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Anais Brasileiros de Dermatologia

Print version ISSN 0365-0596On-line version ISSN 1806-4841

An. Bras. Dermatol. vol.94 no.4 Rio de Janeiro July/Aug. 2019  Epub Oct 17, 2019

http://dx.doi.org/10.1590/abd1806-4841.20198358 

Letters

Efficacy and safety of biosimilar infliximab CT-P13 in the treatment of psoriasis and psoriatic arthritis: 1-year follow-up*

Patricia Shu Kurizky1 
http://orcid.org/0000-0002-5759-2727

Letícia Oba Galvão2 
http://orcid.org/0000-0003-4486-1892

Gladys Aires Martins3 
http://orcid.org/0000-0001-9913-2238

1Dermatology Service, Hospital Universitário de Brasília, Universidade de Brasília, Brasília, DF, Brazil

2Dermatology Service, Hospital Regional da Asa Norte, Brasília, DF, Brazil.

3Psoriasis Outpatient Clinic, Hospital Universitário de Brasília, Universidade de Brasília, Brasília, DF, Brazil

Dear Editor,

The development of immunobiological drugs in recent decades has led to major advances in the treatment of psoriasis and psoriatic arthritis. Drugs such as anti-tumor necrosis factor (anti-TNF) and anti-interleukin 12/23 (anti-IL 12/23), for instance, have proven to be safe and effective alternatives, despite their high production cost.1

Biosimilars are immunobiological drugs that are similar to the original immunobiological product, manufactured using a cell line similar to that of the originally marketed drug.2 In order for biosimilars to be authorized and marketed, the patent on the original drug must expire first.1

The decrease in manufacturing costs and the possibility of expanding treatment to a larger share of the population make biosimilars an attractive alternative, although most regulatory agencies have approved them for psoriasis and psoriatic arthritis as an extrapolation of the efficacy confirmed in studies on other diseases, such as rheumatoid arthritis and ankylosing spondylitis.

CT-P13, an infliximab biosimilar, was authorized by the European Medicines Agency (EMA) in 2013 and the U.S. Food and Drug Administration (FDA) in 2016.3,4 In Brazil, CT-P13 was approved by the National Health Surveillance Agency (ANVISA) in 2016 based on a comparability exercise, thus becoming the first biosimilar drug for the treatment of psoriasis in the country.

Considering that data on efficacy, safety, and immunogenicity of biosimilars for psoriasis and psoriatic arthritis are still limited, replacing an original drug with its biosimilar remains an important matter of debate. In 2017, the Health Department of Brazil’s Federal District demanded that the original infliximab (Remicade®) be substituted by a biosimilar (Remsima®) in both treatment-naïve patients and those already in treatment.

This article reports our experience with the infliximab biosimilar in a 1-year follow-up study.

The study included 40 psoriasis patients who required or were already treated with infliximab, followed at the Brasilia University Hospital or at the Asa Norte Regional Hospital (Table 1).

Table 1 Patients' Profile 

Characteristics Patients Sex Age (year) Presentation Psoriatic Arthritis PASI beforeBiosimilar Use of Remicade (year)
Naive 4 2 men Max. 59 1 erythrodermic 2 Max: 35,4 -
2 women Min. 38 1 palmoplantar Min: 10
Mean: 46 2 vulgar Mean: 17,8
Previous Remicade 36 23 men Max. 83 3 erythrodermic 17 Max: 3,5 Max:16
13 women Min. 28 1 pustulosa Min: 0 Min:1
Mean:52,5 2 palmoplantar Mean: 1 Mean: 5,9
30 vulgar
Total 40 25 men Max. 83 4 erythrodermic 19 Max. 35,4 Max. 16
15 women Min. 28 1 pustulosa Min. 0 Min. 1
Mean: 51,9 3 palmoplantar Mean: 2,68 Mean: 5,9
32 vulgar

After the biosimilar was introduced, all participants were followed for 1 year. During this time, two patients reported mild worsening of their skin lesions, but no significant increase in the PASI score was observed. Two patients developed infliximab-related infusion reactions. One was an infliximab-naïve patient who had a reaction during the second administration of the biosimilar drug (Remsima). The other had been using the original infliximab since 2015, but had stopped treatment 4 months earlier due to shortage of the medication, developing an infusion reaction during the first dose of Remsima. In addition, one infliximab-naïve patient lost weight, had a strong reaction to the PPD test, and developed pulmonary nodules after 7 months of treatment with the biosimilar. When the diagnosis of pulmonary tuberculosis was confirmed, the medication was discontinued and treatment for tuberculosis was initiated.

The 35 remaining patients had no reactions or adverse effects and showed controlled skin and/or joint symptoms, with PASI scores ranging from 0 to 2.7.

CT-P13 (Remsima®, Pfizer) is biologically similar to the original infliximab, a chimeric human-murine monoclonal antibody to TNF-α.3 It has been commercially available in Brazil since 2017, after the patent of the original drug had expired, and it was approved for the same indications as the original drug, including rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, rectal ulcerative colitis, psoriatic arthritis, and psoriasis.

Like previous European studies, our results suggest that the introduction or the switch to CT-P13 appears to be safe. Regarding drug efficacy, the original and the biosimilar showed similar results in most patients. 4,5 It is important to highlight that despite these positive results, most of our patients were clinically stable at the beginning of the study, showing good previous control.

Studies with larger cohorts and longer follow-up are still needed, but our preliminary results show that biosimilars may provide an opportunity to reduce health system costs because of their similarity to reference drugs in terms of safety and efficacy.

*Study conducted at Hospital Universitário de Brasília, Universidade de Brasília, Brasília, DF, Brazil.

Financial support: None.

REFERENCES

1 Puig L, Carretero G, Daudén E, Ferrándiz C, Marrón SE, Martorell A, et al. Biosimilars in Dermatology: Current Situation (Part I). Actas Dermosifiliogr. 2015;106:545-9. [ Links ]

2 Blauvelt A, Cohen AD, Puig L, Vender R, van der Walt J, Wu JJ. Biosimilars for psoriasis: preclinical analytical assessment to determine similarity. Br J Dermatol. 2016;174:282-6. [ Links ]

3 McKeage K. A review of CT-P13: an infliximab biosimilar. BioDrugs. 2014;28:313-21. [ Links ]

4 Dapavo P, Vujic I, Fierro MT, Quaglino P, Sanlorenzo M. The infliximab biosimilar in the treatment of moderate to severe plaque psoriasis. J Am Acad Dermatol. 2016;75:736-9. [ Links ]

5 Jørgensen KK, Olsen IC, Goll GL, Lorentzen M, Bolstad N, Haavardsholm EA, et al. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. Lancet. 2017;389:2304-16 [ Links ]

Received: April 10, 2018; Accepted: September 01, 2018

Mailing Address: Patricia Shu Kurizky. E-mail: patyshu79@gmail.com

Conflict of interest: None.

AUTHORS’ CONTRIBUTIONS

Patricia Shu Kurizky

0000-0002-5759-2727

Approval of the final version of the manuscript; Elaboration and writing of the manuscript; Obtaining, analyzing and interpreting the data; Effective participation in research orientation; Intellectual participation in propaedeutic and/or therapeutic conduct of the cases studied; Critical review of the literature.

Letícia Oba Galvão

0000-0003-4486-1892

pproval of the final version of the manuscript; Obtaining, analyzing and interpreting the data; Critical review of the manuscript.

Gladys Aires Martins

0000-0001-9913-2238

Approval of the final version of the manuscript; Conception and planning of the study; Obtaining, analyzing and interpreting the data; Effective participation in research orientation; Intellectual participation in propaedeutic and/or therapeutic conduct of the cases studied; Critical review of the manuscript.

Creative Commons License This is an Open Access article distributed under the terms of the Creative Commons Attribution NonCommercial License which permits unrestricted noncommercial use, distribution, and reproduction in any medium provided the original work is properly cited.