Are less expensive “biosimilar” drugs as effective at treating ankylosing spondylitis?

Ankylosing spondylitis (AS) is a type of arthritis caused by inflammation, in which the main symptom is back pain. When a substance called tumour necrosis factor (TNF) is over-active in the body, it causes inflammation and damage to bones, cartilage and surrounding tissue. Anti-TNF treatments, including an antibody called Remicade (reference infliximab), block the action of TNF and can reduce inflammation. These so-called ‘biologic drugs’ are difficult to produce and are therefore expensive. Because of this, patients with AS or other immune-related diseases who may benefit from this type of treatment are not always offered it. ‘Biosimilar infliximab’, also known by its project name CT-P13 and brand names Remsima and Inflectra, is a similar but less expensive alternative to Remicade and has been tested side-by-side with Remicade in a number of clinical trials.

Fig. 1. A. The proportion of patients with a 20% improvement in the signs and symptoms of AS* was very similar between those taking CT-P13 (biosimilar infliximab) and those taking Remicade (reference infliximab). B. The average improvement in carrying out daily living tasks** was very similar for patients taking CT-P13 (biosimilar infliximab) and those taking Remicade (reference infliximab). *Patient response measured by ASAS20 at week 54 (after 54 weeks of treatment with CT-P13 or Remicade). **Patient response measured as decrease in difficulty with respect to baseline scores by Bath Ankylosing Spondylitis Functional Index at week 54 (after 54 weeks of treatment with CT-P13 or Remicade).

One such clinical trial was a large multinational study that investigated whether CT-P13 was as effective and safe as Remicade at treating AS. The study, called PLANETAS, involved 250 patients from 10 different countries. Patients took either CT-P13 or Remicade for 1 year and improvements in the signs and symptoms of AS were monitored. The results showed that there was no difference between the patients taking CT-P13 and those taking Remicade in the percentage who had an improvement in signs and symptoms of AS. Figure 1A shows the percentage of patients taking CT-P13 or Remicade who experienced a 20% improvement in the signs and symptoms of AS.

Patients taking CT-P13 or Remicade also completed a questionnaire rating the level of difficulty they experienced in carrying out daily living tasks (e.g. putting on socks, getting out of a chair). Figure 1B shows the improvements in these measures for patients taking CT-P13 and those taking Remicade.

The study also showed that CT-P13 was as safe as Remicade. Most of the side effects that did occur were mild or moderate.

In conclusion, the results from the PLANETAS study demonstrated that over a 1-year period, CT-P13 was as effective and safe as Remicade for treating AS. Being a biosimilar, CT-P13 is less expensive than Remicade and therefore may make effective AS treatment accessible to more patients, and also provide budget savings to healthcare systems.

Won Park and Dae Hyun Yoo
IN-HA University, School of Medicine, Medicine/Rheumatology, Incheon, Republic of Korea
Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea

 

Publication

Comparable long-term efficacy, as assessed by patient-reported outcomes, safety and pharmacokinetics, of CT-P13 and reference infliximab in patients with ankylosing spondylitis: 54-week results from the randomized, parallel-group PLANETAS study.
Park W, Yoo DH, Jaworski J, Brzezicki J, Gnylorybov A, Kadinov V, Sariego IG, Abud-Mendoza C, Escalante WJ, Kang SW, Andersone D, Blanco F, Hong SS, Lee SH, Braun J.
Arthritis Res Ther. 2016 Jan 20

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