Contributions
Abstract: P632
Type: Poster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Background: Daclizumab high-yield process (DAC HYP) is a humanised monoclonal antibody against the interleukin 2 (IL-2) receptor alpha subunit (CD25) that selectively modulates IL-2 receptor signalling and is in late-stage clinical development for the treatment of relapsing-remitting multiple sclerosis. Lymphadenopathy events, including lymphadenitis, were observed at an increased incidence with DAC HYP relative to intramuscular interferon (IFN) beta-1a in the DECIDE study.
Objectives: To report the incidence and describe characteristics of the lymphadenopathy events observed in patients treated with DAC HYP across the clinical development program.
Methods: Lymphadenopathy events were identified using a customised Medical Dictionary for Regulatory Activities (MedDRA) [V16.1] query to search the total DAC HYP experience (cut-off November 14, 2014; DAC HYP exposure: ~5,200 patient-years) clinical databases.
Results: In the 2-3 year active-controlled DECIDE study, the incidence of lymphadenopathy events was higher for patients treated with DAC HYP (6% [59/919]) compared with those treated with the active comparator, IM IFN beta-1a (1% [10/922]). In a pooled safety analysis across all DAC HYP studies including 2236 DAC HYP-treated patients, a total of 159 lymphadenopathy events (an incidence of approximately 6% [124/2236]) was reported. Onset of events occurred throughout the treatment period (mean: 655.9 days; median [range]: 645.0 [1-2346] days). 52% (n=64) of patients with lymphadenopathy events experienced mild events only, 41% (n=51) experienced moderate events, and 7% (n=9) experienced an event classified as severe. Of all patients with lymphadenopathy events, 16% (20/124) experienced a serious event. The majority of serious events were otherwise asymptomatic. The majority (70%) of all cases resolved during study follow up, with a median event duration of 33.5 days (mean [range]: 89.0 [1-979] days). Study treatment was not interrupted nor discontinued in the majority of lymphadenopathy events (77% [123/159]).
Conclusions: Lymphadenopathy events are an identified risk associated with DAC HYP therapy, occurring at an incidence of 6%. The majority of events were mild and asymptomatic and resolved without the need to discontinue treatment. Patients receiving DAC HYP who develop lymphadenopathy events should be referred for further clinical and diagnostic evaluation by a specialist at the discretion of their treating physician.
Disclosure:
Gabriel Lima, Peter McCroskery, Kimberly Umans, and Sami Fam are employees of and hold stock/stock options in Biogen.
Kimberly Umans" family member holds stock in Sinovac Biotech.
Rajan Dewar is a paid independent consultant to Biogen.
Jorge J. Castillo has received consulting honoraria from Biogen.
Joan Holman is an employee of and holds stock/stock options in AbbVie Inc.
Supported by: Biogen and AbbVie Biotherapeutics Inc.
Biogen and AbbVie Biotherapeutics Inc. provided funding for medical writing support in the development of this abstract. Stephanie Douglas (Excel Scientific Solutions, Southport, CT) wrote the first draft of the abstract based on input from authors. Biogen and AbbVie Biotherapeutics Inc. reviewed and provided feedback on the abstract. The authors had full editorial control of the abstract, and provided their final approval of all content.
Abstract: P632
Type: Poster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Background: Daclizumab high-yield process (DAC HYP) is a humanised monoclonal antibody against the interleukin 2 (IL-2) receptor alpha subunit (CD25) that selectively modulates IL-2 receptor signalling and is in late-stage clinical development for the treatment of relapsing-remitting multiple sclerosis. Lymphadenopathy events, including lymphadenitis, were observed at an increased incidence with DAC HYP relative to intramuscular interferon (IFN) beta-1a in the DECIDE study.
Objectives: To report the incidence and describe characteristics of the lymphadenopathy events observed in patients treated with DAC HYP across the clinical development program.
Methods: Lymphadenopathy events were identified using a customised Medical Dictionary for Regulatory Activities (MedDRA) [V16.1] query to search the total DAC HYP experience (cut-off November 14, 2014; DAC HYP exposure: ~5,200 patient-years) clinical databases.
Results: In the 2-3 year active-controlled DECIDE study, the incidence of lymphadenopathy events was higher for patients treated with DAC HYP (6% [59/919]) compared with those treated with the active comparator, IM IFN beta-1a (1% [10/922]). In a pooled safety analysis across all DAC HYP studies including 2236 DAC HYP-treated patients, a total of 159 lymphadenopathy events (an incidence of approximately 6% [124/2236]) was reported. Onset of events occurred throughout the treatment period (mean: 655.9 days; median [range]: 645.0 [1-2346] days). 52% (n=64) of patients with lymphadenopathy events experienced mild events only, 41% (n=51) experienced moderate events, and 7% (n=9) experienced an event classified as severe. Of all patients with lymphadenopathy events, 16% (20/124) experienced a serious event. The majority of serious events were otherwise asymptomatic. The majority (70%) of all cases resolved during study follow up, with a median event duration of 33.5 days (mean [range]: 89.0 [1-979] days). Study treatment was not interrupted nor discontinued in the majority of lymphadenopathy events (77% [123/159]).
Conclusions: Lymphadenopathy events are an identified risk associated with DAC HYP therapy, occurring at an incidence of 6%. The majority of events were mild and asymptomatic and resolved without the need to discontinue treatment. Patients receiving DAC HYP who develop lymphadenopathy events should be referred for further clinical and diagnostic evaluation by a specialist at the discretion of their treating physician.
Disclosure:
Gabriel Lima, Peter McCroskery, Kimberly Umans, and Sami Fam are employees of and hold stock/stock options in Biogen.
Kimberly Umans" family member holds stock in Sinovac Biotech.
Rajan Dewar is a paid independent consultant to Biogen.
Jorge J. Castillo has received consulting honoraria from Biogen.
Joan Holman is an employee of and holds stock/stock options in AbbVie Inc.
Supported by: Biogen and AbbVie Biotherapeutics Inc.
Biogen and AbbVie Biotherapeutics Inc. provided funding for medical writing support in the development of this abstract. Stephanie Douglas (Excel Scientific Solutions, Southport, CT) wrote the first draft of the abstract based on input from authors. Biogen and AbbVie Biotherapeutics Inc. reviewed and provided feedback on the abstract. The authors had full editorial control of the abstract, and provided their final approval of all content.