J&J's Tremfya Fails Phase II Giant Cell Arteritis Trial

Johnson & Johnson has announced the termination of its Phase II THEIA trial evaluating the monoclonal antibody Tremfya (guselkumab) for treating giant cell arteritis (GCA) due to failure to meet the primary endpoint. The study aimed to assess the efficacy of Tremfya in achieving glucocorticoid (GC)-free remission in patients, but the results did not support further development for this specific condition.

The trial details, listed on clinicaltrials.gov, disclose that the study enrolled 53 participants who were assigned either Tremfya or a placebo alongside a 26-week glucocorticoid taper regimen. Despite this well-structured approach, the efficacy findings were deemed insufficient, leading to the trial's cessation. A Johnson & Johnson spokesperson confirmed that no new safety issues were identified during the study.

A company representative expressed disappointment over the trial's outcome but emphasized that this decision is specific to the GCA indication and does not influence other ongoing guselkumab development projects. Johnson & Johnson remains dedicated to discovering innovative treatments for rheumatologic diseases with significant unmet needs.

Giant cell arteritis, an autoimmune disease causing arterial inflammation, can result in severe symptoms such as headaches, scalp tenderness, jaw pain, and potential blindness if left untreated. While this particular study did not yield the desired results, other pharmaceutical companies are progressing in the GCA treatment space. For instance, in April 2024, AbbVie reported that its combination of Rinvoq with a steroid taper regimen achieved its primary endpoint of sustained remission in GCA patients between weeks 12 and 52. Additionally, Roche’s Genentech received FDA approval for Actemra to treat GCA in 2017.

Despite the setback in GCA research, Tremfya has proven successful in other indications. In a Phase III trial last year, Tremfya showed positive outcomes for patients with moderate to severely active ulcerative colitis, achieving a 61.5% clinical response rate compared to 27.9% in the placebo group. Furthermore, in January 2024, Tremfya demonstrated rapid and significant improvement in severe scalp psoriasis and associated itch in a Phase IIIb study. Johnson & Johnson also filed for FDA approval for Tremfya to treat severely active Crohn’s disease during the same period.

Financially, Tremfya has been a strong performer for Johnson & Johnson, generating over $3.1 billion in sales last year and $808 million in the first quarter of 2024. This substantial revenue underscores the drug's importance in the company's portfolio and its efficacy in treating various autoimmune conditions.

Overall, while the failure of the THEIA trial is a setback for Johnson & Johnson in the specific area of GCA, the company remains committed to its broader mission of developing transformative therapies for multiple rheumatologic diseases.