European Commission approves upadacitinib for PsA, ankylosing spondylitis
The European Commission has extended approval for AbbVie’s upadacitinib 15 mg to treat adult patients with active psoriatic arthritis and adult patients with active ankylosing spondylitis, according to a company press release.
Previously approved for rheumatoid arthritis, upadacitinib (Rinvoq) may now be used as monotherapy or in combination with methotrexate in patients with PsA who have responded inadequately to — or who are intolerant to — one or more DMARDs, as well as patients with ankylosing spondylitis who have responded inadequately to conventional therapy.
“Psoriatic arthritis and ankylosing spondylitis have a significant impact on many aspects of life for those living with these conditions,” Tom Hudson, MD, senior vice president of research and development and chief scientific officer for AbbVie, said in the release. “We are proud to provide Rinvoq as a new treatment option to patients with PsA and a first-in-class treatment option to those living with AS. These approvals are important milestones in our commitment to develop a portfolio of solutions that advance standards of care for people living with rheumatic diseases.”
The European Commission based its decision on data from the SELECT-PsA 1, SELECT-PsA 2 and SELECT-AXIS 1 clinical trials. In the phase 3 SELECT-PsA 1 and SELECT-PsA 2 trials, upadacitinib met the primary endpoint —ACR20 response at week 12 compared with placebo — in adults with active PsA who demonstrated an inadequate response to non-biologic or biologic DMARDs, according to the release. In addition, the drug achieved noninferiority to adalimumab (Humira, AbbVie) — 40 mg administered every other week — regarding the ACR20 response at week 12.
According to the company, patients who received upadacitinib demonstrated greater improvements in physical function — as measured by HAQ-DI at week 12 — and skin symptoms — as measured by PASI-75 at week 16. In addition, a greater proportion of patients treated with upadacitinib achieved minimal disease activity compared with those who received placebo at week 24.
In the phase 2/3 SELECT-AXIS 1 trial, upadacitinib met the primary endpoint — Assessment of Spondyloarthritis International Society (ASAS) 40 response at week 14 compared with placebo — in adults who were naïve to biologic DMARDs and had an inadequate response or intolerance to NSAIDs. In addition, the drug achieved statistical significance across several multiplicity-adjusted key secondary endpoints compared with placebo, including ASAS partial remission at week 14 and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 at week 14.
Meanwhile, safety results from all three trials were consistent with those reported in RA, with no new significant risks. Integrated safety data from SELECT-PsA 1 and SELECT-PsA 2 through week 24 demonstrated that serious adverse events occurred in 4.1% of the patients treated with upadacitinib 15 mg, compared with 3.7% in the adalimumab group and 2.7% in the placebo group. The most common adverse events in the upadacitinib group were upper respiratory tract infection, nasopharyngitis and increases in blood creatine phosphokinase, alanine aminotransferase and aspartate transaminase.
In SELECT-AXIS 1, serious adverse events were reported in 1% of participants in both the upadacitinib and placebo groups. The most common adverse events in the upadacitinib group included blood creatine phosphokinase increase, diarrhea, nasopharyngitis, headache and nausea.
The European Commission’s decision means upadacitinib is approved for use in all EU member states as well as Iceland, Liechtenstein and Norway.
“Psoriatic arthritis and ankylosing spondylitis are multifaceted diseases that can cause severe pain, restricted mobility, and lasting structural damage,” Iain McInnes, MD, president of EULAR and director of the Institute of Infection, Immunity and Inflammation at the University of Glasgow, in Scotland, said in the release.
McInnes presented the findings of the SELECT-PsA 1 trial at the American College of Rheumatology Convergence 2020 meeting in November.
“In clinical trials, Rinvoq demonstrated improvements across multiple manifestations of these diseases,” he said in the release. “The approvals of Rinvoq for the treatment of PsA and AS offer physicians in the European Union an important new therapeutic option and for their patients a new opportunity to find meaningful relief from their debilitating symptoms.”