NEW YORK, NY, USA I February 16, 2017 I Pfizer Inc. (NYSE:PFE) announced today top-line results from ORAL Strategy, a Phase 3B/4 study of XELJANZ® (tofacitinib citrate) 5mg twice daily (BID) in the treatment of moderate to severe rheumatoid arthritis (RA). ORAL Strategy is the first trial to compare a JAK inhibitor as monotherapy or in combination with methotrexate (MTX) versus adalimumab (Humira) plus MTX in MTX inadequate responders using ACR50 at Month 6 as the primary endpoint. There were three comparisons, which found:
- XELJANZ 5mg plus MTX met its primary endpoint in demonstrating non-inferiority versus Humira plus MTX
- XELJANZ 5mg monotherapy did not meet its primary endpoint of non-inferiority versus Humira plus MTX or versus XELJANZ plus MTX
“ORAL Strategy is representative of the type of innovative and clinically meaningful trials that Pfizer Inflammation & Immunology believes are important to help advance patient care and the science of JAK inhibition,” said Michael Corbo, Chief Development Officer, Inflammation & Immunology, Global Product Development. “We are pleased that we demonstrated non-inferiority of XELJANZ plus MTX versus Humira plus MTX, reinforcing the efficacy of XELJANZ combination therapy. We will continue to analyze the monotherapy data from this study and look forward to sharing the full results of ORAL Strategy at an upcoming scientific forum.”
ORAL Strategy is a 12-month, double-blind, head-to-head study which included 1,152 patients randomized into one of three study arms that were independently compared against each other:
- XELJANZ 5 mg BID as monotherapy (n=386)
- XELJANZ 5 mg BID in combination with a weekly dose of MTX (15-25 mg) (n=378)
- Humira 40 mg every-other-week via subcutaneous injection in combination with a weekly dose of MTX (15-25 mg) (n=388)
The safety findings were consistent with the known adverse events and serious adverse events profile for XELJANZ.
The RA clinical development program has over 20 clinical trials and to-date represents more than 21,100 patient-years of drug exposure. The long-term extension program, spanning over eight years of safety experience, is one of the largest in the RA category with respect to number of patients and patient-years of exposure.
About XELJANZ (tofacitinib citrate) and XELJANZ XR (tofacitinib citrate) extended-release
XELJANZ®/XELJANZ XR® (tofacitinib citrate) is a prescription medicine called a JAK inhibitor. XELJANZ has been approved for use in more than 50 countries. Since XELJANZ was first approved in the U.S. in 2012, it has been prescribed to more than 90,000 patients worldwide. In the United States, Argentina, and Macau, XELJANZ XR is the first once-daily oral JAK inhibitor approved for the treatment of moderate to severe RA.
Pfizer is committed to advancing the science of JAK inhibition and enhancing the understanding of the efficacy and safety of XELJANZ through robust clinical development programs in the treatment of immune-mediated inflammatory conditions.
XELJANZ/XELJANZ XR U.S. Label Information
XELJANZ (tofacitinib citrate)/XELJANZ XR (tofacitinib citrate) extended-release is a prescription medicine called a Janus kinase (JAK) inhibitor. XELJANZ/XELJANZ XR is used to treat adults with moderately to severely active rheumatoid arthritis in which methotrexate did not work well. XELJANZ/XELJANZ XR may be used as a single agent or in combination with methotrexate (MTX) or other non-biologic disease-modifying antirheumatic drugs (DMARDs). Use of XELJANZ/XELJANZ XR in combination with biologic DMARDs or potent immunosuppressants, such as azathioprine and cyclosporine, is not recommended.
Pfizer Inc.: Working together for a healthier world®
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of healthcare products. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer healthcare products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. For more information, please visit us at www.pfizer.com. In addition, to learn more, follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
SOURCE: Pfizer
Post Views: 72
NEW YORK, NY, USA I February 16, 2017 I Pfizer Inc. (NYSE:PFE) announced today top-line results from ORAL Strategy, a Phase 3B/4 study of XELJANZ® (tofacitinib citrate) 5mg twice daily (BID) in the treatment of moderate to severe rheumatoid arthritis (RA). ORAL Strategy is the first trial to compare a JAK inhibitor as monotherapy or in combination with methotrexate (MTX) versus adalimumab (Humira) plus MTX in MTX inadequate responders using ACR50 at Month 6 as the primary endpoint. There were three comparisons, which found:
- XELJANZ 5mg plus MTX met its primary endpoint in demonstrating non-inferiority versus Humira plus MTX
- XELJANZ 5mg monotherapy did not meet its primary endpoint of non-inferiority versus Humira plus MTX or versus XELJANZ plus MTX
“ORAL Strategy is representative of the type of innovative and clinically meaningful trials that Pfizer Inflammation & Immunology believes are important to help advance patient care and the science of JAK inhibition,” said Michael Corbo, Chief Development Officer, Inflammation & Immunology, Global Product Development. “We are pleased that we demonstrated non-inferiority of XELJANZ plus MTX versus Humira plus MTX, reinforcing the efficacy of XELJANZ combination therapy. We will continue to analyze the monotherapy data from this study and look forward to sharing the full results of ORAL Strategy at an upcoming scientific forum.”
ORAL Strategy is a 12-month, double-blind, head-to-head study which included 1,152 patients randomized into one of three study arms that were independently compared against each other:
- XELJANZ 5 mg BID as monotherapy (n=386)
- XELJANZ 5 mg BID in combination with a weekly dose of MTX (15-25 mg) (n=378)
- Humira 40 mg every-other-week via subcutaneous injection in combination with a weekly dose of MTX (15-25 mg) (n=388)
The safety findings were consistent with the known adverse events and serious adverse events profile for XELJANZ.
The RA clinical development program has over 20 clinical trials and to-date represents more than 21,100 patient-years of drug exposure. The long-term extension program, spanning over eight years of safety experience, is one of the largest in the RA category with respect to number of patients and patient-years of exposure.
About XELJANZ (tofacitinib citrate) and XELJANZ XR (tofacitinib citrate) extended-release
XELJANZ®/XELJANZ XR® (tofacitinib citrate) is a prescription medicine called a JAK inhibitor. XELJANZ has been approved for use in more than 50 countries. Since XELJANZ was first approved in the U.S. in 2012, it has been prescribed to more than 90,000 patients worldwide. In the United States, Argentina, and Macau, XELJANZ XR is the first once-daily oral JAK inhibitor approved for the treatment of moderate to severe RA.
Pfizer is committed to advancing the science of JAK inhibition and enhancing the understanding of the efficacy and safety of XELJANZ through robust clinical development programs in the treatment of immune-mediated inflammatory conditions.
XELJANZ/XELJANZ XR U.S. Label Information
XELJANZ (tofacitinib citrate)/XELJANZ XR (tofacitinib citrate) extended-release is a prescription medicine called a Janus kinase (JAK) inhibitor. XELJANZ/XELJANZ XR is used to treat adults with moderately to severely active rheumatoid arthritis in which methotrexate did not work well. XELJANZ/XELJANZ XR may be used as a single agent or in combination with methotrexate (MTX) or other non-biologic disease-modifying antirheumatic drugs (DMARDs). Use of XELJANZ/XELJANZ XR in combination with biologic DMARDs or potent immunosuppressants, such as azathioprine and cyclosporine, is not recommended.
Pfizer Inc.: Working together for a healthier world®
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of healthcare products. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer healthcare products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. For more information, please visit us at www.pfizer.com. In addition, to learn more, follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
SOURCE: Pfizer
Post Views: 72
