A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study.

Abstract

OBJECTIVES:

To compare the pharmacokinetics (PK), safety and efficacy of innovator infliximab (INX) and CT-P13, a biosimilar to INX, in patients with active ankylosing spondylitis (AS).

METHODS:

Phase 1 randomised, double-blind, multicentre, multinational, parallel-group study. Patients were randomised to receive 5 mg/kg of CT-P13 (n=125) or INX (n=125). Primary endpoints were area under the concentration-time curve (AUC) at steady state and observed maximum steady state serum concentration (Cmax,ss) between weeks 22 and 30. Additional PK, efficacy endpoints, including 20% and 40% improvement response according to Assessment in Ankylosing Spondylitis International Working Group criteria (ASAS20 and ASAS40), and safety outcomes were also assessed.

RESULTS:

Geometric mean AUC was 32 765.8 μgh/ml for CT-P13 and 31 359.3 μgh/ml for INX. Geometric mean Cmax,ss was 147.0 μg/ml for CT-P13 and 144.8 μg/ml for INX. The ratio of geometric means was 104.5% (90% CI 94% to 116%) for AUC and 101.5% (90% CI 95% to 109%) for Cmax,ss. ASAS20 and ASAS40 responses at week 30 were 70.5% and 51.8% for CT-P13 and 72.4% and 47.4% for INX, respectively. In the CT-P13 and INX groups more than one adverse event occurred in 64.8% and 63.9% of patients, infusion reactions occurred in 3.9% and 4.9%, active tuberculosis occurred in 1.6% and 0.8%, and 27.4% and 22.5% of patients tested positive for anti-drug antibodies, respectively.

CONCLUSIONS:

The PK profiles of CT-P13 and INX were equivalent in patients with active AS. CT-P13 was well tolerated, with an efficacy and safety profile comparable to that of INX up to week 30.

• Authors: Won Park, Pawel Hrycaj, Slawomir Jeka, Volodymyr Kovalenko, Grygorii Lysenko, Pedro Miranda, Helena Mikazane, Sergio Gutierrez-Ureña, MieJin Lim, Yeon-Ah Lee, Sang Joon Lee, HoUng Kim, Dae Hyun Yoo, Jürgen Braun
• Journal: Annals of the rheumatic diseases (Ann Rheum Dis) Vol. 72 Issue 10 Pg. 1605-12 (Oct 2013) ISSN: 1468-2060 [Electronic] England
• PMID: 23687259 (Publication Type: Clinical Trial, Phase I, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Monoclonal
• Antirheumatic Agents
• CT-P13
• Immunoglobulin G
• Infliximab

Topics

• Adolescent
• Adult
• Aged
• Antibodies, Monoclonal (adverse effects, blood, immunology, therapeutic use)
• Antibody Formation
• Antirheumatic Agents (adverse effects, blood, immunology, therapeutic use)
• Double-Blind Method
• Female
• Humans
• Immunoglobulin G (adverse effects, blood, immunology, therapeutic use)
• Infliximab
• Male
• Middle Aged
• Prospective Studies
• Severity of Illness Index
• Spondylitis, Ankylosing (blood, drug therapy, immunology)
• Treatment Outcome
• Young Adult