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, non-inferiority 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. ClinialTrials.gov identifier: NCT01781702.

• Authors: In Ah Choi, Han-Joo Baek, Chul-Soo Cho, Yeon-Ah Lee, Won Tae Chung, Young Eun Park, Yun Jong Lee, Yong-Beom Park, Jisoo Lee, Shin-Seok Lee, Wan-Hee Yoo, Jung-Soo Song, Seong Wook Kang, Hyun Ah Kim, Yeong Wook Song
• Journal: BMC musculoskeletal disorders (BMC Musculoskelet Disord) Vol. 15 Pg. 375 (Nov 18 2014) ISSN: 1471-2474 [Electronic] England
• PMID: 25403311 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Cyclooxygenase 2 Inhibitors
• Phenylpropionates
• Pyrazoles
• Sulfonamides
• pelubiprofen
• Celecoxib

Topics

• Adult
• Aged
• Arthritis, Rheumatoid (diagnosis, drug therapy)
• Celecoxib
• Cyclooxygenase 2 Inhibitors (adverse effects, therapeutic use)
• Double-Blind Method
• Edema (chemically induced)
• Female
• Gastrointestinal Diseases (chemically induced)
• Humans
• Male
• Middle Aged
• Pain Measurement (drug effects, methods)
• Phenylpropionates (adverse effects, therapeutic use)
• Pyrazoles (adverse effects, therapeutic use)
• Sulfonamides (adverse effects, therapeutic use)
• Time Factors