On the same day Novartis announced that its Cosentyx didn’t prove itself superior to AbbVie’s Humira in psoriatic arthritis, AbbVie announced that its Rinvoq met the primary endpoint in active psoriatic arthritis in its SELECT-PsA 2 Phase III trial.
On the same day Novartis announced that its Cosentyx didn’t prove itself superior to AbbVie’s Humira in psoriatic arthritis, AbbVie announced that its Rinvoq met the primary endpoint in active psoriatic arthritis in its SELECT-PsA 2 Phase III trial.
In both doses of Rinvoq (upadacitinib), 15 mg and 30 mg, the drug hit the primary endpoint of ACR20 response at week 12 compared to placebo in adults with active psoriatic arthritis who haven’t responded enough to one or more biologic disease modifying anti-rheumatic drugs (bDMARDs). Also, patients receiving both doses had significantly better responses compared to placebo for all ranked secondary endpoints.
Rinvoq is a selective and reversible JAK inhibitor. It was discovered and developed by AbbVie and is being advanced as a once-daily therapy for psoriatic arthritis and multiple immune-mediated diseases.
“Too many people living with psoriatic arthritis still fail to achieve their treatment goals, underscoring a clear medical need for additional therapeutic options,” said Michael Severino, AbbVie’s vice chairman and president. “We are pleased with these data, which show the potential of Rinvoq to improve outcomes for people with psoriatic arthritis across a variety of symptoms. Data from this Phase III study will support regulatory submissions for Rinvoq in psoriatic arthritis.”
At week 12, 57% of patients receiving the 15 mg dose and 64% of those receiving the 30 mg dose of RiInvoq achieved ACR20 compared to 24% in the placebo group. ACR50 was hit by 32% and 38% in the 15 mg and 30 mg groups, respectively, compared to only 5% of the placebo group.
ACR20 is a composite measurement defined as both improvement of 20% of the number of tender and number of swollen joints in addition to a 20% improvement in three of five of the following: patient global assessment, physician global assessment, Health Assessment Questionnaire (HAQ), visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).
ACR50 and ACR70, then, is the same definition only for 50% and 70%, respectively.
The study found 9% of patients in the 15 mg group and 17% of patients in the 30 mg group achieved ACR70 at 12 weeks compared to 0.5% in the placebo group.
Psoriatic arthritis is a general systemic inflammatory disease that is observed mostly in the joints and skin. It affects more than 50 million people globally. The immune system causes inflammation that can lead to pain, fatigue and stiffness in the joints.
Earlier this year, the U.S. Food and Drug Administration (FDA) approved Rinvoq for adults with moderately to severely active rheumatoid arthritis. It received a positive opinion from the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) and is awaiting approval by the European Commission (EC).
The drug is also being evaluated in Phase III trials for psoriatic arthritis, Crohn’s disease, atopic dermatitis, ulcerative colitis and giant cell arteritis. It is also being studied for ankylosing spondylitis.
AbbVie’s Humira is the dominant player in this arena but is facing biosimilar competition in Europe and a patent cliff in the U.S. in 2023. Rinvoq is expected to fill in some of the gap, with projected annual sales by 2023 of $2.2 billion. Novartis’ Cosentyx brought in $2.8 billion in 2018, but Humira, the world’s best-selling drug, still managed to bring in almost $20 billion. Other drugs in the market include AbbVie’s Skyrizi (risankizumab), Johnson & Johnson’s Tremfya, which was approved in 2017, and Eli Lilly’s Taltz.
