In the Journals

Infliximab biosimilar safe, effective for Crohn’s disease

The biosimilar of infliximab, CT-P13, demonstrated equivalency in safety and efficacy for the treatment of Crohn’s disease, according to data published in Annals of Internal Medicine.

“CT-P13 is a biosimilar of the reference product infliximab, with demonstrated efficacy and safety for some inflammatory arthritides,” Antoine Meyer, MD, from Hôpital Bicêtre, Le Kremlin-Bicêtre, France, and colleagues wrote. “It was approved for the treatment of Crohn’s disease on that basis, without specific studies examining its effects in Crohn’s disease.”

Meyer and colleagues conducted a comparative equivalence cohort study to determine the effectiveness and safety of CT-P13 vs. infliximab in infliximab-naive patients with Crohn’s disease who were older than 15 years. Of the 5,050 participants, 2,551 started treatment with infliximab and 2,499 started treatment with CT-P13.

The primary outcomes included a composite end point of death, Crohn’s-related surgery, all-cause hospitalization and reimbursement of another biologic therapy.

The composite endpoint was met by 1,147 patients in the infliximab group and 952 patients in the CT-P13 group. CT-P13 demonstrated equivalency to infliximab regarding efficacy (HR = 0.92; 95% CI, 0.85-0.99).

Safety outcomes did not differ between the CT-P13 group and infliximab group. The HR for serious infections was 0.82 (95% CI, 0.61-1.11), tuberculosis was 1.1 (95% CI, 0.36-3.34) and solid or hematologic cancer was 0.66 (95% CI, 0.33-1.32).

“Our observational study of real-life data suggests that effectiveness of CT-P13 is equivalent to that of [infliximab] in infliximab-naive patients... The choice between the two products can therefore be based on cost only,” Meyer and colleagues concluded.

In a related editorial, Ole Haagen Nielsen, MD, DMSc, from the University of Copenhagen Herlev Hospital, Denmark, and Mark Andrew Ainsworth, MD, PhD, DMSc, from Odense University Hospital, Denmark, note that biosimilars offer cost savings and more economic benefits are expected with increased use of these products.

“When a patient is switching to a biosimilar or a treatment-naive patient is starting therapy with a biosimilar, communication must be open and clear and patient concerns must be considered,” they wrote. “Most important, to alleviate concerns, health care professionals must be proactive in increasing patients’ confidence by providing evidence-based information from the growing experience with biosimilars.” – by Alaina Tedesco

 

Disclosures: Ainsworth and Nielsen report no relevant financial disclosures. Meyer reports no relevant financial disclosures. Please see study for all other authors’ relevant financial disclosures.

The biosimilar of infliximab, CT-P13, demonstrated equivalency in safety and efficacy for the treatment of Crohn’s disease, according to data published in Annals of Internal Medicine.

“CT-P13 is a biosimilar of the reference product infliximab, with demonstrated efficacy and safety for some inflammatory arthritides,” Antoine Meyer, MD, from Hôpital Bicêtre, Le Kremlin-Bicêtre, France, and colleagues wrote. “It was approved for the treatment of Crohn’s disease on that basis, without specific studies examining its effects in Crohn’s disease.”

Meyer and colleagues conducted a comparative equivalence cohort study to determine the effectiveness and safety of CT-P13 vs. infliximab in infliximab-naive patients with Crohn’s disease who were older than 15 years. Of the 5,050 participants, 2,551 started treatment with infliximab and 2,499 started treatment with CT-P13.

The primary outcomes included a composite end point of death, Crohn’s-related surgery, all-cause hospitalization and reimbursement of another biologic therapy.

The composite endpoint was met by 1,147 patients in the infliximab group and 952 patients in the CT-P13 group. CT-P13 demonstrated equivalency to infliximab regarding efficacy (HR = 0.92; 95% CI, 0.85-0.99).

Safety outcomes did not differ between the CT-P13 group and infliximab group. The HR for serious infections was 0.82 (95% CI, 0.61-1.11), tuberculosis was 1.1 (95% CI, 0.36-3.34) and solid or hematologic cancer was 0.66 (95% CI, 0.33-1.32).

“Our observational study of real-life data suggests that effectiveness of CT-P13 is equivalent to that of [infliximab] in infliximab-naive patients... The choice between the two products can therefore be based on cost only,” Meyer and colleagues concluded.

In a related editorial, Ole Haagen Nielsen, MD, DMSc, from the University of Copenhagen Herlev Hospital, Denmark, and Mark Andrew Ainsworth, MD, PhD, DMSc, from Odense University Hospital, Denmark, note that biosimilars offer cost savings and more economic benefits are expected with increased use of these products.

“When a patient is switching to a biosimilar or a treatment-naive patient is starting therapy with a biosimilar, communication must be open and clear and patient concerns must be considered,” they wrote. “Most important, to alleviate concerns, health care professionals must be proactive in increasing patients’ confidence by providing evidence-based information from the growing experience with biosimilars.” – by Alaina Tedesco

 

Disclosures: Ainsworth and Nielsen report no relevant financial disclosures. Meyer reports no relevant financial disclosures. Please see study for all other authors’ relevant financial disclosures.

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