Pain relief over 12 weeks was higher for low-dose meloxicam compared with placebo in patients with osteoarthritis of the hip or knee, according to secondary analyses of a phase 3 study presented at the 2016 Osteoarthritis Research Society International (OARSI) World Congress.
“Low-dose…meloxicam is a potentially promising treatment option for adults with osteoarthritis pain,” stated lead investigator Clarence Young, MD, Iroko Pharmaceuticals, Philadelphia, Pennsylvania, presenting the findings in a poster here on April 1. A 5-mg and 10-mg low-dose version of the non-steroidal anti-inflammatory drug (NSAID) was recently approved by the US Food & Drug Administration.
Primary outcomes from the study have already shown that both doses led to a higher change from baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscore at week 12 compared with placebo (Curr Med Res Opin 2015; 31:2331-43, doi:10.1185/03007995.2015.1112772).
The current analysis evaluated secondary outcomes.
Dr. Young and colleagues examined results from the cohort, which comprised 403 patients (65.9% female; mean age: 60.7 years) with hip or knee osteoarthritis (radiographically confirmed as Kellgren-Lawrence grade 2 or 3). All subjects were chronic users of NSAIDs or acetaminophen, had a WOMAC pain subscore of 40 mm or higher (100 mm visual analogue scale), and had a documented osteoarthritis pain flare, defined as an increase of at least 15 mm on the WOMAC pain subscore following washout of prior analgesics.
Low-dose meloxicam was dosed at 5 mg (n = 139) or 10 mg (n = 130) once daily in a double-blind fashion for 12 weeks; placebo was similarly dosed (n = 134). A total of 350 patients completed the study.
Results demonstrated that when treatment response was defined as a reduction of 30% or more in the WOMAC pain subscore from baseline levels, a significantly greater proportion of patients in the meloxicam 5-mg group were responders compared with placebo, at all visits — week 2 (61.0% vs 38.6%, P = .0002), week 6 (65.7% vs 49.2%, P =.0072), and week 12 (74.0% vs 57.5%, P = .0050). For the meloxicam 10-mg group, the proportion of responders was numerically higher than placebo at all 3 visits, but statistically significant only at week 6 (68.6% vs 49.2%, P = .0020).
When the threshold was raised to a ≥50% reduction in the WOMAC pain subscore from baseline, again, the difference compared with placebo was significantly in favour of meloxicam 5-mg treatment at all 3 visits, while for meloxicam 10 mg, the difference with placebo was significant at weeks 6 and 12, but not week 2.
A continuous-responder analysis at week 12 revealed that close to 65% of patients in both meloxicam dose groups experienced reductions on the WOMAC pain subscore by ≥30%, while more than half of all patients in both dose groups experienced reduction on the subscore by ≥50%.
When treatment response was defined as per the Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) criteria, 75.9% of patients receiving meloxicam 5 mg (P = .0390 vs placebo) and 79.0% of patients in the 10-mg dose group (P = .0096 vs placebo) were classed as responders at week 12, both of which were significantly higher than placebo (64.3%).
Adverse events (AEs) most commonly seen in the combined meloxicam groups (which occurred in ≥2% of patients) were diarrhoea, headache, and nausea. No deaths or serious AEs were reported during the study.
Funding for this study was provided by Iroko Pharmaceuticals.[Presentation title: Low-Dose Solumatrix Meloxicam Results In Clinically Meaningful Improvements In Pain In A Phase 3 Study Of Patients With Osteoarthritis. Abstract 702]