AbbVie’s Rinvoq adds indications including atopic dermatitis

AbbVie’s selective and irreversible JAK inhibitor Rinvoq (upadacitinib) expanded indications for psoriatic arthritis, ankylosing spondylitis, and atopic dermatitis, in addition to the existing rheumatoid arthritis.

On Tuesday, the Ministry of Food and Drug Safety authorized Rinvoq to treat psoriatic arthritis, ankylosing spondylitis, and atopic dermatitis.

More specifically, Rinvoq is indicated as monotherapy or in combination with nonbiologic disease-modifying anti-rheumatic drug (DMARD) to treat adult patients with active psoriatic arthritis who have responded inadequately to or not who intolerant to one or more DMARDs.

Also, it is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy and for the treatment of moderate to severe atopic dermatitis in adults and adolescents aged 12 or older are subject to systemic treatment.

The approved dose for Rinvoq in the expanded indications is 15 mg once daily. For example, Rinvoq 15 mg or 30mg can be administered once daily to treat atopic dermatitis, depending on the patient’s symptoms.

The approval for psoriatic arthritis was based on the results of the phase 3 SELECT-PsA 1 and SELECT-PsA 2 studies in adult patients with active psoriatic arthritis who did not respond to or were intolerant to nonbiologic or biologic anti-rheumatic drugs.

In these trials, the Rinvoq-treated group achieved a higher ACR 20 at week 12 than the placebo group, which met the primary endpoint.

Compared to the adalimumab 40mg biweekly treatment regiment, Rinvoq confirmed non-inferiority in ACR 20 at week 12.

Also, Rinvoq-treated patients showed improved body function and skin symptoms in the HAQ-DI (Health Assessment Questionnaire Disability Index) at week 12 and PASI 75 at week 16. The Rinvoq group’s rate of achieving minimal disease activity at week 24 was also higher than that of the placebo group.

The approval for the treatment of ankylosing spondylitis was based on the phase 2/3 SELECT-AXIS 1 trial results in adult patients with active ankylosing spondylitis who have not been treated with biologic DMARDs and who have an insufficient response or intolerability to nonsteroidal anti-inflammatory drugs (NSAIDs).

The Rinvoq group achieved ASAS 40 response in the trial, higher than the placebo group, at week 14 and met the primary endpoint.

Professor of Kim Tae-hwan of rheumatology at Hanyang University Medical Center said ankylosing spondylitis develops at a relatively young age, under 45 years.

If left untreated, the disease may damage the bones and cause functional disorders that interfere with daily life, he said.

“With the addition of Rinvoq’s indications for ankylosing spondylitis and psoriatic arthritis, we expect that patients who did not respond adequately to existing therapies will be able to participate in social activities, restore their quality of life and improve work productivity,” he said.

The approval for the treatment of atopic dermatitis was based on the results of the phase 3 trials -- Measure Up 1, Measure Up 2, and AD Up – in 2,500 adults and adolescents aged 12 or more with moderate to severe atopic dermatitis.