Amgen And Allergan Announce Positive Top-Line Results From Phase 1/ Phase 3 Study Of ABP 798, Biosimilar Candidate To Rituximab
The primary objective of the study was PK similarity comparing ABP 798 to rituximab. The PK endpoints of the study were area under the serum concentration–time curve (AUC) and maximum serum concentration (Cmax), both of which were within the pre-specified equivalence margin. The pre-specified equivalence in efficacy endpoint was measured by Disease Activity Score 28-joint count C reactive protein (DAS28-CRP) change from baseline at week 24. Overall, safety and immunogenicity of ABP 798 were comparable to rituximab. This is the first of two studies intended to form the basis for global regulatory submissions for ABP 798. The second study is being conducted in patients with non-Hodgkin's lymphoma.
"Results from this study show pharmacokinetic and clinical equivalence between ABP 798 and rituximab, further demonstrating
ABP 798 is being developed as a biosimilar candidate to rituximab, a CD20-directed cytolytic antibody that is approved in many regions for the treatment of adult patients with moderate-to-severe rheumatoid arthritis, non-Hodgkin's lymphoma, chronic lymphocytic leukemia, pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis.
About the Study Design
The above referenced Phase 1/ Phase 3 study was a randomized, double-blind trial (study number NCT02792699) that evaluated the PK, efficacy and safety of ABP 798 compared to rituximab in patients with moderate-to-severe rheumatoid arthritis. There were 311 patients enrolled and randomized (1:1:1) to receive either ABP 798, rituximab sourced from the U.S., or rituximab sourced from the EU, administered as an intravenous (IV) infusion at baseline and again at week 24. Among them, 104 patients were randomized to the ABP 798 group, 103 patients were randomized to the rituximab (U.S.) group and 104 patients were randomized to the rituximab (EU) group. The primary PK endpoints of the study were AUC and Cmax. The pre-specified equivalence in efficacy endpoint was measured by DAS28-CRP change from baseline at week 24, and the overall study duration was 48 weeks. Additionally, the study included a single transition for subjects on rituximab (U.S.) to ABP 798.
About Rheumatoid Arthritis
Rheumatoid arthritis (RA) is a chronic inflammatory disease of unknown etiology that affects approximately one percent of the adult population worldwide.1 RA can cause pain, stiffness, swelling and limitations in the motion and function of multiple joints.2 In RA, joint damage can significantly worsen over time, especially if left untreated and may impair function.3
About ABP 798
ABP 798 is being developed as a biosimilar candidate to rituximab, a CD20-directed cytolytic antibody that is approved in the U.S., EU and other regions for the treatment of adult patients with rheumatoid arthritis, non-Hodgkin's lymphoma, chronic lymphocytic leukemia, pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis. The active ingredient of ABP 798 is a CD20-directed cytolytic antibody that has the same amino acid sequence as rituximab. ABP 798 also has the same pharmaceutical dosage form and strength as rituximab.
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- Gibofsky A. Overview of Epidemiology, Pathophysiology, and Diagnosis of Rheumatoid Arthritis. Am J Manag Care. 2012;18:S295-S302.
Arthritis Foundation. Rheumatoid arthritis symptoms. http://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/symptoms.php. Accessed June 6, 2018. Arthritis Foundation. Joint deformities in rheumatoid arthritis. http://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/articles/ra-deformities.php. Accessed June 6, 2018.
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