Arcoxiatm (etoricoxib) significantly reduced the risk of upper gastrointestinal (GI) side effects, such as stomach ulcers and bleeding, by half compared to three commonly prescribed non-steroidal anti-inflammatory drugs (NSAIDs), according to an analysis of 10 studies presented at the annual congress of the European League Against Rheumatism (EULAR).
The analysis combined the results of 10 clinical studies (phase II/III) for Arcoxia in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. The analysis compared GI safety between the combined group of 3,226 patients taking Arcoxia (60, 90 or 120 mg once-daily, or sequences thereof) to the combined group of 2,215 patients taking naproxen 1,000 mg, diclofenac 150 mg or ibuprofen 2,400 mg daily.
The analysis assessed the incidence of upper GI events collectively referred to as 'PUBs' (perforations in the upper GI tract, symptomatic gastroduodenal ulcers and bleeding in the upper GI tract). The primary endpoint of the analysis was PUBs confirmed by an independent adjudication committee, and the secondary endpoint was all investigator-reported PUBs. Confirmed complicated PUBs, a subset of PUBs that includes perforations, obstructions and more severe upper GI bleeding, were included as an exploratory endpoint in the analysis.
The analysis included all PUBs occurring during active treatment periods or within 14 days of stopping treatment. Because the 10 studies combined in the analysis ranged in length from six to 190 weeks, the results are expressed as the number of events per 100 patients per year.
In the analysis, Arcoxia significantly reduced the incidence of confirmed PUBs compared to the comparator NSAIDs. There were 2.47 confirmed PUBs per 100 patients per year for patients taking NSAIDs vs. 1.00 confirmed PUBs for patients taking Arcoxia, for a risk reduction of 52 per cent (p<0.001). Overall, 55 of the 2,215 patients taking NSAIDs experienced a confirmed PUB, compared to 40 of the 3,226 patients taking Arcoxia.
Arcoxia also significantly reduced the incidence of investigator-reported PUBs compared to the comparator NSAIDs. There were 2.88 investigator-reported PUBs per 100 patients per year for patients taking NSAIDs vs. 1.17 investigator-reported PUBs for patients taking Arcoxia, for a risk reduction of 51 percent (p<0.001). Overall, 64 of the 2,215 patients taking NSAIDs experienced an investigator-reported PUB, compared to 47 of the 3,226 patients taking Arcoxia.
"In this analysis, Arcoxiatm reduced a patient's risk of having an upper GI event by 50 per cent compared to treatment with other NSAIDs," said Alise Reicin, vice president, clinical research, Merck Research Laboratories.
On the exploratory endpoint of confirmed complicated PUBs, fewer complicated PUBs were observed in the group taking Arcoxia compared to the other NSAIDs studied (p=0.09). Although the magnitude of the risk reduction for confirmed complicated PUBs was consistent with what was observed for confirmed PUBs (primary endpoint), the estimate for the exploratory endpoint is less precise due to a smaller number of these events.
Arcoxiatm is the investigational COX-2 specific inhibitor for arthritis and pain from Merck & Co., Inc. of Whitehouse Station, NJ, USA.
The FDA currently is reviewing Merck's New Drug Application for Arcoxia, which seeks indications for the treatment of osteoarthritis, rheumatoid arthritis, chronic low back pain, acute pain, dysmenorrhea (menstrual pain), acute gouty arthritis and ankylosing spondylitis.