Navigation Links
Biosimilar CT-P13 matches infliximab in improving ankylosing spondylitis disease activity
Date:6/11/2014

New data presented today at the European League Against Rheumatism Annual Congress (EULAR 2014) show that the newly-approved infliximab biosimilar CT-P13 achieves statistically similar improvements in disease activity, disability and mobility in patients with Ankylosing Spondylitis (AS) compared to its original reference product infliximab (INX).1

CT-P13 is the world's first biosimilar monoclonal antibody to receive a positive opinion from an advanced and developed nations' regulatory body. According to Dr Won Park, Inha University Hospital, Korea, and lead investigator of the PLANETAS* study, "the challenge for biosimilars is to demonstrate similarity in therapeutic effectiveness, safety and immunogenicity to their reference product, not just biochemical and pharmacokinetic equivalence."

"By demonstrating comparable efficacy and safety, the results of our clinical trials should give physicians confidence in using CT-P13 as an alternative treatment option to INX in AS patients," Dr Park added. "This is good news for patients who may previously have had limited access to costly antibody biopharmaceuticals."

AS is a type of chronic arthritis affecting an estimated 1.4 million patients in Europe.2 In AS, inflammation in the joints and ligaments causes pain and stiffness in the neck, back and buttocks. The cause of AS is unknown, and there is no known cure, so the current aim of treatment is to reduce pain and stiffness and to keep the spine flexible.3

These new data captured clinical measures of disease activity via ASAS20/40 and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), disability via the Bath Ankylosing Spondylitis Functional Index (BASFI) and mobility via the Bath Ankylosing Spondylitis Metrology Index (BASMI). In addition, the Student's t test was used to compare mean change of three indices from baseline in both treatment groups.

At week 54, BASDAI improved significantly from baseline in both treatment groups (CT-P13: from 6.74 to 3.78 and INX: from 6.57 to 3.70) and this improvement was similar between groups (difference of means -0.29; CI of the difference -0.91 to 0.32). BASFI and BASMI were also similarly improved: BASFI (CT-P13: from 6.20 to 3.42 and INX: from 6.24 to 3.46) and BASMI (CT-P13: from 4.0 to 2.8 and INX: from 4.1 to 3.2).

In addition, a 50% improvement of the baseline BASDAI (BASDAI50) was achieved in 44.3% for CT-P13 and 46.3% for INX at week 54; the BASDAI50 response rate was comparable between the two groups (p=0.7737).

A second objective of the study was to assess the effect of anti-drug antibody (ADA) on clinical outcomes. The use of biological agents can cause the production of ADA leading to reduced levels of treatment in the blood, impacting treatment response and/or increasing rates of infusion reaction. In the study, the presence of ADA was measured using electrochemiluminescent methodology and clinical responses in all treatment groups were examined in relation to the presence of ADA. Higher ASAS20/40 responses were seen in the ADA negative patients (72.7%/56.5%) compared with ADA positive patients (54.7%/37.7%) at week 54.

The BASDAI and BASFI improved significantly in the ADA negative subgroup compared to the ADA positive subgroup (BASDAI: -3.13 vs. -2.30 and BASFI: -2.97 vs. -2.18), but no clear association with ADA was seen for BASMI. A greater clinical response was shown in the ADA negative subgroup in all three indices. However, the incidence of the ADA and their magnitude of impact on the clinical response or adverse event were similar between biosimilar CT-P13 and innovator infliximab.

CT-P13 has previously demonstrated pharmacokinetic (PK) equivalence to INX in the PLANETAS trial, a randomised double-blind, parallel group study of 250 patients with AS, and was recently approved by the European Medicines Agency.


'/>"/>

Contact: EULAR Press Office
eularpressoffice@cohnwolfe.com
44-078-801-73209
European League Against Rheumatism
Source:Eurekalert

Related medicine news :

1. Kantar Health Uncovers Opportunities and Challenges for Biosimilars in Asia
2. Oncology Leads Biosimilars Market Growth to 2018 Forecasts in New Research Report at RnRMarketResearch.com
3. Real-world patient survival with defibrillators matches trial expectations
4. Guinness International Champions Cup Ticket Prices Slashed for Matches Featuring Real Madrid, Juventus, LA Galaxy, Everton, Inter Milan, Chelsea FC, AC Milan & Valencia
5. In Honor of Breast Cancer Awareness Month, Cakejournal.com Matches Donations from their Readers
6. Callahan honored for improving older adults health in their doctors offices
7. Air Quality Improving in Many U.S. Cities: Report
8. Cedars-Sinai stroke team earns award for improving regions quality of care
9. Physician-Patient Alliance for Health & Safety: The Path to a Safer PCA Pump - Improving Patient Safety with Integrated Capnography
10. Supporting patient autonomy is critical to improving health
11. Improving the oral health of adults with special needs proves challenging
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... ... , ... Quality metrics are proliferating in cancer care, and are derived from ... of the beholder, according to experts who offered insights and commentary in the current ... For the full issue, click here . , For the American Society of ...
(Date:6/26/2016)... Lake Orion, Clarkston, Michigan (PRWEB) , ... June ... ... direction with respect to fertility once they have been diagnosed with endometriosis. These ... tolerable intercourse but they also require a comprehensive approach that can help for ...
(Date:6/25/2016)... ... ... First Choice Emergency Room , the largest network of independent freestanding ... of its new Mesquite-Samuell Farm facility. , “We are pleased to announce Dr. ... James M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. , Dr. ...
(Date:6/24/2016)... ... June 24, 2016 , ... A recent article published ... unfamiliar with. The article goes on to state that individuals are now more comfortable ... less common operations such as calf and cheek reduction. The Los Angeles area medical ...
(Date:6/24/2016)... ... June 24, 2016 , ... Global law firm Greenberg Traurig, P.A. ... The attorneys chosen by their peers for this recognition are considered among the top ... Shareholders received special honors as members of this year’s Legal Elite Hall of Fame: ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... KNOXVILLE, Tenn. , June 24, 2016 /PRNewswire/ ... market providing less invasive and more durable cerebrospinal ... million in funding.  The Series-A funding is led ... the Lighthouse Fund, and other private investors.  Arkis, ... less-invasive neurosurgical instrumentation and the market release of ...
(Date:6/23/2016)... Calif. , June 23, 2016 Any dentist ... many challenges of the current process. Many of them do ... of the technical difficulties and high laboratory costs involved. And ... to offer it at such a high cost that the ... it. Dr. Parsa Zadeh , founder of ...
(Date:6/23/2016)... -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that ... PCT (procalcitonin) assay as a dedicated testing solution for ... clearance, Roche is the first IVD company in the ... risk assessment and management. PCT is a ... in blood can aid clinicians in assessing the risk ...
Breaking Medicine Technology: