Meeting News

Biosimilar shows comparable safety, efficacy to Remicade in Crohn's

Treatment with the infliximab biosimilar, Inflectra, demonstrated comparable safety and efficacy to the originator, Remicade, in a phase 3 randomized controlled trial of patients with moderate-to-severe Crohn’s disease, the results of which were recently presented at the 12th Congress of the European Crohn’s and Colitis Organization.

Additional studies of Inflectra (CT-P13; infliximab-dyyb; Celltrion/Pfizer) demonstrating efficacy in pediatric patients with IBD and in patients with fistulizing Crohn’s disease were also presented at ECCO 2017.

RCT data

In the phase 3 double blind, parallel-group study, investigators randomly assigned 220 patients with moderate-to-severe Crohn’s disease from 58 centers across 16 countries to receive treatment with biosimilar or originator infliximab (Remicade, Janssen). This 54-week trial is ongoing, but researchers presented 6-week data at the congress. At least a 70-point reduction in Crohn’s Disease Activity Index scores at week 6 served as the primary endpoint.

Of the 214 patients who completed the study through week 6, 71.4% of patients treated with biosimilar infliximab achieved the primary endpoint compared with 75.2% of those treated with originator infliximab, which was statistically comparable.

CDAI-100 response rates were also comparable (61.9% vs. 64.4%), as were clinical remission rates (42.9% vs. 44.6%), the proportions of patients with a treatment-emergent adverse event (30.6% vs. 35.8%), and the proportions of patients with a serious treatment-emergent adverse event (1.8% vs. 1.8%).

Jørgen Jahnsen, MD, PhD

Jørgen Jahnsen

“This is the first RCT to examine the use of a biosimilar in inflammatory bowel disease,” Jørgen Jahnsen, MD, PhD, professor of gastroenterology at the University of Oslo, Norway, who was not involved with the study, said in a press release from Celltrion. “While we already have a wealth of extrapolated and real-world data for CT-P13, gastroenterologists have for some time wanted the reassurance of an RCT and it’s encouraging to see such positive data from Celltrion’s RCT trial.”

These data are consistent with the findings of the NOR-SWITCH trial, which were presented by Jahnsen and colleagues last year at UEG Week, and showed switching to biosimilar infliximab was safe and noninferior to continued treatment with the originator across multiple indications.

Long-term safety and efficacy data from the ongoing RCT will be reported later this year, including data on patients who will switch treatments at week 30, according to the press release.

Observational studies

Also at the ECCO Congress, researchers presented the results of a South Korean multicenter observational study evaluating biosimilar infliximab in 51 children with IBD. The study included 26 anti-TNF-naive Crohn’s patients and 25 Crohn’s patients who were switched to the biosimilar, as well as 16 naive and seven switched patients with ulcerative colitis. Crohn’s patients were aged 14.3 years on average, and UC patients were aged 13.6 years on average.

Through week 30, 87.5% of naive Crohn’s patients and 80% of naive UC patients achieved remission, compared with 86.4% and 100% of the switch groups, respectively.

Treatment related adverse events occurred in two of the switch patients and in none of the naive patients. Treatment-related serious adverse events occurred in four (9.5%) of the naive patients and in one of the switch patients, but investigators determined they were not related to treatment.

The researchers concluded that biosimilar infliximab was effective and well tolerated in this patient population.

The same study group also performed an observational study of biosimilar infliximab in 204 anti-TNF-naive and switched adults with Crohn’s disease, including 24 with fistulizing Crohn’s disease.

Overall, 40% of the treatment-naive patients with fistulizing Crohn’s disease achieved remission at week 14, and 60% of them achieved remission by week 30. In addition, 72% of the treatment-naive Crohn’s disease cohort achieved remission by week 2 and 81.4% of them achieved remission by week 30.

Further, 87.5% of the switch patients with fistulizing Crohn’s disease and 80% of the switch patients with Crohn’s disease achieved remission during post-baseline visits.

Infusion-related reactions occurred in three patients, treatment-emergent adverse events occurred in one of the fistulizing Crohn’s patients and in 11 (6.1%) of the Crohn’s patients, and treatment-emergent serious adverse events occurred in six (25%) of the fistulizing Crohn’s patients and in 11 (6.1%) of the Crohn’s patients.

The researchers concluded these efficacy findings were consistent with previously reported data, and showed the biosimilar was well tolerated up to 6 months in these patients.

Economic data

Finally, investigators reported real-world cost savings associated with the use of this biosimilar for all indications across five European countries from the beginning of 2015 to the end of the second quarter of 2016. The data was based on surveys conducted by IMS Health.

Total cost savings were more than 2.7 million in Germany, 12.2 million in Spain, 9.9 million in Italy and 7.4 million in the U.K. The investigators suggested the use of this biosimilar could expand treatment access to 5,428 additional patients per year across these countries.

“Even in France, where the price of CT-P13 and [the reference product] is the same, use of the biosimilar has gradually increased,” they wrote.

Overall, the results from the pivotal RCT “are consistent with our other RCTs and many real-world IBD studies that have been conducted, [and] more broadly, it’s rewarding to see the changes that CT-P13 is making in financially-constrained health systems in Europe,” Man Hoon Kim, president and CEO of Celltrion Healthcare, said in the press release. – by Adam Leitenberger

Reference:

Kim YH, et al. Abstract DOP061. Presented at: ECCO Congress; February 15-18, 2017. Barcelona.

Choe YH, et al. Abstract P487. Presented at: ECCO Congress; February 15-18, 2017. Barcelona.

Choe YH, et al. Abstract P500. Presented at: ECCO Congress; February 15-18, 2017. Barcelona.

Han S et al. Abstract P582. Presented at: ECCO Congress; February 15-18, 2017. Barcelona.

Disclosures: The randomized controlled trial was funded by Pfizer and Celltrion. Kim, Jahnsen, and other study investigators report financial ties to Celltrion. Please see the ECCO disclosure database for a full list of all other researchers’ relevant financial disclosures. Man Hoon Kim is employed by Celltrion.

Treatment with the infliximab biosimilar, Inflectra, demonstrated comparable safety and efficacy to the originator, Remicade, in a phase 3 randomized controlled trial of patients with moderate-to-severe Crohn’s disease, the results of which were recently presented at the 12th Congress of the European Crohn’s and Colitis Organization.

Additional studies of Inflectra (CT-P13; infliximab-dyyb; Celltrion/Pfizer) demonstrating efficacy in pediatric patients with IBD and in patients with fistulizing Crohn’s disease were also presented at ECCO 2017.

RCT data

In the phase 3 double blind, parallel-group study, investigators randomly assigned 220 patients with moderate-to-severe Crohn’s disease from 58 centers across 16 countries to receive treatment with biosimilar or originator infliximab (Remicade, Janssen). This 54-week trial is ongoing, but researchers presented 6-week data at the congress. At least a 70-point reduction in Crohn’s Disease Activity Index scores at week 6 served as the primary endpoint.

Of the 214 patients who completed the study through week 6, 71.4% of patients treated with biosimilar infliximab achieved the primary endpoint compared with 75.2% of those treated with originator infliximab, which was statistically comparable.

CDAI-100 response rates were also comparable (61.9% vs. 64.4%), as were clinical remission rates (42.9% vs. 44.6%), the proportions of patients with a treatment-emergent adverse event (30.6% vs. 35.8%), and the proportions of patients with a serious treatment-emergent adverse event (1.8% vs. 1.8%).

Jørgen Jahnsen, MD, PhD

Jørgen Jahnsen

“This is the first RCT to examine the use of a biosimilar in inflammatory bowel disease,” Jørgen Jahnsen, MD, PhD, professor of gastroenterology at the University of Oslo, Norway, who was not involved with the study, said in a press release from Celltrion. “While we already have a wealth of extrapolated and real-world data for CT-P13, gastroenterologists have for some time wanted the reassurance of an RCT and it’s encouraging to see such positive data from Celltrion’s RCT trial.”

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These data are consistent with the findings of the NOR-SWITCH trial, which were presented by Jahnsen and colleagues last year at UEG Week, and showed switching to biosimilar infliximab was safe and noninferior to continued treatment with the originator across multiple indications.

Long-term safety and efficacy data from the ongoing RCT will be reported later this year, including data on patients who will switch treatments at week 30, according to the press release.

Observational studies

Also at the ECCO Congress, researchers presented the results of a South Korean multicenter observational study evaluating biosimilar infliximab in 51 children with IBD. The study included 26 anti-TNF-naive Crohn’s patients and 25 Crohn’s patients who were switched to the biosimilar, as well as 16 naive and seven switched patients with ulcerative colitis. Crohn’s patients were aged 14.3 years on average, and UC patients were aged 13.6 years on average.

Through week 30, 87.5% of naive Crohn’s patients and 80% of naive UC patients achieved remission, compared with 86.4% and 100% of the switch groups, respectively.

Treatment related adverse events occurred in two of the switch patients and in none of the naive patients. Treatment-related serious adverse events occurred in four (9.5%) of the naive patients and in one of the switch patients, but investigators determined they were not related to treatment.

The researchers concluded that biosimilar infliximab was effective and well tolerated in this patient population.

The same study group also performed an observational study of biosimilar infliximab in 204 anti-TNF-naive and switched adults with Crohn’s disease, including 24 with fistulizing Crohn’s disease.

Overall, 40% of the treatment-naive patients with fistulizing Crohn’s disease achieved remission at week 14, and 60% of them achieved remission by week 30. In addition, 72% of the treatment-naive Crohn’s disease cohort achieved remission by week 2 and 81.4% of them achieved remission by week 30.

Further, 87.5% of the switch patients with fistulizing Crohn’s disease and 80% of the switch patients with Crohn’s disease achieved remission during post-baseline visits.

Infusion-related reactions occurred in three patients, treatment-emergent adverse events occurred in one of the fistulizing Crohn’s patients and in 11 (6.1%) of the Crohn’s patients, and treatment-emergent serious adverse events occurred in six (25%) of the fistulizing Crohn’s patients and in 11 (6.1%) of the Crohn’s patients.

The researchers concluded these efficacy findings were consistent with previously reported data, and showed the biosimilar was well tolerated up to 6 months in these patients.

Economic data

Finally, investigators reported real-world cost savings associated with the use of this biosimilar for all indications across five European countries from the beginning of 2015 to the end of the second quarter of 2016. The data was based on surveys conducted by IMS Health.

Total cost savings were more than 2.7 million in Germany, 12.2 million in Spain, 9.9 million in Italy and 7.4 million in the U.K. The investigators suggested the use of this biosimilar could expand treatment access to 5,428 additional patients per year across these countries.

“Even in France, where the price of CT-P13 and [the reference product] is the same, use of the biosimilar has gradually increased,” they wrote.

Overall, the results from the pivotal RCT “are consistent with our other RCTs and many real-world IBD studies that have been conducted, [and] more broadly, it’s rewarding to see the changes that CT-P13 is making in financially-constrained health systems in Europe,” Man Hoon Kim, president and CEO of Celltrion Healthcare, said in the press release. – by Adam Leitenberger

Reference:

Kim YH, et al. Abstract DOP061. Presented at: ECCO Congress; February 15-18, 2017. Barcelona.

Choe YH, et al. Abstract P487. Presented at: ECCO Congress; February 15-18, 2017. Barcelona.

Choe YH, et al. Abstract P500. Presented at: ECCO Congress; February 15-18, 2017. Barcelona.

Han S et al. Abstract P582. Presented at: ECCO Congress; February 15-18, 2017. Barcelona.

Disclosures: The randomized controlled trial was funded by Pfizer and Celltrion. Kim, Jahnsen, and other study investigators report financial ties to Celltrion. Please see the ECCO disclosure database for a full list of all other researchers’ relevant financial disclosures. Man Hoon Kim is employed by Celltrion.

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