The Combined Effect of Nursing Support and Adverse Event Mitigation on Adherence to Interferon Beta-1b Therapy in Early Multiple Sclerosis: The START Study.
There is limited clinical evidence on the impact of nurse support and adverse event (AE) mitigation techniques on adherence to interferon beta-1b (IFNβ-1b) therapy in multiple sclerosis (MS) in a real-world setting. The aim of the Success of Titration, analgesics, and BETA nurse support on Acceptance Rates in MS Treatment (START) trial was to assess the combined effect of titration, analgesics, and BETA (Betaseron Education, Training, Assistance) nurse support on adherence to IFNβ-1b therapy in patients with early-onset MS and to evaluate safety. Participants were instructed to titrate IFNβ-1b and use analgesics to minimize flu-like symptoms. All received BETA nurse follow-up at frequent intervals: live training, two telephone calls during the first month of therapy, and monthly calls thereafter. Participants were considered adherent if they took at least 75% of the total prescribed doses over 12 months (≥75% compliance). Safety was monitored via reported AEs and laboratory test results. Participants who took at least one IFNβ-1b dose over 12 months were analyzed (N = 104); 73.8% of participants completed the study. The mean age of participants was 37.2 years; 72.1% were women and 78.8% were white. Ninety participants had relapsing-remitting MS and 14 had clinically isolated syndrome. The mean compliance rate, reported for 96 participants with complete dose interruption records, was 84.4%. At 12 months, 78.1% of participants were considered adherent. The serious adverse event rate was 9.6%; most events were unrelated to therapy. Thus in the START study, in which participants received nursing support combined with dose titration and use of analgesics, the majority of participants were adherent to therapy.
UMDNJ-Robert Wood Johnson Medical School, New Brunswick, NJ, USA (SDJ); University of Pennsylvania, Philadelphia, PA, USA (CM); and Bayer HealthCare, Wayne, NJ, USA (PP, FB, MR).
Suhayl
S
Dhib-Jalbut
UMDNJ-Robert Wood Johnson Medical School, New Brunswick, NJ, USA (SDJ); University of Pennsylvania, Philadelphia, PA, USA (CM); and Bayer HealthCare, Wayne, NJ, USA (PP, FB, MR).
Clyde
C
Markowitz
UMDNJ-Robert Wood Johnson Medical School, New Brunswick, NJ, USA (SDJ); University of Pennsylvania, Philadelphia, PA, USA (CM); and Bayer HealthCare, Wayne, NJ, USA (PP, FB, MR).
Payal
P
Patel
UMDNJ-Robert Wood Johnson Medical School, New Brunswick, NJ, USA (SDJ); University of Pennsylvania, Philadelphia, PA, USA (CM); and Bayer HealthCare, Wayne, NJ, USA (PP, FB, MR).
Francis
F
Boateng
UMDNJ-Robert Wood Johnson Medical School, New Brunswick, NJ, USA (SDJ); University of Pennsylvania, Philadelphia, PA, USA (CM); and Bayer HealthCare, Wayne, NJ, USA (PP, FB, MR).
Mark
M
Rametta