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.