Onset and durability of pain relief in knee osteoarthritis: Pooled results from two placebo trials of naproxen/esomeprazole combination and celecoxib

Abstract

(2015) Onset and durability of pain relief in knee osteoarthritis: Pooled results from two placebo trials of naproxen/esomeprazole combination and celecoxib, The Physician and Sportsmedicine, 43:3, 200-212, DOI: 10.1080/00913847.2015 AbstractObjective. To further characterize time-to-first pain relief, effect size, correlations between various outcome measures and durability of relief for single-tablet naproxen 500 mg/esomeprazole 20 mg (NAP/ESO) given twice daily and celecoxib (CEL) (200 mg) given once daily versus placebo in knee osteoarthritis (OA). Methods. Unpublished data from two double-blind, double-dummy, placebo-controlled trials in which patients aged ‡50 years with knee OA were randomized to NAP/ESO (n = 487), CEL (n = 486) or placebo (n = 246) were pooled (NCT00664560 and NCT00665431). Acute response endpoints: 1) Time to first significant pain response, 2) Western Ontario and McMaster Osteoarthritis Index (WOMAC) pain subscale and 3) American Pain Society Patient Outcome Questionnaire (APS-POQ) scores. Sustainability endpoints: 1) Routine Assessment of Patient Index Data (RAPID3) and 2) WOMAC Stiffness, Pain and Total scores; and Patient Global Assessment (PGA) at 6 and 12 weeks. Effect sizes for all measures were calculated. Rescue pain medication use also was analyzed, as was the correlation of WOMAC to RAPID3. Results. NAP/ESO produced statistically significant decreases in WOMAC Pain on Days 2-7 and at Weeks 6 and 12 (all p < 0.05); most APS-POQ pain assessments with NAP/ESO were significantly improved on Days 2-7 compared with placebo (all p < 0.05). A good or excellent response occurred in a median of 6 days. RAPID3 and WOMAC total/stiffness/function/PGA scores decreased significantly at Weeks 6 and 12 (all p < 0.05). Placebo-adjusted WOMAC pain effect sizes were 0.44, 0.34 and 0.25 at Day 7, week 6 and week 12, respectively. RAPID3 to WOMAC total and WOMAC pain to RAPID3: Pain scores were highly correlated at 6 and 12 weeks (correlation coefficients >0.80). No significant differences in overall responses were found between CEL and NAP/ESO. Conclusion. Naproxen/esomeprazole produced a significant absolute moderate early pain response, which was maintained for 12 weeks. RAPID3 was found to be highly correlated with the typical OA measure (WOMAC) and might be a useful clinical tool for measuring NSAID response. NCT00664560: https://clinicaltrials.gov/ct2/show/NCT00664560, NCT00665431: https:// www.clinicaltrials.gov/ct2/show/NCT00665431.

Value of the Routine Assessment of Patient Index Data 3 in Patients With Psoriatic Arthritis: Results From a Tight‐Control Clinical Trial and an Observational Cohort

“…The RAPID3 score is a generic tool developed to assess patient status quantitatively in clinical practice. It was developed in RA and has been found of value in many rheumatic conditions, including spondyloarthritis , osteoarthritis , gout systemic lupus erythematosus , and other arthritides . However, in PsA, in addition to the musculoskeletal manifestations, most patients also have skin psoriasis.…”

“…The primary initial goal for RAPID3 was to provide a feasible quantitative index for management of RA that was comparable to the Disease Activity Score in 28 joints to distinguish active from control treatment in clinical trials . Subsequently, RAPID3 has been found informative in axial spondyloarthritis , osteoarthritis , gout systemic lupus erythematosus , and other arthritides .…”

Factors associated with knee pain in 5148 women aged 50 years and older: A population-based study

“…However, previous studies did not consider the effect of malignant diseases, pain medication or arthritis treatment, or presence of hip or low back pain, which could be confounding factors affecting knee pain. Malignant disease itself and chemotherapy can cause or aggravate arthralgia [ 8 , 9 ], and pain medication or arthritis treatment can attenuate the corresponding knee pain to a radiographic grade of knee osteoarthritis [ 10 , 11 ]. Although sufficient evidence is lacking, the presence of hip or spine problems may cause knee pain through either referred pain or increased pain sensitivity in the lower extremity area.…”

Efficacy and Safety of Celecoxib Therapy in Osteoarthritis

“…After full-text reading, 13 articles were deemed unsuitable and were therefore excluded, and 12 articles were identified to be included for qualitative analysis. Finally, 12 articles including 15 studies 16 , 19 – 29 were incorporated into the current meta-analysis (Table 1 ). The flow-chart of selection of studies and reasons for exclusion is presented in Figure 1 .…”