The JAK inhibitor showed efficacy across multiple measures of disease activity in active PsA with a safety profile consistent with that seen in rheumatoid arthritis.

The U.S. Food and Drug Administration (FDA) has approved RINVOQ (upadacitinib; 15 mg, once daily) for the treatment of adults with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers.

"The efficacy of RINVOQ in relieving the many manifestations of psoriatic arthritis is well-characterized in two large, long term clinical studies," says Michael Severino, M.D., vice chairman and president of AbbVie, in a news release. "This new approval underscores our mission to deliver a portfolio of therapies that can help more people with rheumatic diseases achieve disease control."

The FDA approval is supported by data from two pivotal Phase 3 trials, SELECT-PsA 1 and SELECT-PsA 2, which assessed the efficacy, safety and tolerability of RINVOQ in patients with PsA. In both studies, the safety profile in patients with active PsA treated with RINVOQ 15 mg was consistent with the safety profile observed in patients with rheumatoid arthritis.

"Many adults still struggle to find a treatment option that helps them lower their disease activity," says Iain McInnes, professor of medicine and Versus Arthritis professor of rheumatology at University of Glasgow, U.K., and lead investigator of the SELECT-PsA 1 trial. "With this FDA approval, RINVOQ has the potential to help more people find meaningful relief from the signs and symptoms of psoriatic arthritis that they see and feel and to help reach their treatment goals." 

Across SELECT-PsA 1 and SELECT-PsA 2 Phase 3 clinical trials, RINVOQ met its primary endpoint of ACR20 at week 12 with patients taking RINVOQ 15 mg achieving significantly higher ACR20 responses (71% and 57%, respectively) versus placebo (36% and 24%, respectively).

Joint Efficacy

Across both SELECT-PsA 1 and SELECT-PsA 2 Phase 3 clinical trials, patients treated with RINVOQ 15 mg achieved higher ACR50 responses (38% and 32%, respectively) at week 12 compared to placebo (13% and 5%, respectively).

Patients treated with RINVOQ 15 mg across the SELECT-PsA 1 and SELECT-PsA 2 clinical trials achieved higher ACR70 responses (16% and 9%, respectively) compared to placebo (2% and 1%, respectively) at week 12.

Treatment with RINVOQ 15 mg resulted in improvement in dactylitis and enthesitis in patients with pre-existing dactylitis or enthesitis.

In SELECT-PsA 1, treatment with RINVOQ 15 mg significantly inhibited the progression of structural joint damage (-0.02 change from baseline) compared to placebo (0.23) as assessed by the change from baseline in modified Total Sharp Score (mTSS) at week 24.

Physical Function

Across SELECT-PsA 1 and SELECT-PsA 2 clinical trials, patients treated with RINVOQ 15 mg showed significant improvement in physical function from baseline compared to placebo as assessed by HAQ-DI at week 12.

Fatigue 

In both Phase 3 clinical trials, patients receiving RINVOQ 15 mg experienced significantly greater improvement from baseline in fatigue, as measured by the Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F) score, at Week 12 compared to placebo.

Skin Response 

Treatment with RINVOQ 15 mg resulted in improvement in skin manifestations in patients with PsA. However, RINVOQ has not been studied in and is not indicated for the treatment of plaque psoriasis.

Safety

Overall, the safety profile observed in patients with active PsA treated with RINVOQ 15 mg was consistent with the safety profile observed in patients with rheumatoid arthritis. During the 24-week placebo-controlled period, the most common adverse events reported with RINVOQ 15 mg were upper respiratory tract infection and blood creatine phosphokinase elevations. The frequencies of herpes zoster and herpes simplex were 1.1% and 1.4%, respectively, with RINVOQ 15 mg and 0.8% and 1.3%, respectively, with placebo. A higher incidence of acne and bronchitis was also observed in patients treated with RINVOQ 15 mg (1.3% and 3.9%, respectively) compared to placebo (0.3% and 2.7%, respectively).

RINVOQ may cause serious side effects, including:

• Serious infections. RINVOQ can lower your ability to fight infections. Serious infections have happened while taking RINVOQ, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections.
• Increased risk of death in people 50 years and older with at least 1 heart disease (cardiovascular) risk factor.
• Cancer and immune system problems. RINVOQ may increase your risk of certain cancers, including lymphoma, skin, and lung cancer, as these can happen. Current or past smokers are at higher risk.
• Increased risk of major cardiovascular events such as heart attack, stroke, or death in people 50 years and older with at least 1 heart disease (cardiovascular) risk factor, especially in current or past smokers.
• Blood clots. Blood clots in the veins of the legs or lungs and arteries can happen with RINVOQ. This may be life-threatening and cause death. This has happened more often in people 50 years and older with at least 1 heart disease (cardiovascular) risk factor.
• Other serious side effects include tears in the stomach or intestines and changes in certain laboratory test results.

Ease of Use and Access

Designed to help accommodate the physical limitations of people living with rheumatic diseases, the packaging for RINVOQ includes a bottle cap with a wide, easy-to-grip texture and an embedded tool that punctures the foil liner to simplify medication access. This packaging design was awarded the Arthritis Foundation Ease of Use Commendation.

AbbVie continues to work closely with key stakeholders to support patient access to RINVOQ, including offering a patient support program and a co-pay card that may reduce out-of-pocket costs to $5 per month for eligible, commercially insured patients. For those with limited or no health insurance, AbbVie offers myAbbVie Assist, a patient assistance program that provides RINVOQ to qualifying patients. For more details, please visit AbbVie.com/myAbbVieAssist.

About SELECT-PsA 1

SELECT-PsA 1 is a Phase 3, multicenter, randomized, double-blind, active comparator- and placebo-controlled study designed to evaluate the safety and efficacy of RINVOQ compared to placebo and adalimumab in adult patients with moderately to severely active psoriatic arthritis who have a history of intolerance or inadequate response to at least one non-biologic DMARD. Patients were randomized to RINVOQ 15 mg, RINVOQ 30 mg, adalimumab 40 mg every other week, or placebo followed by either RINVOQ 15 mg or RINVOQ 30 mg at week 24.

The primary endpoint was the percentage of subjects receiving RINVOQ 15 mg or 30 mg who achieved an ACR20 response after 12 weeks of treatment versus placebo. Key secondary endpoints included change from baseline in HAQ-DI at week 12, proportion of patients achieving, percentage of patients achieving a static Investigator Global Assessment (sIGA) of psoriasis of 0 or 1 and at least a 2-point improvement from baseline at week 16; percentage of patients achieving PASI 75 response at week 16; inhibition of radiographic progression at week 24 per the change from baseline in mTSS; the percentage of patients achieving MDA at week 24; percentage of participants with resolution of enthesitis at week 24; change from baseline in FACIT-F questionnaire at week 12; and percentage of patients with resolution of dactylitis at week 24. These are not all of the secondary endpoints. The long-term extension of the trial is ongoing. More information on this trial can be found at www.clinicaltrials.gov (NCT03104400).

About SELECT-PsA 2

SELECT-PsA 2 is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of RINVOQ in adult patients with moderately to severely active psoriatic arthritis who have a history of intolerance or inadequate response to at least one biologic DMARD. Patients were randomized to RINVOQ 15 mg, RINVOQ 30 mg or placebo followed by either RINVOQ 15 mg or RINVOQ 30 mg at week 24.

The primary endpoint was the percentage of subjects achieving an ACR20 response after 12 weeks of treatment vs placebo. Key secondary endpoints included change from baseline in HAQ-DI at week 12, proportion of patients achieving ACR50 and ACR70 at week 12, proportion of patients achieving PASI 75 at week 16, as well as proportion of patients achieving MDA at week 24. These are not all of the secondary endpoints. The long-term extension of the trial is ongoing. More information on this trial can be found at www.clinicaltrials.gov (NCT03104374).