Contributions
Abstract: EP1482
Type: ePoster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Background: Daclizumab high-yield process (DAC HYP) is administered subcutaneously using a pre-filled syringe (PFS) in EXTEND. EXTEND is an ongoing, open-label extension study of DECIDE that includes a substudy using a DAC HYP pre-filled pen (PFP). A previous study found the pharmacokinetic profiles of the PFP and PFS comparable.
Objectives: Evaluate patient experience with a DAC HYP PFP, including safety/tolerability and treatment satisfaction with the PFP in the EXTEND substudy.
Methods: Patients in EXTEND receive DAC HYP 150mg subcutaneous every 4 weeks for up to 5 years. At selected sites, patients could enrol in the optional PFP substudy after they received 6 consecutive DAC HYP doses with the PFS. The PFP substudy included 6 doses of DAC HYP 150mg administered using a single-use PFP containing a PFS. Outcomes included injection site assessment by a clinician, injection-site adverse events (AEs), patient-reported injection-site pain using a visual analogue scale (VAS) (range [none-worst]: 0-10), Treatment Satisfaction and Patient Usability Surveys, and immunogenicity.
Results: The PFP substudy enrolled 97 patients: 88 (91%) completed and 9 withdrew from the substudy (reasons: AE n=5; consent withdrawn n=3; other n=1). 81 patients (84%) received 6 PFP doses. Injection-site AEs occurred in 10% of patients (pain 6%; bruising 2%; erythema 2%). Mean (SD) VAS scores were 1.7 (2.5) and 1.6 (2.3) after the 1st and 4th injection. There were few clinician-reported injection site abnormalities (≤10%) after the 1st injection and none just prior to the 4th injection. At the last PFP dose, 85% (72/85) of patients self-injected DAC HYP vs 24% (23/97) of patients who self-injected their last PFS dose. 94% (80/85) of patients were very satisfied/satisfied with their method of injection, 97% (70//72) reported the PFP as very easy/easy to self-inject, 92% (66/72) were confident/very confident with administration and were very independent/independent with administration. After the last dose, most patients (range: 79%-90%) reported the PFP to be extremely easy/easy to set up, hold and grip, use, and dispose. Before the 4th PFP dose, 6% (4/69) of patients had antidrug antibodies and 3% (2/69) had neutralising antibodies.
Conclusions: Use of the DAC HYP PFP was associated with low rates of injection-related AEs and immunogenicity, little pain, and good tolerability. Patients found the PFP convenient to use and reported high levels of satisfaction and independence.
Disclosure:
Krzysztof Selmaj: compensation for consulting services: Genzyme, Novartis, Ono, Roche, Synthon, and Teva; compensation for speaking: Biogen;
Eva Havrdova: honoraria/research support: Bayer HealthCare, Biogen, Genzyme, Merck Serono, Novartis and Teva; advisory boards: Biogen, Genzyme, Merck Serono, Novartis, Teva; supported by the Czech Ministry of Education research project PRVOUK-P26/LF1/4;
Oksana Mokliatchouk, Peter McCroskery, Gabriel Lima: employees of and hold stock/stock options in Biogen;
Steven J Greenberg: 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. Alison Gagnon (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: EP1482
Type: ePoster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Background: Daclizumab high-yield process (DAC HYP) is administered subcutaneously using a pre-filled syringe (PFS) in EXTEND. EXTEND is an ongoing, open-label extension study of DECIDE that includes a substudy using a DAC HYP pre-filled pen (PFP). A previous study found the pharmacokinetic profiles of the PFP and PFS comparable.
Objectives: Evaluate patient experience with a DAC HYP PFP, including safety/tolerability and treatment satisfaction with the PFP in the EXTEND substudy.
Methods: Patients in EXTEND receive DAC HYP 150mg subcutaneous every 4 weeks for up to 5 years. At selected sites, patients could enrol in the optional PFP substudy after they received 6 consecutive DAC HYP doses with the PFS. The PFP substudy included 6 doses of DAC HYP 150mg administered using a single-use PFP containing a PFS. Outcomes included injection site assessment by a clinician, injection-site adverse events (AEs), patient-reported injection-site pain using a visual analogue scale (VAS) (range [none-worst]: 0-10), Treatment Satisfaction and Patient Usability Surveys, and immunogenicity.
Results: The PFP substudy enrolled 97 patients: 88 (91%) completed and 9 withdrew from the substudy (reasons: AE n=5; consent withdrawn n=3; other n=1). 81 patients (84%) received 6 PFP doses. Injection-site AEs occurred in 10% of patients (pain 6%; bruising 2%; erythema 2%). Mean (SD) VAS scores were 1.7 (2.5) and 1.6 (2.3) after the 1st and 4th injection. There were few clinician-reported injection site abnormalities (≤10%) after the 1st injection and none just prior to the 4th injection. At the last PFP dose, 85% (72/85) of patients self-injected DAC HYP vs 24% (23/97) of patients who self-injected their last PFS dose. 94% (80/85) of patients were very satisfied/satisfied with their method of injection, 97% (70//72) reported the PFP as very easy/easy to self-inject, 92% (66/72) were confident/very confident with administration and were very independent/independent with administration. After the last dose, most patients (range: 79%-90%) reported the PFP to be extremely easy/easy to set up, hold and grip, use, and dispose. Before the 4th PFP dose, 6% (4/69) of patients had antidrug antibodies and 3% (2/69) had neutralising antibodies.
Conclusions: Use of the DAC HYP PFP was associated with low rates of injection-related AEs and immunogenicity, little pain, and good tolerability. Patients found the PFP convenient to use and reported high levels of satisfaction and independence.
Disclosure:
Krzysztof Selmaj: compensation for consulting services: Genzyme, Novartis, Ono, Roche, Synthon, and Teva; compensation for speaking: Biogen;
Eva Havrdova: honoraria/research support: Bayer HealthCare, Biogen, Genzyme, Merck Serono, Novartis and Teva; advisory boards: Biogen, Genzyme, Merck Serono, Novartis, Teva; supported by the Czech Ministry of Education research project PRVOUK-P26/LF1/4;
Oksana Mokliatchouk, Peter McCroskery, Gabriel Lima: employees of and hold stock/stock options in Biogen;
Steven J Greenberg: 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. Alison Gagnon (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.