J&J's Tremfya falls short in giant cell arteritis after IBD success

Johnson & Johnson (J&J) has decided to halt its phase 2 THEIA study of Tremfya in adults with giant cell arteritis (GCA) because the study did not meet its primary endpoint, which was the percentage of patients achieving glucocorticoid (GC)-free remission. A J&J spokesperson explained that the decision was based on "insufficient efficacy findings to support continued study," despite the trial revealing no new safety concerns.

This specific decision to stop the GCA study will not influence other development programs for Tremfya (guselkumab), the spokesperson emphasized. J&J remains dedicated to developing innovative treatments for rheumatologic diseases that have unmet medical needs.

GCA is an autoimmune disease characterized by inflammation of large blood vessels in the scalp, neck, and arms, which can obstruct blood flow. Symptoms include headaches, scalp tenderness, jaw pain, and vision issues. If untreated, GCA can lead to blindness. Steroids are commonly used as the first-line treatment for this condition, according to the Mayo Clinic.

Despite the setback in GCA, Tremfya has recently achieved several positive outcomes in other disease areas. Last month, the drug showed success in back-to-back trials for two subtypes of inflammatory bowel disease (IBD)—ulcerative colitis and Crohn’s disease. Additionally, the subcutaneous version of Tremfya met both co-primary endpoints in the phase 3 GRAVITI trial for Crohn’s disease, demonstrating a statistically significant improvement compared to placebo at week 12 for both remission and endoscopic response.

Meanwhile, other pharmaceutical companies are making significant progress in the GCA treatment landscape. AbbVie’s Rinvoq recently met its primary endpoint in the SELECT-GCA trial, with 46% of patients achieving sustained remission from week 12 through week 52, compared to 29% of patients on placebo and a one-year steroid taper regimen. The safety profile of Rinvoq remained consistent with previous findings. Additionally, Roche’s Actemra was the first drug specifically approved for GCA back in 2017.

Despite the discontinued GCA study, Tremfya remains a crucial product for J&J. Last year, the drug generated approximately $3.1 billion in global sales, representing an 18% increase from its 2022 earnings.