Do COX-2 inhibitors provide additional pain relief and anti-inflammatory effects in patients with rheumatoid arthritis who are on biological disease-modifying anti-rheumatic drugs and/or corticosteroids? Post-hoc analyses from a randomized clinical trial with etoricoxib.

Tore K Kvien,Paul M Peloso,Anish Mehta,Hongwei Wang,Arnold Gammaitoni,Maria Greenwald

doi:10.1186/s12891-015-0468-7

Abstract

BackgroundOur objective was to evaluate the effect of background biological disease-modifying anti-rheumatic drugs (bDMARDs) and/or corticosteroids (CS) on response to nonsteroidal anti-inflammatory drugs (NSAIDs) in rheumatoid arthritis (RA) patients.MethodsThe following efficacy endpoints were evaluated using time-weighted change from baseline in a 12-week, randomized controlled clinical trial with etoricoxib: Patient Global Assessment of Pain, Swollen Joint Count, Tender Joint Count, Health Assessment Questionnaire. The following three treatment groups were evaluated: placebo, pooled etoricoxib 10/30/60 mg, and etoricoxib 90 mg. Screening values, values post flare, as well as changes after treatment were analyzed.ResultsOf the 1014 patients screened, 761 were randomized; 50% were on no background bDMARDs and/or CS therapy, 23% used bDMARDs, 34% used CS, and 8% used both bDMARDs and CS. It was demonstrated that RA patients on bDMARDs or CS had similar pain levels at screening as patients without this co-medication. They experienced flare upon NSAID withdrawal and demonstrated dose-dependent pain improvement with etoricoxib.ConclusionThese results support that RA patients receiving bDMARDs or CS may still require the use of concomitant analgesics to treat pain. Clinicians should continue to monitor and treat pain even after initiating a bDMARD and/or CS.Trial Registration[clinicaltrials.gov; NCT00264147]

Highlights

Our objective was to evaluate the effect of background biological disease-modifying anti-rheumatic drugs and/or corticosteroids (CS) on response to nonsteroidal anti-inflammatory drugs (NSAIDs) in rheumatoid arthritis (RA) patients
If nonsteroidal anti-inflammatory drugs (NSAIDs) have any additive role in RA beyond the use of biological disease-modifying anti-rheumatic drugs (bDMARDs) and CS, it would be predicted that three relationships should hold true: (1) patients with RA and on bDMARDs and/or CS who stop their NSAIDs should have the same degree of flare in RA symptoms as those who are not on such comedication; ( 2) those on bDMARDs and/or CS should experience the same degree of response with the addition of another NSAID; and (3) dose–response relationships should be similar in patients on versus not on bDMARDs and/or CS
BDMARDs or CS therapy was used in 23% and 34% of patients, respectively, the subgroup of patients on both agents was small (8%)

Summary

Introduction

Our objective was to evaluate the effect of background biological disease-modifying anti-rheumatic drugs (bDMARDs) and/or corticosteroids (CS) on response to nonsteroidal anti-inflammatory drugs (NSAIDs) in rheumatoid arthritis (RA) patients. Three subpopulations were evaluated based on the dose–response relationships established in the primary trial analysis: patients on the labeled dose of etoricoxib in RA (90 mg), those on other doses of etoricoxib (10-, 30-, and 60-mg groups combined for these analyses), and patients on placebo. Each of these three groups was further considered based on four possible combinations of bDMARDs and/or CS use (no bDMARD or CS, bDMARD alone, CS alone, or both bDMARD and CS). Those on DMARDs and CS before study entry were continued on the same doses throughout the trial

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