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Brodalumab effectively treated psoriatic arthritis patients
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Brodalumab was effective and relatively safe in treating patients with psoriatic arthritis, according to research presented at the annual congress of the European League Against Rheumatism in Madrid.
“There is a need for therapies to better manage patient outcomes, and prevent long-term bone loss and permanent joint damage, especially in those patients for whom anti-tumor necrosis factor therapy is not effective or tolerated,” researcher Philip J. Mease, MD, clinical professor at University of Washington School of Medicine and director of the Rheumatology Clinical Research Division of Swedish Medical Center, Seattle, said in a press release. “These significant patient responses support continued evaluation of brodalumab for the treatment of psoriatic arthritis and clearly show that cytokine-targeting strategies aimed at blocking signaling through the interleukin-17 receptor may represent a new treatment strategy.”
In a randomized study, researchers evaluated 168 adults (64% women) who had psoriatic arthritis (PsA) for at least 6 months and were assigned brodalumab (n=113; 140 mg or 280 mg every 2 weeks) or placebo (n=55). Patients achieving American College of Rheumatology 20% response (ACR20) at week 12 was primary endpoint. ACR50, ACR70, changes in Disease Activity Score 28 (DAS28) and ACR components were secondary endpoints.
One hundred fifty-nine patients (mean age, 52.2 years; mean PsA duration, 8.7 years) completed the 12-week study and exhibited a mean C-reactive protein of 5 mg/L. Fifty-one percent of patients had previously used biologics.
Overall, 37% and 39% of the 140- and 280-mg brodalumab-treated patients, respectively, achieved ACR20, compared with 18% of placebo patients (P<.05). Among biologic-naive subjects ACR20 response rates were 36% [140 mg], 37% [280 mg] and 20% [placebo], compared with respective rates of 37%, 42% and 16% in patients with previous biologic exposure.
ACR50 responses were 4% (placebo), 14% (140 mg; P=.051) and 14% (280 mg; P=.047).
Adverse events (AE) were balanced between groups and included upper respiratory tract infection (7%, placebo; 12% brodalumab groups), headache (7%, 6%), nasopharyngitis (6%, 0%), psoriatic anthropathy (6%, 4%), injection site erythema (6%, 2%), fatigue (4%, 7%), diarrhea (4%, 6%), nausea (4%, 5%) and dizziness (4%, 5%). No clinically significant neutropenia, death or mycobacterial or fungal/opportunistic infections were reported.
“These results support continued evaluation of brodalumab for treatment of PsA,” the researchers concluded.
Disclosure: See the abstract for a full list of relevant disclosures.
For more information:
Mease PJ. OP0103: Efficacy of Brodalumab, an Anti-IL-17R Antibody, in Subjects with Psoriatic Arthritis. Presented at: EULAR 2013; June 12-15, Madrid.