Pivotal trial results for olokizumab, which included adalimumab as a key active comparator, were officially published on 2022-01-01 in the New England Journal of Medicine. This publication detailed the findings of the CREDO 2 study, a significant evaluation of olokizumab's efficacy and safety in patients with active rheumatoid arthritis despite ongoing methotrexate treatment.
Background
Adalimumab (marketed under brand names such as Humira, Hulio, and Yusimry, among others) is a widely used tumor necrosis factor (TNF) inhibitor. It is approved for the treatment of various autoimmune diseases, including moderate to severe rheumatoid arthritis in adults. In the CREDO 2 study, adalimumab served as an active comparator arm, providing a benchmark against which the investigational drug olokizumab was evaluated for its efficacy and safety profile in patients with rheumatoid arthritis.
Trial design
The CREDO 2 trial was designed to evaluate the efficacy and safety of two distinct dosing regimens of olokizumab. The study enrolled subjects diagnosed with rheumatoid arthritis (RA) who had active disease despite being on a stable dose of methotrexate. The trial's design included three main treatment arms: two different doses of olokizumab, a placebo arm, and an active comparator arm featuring adalimumab. This setup aimed to provide a comprehensive comparison of olokizumab's performance against both an inactive control and an established standard of care for RA.
What this means
The publication of the CREDO 2 trial results is a significant development for the rheumatoid arthritis treatment landscape. It makes available the comprehensive data on olokizumab's efficacy and safety, particularly in comparison to both placebo and the established biologic adalimumab. Clinicians and researchers can now review the full details of this pivotal study to understand the potential role of olokizumab for patients with active rheumatoid arthritis who are currently taking methotrexate. The availability of this peer-reviewed data is crucial for informing future treatment decisions and guidelines.
Source
The information regarding this pivotal trial publication was obtained from PubMed, a leading database for biomedical literature. The article, titled "Olokizumab versus Placebo or Adalimumab in Rheumatoid Arthritis," was published on 2022-01-01 in the New England Journal of Medicine and is accessible through the host pubmed.ncbi.nlm.nih.gov. This publication details the full findings of the CREDO 2 study.