Rinvoq Approved in Canada for Difficult-to-treat, Active AS 

Upadacitinib approval, also in US and EU, supported by clinical trials

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by Patricia Inacio PhD |

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Health Canada has approved Rinvoq (upadacitinib) to treat active ankylosing spondylitis (AS) in adults who fail to respond to a biologic disease-modifying anti-rheumatic drug (DMARD) or cannot tolerate these therapies.

Rinvoq, developed and marketed by AbbVie, can be used alone or in combination with non-steroidal anti-inflammatory drugs (NSAIDs), a common first line treatment to manage AS.

“We are pleased to learn that Rinvoq has received Health Canada approval for the treatment of adults with ankylosing spondylitis. Our hope is that this approval is followed by timely and equitable access for all patients,” Elie Karam, MD, chair at the board of directors of the Canadian Spondylitis Association, said in a company press release.

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“Diverse and affordable treatment options are essential for those living with this painful and debilitating condition affecting both physical and mental health,” Karam added.

Rinvoq is an oral medication that blocks the activity of an enzyme called Janus kinase (JAK). This interferes with the JAK-STAT signaling pathway, suppressing immune responses and lessening the inflammation that drives AS.

Rinvok also approved AS treatment in EU, US

The medication was approved in the European Union in early 2021 to treat active AS in adults who have responded inadequately to conventional therapy, as well as to treat active psoriatic arthritis (PsA) in adults who have not responded to, or are intolerant of, standard therapies.

In April, it was approved in the U.S. for adults with active ankylosing spondylitis who respond poorly to or cannot tolerate DMARDS known as tumor necrosis factor (TNF) blockers.

“To date, there have been limited treatments options for people living with AS, so it is very encouraging to now have a new, oral therapeutic choice available for patients,” said Walter Maksymowych, a professor of medicine at the University of Alberta, and chief medical officer of CARE Arthritis.

Health Canada’s decision was supported by data from two pivotal studies — the Phase 2/3 SELECT-AXIS 1(NCT03178487) and the Phase 3 SELECT-AXIS 2 (NCT04169373) — involving more than 600 people with active AS.

Participants in SELECT-AXIS 1 had never taken DMARDs and had an inadequate response or were intolerant to at least two NSAIDs, while those in SELECT-AXIS 2 had an inadequate response to one or two DMARDs.

In both trials, participants were randomly assigned to oral Rinvoq (15 mg) or a placebo.

SELECT-AXIS 1 met its primary goal with significantly more patients on Rinvoq than on a placebo achieving at least a 40% clinical improvement at week 14 — 52% vs. 26% — as measured with the Assessment of Spondyloarthritis International Society (ASAS40) criteria. This is a tool that asses four domains: pain, function, inflammation, and a patient global assessment.

Other benefits included greater proportions of Rinvoq-treated patients in partial remission and with lesser disease activity.

Findings in SELECT-AXIS 2 had significantly more patients on Rinvoq (45%) showing a 40% or better clinical improvement after 14 weeks of treatment than those on placebo (18%), as measured using the Assessment of SpondyloArthritis international Society 40 percent response criteria or ASAS40, with addresses issues including pain, function, and inflammation.

Multiple secondary measures of efficacy were also achieved, with Rinvoq-treated patients showing a reduction in disease activity, measured by the Ankylosing Spondylitis Disease Activity Score or ASDAS, and in back pain compared with measures taken at the study’s start.

Improvements were also seen in spinal MRI scans, and in daily life abilities, as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) and the Ankylosing Spondylitis Quality of Life (ASQoL) questionnaire.

Rinvoq’s approval in Canada was welcomed by patients and the therapy’s developers, who stressed the high unmet need for treatments in this patient population.

“Living with AS for most of my adult life, I have gotten used to living with pain. I had muscle spasms, and I couldn’t walk. It was hard to move. The pain in my back and my glutes made everyday movement, particularly anything that involved hip movement, really difficult,” Marianne Skippings, a patient living in Edmonton, Alberta, said in the release.

“Finding a treatment that works for me has been life changing and has allowed me to get back to normal and simply focus on living,” Skippings added.

“At AbbVie … we are proud to expand our portfolio of treatment options for Canadians impacted by ankylosing spondylitis, in particular, offering patients the first once-daily oral advanced therapy in AS,” said Tracey Ramsey, vice president and general manager, AbbVie Canada.

Rinvok is also approved by U.S. Food and Drug Administration (FDA) to treat adults with active rheumatoid, psoriatic arthritis, or ulcerative colitis, and for children 12 and older and adults with moderate-to-severe atopic dermatitis, provided all these patients are unresponsive to or intolerant of standard anti-rheumatic treatments.

Its FDA label carries a box warning of potential side effects with Rinvok’s use, including a risk of serious bacterial, viral, and other infections; a higher risk of cancers like lymphoma; and a higher risk of a heart attack or other cardiovascular events, particularly for people who are current or former smokers.