Receive our newsletter – data, insights and analysis delivered to you
  1. News
  2. Company News
January 28, 2019updated 09 Aug 2019 10:54am

Amgen and Allergan report positive top-line data from arthritis trial

Amgen and Allergan have reported positive top-line results from a Phase l/lll trial of ABP 798 in comparison with rituximab for the treatment of patients with moderate-to-severe rheumatoid arthritis.

Amgen and Allergan have reported positive top-line results from a Phase I/III trial of ABP 798 in comparison with rituximab for the treatment of patients with moderate-to-severe rheumatoid arthritis.

ABP 798 is currently being studied as a biosimilar candidate to Rituxan (rituximab), a CD20-directed cytolytic antibody that is approved in various regions for the treatment of moderate-to-severe rheumatoid arthritis and other conditions.

The newly published data showed that the trial met its primary objective of pharmacokinetic (PK) similarity.

Pre-defined equivalence in efficacy was also established and a positive safety profile was achieved.

“Results from this study show pharmacokinetic and clinical equivalence between ABP 798 and rituximab.”

Amgen Research and Development executive vice-president said: “Results from this study show pharmacokinetic and clinical equivalence between ABP 798 and rituximab, further demonstrating Amgen’s commitment to providing patients with access to high-quality, biological therapies.”

The 48-week long trial included a randomised, double-blind design.

Content from our partners
Africa’s last mile: Building viable vaccine supply chains
Why this global life sciences COO believes relocation to Charleston, SC, was key to achieving next-level success
Patient-centric pharma logistics: How CRYOPDP delivers hope worldwide

During the trial, 311 patients were enrolled and randomised in 1:1:1 ratio to receive either ABP 798, rituximab sourced from the US, or rituximab sourced from the EU.

The study drugs were administered as an intravenous (IV) infusion at baseline and then at week 24.

Of the enrolled patients, 104 were randomised to the ABP 798 group, 103 were assigned to the rituximab US group and 104 patients were included in the rituximab EU group.

The trial’s primary PK objectives were area under the serum concentration–time curve (AUC) and maximum serum concentration (Cmax).

The efficacy objective was measured by Disease Activity Score 28-joint count C reactive protein (DAS28-CRP) change from baseline at week 24.

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU