Jaw inflammation

AbbVie has submitted regulatory applications to both the FDA and the EMA for the approval of upadacitinib, branded Rinvoq, for treating giant cell arteritis (GCA) in adults. The applications for the new indication are supported by data from the phase 3 SELECT-GCA study, which demonstrated that upadacitinib 15 mg, taken once daily in conjunction with a 26-week steroid taper regimen, met the primary endpoint of sustained remission from week 12 through week 52. Giant cell arteritis is an autoimmune disease affecting medium and large arteries, leading to symptoms like headache, jaw pain, and vision changes, including sudden and permanent vision loss. Most patients rely on glucocorticoids, which many cannot discontinue without symptom recurrence. Upadacitinib, a JAK inhibitor, was first approved in August 2019 for treating moderately to severely active rheumatoid arthritis. Since, the drug has been approved for treating various conditions including psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, polyarticular juvenile idiopathic arthritis, juvenile psoriatic arthritis, atopic dermatitis, ulcerative colitis, and Crohn's disease. If approved for GCA, the drug will compete against Genentech's blockbuster Actemra (tocilizumab), the first drug approved specifically for treatment of GCA.

A J&J spokesperson told Fierce that the company had “insufficient efficacy findings to support continued study.” As other immunology players make inroads into the giant cell arteritis (GCA) arena, one of Johnson & Johnson’s top-grossing medicines, Tremfya, has come up short in the disease. J&J has nixed its phase 2 THEIA study for Tremfya in adults with GCA because the trial’s primary endpoint—the percentage of patients who achieved glucocorticoid (GC)-free remission—was not met, according to clinicaltrials.gov. A J&J spokesperson told Fierce that the company had “insufficient efficacy findings to support continued study,” while adding that no new safety signals cropped up. The indication-specific decision won’t affect other development programs for Tremfya (guselkumab), the spokesperson added. He noted that J&J will remain committed to developing new therapies for rheumatologic diseases with unmet needs. GCA is a presumed autoimmune disease that affects the large blood vessels of the scalp, neck and arms, in which inflammation narrows or blocks blood vessels and interrupts blood flow. The disease frequently causes headaches, scalp tenderness, jaw pain and vision problems and—if left untreated—can lead to blindness. First-line treatment of the disease often revolves around steroids, according to the Mayo Clinic. Temfya’s miss in GCA follows several positive readouts for the drug in other indications. Last month, the drug delivered back-to-back trial wins in the two inflammatory bowel disease (IBD) subtypes, ulcerative colitis and Crohn’s disease. Then, late last week, the med’s subcutaneous version met both co-primary endpoints in Crohn’s disease in the phase 3 GRAVITI trial, delivering a statistically significant improvement versus placebo at week 12 for both remission and endoscopic response. Elsewhere, AbbVie’s Rinvoq recently aced its primary endpoint in the SELECT-GCA trial, helping 46% of GCA patients hit sustained remission from week 12 through week 52 of the study. That was significantly better than the 29% sustained remission rate posted by patients on placebo and a one-year steroid taper regimen, AbbVie said in a release at the time. Safety was consistent with the medicine's known profile. Roche’s Actemra became the first drug specifically approved for GCA back in 2017. Tremfya continues to be one of J&J’s top-selling medicines. For all of last year, the drug brought home roughly $3.1 billion in worldwide sales, marking an 18% increase over the sum it generated in 2022.

AbbVie expects Rinvoq and its other new immunology med Skyrizi to pull down a combined $16 billion in global sales this year. Less than a year ago, AbbVie's star immunology drug Rinvoq picked up its seventh FDA approval when the agency endorsed it in Crohn's disease. After a new positive pivotal trial, the drug could be bound for another label expansion. On Thursday, AbbVie said that Rinvoq, also known as upadacitinib, met its primary endpoint in the SELECT-GCA trial in patients with giant cell arteritis (GCA). Specifically, 46% of patients treated with the AbbVie drug at the 15 mg dose—plus a 26-week steroid taper regimen—achieved sustained remission from week 12 through week 52.  As for patients on placebo and a 52-week steroid taper remission, the rate of sustained remission was 29% during that timeframe, AbbVie said in a release. Safety was consistent with the medicine's known profile. "Based on these results, upadacitinib has the potential to be the first oral treatment option for patients with GCA, a disease with inflammation of the large arteries that primarily impacts older people and has only one approved treatment to date commonly used with steroids," study lead investigator Daniel Blockmans, M.D., Ph.D., said in a statement. Rinvoq did not meet any trial endpoints at the lower 7.5 mg dose. Giant cell arteritis causes inflammation in medium and large arteries and usually affects people older than 50, according to AbbVie. The disease disproportionately affects women and causes patients to experience headaches, jaw pain and sudden vision changes, including loss of vision. The other FDA-approved drug in GCA is Roche's Actemra. The FDA has approved Actemra biosimilars from Biogen and Fresenius Kabi in recent months, but those don't appear to have reached the U.S. market. After AbbVie last year lost U.S. exclusivity for its stalwart immunology med Humira, Rinvoq is a key pillar in the company's business plan for the coming years. The company expects its newer immunology duo of Rinvoq and Skyrizi to pull down $27 billion by 2027, far eclipsing Humira's 2022 peak of $21 billion.  Last year, the duo generated nearly $12 billion. The combined sales figure is expected to climb to $16 billion for 2024. Rinvoq won its original FDA approval in 2019 and already carries the agency endorsements to treat seven diseases. AbbVie has said expansions into new disease areas will fuel growth in the years to come. In the SELECT-GCA trial, Rinvoq also met its secondary endpoints of improving rates of complete remission and reducing disease flares. AbbVie said it will share full trial results at an upcoming medical meeting.