Endless schreef op 15 juni 2019 13:16:
At week 24, ACR20, ACR50, and ACR70 response rates in the adalimumab group were similar to those in the filgotinib groups.
When the percentage of patients with low disease activity (DAS28-CRP = 3.2) was assessed, filgotinib 200 mg was considered noninferior to adalimumab.
There were no significant safety differences between the study groups, and rates of serious infections, venous thrombosis, and other adverse events were low. Serious infections were slightly higher in the filgotinib groups than in the placebo group, and were higher in all those groups than in the adalimumab group.
The relatively high response rates in the placebo group were not a surprise, said Combe, who noted that the trial is ongoing, "so we're looking for an explanation." Participants from Eastern Europe had a much higher placebo responses than those in North America and Western Europe, he added.
Filgotinib could be an alternative JAK inhibitor for RA, if it's approved.
Because participants had taken methotrexate before baseline, "there could still be a methotrexate effect during the trial," despite the seeming inadequate response before data were collected, he pointed out.
This trial is "huge" compared with others testing JAK inhibitors in rheumatoid arthritis, said Thomas Dörner, MD, from Charité Universitätsmedizin Berlin, who is chair of the EULAR scientific program committee.
He said he agrees that the apparent effects of filgotinib in patients with rheumatoid arthritis are similar to the effects of other JAK inhibitors, and that it might be useful as a monotherapy.
"The safety profile also looks comparable to what we've seen for other compounds, so I think this represents what one would expect in this class of molecules in a phase 3 trial," Dörner told Medscape Medical News.
"For me, this is a successful trial," he added. "It's convincing, and filgotinib could be an alternative JAK inhibitor for RA, if it's approved."
Additional data are needed, including safety data, said Combe, but filgotinib is "clearly promising" and "we can assume that the likelihood of it being on the market within 2 years is very good."
Combe is a consultant for AbbVie, Bristol-Myers Squibb, Gilead, Janssen, Eli Lilly, MSD, Novartis, Pfizer, Roche-Chugai, Sanofi, and UCB. Dörner receives grant/research support or is a consultant for Eli Lilly, Janssen, Roche, and UCB Pharma, and is a member of the speakers' bureau for Eli Lilly and Janssen.
European League Against Rheumatism (EULAR) 2019 Congress: Abstract LB0001. Presented June 12, 2019.
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