Pfizer in partnership with Celltrion Healthcare presents new data for INFLECTRA in Crohn’s disease
NEW YORK, NY, USA I February 17, 2017 I Data announced jointly today by Pfizer Inc. (NYSE:PFE) and Celltrion Healthcare, at the 12th 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).1 The randomized 54 week clinical trial (RCT)2 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,1 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.1 No new safety 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.2
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.2
INFLECTRA is a prescription medication used to treat:
Crohn’s Disease
- Can reduce signs and symptoms and induce and maintain remission in adult patients with moderately to severely active Crohn’s disease who haven’t responded well to other therapies
Pediatric Crohn’s Disease
- Can reduce signs and symptoms and induce and maintain remission in children (ages 6-17) with moderately to severely active Crohn’s disease who haven’t responded well to other therapies
Ulcerative Colitis
- Can reduce signs and symptoms, induce and maintain remission, promote intestinal healing, and reduce or stop the need for steroids in adult patients with moderately to severely active ulcerative colitis who haven’t responded well to other therapies
Rheumatoid Arthritis
- Can reduce signs and symptoms, help stop further joint damage, and improve physical function in patients with moderately to severely active rheumatoid arthritis, in combination with methotrexate
Ankylosing Spondylitis
- Can reduce signs and symptoms in patients with active ankylosing spondylitis
Psoriatic Arthritis
- Can reduce signs and symptoms of active arthritis, help stop further joint damage, and improve physical function in patients with psoriatic arthritis
Plaque Psoriasis
- Approved for the treatment of adult patients with chronic severe (extensive and/or disabling) plaque psoriasis under the care of a physician who will determine if INFLECTRA is appropriate considering other available therapies
Please see full Prescribing Information for 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.
1 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
2 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
SOURCE: Pfizer
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Pfizer in partnership with Celltrion Healthcare presents new data for INFLECTRA in Crohn’s disease
NEW YORK, NY, USA I February 17, 2017 I Data announced jointly today by Pfizer Inc. (NYSE:PFE) and Celltrion Healthcare, at the 12th 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).1 The randomized 54 week clinical trial (RCT)2 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,1 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.1 No new safety 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.2
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.2
INFLECTRA is a prescription medication used to treat:
Crohn’s Disease
- Can reduce signs and symptoms and induce and maintain remission in adult patients with moderately to severely active Crohn’s disease who haven’t responded well to other therapies
Pediatric Crohn’s Disease
- Can reduce signs and symptoms and induce and maintain remission in children (ages 6-17) with moderately to severely active Crohn’s disease who haven’t responded well to other therapies
Ulcerative Colitis
- Can reduce signs and symptoms, induce and maintain remission, promote intestinal healing, and reduce or stop the need for steroids in adult patients with moderately to severely active ulcerative colitis who haven’t responded well to other therapies
Rheumatoid Arthritis
- Can reduce signs and symptoms, help stop further joint damage, and improve physical function in patients with moderately to severely active rheumatoid arthritis, in combination with methotrexate
Ankylosing Spondylitis
- Can reduce signs and symptoms in patients with active ankylosing spondylitis
Psoriatic Arthritis
- Can reduce signs and symptoms of active arthritis, help stop further joint damage, and improve physical function in patients with psoriatic arthritis
Plaque Psoriasis
- Approved for the treatment of adult patients with chronic severe (extensive and/or disabling) plaque psoriasis under the care of a physician who will determine if INFLECTRA is appropriate considering other available therapies
Please see full Prescribing Information for 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.
1 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
2 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
SOURCE: Pfizer
Post Views: 66
