02/17/2017 | Press release | Distributed by Public on 02/17/2017 11:04
NEW YORK--(BUSINESS WIRE)--Data announced jointly today by Pfizer Inc. (NYSE:PFE) and Celltrion Healthcare, at the 12 Congress of the European Crohn's and Colitis Organisation (ECCO), showed that for patients with moderate-to-severe Crohn's disease (CD), treatment with INFLECTRA (infliximab CT-P13) has similar efficacy and safety to treatment with REMICADE (infliximab). The randomized 54 week clinical trial (RCT) in 214 patients met its primary end point demonstrating that, at six weeks, INFLECTRA was similar to REMICADE in the treatment of CD thereby meeting the criterion for non-inferiority. The trial evaluated the number of patients experiencing a fall of 70 points or greater in the Crohn's Disease Activity Index (CDAI-70), a well-established assessment of treatment response in CD. The response rates, 71.4% for INFLECTRA and 75.2% for REMICADE,were not statistically significantly different.INFLECTRA is marketed as INFLECTRA (infliximab-dyyb) in the United States (U.S.) and under other brand names in some countries.
'Today's presentation of randomized control trial data in patients with Crohn's disease further supports the existing clinical profile of CT-P13 in inflammatory bowel disease. In addition to existing data from the registration studies, real-world experience and the NOR-SWITCH trial, this data adds to the body of evidence supporting use of CT-P13 across its approved indications,' said Sam Azoulay, M.D., Senior Vice President, Chief Medical Officer, Pfizer Essential Health, Pfizer.
Additional disease activity measures used in the trial, clinical remission and CDAI-100 response rates, demonstrated similar and consistent efficacy between the two treatments. Six-week data also showed that INFLECTRA had a similar safety and tolerability profile as REMICADE. The number of patients experiencing at least one adverse event, serious adverse events, and adverse events of special interest (such as infusion reaction and infection) were similar between the two treatment arms.No newsafety signals were identified.
Further results on the longer-term safety and efficacy of INFLECTRA from this ongoing 54-week study in CD are expected later this year. The study is also examining the treatment response and safety profile in patients when switched from REMICADE to INFLECTRA, and from INFLECTRA to REMICADE.
About the trial
This is a randomized, double-blind, parallel-group, phase III study being conducted in patients with moderately-to-severe Crohn's disease to compare overall safety and efficacy between INFLECTRA and REMICADE in terms of Crohn's Disease Activity Index (CDAI)-70 response rates. The primary endpoint of the 54-week study was collected at week six to demonstrate that INFLECTRA is similar to REMICADE in the treatment of CD. The study used the standard assessment of CDAI-70 as primary endpoint. From Week 30, patients on REMICADE will be randomized to either continue on the same treatment or switch to INFLECTRA while patients on INFLECTRA will be randomized to either continue on the same treatment or switch to the REMICADE. Further results will be collected and reported at 54-weeks.
ABOUT INFLECTRA: IMPORTANT SAFETY INFORMATION AND INDICATIONS FROM THE U.S. PRESCRIBING INFORMATION
Only your doctor can recommend a course of treatment after checking your health condition. INFLECTRA (infliximab-dyyb) can cause serious side effects such as lowering your ability to fight infections. Some patients, especially those 65 years and older, have had serious infections caused by viruses, fungi or bacteria that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Your doctor should monitor you closely for signs and symptoms of TB during treatment with INFLECTRA.
Unusual cancers have been reported in children and teenage patients taking TNF-blocker medicines. Hepatosplenic T-cell lymphoma, a rare form of fatal lymphoma, has occurred mostly in teenage or young adult males with Crohn's disease or ulcerative colitis who were taking infliximab products and azathioprine or 6-mercaptopurine. For children and adults taking TNF blockers, including INFLECTRA, the chances of getting lymphoma or other cancers may increase.
You should discuss any concerns about your health and medical care with your doctor.
What should I tell my doctor before I take INFLECTRA?
You should let your doctor know if you have or ever had any of the following:
Also tell your doctor if you:
What should I watch for and talk to my doctor about before or while taking INFLECTRA?
The following serious (sometimes fatal) side effects have been reported in people taking INFLECTRA.
You should tell your doctor right away if you have any of the signs listed below:
The more common side effects with infliximab products are respiratory infections (that may include sinus infections and sore throat), headache, rash, coughing, and stomach pain.
INFLECTRA is a prescription medication used to treat:
Pediatric Crohn's Disease
Please see full Prescribing Informationfor INFLECTRA (infliximab-dyyb).
About Pfizer: 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 health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care 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.
DISCLOSURE NOTICE: The information contained in this release is as of February 17, 2017. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about INFLECTRA (infliximab-dyyb),including its potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of INFLECTRA; the uncertainties inherent in research and development, including, without limitation, the possibility of unfavorable clinical trial results, including unfavorable new clinical data and additional analyses of existing clinical data; intellectual property and/or litigation implications; relationship with the application sponsor; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of INFLECTRA; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2015, including in the sections thereof captioned 'Risk Factors' and 'Forward-Looking Information and Factors That May Affect Future Results', as well as in its subsequent reports on Form 10-Q and Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.
REMICADE is a U.S. registered trademark of Janssen Biotech, Inc.
Kim YH., et al., Phase III Randomised, Double-blind, Controlled Trial to Compare Biosimilar Infliximab (CT-P13) with Innovator Infliximab (INX) in Patients with Active Crohn's Disease: Early Efficacy and Safety Results. DOP061, presented at ECCO 2017
Clinical Trials.gov.Demonstrate Noninferiority in Efficacy and to Assess Safety of CT-P13 in Patients With Active Crohn's Disease. Available at: https://www.clinicaltrials.gov/ct2/show/NCT02096861?term=ct-p13+crohns&rank=1. Last accessed February 2017