 (link)], but not randomized due to randomization closure. Patients were ineligible if they had an adverse event (AE) deemed related to dupilumab that led to treatment discontinuation or had a serious AE deemed related to dupilumab in the parent study.
Patients enrolled from October 2013 received subcutaneous dupilumab 200 mg weekly (400 mg loading dose). Following protocol amendment on 12 December 2013, patients received 300 mg weekly based on the dose regimens selected for phase III studies.
Rescue medications included systemic corticosteroids (SCSs) and nonsteroidal systemic immunosuppressive medications (including phototherapy). Patients who received rescue medication discontinued study treatment for the duration of the rescue treatment plus five half-lives, after which they could resume dupilumab treatment. Protocol Amendment 7 allowed patients who used SCSs as rescue medication to continue treatment with study drug. Other concomitant treatments for AD, including TCSs and topical calcineurin inhibitors (TCIs), were permitted.
The original planned study duration per patient was up to 3 years of treatment or until regulatory approval/commercial availability of dupilumab in the patient’s geographic region, whichever came first. Country-specific protocol Amendment 7 for France, Germany, Poland, and Japan permitted those patients who had already completed 3 years of treatment to continue or restart and continue treatment through 31 December 2017. Region-specific Amendment 8 extended the treatment period to 5 years in Poland and Finland, and to September 2018 in France.
Patients were included if they participated in previous phase I–III dupilumab studies (including patients in the placebo groups) [10 (link)–12 (link), 14 (link)–21 (link)] and adequately completed the required parent study assessments or were screened for phase III studies (NCT02277743/NCT02277769) [12 (link)], but not randomized due to randomization closure. Patients were ineligible if they had an adverse event (AE) deemed related to dupilumab that led to treatment discontinuation or had a serious AE deemed related to dupilumab in the parent study.
Patients enrolled from October 2013 received subcutaneous dupilumab 200 mg weekly (400 mg loading dose). Following protocol amendment on 12 December 2013, patients received 300 mg weekly based on the dose regimens selected for phase III studies.
Rescue medications included systemic corticosteroids (SCSs) and nonsteroidal systemic immunosuppressive medications (including phototherapy). Patients who received rescue medication discontinued study treatment for the duration of the rescue treatment plus five half-lives, after which they could resume dupilumab treatment. Protocol Amendment 7 allowed patients who used SCSs as rescue medication to continue treatment with study drug. Other concomitant treatments for AD, including TCSs and topical calcineurin inhibitors (TCIs), were permitted.
The original planned study duration per patient was up to 3 years of treatment or until regulatory approval/commercial availability of dupilumab in the patient’s geographic region, whichever came first. Country-specific protocol Amendment 7 for France, Germany, Poland, and Japan permitted those patients who had already completed 3 years of treatment to continue or restart and continue treatment through 31 December 2017. Region-specific Amendment 8 extended the treatment period to 5 years in Poland and Finland, and to September 2018 in France.
