Despite a recent FDA label restriction, AbbVie is still churning out new data for Rinvoq in the hope that adding more evidence will back the JAK inhibitor’s megablockbuster potential.
A phase 3 trial testing Rinvoq in adults with nonradiographic axial spondyloarthritis (nr-axSpA) has hit its goal as significantly more patients on the drug versus placebo achieved an at least 40% improvement on a composite marker that measures signs and symptoms, including back pain, as well as physical function and disease activity, AbbVie said in a statement.
AbbVie already has an application under review with the FDA—and is approved in EU—for ankylosing spondylitis. Compared with nr-axSpA, ankylosing spondylitis covers cases where inflammatory changes to the joints or the spine can be seen on X-ray. AbbVie has pegged Rinvoq could reach $1 billion sales by 2025 across the entire spondyloarthritis spectrum.
“Nonradiographic axial spondyloarthritis affects a younger adult patient population, which can have a significant impact during prime years of those dealing with the disease,” Atul Deodhar, M.D., at Oregon Health & Science University, explained in a statement.
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Specifically, in one portion of the phase 3 Select-Axis 2 trial, 45% of nr-axSpA patients who took Rinvoq enjoyed a 40% improvement on a widely used treatment response marker, ASAS, at week 14. In contrast, only 23% of individuals in the placebo group saw that level of benefit.
The trial also met several secondary endpoints. Significantly more Rinvoq patients achieved low disease activity and achieved better improvements on MRI scan than placebo, AbbVie said.
AbbVie also noted that the other portion of the Select-Axis 2 trial hit its goal, showing Rinvoq beat placebo on the ASAS40 response marker. That part enrolled patients with ankylosing spondylitis (AS) who had an inadequate response to existing biologic disease-modifying antirheumatic drugs (bDMARDs), such as TNF blockers.
Rinvoq in January won a European Commission nod in AS with data from the phase 2/3 Select-Axis 1 trial, which tested the JAK inhibitor in patients who didn’t receive bDMARDs and didn’t respond well or couldn’t tolerate nonsteroidal anti-inflammatory drugs. AbbVie used the same dataset for its FDA filing in AS.
The FDA has pushed back its decisions on Rinvoq’s applications for atopic dermatitis, psoriatic arthritis and ankylosing spondylitis as the agency took its time to review postmarketing safety data from Pfizer’s fellow oral JAK inhibitor Xeljanz.
In September, the FDA slapped a class-wide boxed warning on Rinvoq’s label to include information about increased risks of serious heart-related events, cancer, blood clots and death, and downgraded its use in rheumatoid arthritis behind TNF blockers in its approved indication. Xeljanz and Eli Lilly’s Olumiant received the same treatment. But the agency has yet to deliver a verdict on those delayed Rinvoq label expansion requests.
The new FDA restriction will likely hurt Rinvoq’s peak sales potential in large indications like rheumatoid arthritis and eczema, while smaller indications such as psoriatic arthritis and ankylosing spondylitis remain unchanged, analysts at SVB Leerink recently projected.