Rapid onset of efficacy predicts response to therapy with certolizumab plus methotrexate in patients with active rheumatoid arthritis

Young Mo Kang, Young Eun Park, Won Park, Jung Yoon Choe, Chul Soo Cho, Seung Cheol Shim, Sang Cheol Bae, Chang Hee Suh, Hoon Suk Cha, Eun Mi Koh, Yeong Wook Song, Bin Yoo, Shin Seok Lee, Min Chan Park, Sang Heon Lee, Catherine Arendt, Willem Koetse, Soo Kon Lee

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Background/Aims: The objective of this study was to determine the efficacy and safety of add-on therapy with certolizumab pegol (CZP) in active rheumatoid arthritis (RA) patients of a single ethnicity. Methods: In this 24-week, phase 3, randomized, double-blind, placebo-controlled trial, eligible patients (n = 127) were randomized 2:1 to subcutaneous CZP + methotrexate (MTX; 400 mg at week 0, 2, and 4 followed by 200 mg every 2 weeks) or placebo + MTX. Results: At week 24, the American College of Rheumatology criteria for 20% (ACR20) response rate was significantly greater with CZP + MTX than with placebo (66.7% vs. 27.5%, p < 0.001). Differences in ACR20 response rates for CZP vs. placebo were significant from week 1 (p < 0.05) and remained significant through week 24. The CZP group reported significant improvement in physical function and disability compared to the placebo group (p < 0.001) at week 24, as assessed by Korean Health Assessment Questionnaire-Disability Index (KHAQ-DI). Post hoc analysis indicated that the proportion of patients who had ACR70 responses, Disease Activity Score 28 (DAS28) low disease activity, and DAS28 remission at week 24 was greater in CZP + MTX-treated patients who achieved a decrease in DAS28 ≥ 1.2 (43.8%) at week 4 than in nonresponders. Among 18 (22.2%) and 14 patients (35.0%) in CZP and placebo groups who had latent tuberculosis (TB), none developed active TB. Most adverse events were mild or moderate. Conclusions: CZP treatment combined with MTX in active RA patients with moderate to severe disease activity and an inadequate response to MTX resulted in rapid onset of efficacy, which is associated with better clinical outcome at week 24 and has an acceptable safety profile, especially in an intermediate TB-burden population.

Original languageEnglish
Pages (from-to)1224-1233
Number of pages10
JournalKorean Journal of Internal Medicine
Volume33
Issue number6
DOIs
StatePublished - Nov 2018

Fingerprint

Methotrexate
Rheumatoid Arthritis
Placebos
Therapeutics
Tuberculosis
Latent Tuberculosis
Safety
Certolizumab Pegol
Health
Population

Keywords

  • Certolizumab
  • Clinical trial
  • Methotrexate
  • Rheumatoid arthritis
  • Tumor necrosis factor inhibitor

Cite this

Kang, Young Mo ; Park, Young Eun ; Park, Won ; Choe, Jung Yoon ; Cho, Chul Soo ; Shim, Seung Cheol ; Bae, Sang Cheol ; Suh, Chang Hee ; Cha, Hoon Suk ; Koh, Eun Mi ; Song, Yeong Wook ; Yoo, Bin ; Lee, Shin Seok ; Park, Min Chan ; Lee, Sang Heon ; Arendt, Catherine ; Koetse, Willem ; Lee, Soo Kon. / Rapid onset of efficacy predicts response to therapy with certolizumab plus methotrexate in patients with active rheumatoid arthritis. In: Korean Journal of Internal Medicine. 2018 ; Vol. 33, No. 6. pp. 1224-1233.
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abstract = "Background/Aims: The objective of this study was to determine the efficacy and safety of add-on therapy with certolizumab pegol (CZP) in active rheumatoid arthritis (RA) patients of a single ethnicity. Methods: In this 24-week, phase 3, randomized, double-blind, placebo-controlled trial, eligible patients (n = 127) were randomized 2:1 to subcutaneous CZP + methotrexate (MTX; 400 mg at week 0, 2, and 4 followed by 200 mg every 2 weeks) or placebo + MTX. Results: At week 24, the American College of Rheumatology criteria for 20{\%} (ACR20) response rate was significantly greater with CZP + MTX than with placebo (66.7{\%} vs. 27.5{\%}, p < 0.001). Differences in ACR20 response rates for CZP vs. placebo were significant from week 1 (p < 0.05) and remained significant through week 24. The CZP group reported significant improvement in physical function and disability compared to the placebo group (p < 0.001) at week 24, as assessed by Korean Health Assessment Questionnaire-Disability Index (KHAQ-DI). Post hoc analysis indicated that the proportion of patients who had ACR70 responses, Disease Activity Score 28 (DAS28) low disease activity, and DAS28 remission at week 24 was greater in CZP + MTX-treated patients who achieved a decrease in DAS28 ≥ 1.2 (43.8{\%}) at week 4 than in nonresponders. Among 18 (22.2{\%}) and 14 patients (35.0{\%}) in CZP and placebo groups who had latent tuberculosis (TB), none developed active TB. Most adverse events were mild or moderate. Conclusions: CZP treatment combined with MTX in active RA patients with moderate to severe disease activity and an inadequate response to MTX resulted in rapid onset of efficacy, which is associated with better clinical outcome at week 24 and has an acceptable safety profile, especially in an intermediate TB-burden population.",
keywords = "Certolizumab, Clinical trial, Methotrexate, Rheumatoid arthritis, Tumor necrosis factor inhibitor",
author = "Kang, {Young Mo} and Park, {Young Eun} and Won Park and Choe, {Jung Yoon} and Cho, {Chul Soo} and Shim, {Seung Cheol} and Bae, {Sang Cheol} and Suh, {Chang Hee} and Cha, {Hoon Suk} and Koh, {Eun Mi} and Song, {Yeong Wook} and Bin Yoo and Lee, {Shin Seok} and Park, {Min Chan} and Lee, {Sang Heon} and Catherine Arendt and Willem Koetse and Lee, {Soo Kon}",
year = "2018",
month = "11",
doi = "10.3904/kjim.2016.213",
language = "English",
volume = "33",
pages = "1224--1233",
journal = "The Korean journal of internal medicine",
issn = "1226-3303",
publisher = "Korean Association of Internal Medicine",
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Kang, YM, Park, YE, Park, W, Choe, JY, Cho, CS, Shim, SC, Bae, SC, Suh, CH, Cha, HS, Koh, EM, Song, YW, Yoo, B, Lee, SS, Park, MC, Lee, SH, Arendt, C, Koetse, W & Lee, SK 2018, 'Rapid onset of efficacy predicts response to therapy with certolizumab plus methotrexate in patients with active rheumatoid arthritis', Korean Journal of Internal Medicine, vol. 33, no. 6, pp. 1224-1233. https://doi.org/10.3904/kjim.2016.213

Rapid onset of efficacy predicts response to therapy with certolizumab plus methotrexate in patients with active rheumatoid arthritis. / Kang, Young Mo; Park, Young Eun; Park, Won; Choe, Jung Yoon; Cho, Chul Soo; Shim, Seung Cheol; Bae, Sang Cheol; Suh, Chang Hee; Cha, Hoon Suk; Koh, Eun Mi; Song, Yeong Wook; Yoo, Bin; Lee, Shin Seok; Park, Min Chan; Lee, Sang Heon; Arendt, Catherine; Koetse, Willem; Lee, Soo Kon.

In: Korean Journal of Internal Medicine, Vol. 33, No. 6, 11.2018, p. 1224-1233.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Rapid onset of efficacy predicts response to therapy with certolizumab plus methotrexate in patients with active rheumatoid arthritis

AU - Kang, Young Mo

AU - Park, Young Eun

AU - Park, Won

AU - Choe, Jung Yoon

AU - Cho, Chul Soo

AU - Shim, Seung Cheol

AU - Bae, Sang Cheol

AU - Suh, Chang Hee

AU - Cha, Hoon Suk

AU - Koh, Eun Mi

AU - Song, Yeong Wook

AU - Yoo, Bin

AU - Lee, Shin Seok

AU - Park, Min Chan

AU - Lee, Sang Heon

AU - Arendt, Catherine

AU - Koetse, Willem

AU - Lee, Soo Kon

PY - 2018/11

Y1 - 2018/11

N2 - Background/Aims: The objective of this study was to determine the efficacy and safety of add-on therapy with certolizumab pegol (CZP) in active rheumatoid arthritis (RA) patients of a single ethnicity. Methods: In this 24-week, phase 3, randomized, double-blind, placebo-controlled trial, eligible patients (n = 127) were randomized 2:1 to subcutaneous CZP + methotrexate (MTX; 400 mg at week 0, 2, and 4 followed by 200 mg every 2 weeks) or placebo + MTX. Results: At week 24, the American College of Rheumatology criteria for 20% (ACR20) response rate was significantly greater with CZP + MTX than with placebo (66.7% vs. 27.5%, p < 0.001). Differences in ACR20 response rates for CZP vs. placebo were significant from week 1 (p < 0.05) and remained significant through week 24. The CZP group reported significant improvement in physical function and disability compared to the placebo group (p < 0.001) at week 24, as assessed by Korean Health Assessment Questionnaire-Disability Index (KHAQ-DI). Post hoc analysis indicated that the proportion of patients who had ACR70 responses, Disease Activity Score 28 (DAS28) low disease activity, and DAS28 remission at week 24 was greater in CZP + MTX-treated patients who achieved a decrease in DAS28 ≥ 1.2 (43.8%) at week 4 than in nonresponders. Among 18 (22.2%) and 14 patients (35.0%) in CZP and placebo groups who had latent tuberculosis (TB), none developed active TB. Most adverse events were mild or moderate. Conclusions: CZP treatment combined with MTX in active RA patients with moderate to severe disease activity and an inadequate response to MTX resulted in rapid onset of efficacy, which is associated with better clinical outcome at week 24 and has an acceptable safety profile, especially in an intermediate TB-burden population.

AB - Background/Aims: The objective of this study was to determine the efficacy and safety of add-on therapy with certolizumab pegol (CZP) in active rheumatoid arthritis (RA) patients of a single ethnicity. Methods: In this 24-week, phase 3, randomized, double-blind, placebo-controlled trial, eligible patients (n = 127) were randomized 2:1 to subcutaneous CZP + methotrexate (MTX; 400 mg at week 0, 2, and 4 followed by 200 mg every 2 weeks) or placebo + MTX. Results: At week 24, the American College of Rheumatology criteria for 20% (ACR20) response rate was significantly greater with CZP + MTX than with placebo (66.7% vs. 27.5%, p < 0.001). Differences in ACR20 response rates for CZP vs. placebo were significant from week 1 (p < 0.05) and remained significant through week 24. The CZP group reported significant improvement in physical function and disability compared to the placebo group (p < 0.001) at week 24, as assessed by Korean Health Assessment Questionnaire-Disability Index (KHAQ-DI). Post hoc analysis indicated that the proportion of patients who had ACR70 responses, Disease Activity Score 28 (DAS28) low disease activity, and DAS28 remission at week 24 was greater in CZP + MTX-treated patients who achieved a decrease in DAS28 ≥ 1.2 (43.8%) at week 4 than in nonresponders. Among 18 (22.2%) and 14 patients (35.0%) in CZP and placebo groups who had latent tuberculosis (TB), none developed active TB. Most adverse events were mild or moderate. Conclusions: CZP treatment combined with MTX in active RA patients with moderate to severe disease activity and an inadequate response to MTX resulted in rapid onset of efficacy, which is associated with better clinical outcome at week 24 and has an acceptable safety profile, especially in an intermediate TB-burden population.

KW - Certolizumab

KW - Clinical trial

KW - Methotrexate

KW - Rheumatoid arthritis

KW - Tumor necrosis factor inhibitor

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