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Characteristics and outcomes of rheumatoid arthritis patients who started biosimilar infliximab

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Abstract

To compare the characteristics of rheumatoid arthritis (RA) patients receiving either biosimilar or originator infliximab and to identify the effectiveness and safety of biosimilar infliximab in RA patients in real-world practice. RA patients who started either biosimilar or originator infliximab were selected using the prospective biologic disease-modifying anti-rheumatic drugs (DMARDs) registry: BIOlogics Pharmacoepidemiologic StudY (BIOPSY). Baseline characteristics of the two groups were compared, and short-term treatment outcomes, including DAS28-ESR and HAQ-DI scores, were compared after initiation of biosimilar or originator infliximab. The drug retention rates of the two groups were also compared. A total of 100 RA patients, 55 biosimilar, and 45 originator infliximab users were included in this analysis. Baseline characteristics of age, disease duration, and previous or current medications were similar in the two groups. Baseline DAS28-ESR was higher in the originator infliximab group (6.3 ± 1.1 vs. 5.8 ± 1.1, p = 0.02). The early DAS28-ESR remission rates observed 7.9 ± 1.8 months after starting biosimilar and originator infliximab were 15.0 and 25.0%, respectively (p = 0.47). The change in HAQ-DI did not differ between the two groups (0.4 ± 0.7 vs. 0.4 ± 0.8, p = 0.94). Patients treated with biosimilar infliximab in clinical practice had lower disease activity at the start of treatment than those receiving originator infliximab. Biosimilar infliximab was well-tolerated, safe, and of similar clinical effectiveness to originator infliximab. Larger number of patient and longer follow-up data will be needed to confirm the effectiveness and safety of biosimilar infliximab in clinical practice.

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Abbreviations

RA:

Rheumatoid arthritis

AS:

Ankylosing spondylitis

DMARDs:

Disease-modifying anti-rheumatic drugs

EMA:

European Medicines Agency

FDA:

Food and Drug Administration

RCTs:

Randomized controlled trials

DAS28-ESR:

Disease activity score-erythrocyte sedimentation rate

IRB:

Institutional review board

PYs:

Person years

CDAI:

Clinical disease activity index

SDAI:

Simple disease activity index

PROs:

Patient-reported outcomes

VAS:

Visual analogue scale

HAQ-DI:

Health Assessment Questionnaire disability index

EQ-5D:

EuroQoL-5dimension

AEs:

Adverse events

SAEs:

Serious adverse events

SOC:

System organ class

IRs:

Incidence rates

IQR:

Interquartile range

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Acknowledgements

The authors wish to acknowledge the assistance of the following investigators who have enrolled patients in KORONA: Drs. Hoon-Suk Cha, Jung-Yoon Choe, Chan Hong Jeon, Jae-Bum Jun, Tae-Hwan Kim, Jaejoon Lee, Jisoo Lee, Shin-Seok Lee, Yeon-Ah Lee, Seong-Su Nah, Dong Hyuk Sheen, Ran Song, Bo Young Yoon, Won Tae Chung, Young Ok Jung, Jinseok Kim, Seong-Kyu Kim, Sang-Hoon Lee, Mi Kyoung Lim, Sung Won Lee, and Seung-Cheol Shim.

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Authors and Affiliations

  1. Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea

    Yoon-Kyoung Sung, Soo-Kyung Cho, Dam Kim, Chan-Bum Choi, Dae-Hyun Yoo & Sang-Cheol Bae

  2. Clinical Research Center for Rheumatoid Arthritis (CRCRA), Seoul, South Korea

    Yoon-Kyoung Sung, Soo-Kyung Cho, Dam Kim, Soyoung Won, Chan-Bum Choi & Sang-Cheol Bae

  3. Department of Rheumatology, Hanyang University Guri Hospital, Guri, South Korea

    So-Young Bang & Hye-Soon Lee

  4. Department of Rheumatology, Kyung Hee University Hospital, Seoul, South Korea

    Seung-Jae Hong

  5. Department of Rheumatology, Ajou University Hospital, Suwon, South Korea

    Hyoun Ah Kim & Chang-Hee Suh

  6. Department of Rheumatology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea

    Eun-Mi Koh

Authors
  1. Yoon-Kyoung Sung
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  2. Soo-Kyung Cho
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  9. Eun-Mi Koh
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  13. Sang-Cheol Bae
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Corresponding author

Correspondence to Sang-Cheol Bae.

Ethics declarations

Ethics approval and consent to participate

This study was approved by the Institutional Review Board of Hanyang University Hospital (HYUH IRB 2009-04-003). All participants provided informed consent under a protocol approved by the Institutional Review Board.

Conflict of interest

The authors declare no conflicts of interest.

Funding

This research was supported by a grant from the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea (Grant Number: HI16C0061).

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Sung, YK., Cho, SK., Kim, D. et al. Characteristics and outcomes of rheumatoid arthritis patients who started biosimilar infliximab. Rheumatol Int 37, 1007–1014 (2017). https://doi.org/10.1007/s00296-017-3663-z

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  • DOI: https://doi.org/10.1007/s00296-017-3663-z

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