Comparison of the efficacy and safety profiles of a pelubiprofen versus celecoxib in patients with rheumatoid arthritis: A 6-week, multicenter, randomized, double-blind, phase III, noninferiority clinical trial

In Ah Choi, Han Joo Baek, Chul Soo Cho, Yeon Ah Lee, Won Tae Chung, Young Eun Park, Yun Jong Lee, YongBeom Park, Jisoo Lee, Shin Seok Lee, Wan Hee Yoo, Jung Soo Song, Seong Wook Kang, Hyun Ah Kim, Yeong Wook Song

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Abstract

Background: Pelubiprofen is a prodrug of 2-arylpropionic acid with relatively selective effects on cyclooxygenase-2 activity. The aim of this study was to compare the efficacy and safety profiles of pelubiprofen with those of celecoxib in patients with rheumatoid arthritis. Methods: This was a 6-week, multicenter, randomized, double-blind, double-dummy, parallel-group, phase III, non-inferiority clinical trial. The primary end point was non-inferiority of pain decrease from baseline to week-6 as determined using a 100 mm pain visual analog scale (VAS). Pelubiprofen was considered non-inferior to celecoxib if the lower limit of the 97.5% confidence interval for treatment difference [(pain reduction in pelubiprofen group) - (pain reduction in celecoxib group)] was more than -10 mm. The secondary end points were as follows: non-inferiority of (1) reduction of Korean health assessment questionnaire (KHAQ) score; (2) decreased duration of morning stiffness; and (3) decrease in the frequency and total dose of rescue drugs after 6 weeks of treatment. Results: Seventy-seven patients in the pelubiprofen group and 68 patients in the celecoxib group started the study medication. Pelubiprofen was non-inferior to celecoxib with regard to reduction in VAS pain severity (difference, mean ± SD 5.0 ± 20.1; 97.5% CI, -2.3 to ∞). Pelubiprofen was also non-inferior to celecoxib in terms of the secondary end points, such as, decrease in KHAQ score (0.0 ± 0.5, 97.5% CI -0.2 to ∞), decrease in duration of morning stiffness (median 0.0 minute in both groups), and decrease in the frequency (0.7 ± 3.5, 97.5% CI -0.6 to ∞) and total amount (0.7 ± 3.6, 97.5% CI -0.6 to ∞) of rescue medication uses during the 6 week study period. Safety analysis revealed 31.2% patients in the pelubiprofen group and 20.6% patients in the celecoxib group experienced an adverse drug reaction (ADR). The frequency of gastrointestinal ADRs was 20.8 % and 8.8%, respectively. Conclusions: Pelubiprofen was found to be as effective as celecoxib at pain reduction and for relieving stiffness in RA patients. However, more patients in the pelubiprofen group experienced ADR and the frequency of gastrointestinal ADRs was higher in the pelubiprofen group.

Original languageEnglish
Article number375
JournalBMC Musculoskeletal Disorders
Volume15
Issue number1
DOIs
Publication statusPublished - 2014 Jan 1

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Celecoxib
Phase III Clinical Trials
Rheumatoid Arthritis
Safety
Pain
Pain Measurement
Drug-Related Side Effects and Adverse Reactions
pelubiprofen
Drug Repositioning

All Science Journal Classification (ASJC) codes

  • Rheumatology
  • Orthopedics and Sports Medicine

Cite this

Choi, In Ah ; Baek, Han Joo ; Cho, Chul Soo ; Lee, Yeon Ah ; Chung, Won Tae ; Park, Young Eun ; Lee, Yun Jong ; Park, YongBeom ; Lee, Jisoo ; Lee, Shin Seok ; Yoo, Wan Hee ; Song, Jung Soo ; Kang, Seong Wook ; Kim, Hyun Ah ; Song, Yeong Wook. / Comparison of the efficacy and safety profiles of a pelubiprofen versus celecoxib in patients with rheumatoid arthritis : A 6-week, multicenter, randomized, double-blind, phase III, noninferiority clinical trial. In: BMC Musculoskeletal Disorders. 2014 ; Vol. 15, No. 1.
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title = "Comparison of the efficacy and safety profiles of a pelubiprofen versus celecoxib in patients with rheumatoid arthritis: A 6-week, multicenter, randomized, double-blind, phase III, noninferiority clinical trial",
abstract = "Background: Pelubiprofen is a prodrug of 2-arylpropionic acid with relatively selective effects on cyclooxygenase-2 activity. The aim of this study was to compare the efficacy and safety profiles of pelubiprofen with those of celecoxib in patients with rheumatoid arthritis. Methods: This was a 6-week, multicenter, randomized, double-blind, double-dummy, parallel-group, phase III, non-inferiority clinical trial. The primary end point was non-inferiority of pain decrease from baseline to week-6 as determined using a 100 mm pain visual analog scale (VAS). Pelubiprofen was considered non-inferior to celecoxib if the lower limit of the 97.5{\%} confidence interval for treatment difference [(pain reduction in pelubiprofen group) - (pain reduction in celecoxib group)] was more than -10 mm. The secondary end points were as follows: non-inferiority of (1) reduction of Korean health assessment questionnaire (KHAQ) score; (2) decreased duration of morning stiffness; and (3) decrease in the frequency and total dose of rescue drugs after 6 weeks of treatment. Results: Seventy-seven patients in the pelubiprofen group and 68 patients in the celecoxib group started the study medication. Pelubiprofen was non-inferior to celecoxib with regard to reduction in VAS pain severity (difference, mean ± SD 5.0 ± 20.1; 97.5{\%} CI, -2.3 to ∞). Pelubiprofen was also non-inferior to celecoxib in terms of the secondary end points, such as, decrease in KHAQ score (0.0 ± 0.5, 97.5{\%} CI -0.2 to ∞), decrease in duration of morning stiffness (median 0.0 minute in both groups), and decrease in the frequency (0.7 ± 3.5, 97.5{\%} CI -0.6 to ∞) and total amount (0.7 ± 3.6, 97.5{\%} CI -0.6 to ∞) of rescue medication uses during the 6 week study period. Safety analysis revealed 31.2{\%} patients in the pelubiprofen group and 20.6{\%} patients in the celecoxib group experienced an adverse drug reaction (ADR). The frequency of gastrointestinal ADRs was 20.8 {\%} and 8.8{\%}, respectively. Conclusions: Pelubiprofen was found to be as effective as celecoxib at pain reduction and for relieving stiffness in RA patients. However, more patients in the pelubiprofen group experienced ADR and the frequency of gastrointestinal ADRs was higher in the pelubiprofen group.",
author = "Choi, {In Ah} and Baek, {Han Joo} and Cho, {Chul Soo} and Lee, {Yeon Ah} and Chung, {Won Tae} and Park, {Young Eun} and Lee, {Yun Jong} and YongBeom Park and Jisoo Lee and Lee, {Shin Seok} and Yoo, {Wan Hee} and Song, {Jung Soo} and Kang, {Seong Wook} and Kim, {Hyun Ah} and Song, {Yeong Wook}",
year = "2014",
month = "1",
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doi = "10.1186/1471-2474-15-375",
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Comparison of the efficacy and safety profiles of a pelubiprofen versus celecoxib in patients with rheumatoid arthritis : A 6-week, multicenter, randomized, double-blind, phase III, noninferiority clinical trial. / Choi, In Ah; Baek, Han Joo; Cho, Chul Soo; Lee, Yeon Ah; Chung, Won Tae; Park, Young Eun; Lee, Yun Jong; Park, YongBeom; Lee, Jisoo; Lee, Shin Seok; Yoo, Wan Hee; Song, Jung Soo; Kang, Seong Wook; Kim, Hyun Ah; Song, Yeong Wook.

In: BMC Musculoskeletal Disorders, Vol. 15, No. 1, 375, 01.01.2014.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Comparison of the efficacy and safety profiles of a pelubiprofen versus celecoxib in patients with rheumatoid arthritis

T2 - A 6-week, multicenter, randomized, double-blind, phase III, noninferiority clinical trial

AU - Choi, In Ah

AU - Baek, Han Joo

AU - Cho, Chul Soo

AU - Lee, Yeon Ah

AU - Chung, Won Tae

AU - Park, Young Eun

AU - Lee, Yun Jong

AU - Park, YongBeom

AU - Lee, Jisoo

AU - Lee, Shin Seok

AU - Yoo, Wan Hee

AU - Song, Jung Soo

AU - Kang, Seong Wook

AU - Kim, Hyun Ah

AU - Song, Yeong Wook

PY - 2014/1/1

Y1 - 2014/1/1

N2 - Background: Pelubiprofen is a prodrug of 2-arylpropionic acid with relatively selective effects on cyclooxygenase-2 activity. The aim of this study was to compare the efficacy and safety profiles of pelubiprofen with those of celecoxib in patients with rheumatoid arthritis. Methods: This was a 6-week, multicenter, randomized, double-blind, double-dummy, parallel-group, phase III, non-inferiority clinical trial. The primary end point was non-inferiority of pain decrease from baseline to week-6 as determined using a 100 mm pain visual analog scale (VAS). Pelubiprofen was considered non-inferior to celecoxib if the lower limit of the 97.5% confidence interval for treatment difference [(pain reduction in pelubiprofen group) - (pain reduction in celecoxib group)] was more than -10 mm. The secondary end points were as follows: non-inferiority of (1) reduction of Korean health assessment questionnaire (KHAQ) score; (2) decreased duration of morning stiffness; and (3) decrease in the frequency and total dose of rescue drugs after 6 weeks of treatment. Results: Seventy-seven patients in the pelubiprofen group and 68 patients in the celecoxib group started the study medication. Pelubiprofen was non-inferior to celecoxib with regard to reduction in VAS pain severity (difference, mean ± SD 5.0 ± 20.1; 97.5% CI, -2.3 to ∞). Pelubiprofen was also non-inferior to celecoxib in terms of the secondary end points, such as, decrease in KHAQ score (0.0 ± 0.5, 97.5% CI -0.2 to ∞), decrease in duration of morning stiffness (median 0.0 minute in both groups), and decrease in the frequency (0.7 ± 3.5, 97.5% CI -0.6 to ∞) and total amount (0.7 ± 3.6, 97.5% CI -0.6 to ∞) of rescue medication uses during the 6 week study period. Safety analysis revealed 31.2% patients in the pelubiprofen group and 20.6% patients in the celecoxib group experienced an adverse drug reaction (ADR). The frequency of gastrointestinal ADRs was 20.8 % and 8.8%, respectively. Conclusions: Pelubiprofen was found to be as effective as celecoxib at pain reduction and for relieving stiffness in RA patients. However, more patients in the pelubiprofen group experienced ADR and the frequency of gastrointestinal ADRs was higher in the pelubiprofen group.

AB - Background: Pelubiprofen is a prodrug of 2-arylpropionic acid with relatively selective effects on cyclooxygenase-2 activity. The aim of this study was to compare the efficacy and safety profiles of pelubiprofen with those of celecoxib in patients with rheumatoid arthritis. Methods: This was a 6-week, multicenter, randomized, double-blind, double-dummy, parallel-group, phase III, non-inferiority clinical trial. The primary end point was non-inferiority of pain decrease from baseline to week-6 as determined using a 100 mm pain visual analog scale (VAS). Pelubiprofen was considered non-inferior to celecoxib if the lower limit of the 97.5% confidence interval for treatment difference [(pain reduction in pelubiprofen group) - (pain reduction in celecoxib group)] was more than -10 mm. The secondary end points were as follows: non-inferiority of (1) reduction of Korean health assessment questionnaire (KHAQ) score; (2) decreased duration of morning stiffness; and (3) decrease in the frequency and total dose of rescue drugs after 6 weeks of treatment. Results: Seventy-seven patients in the pelubiprofen group and 68 patients in the celecoxib group started the study medication. Pelubiprofen was non-inferior to celecoxib with regard to reduction in VAS pain severity (difference, mean ± SD 5.0 ± 20.1; 97.5% CI, -2.3 to ∞). Pelubiprofen was also non-inferior to celecoxib in terms of the secondary end points, such as, decrease in KHAQ score (0.0 ± 0.5, 97.5% CI -0.2 to ∞), decrease in duration of morning stiffness (median 0.0 minute in both groups), and decrease in the frequency (0.7 ± 3.5, 97.5% CI -0.6 to ∞) and total amount (0.7 ± 3.6, 97.5% CI -0.6 to ∞) of rescue medication uses during the 6 week study period. Safety analysis revealed 31.2% patients in the pelubiprofen group and 20.6% patients in the celecoxib group experienced an adverse drug reaction (ADR). The frequency of gastrointestinal ADRs was 20.8 % and 8.8%, respectively. Conclusions: Pelubiprofen was found to be as effective as celecoxib at pain reduction and for relieving stiffness in RA patients. However, more patients in the pelubiprofen group experienced ADR and the frequency of gastrointestinal ADRs was higher in the pelubiprofen group.

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