Unfortunately, a post-marketing safety study did not go so well for Pfizer, whose drug XELJANZ (Tofacitinib) failed to meet one of its co-primary endpoints. Biospace explains that XELJANZ is designed to treat patients with rheumatoid arthritis (RA). Although the trial did not have the intended outcomes, Pfizer believes that additional studies will show the safety and efficacy of this drug.

XELJANZ

XELJANZ is a Janus kinase (JAK) inhibitor designed to treat patients with a variety of inflammatory conditions, including RA, psoriatic arthritis, and ulcerative colitis. Additionally, it is now approved for pediatric patients (ages 2+) with polyarticular juvenile idiopathic arthritis (JIA). Typically, XELJANZ is used in cases where methotrexate was not effective. The drug is orally administered, offering a more efficient and accessible option than injections.

In another press release, Pfizer shares that the ORAL Surveillance study was designed to evaluate 5mg and 10mg XELJANZ doses. According to the release:

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.

Patients in the study were ages 50+ who already had an additional cardiovascular risk factor. Out of the 4362 participants, 135 (3.09%) developed MACE – with the most reported being myocardial infarction – and 164 (3.75%) developed other malignancies, with the most common being lung cancer.

Pfizer hopes to continue with some additional safety studies moving forward to ensure that the drug is safe for patients. Additional data from the ORAL Surveillance study is not yet available.

Rheumatoid Arthritis (RA)

Rheumatoid arthritis (RA) is a chronic inflammatory disorder which affects joints throughout the body, including those in the hands and feet. While RA sometimes progresses slowly, or rapidly, it merely plateaus in other cases. Thus, it can be difficult to understand how RA may affect someone, as each patient’s experience differs. An estimated 200,000 new cases of RA occur in America yearly. The risk rises with age. Additionally, women are 2x more likely to develop RA than men. Symptoms include:

• Finger swelling and bumps
• Fatigue
• Anemia (low red blood cell count)
• Dry mouth
• Joint, muscle, and back pain
• Joint stiffness, inflammation, and tenderness
• Skin redness