title: 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.
abstract: BACKGROUND
  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.
  
  
  METHODS
  The 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.
  
  
  RESULTS
  Of 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.
  
  
  CONCLUSIONS
  These 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.
  
  
  BACKGROUND
  [clinicaltrials.gov; NCT00264147].
authors.affiliation: Department of Rheumatology, Diakonhjemmet Hospital, Box 23, Vinderen, N-0319, Oslo, Norway. t.k.kvien@medisin.uio.no.
authors.forename: Tore K
authors.initials: TK
authors.lastname: Kvien
authors.affiliation: Desert Medical Advances, Palm Desert, CA, USA. greenwald.maria@gmail.com.
authors.forename: Maria
authors.initials: M
authors.lastname: Greenwald
authors.affiliation: Clinical Research, Merck & Co., Inc., Kenilworth, NJ, USA. paul.peloso@abbvie.com.
authors.forename: Paul M
authors.initials: PM
authors.lastname: Peloso
authors.affiliation: Clinical Research, Merck & Co., Inc., Kenilworth, NJ, USA. hwwang73@yahoo.com.
authors.forename: Hongwei
authors.initials: H
authors.lastname: Wang
authors.affiliation: Clinical Research, Merck & Co., Inc., Kenilworth, NJ, USA. anish_mehta@merck.com.
authors.forename: Anish
authors.initials: A
authors.lastname: Mehta
authors.affiliation: Clinical Research, Merck & Co., Inc., Kenilworth, NJ, USA. agammaitoni@nuvoresearch.com.
authors.forename: Arnold
authors.initials: A
authors.lastname: Gammaitoni
mesh_terms: D000700:Analgesics / Q000627:therapeutic use*; D018771:Arthralgia / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D001172:Arthritis, Rheumatoid / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D001688:Biological Products / Q000627:therapeutic use*; D003105:Colombia; D052246:Cyclooxygenase 2 Inhibitors / Q000627:therapeutic use*; D018450:Disease Progression; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D000077613:Etoricoxib; D006304:Health Status; D006801:Humans; D009656:North America; D010147:Pain Measurement; D011725:Pyridines / Q000627:therapeutic use*; D013450:Sulfones / Q000627:therapeutic use*; D011795:Surveys and Questionnaires; D013557:Switzerland; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000700:Analgesics; D001688:Biological Products; D052246:Cyclooxygenase 2 Inhibitors; D011725:Pyridines; D013450:Sulfones; D000077613:Etoricoxib