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Pfizer: The Impact of Its Many Recent Developments

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Part 2
Pfizer: The Impact of Its Many Recent Developments PART 2 OF 9

Pfizer’s Xeljanz: Results from the ORAL Strategy

Xeljanz

Pfizer’s (PFE) Xeljanz (tofacitinib citrate) is a Janus kinase inhibitor (or JAK) drug used for the treatment of patients with moderate to severe rheumatoid arthritis. The drug has proved to reduce pain, swelling, and joint damage associated with rheumatoid arthritis. Xeljanz’s extended release version is called Xeljanz XR, which is a once-daily medicine.

Pfizer’s Xeljanz: Results from the ORAL Strategy

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On June 16, 2017, Pfizer announced detailed results from its ORAL (Oral Rheumatoid Arthritis TriaL) Strategy, a double-blind, head-to-head, non-inferiority, randomized Phase 3b/4 study evaluating Xeljanz 5 mg (milligram) twice daily, both as a monotherapy and in combination with methotrexate, compared to the use of the combination of AbbVie’s (ABBV) Humira (adalimumab) and methotrexate for the treatment of patients with moderate to severe rheumatoid arthritis over a period of one year.

Details about the study

According to the company’s press release, the results included both efficacy and safety results. Let’s take a look at the results.

Results

The ORAL Strategy included 1,146 patients, of which 384 were treated with only Xeljanz, 376 were treated with a combination of Xeljanz and methotrexate, and 386 were treated with Humira and methotrexate.

At the end of six months, a 50.0% reduction in the disease, according to the definition of the American College of Rheumatology, also termed ACR50, was observed as follows:

  • Xeljanz monotherapy: ACR50 was attained in 147 patients, or ~38.3% of the total patients in this group; 23 patients, or ~6.0% of the total patients in this group, discontinued the treatment due to adverse effects. Two patients who received Xeljanz monotherapy died during the study.
  • Xeljanz and methotrexate combination: ACR50 was attained in 173 patients, or ~46.0% of the total patients in this group; 26 patients, or ~7.0% of the total patients in this group, discontinued the treatment due to adverse effects.
  • Humira and methotrexate combination: ACR50 was attained in 169 patients, or ~43.8% of the total patients in this group; 36 patients, or ~9.0% of the total patients in this group, discontinued the treatment due to adverse effects.

The combination of Xeljanz and methotrexate was non-inferior compared to the combination of Humira and methotrexate for the treatment of patients with moderate to severe rheumatoid arthritis who are not responsive to methotrexate.

However, the Xeljanz monotherapy was not shown to be non-inferior to either of the combinations.

To invest in Pfizer and divest the risk, you can consider the Healthcare Select Sector SPDR ETF (XLV), which holds 7.1% of its total assets in Pfizer. XLV also holds 4.3% in Amgen (AMGN), 3.7% in AbbVie (ABBV), and 3.2% in Allergan (AGN).

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