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Pfizer Says Prespecified Non-inferiority Criteria Of Tofacitinib Not Met In ORAL Surveillance

Pfizer Inc. (PFE) on Wednesday announced co-primary endpoint results from a recently completed post-marketing required safety study, ORAL Surveillance (A3921133; NCT02092467).

The primary objective of this study was to evaluate the safety of tofacitinib at two doses (5 mg twice daily and 10 mg twice daily) versus a TNF inhibitor or TNFi in subjects with rheumatoid arthritis (RA) who were 50 years of age 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)).

According to Pfizer, 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).

Pfizer noted that full study results, beyond the co-primary endpoints (including, but not limited to, secondary endpoints such as pulmonary embolism and mortality as well as efficacy data), are not yet available.

Pfizer said it is working with the U.S. Food and Drug Administration or FDA and other regulatory agencies to review the full results and analyses as they become available.

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