Pfizer Inc. (NYSE:PFE) announced today that 20 abstracts for XELJANZ ® (tofacitinib citrate), the first in a new class for the treatment of rheumatoid arthritis (RA), oral Janus kinase (JAK) inhibitors, will be presented at the American College of Rheumatology (ACR) / Association of Rheumatology Health Professionals (ARHP) 2013 Annual Meeting, which is being held October 25-30 in San Diego, CA. XELJANZ is approved in the United States for the treatment of adults with moderately to severely active RA who have had an inadequate response or intolerance to methotrexate, at a dose of 5 mg tablet twice daily.
These data add to the understanding of the efficacy and safety profile of XELJANZ in the treatment of RA. XELJANZ was studied in a comprehensive, global, multi-study program that included approximately 5,000 patients across Phase 2 and 3 trials in more than 40 countries, resulting in 7,000 patient-years of exposure through 2011, the time of regulatory submission. These data further inform rheumatologists who are prescribing or considering prescribing XELJANZ for appropriate patients.
Among the analyses being presented are open-label safety and efficacy data up to five years in long-term extension (LTE) studies; integrated and post-hoc analyses of safety data; and post-hoc safety and efficacy analyses of clinical trial sub-populations, notably one that analyzed the safety profile and efficacy of XELJANZ in U.S. patients versus patients from the Rest of World (ROW). More details on these abstracts are found below.
|LTE Safety and Efficacy Data Up to Five Years|
|Tofacitinib, an Oral Janus Kinase Inhibitor, in the Treatment of Rheumatoid Arthritis: Open Label, Long-Term Extension Safety and Efficacy Up To 5 Years||
Data from a pooled analysis of two open-label LTE studies (global
A3921024 ORAL Sequel Study and Japan A3921041 Study) involving
patients with moderately to severely active RA who had
participated in randomized Phase 2 or 3 studies of XELJANZ dosed
at 5 or 10 mg BID.
||Poster Abstract #: 33993 Date: October 29, 2013|
|Post-Hoc Analysis Of Risk Factors for Serious Infection Events (SIE)|
|Post-Hoc Analysis Of Serious Infection Events and Selected Clinical Factors In Rheumatoid Arthritis Patients Treated With Tofacitinib||
Data from a pooled analysis of five randomized Phase 2 studies,
five randomized Phase 3 studies and two open-label LTE studies
involving patients with moderately to severely active RA who had
received XELJANZ dosed at 5 or 10 mg BID were analyzed to
determine risk factors for SIEs.
||Poster Abstract #: 34301 Date: October 27, 2013|
|Integrated Safety Analysis Of Malignancies|
|Tofacitinib, An Oral Janus Kinase Inhibitor: Analysis Of Malignancies Across The Rheumatoid Arthritis Clinical Program||
Data from a pooled analysis of six randomized Phase 2 studies, six
randomized Phase 3 studies and two open-label LTE studies
involving patients with moderately to severely active RA who had
received XELJANZ dosed at 5 or 10 mg BID were analyzed with
regards to malignancies.
||Oral presentation Abstract #: 34063 Date: October 27, 2013|
|Safety and Efficacy of XELJANZ in U.S. Versus ROW Study Populations|
|Efficacy and Safety Analyses Of Tofacitinib From Pooled Phase 2, Phase 3 and Long-Term Extension Rheumatoid Arthritis Studies: U.S. Compared With Non-U.S. Populations||
Pooled data from DMARD-inadequate responder patients with
moderately to severely active RA in six Phase 2 and five Phase 3
randomized studies and two open-label LTE studies who received
XELJANZ dosed at 5 or 10 mg BID were analyzed to determine whether
there were any differences in efficacy and/or safety between the
U.S. and ROW populations.
||Poster Abstract #: 34280 Date: October 27, 2013|
Additional XELJANZ Data to be Presented:
|Tofacitinib, An Oral Janus Kinase Inhibitor: Analysis Of Gastrointestinal Adverse Events Across The Rheumatoid Arthritis Clinical Program||Integrated safety analysis of gastrointestinal adverse events||Poster Abstract #:34071 Date: October 27, 2013|
|Cardiovascular Safety Findings In Rheumatoid Arthritis Patients Treated With Tofacitinib, A Novel, Oral Janus Kinase Inhibitor||Integrated safety analysis of cardiovascular adverse events||Poster Abstract #:34076 Date: October 27, 2013|
|Relationship Between Lymphocyte Count and Risk Of Infection In Rheumatoid Arthritis Patients Treated With Tofacitinib||Relationship between lymphocytes and rates of infection||Poster Abstract #:34133 Date: October 29, 2013|
|Association Of Mean Changes In Laboratory Safety Parameters With C-Reactive Protein At Baseline and Week 12 In Rheumatoid Arthritis Patients Treated With Tofacitinib||Relationship between laboratory safety parameters and disease activity||Poster Abstract #:34294 Date: October 29, 2013|
|Reversibility Of Pharmacodynamic Effects After Short- and Long-Term Treatment With Tofacitinib In Patients With Rheumatoid Arthritis||Reversibility of the pharmacodynamic effects||Poster Abstract #:34285 Date: October 27, 2013|
|Tolerability and Non-Serious Adverse Events In Rheumatoid Arthritis Patients Treated With Tofacitinib As Monotherapy Or In Combination Therapy||Tolerability||Poster Abstract #:34275 Date: October 27, 2013|
|Tofacitinib, An Oral Janus Kinase Inhibitor: Safety Comparison In Patients With Rheumatoid Arthritis and An Inadequate Response To Nonbiologic Or Biologic Disease-Modifying Anti-Rheumatic Drugs||Comparison of tofacitinib safety between nonbiologic DMARD-IR and biologic DMARD-IR populations||Poster Abstract #:34132 Date: October 27, 2013|
|Mechanism of Action|
|The Jak Inhibitor Tofacitinib Suppresses Synovial Jak-Stat Signaling In Rheumatoid Arthritis||Synovial biopsy study and inflammatory biomarkers||Oral presentation Abstract #: 35154 Date: October 28, 2013|
|Health Economics and Outcomes Research|
|Effects Of The Oral JAK Inhibitor Tofacitinib In Combination With Methotrexate On Patient Reported Outcomes In a 24-Month Phase 3 Trial Of Active Rheumatoid Arthritis||Patient-reported outcomes at two years in A3921044 ORAL Scan Study||Poster Abstract #:34297 Date: October 29, 2013|
|Effects Of Tofacitinib, An Oral Janus Kinase Inhibitor, On Work Limitations In Patients With Rheumatoid Arthritis||Work productivity||Poster Abstract #:35376 Date: October 29, 2013|
|Improvements In Physical Function Correlate With Improvements In Health Related Quality Of Life: Reported Outcomes In Rheumatoid Arthritis Patients Treated With Tofacitinib: Results From 3 Randomized Phase 3 Trials||Correlation between physical function and improvements in health-related quality of life||Poster Abstract #:34053 Date: October 29, 2013|
|Effects Of Smoking Status On Response To Treatment With Tofacitinib In Patients With Rheumatoid Arthritis||Smokers versus non-smokers||Poster Abstract #:34276 Date: October 28, 2013|
|Assessment of Lipid Changes and Infection Risk In Diabetic and Nondiabetic Patients With Rheumatoid Arthritis Treated With Tofacitinib||Diabetic versus nondiabetic patients||Poster Abstract #:34273 Date: October 29, 2013|
|Efficacy and Safety Of Tofacitinib In Older and Younger Patients With Rheumatoid Arthritis||Elderly versus non-elderly||Poster Abstract #:34271 Date: October 29, 2013|
|Remission At 3 Or 6 Months and Radiographic Non-Progression At 12 Months In Methotrexate-Naïve Rheumatoid Arthritis Patients Treated With Tofacitinib Or Methotrexate: A Post-Hoc Analysis Of The ORAL Start Trial||Prediction of response||Poster Abstract #:34274 Date: October 29, 2013|
|Tofacitinib, An Oral Janus Kinase Inhibitor, In A Rheumatoid Arthritis Open-Label Extension Study Following Adalimumab Therapy In A Phase 3 Randomized Clinical Trial||Switch from adalimumab to tofacitinib||Poster Abstract #:34048 Date: October 27, 2013|
- XELJANZ can lower the ability of the immune system to fight infections. Some people have serious infections while taking XELJANZ, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Healthcare providers should test patients for TB before starting XELJANZ, and monitor them closely for signs and symptoms of TB and other infections during treatment. People should not start taking XELJANZ if they have any kind of infection unless their healthcare provider tells them it is okay.
- XELJANZ may increase the risk of certain cancers by changing the way the immune system works. Lymphoma and other cancer can happen in patients taking XELJANZ.
- Some people taking XELJANZ get tears in their stomach or intestines. Patients should tell their healthcare provider right away if they have fever and stomach-area pain that does not go away, or a change in bowel habits.
- XELJANZ can cause changes in certain lab test results including low blood cell counts, increases in certain liver tests, and increases in cholesterol levels. Healthcare providers should do blood tests before starting patients on XELJANZ and while they are taking XELJANZ, to check for these side effects. Normal cholesterol levels are important to good heart health. Healthcare providers may stop XELJANZ treatment because of changes in blood cell counts or liver test results.
- Patients should tell their healthcare providers if they plan to become pregnant or are pregnant. It is not known if XELJANZ will harm an unborn baby. To monitor the outcomes of pregnant women exposed to XELJANZ, a registry has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-877-311-8972.
- Patients should tell their healthcare providers if they plan to breastfeed or are breastfeeding. Patients and their healthcare provider should decide if they will take XELJANZ or breastfeed. They should not do both.
- In carriers of the hepatitis B or C virus (viruses that affect the liver), the virus may become active while using XELJANZ. Healthcare providers may do blood tests for hepatitis before and during treatment with XELJANZ.
- Common side effects include upper respiratory tract infections (common cold, sinus infections), headache, diarrhea, nasal congestion, sore throat, and runny nose (nasopharyngitis).
- It is not known if XELJANZ is safe and effective in people with Hepatitis B or C.
- XELJANZ is not for people with severe liver problems.
- It is not known if XELJANZ is safe and effective in children.
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