Pfizer’s rheumatoid arthritis drug fails to meet safety criteria
pharmafile | January 28, 2021 | News story | | Pfizer
Pfizer has announced that its rheumatoid arthritis (RA) drug XELJANZ (tofacitinib) has failed to meet the co-primary endpoint in its post-marketing safety study.
The primary objective of the study was to evaluate the safety of tofacitinib at two doses (5mg twice daily and 10mg twice daily) compared with a tumour necrosis factor inhibitor (TNFi) in subjects with rheumatoid arthritis (RA) who were aged 50 or older, and had at least one additional cardiovascular (CV) risk factor.
The co-primary endpoints of this study were non-inferiority of tofacitinib compared to TNFi in regard to major adverse cardiovascular events (MACE) and malignancies (excluding non-melanoma skin cancer (NMSC)). Results showed that for these co-primary endpoints, the prespecified non-inferiority criteria were not met for the primary comparison of the combined tofacitinib doses to TNFi. Based on the prespecified secondary comparisons, there was no evidence of a difference in the primary endpoints between the two tofacitinib treatment groups.
The study included 4,362 subjects who received study treatments. The primary analyses included 135 subjects with MACE and 164 subjects with malignancies (excluding NMSC). For tofacitinib, the most frequently reported MACE was myocardial infarction and the most frequently reported malignancy (excluding NMSC) was lung cancer. In those subjects with a higher prevalence of known risk factors for MACE and malignancy (for example, older age, and smoking), a higher occurrence of events was seen across all treatment groups.
Dr Tamas Koncz, Chief Medical Officer of Inflammation and Immunology at Pfizer, said: “Providing information on the safe and effective use of our medicines is imperative.
“We believe that extensive additional analyses of these study data, and communicating them as soon as possible, will further clarify the benefit and risk profile of tofacitinib to help inform medical decision making and patient care.”
XELJANZ is the first and only JAK inhibitor approved for three conditions in adults: moderate to severe rheumatoid arthritis, active psoriatic arthritis, and moderate to severe ulcerative colitis.
Darcy Jimenez
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