October 15, 2023
AbbVie Presented Positive Head-to-Head of Skyrizi versus Stelara in Crohn's Disease
AbbVie's Phase 3 clinical trial, known as SEQUENCE, has resulted in positive outcomes in a head-to-head comparison of two medications, Skyrizi (risankizumab) and Stelara (ustekinumab), in Crohn's disease. These patients had previously not responded to one or more anti-TNF medications. The study assessed the efficacy in adults with moderate to severe symptoms.
The SEQUENCE study aimed to assess the effectiveness and safety of risankizumab, administered as a 600 mg intravenous (IV) dose at week 0, 4, and 8, followed by 360 mg subcutaneous (SC) doses starting at week 12 and every eight weeks after that, in comparison to ustekinumab, which was administered as an IV dose at week 0, followed by 90 mg SC doses every eight weeks. The primary endpoints in this study included clinical remission (assessed by the Crohn's Disease Activity Index [CDAI]) at week 24 and endoscopic remission (evaluated by the Simple Endoscopic Score for Crohn's disease) at week 48.
Skyrizi not only demonstrated non-inferiority to ustekinumab for the first primary endpoint, clinical remission at week 24, with remission rates of 59% for Skyrizi and 40% for Stelara but also showed superiority upon further analysis. This outcome was statistically significant.
Regarding the second primary endpoint, endoscopic remission at week 48, Skyrizi was superior to Stealra, with remission rates of 32% for Skyrizi and 16% for Stelara, a significant difference.
Furthermore, Skyrizi outperformed Stelara in all secondary endpoints, including the achievement of clinical remission at week 48, the endoscopic response at both week 24 and 48, steroid-free endoscopic remission at week 48, and steroid-free clinical remission at week 48. Clinical remission at Week 48 was 61% in the Skyrizi arm versus 41% in patients on Stelara.
Notably, the safety profile of Skyrizi remained consistent with prior knowledge, with no new safety concerns identified in this study.
October 16, 2023
Janssen Presented Long-Term Data of Tremfya in Crohn's Disease Patients.
Janssen Pharmaceuticals presented new findings from the extended phase of the GALAXI Phase 2 study, showcasing the sustained effectiveness of Tremfya (guselkumab) over three years in patients with Crohn's disease (CD). The study focused on key efficacy measures, including clinical remission, patient-reported outcome remission, and endoscopic response.
The results from this long-term extension (LTE) study highlight that the clinical remission and endoscopic response rates achieved in the initial 48-week GALAXI study have been maintained over three years. TREMFYA, an IL-23 p19 inhibitor, demonstrated its ability to provide durable relief for individuals with Crohn's disease, and its safety profile remained consistent with its previously approved uses.
Following the completion of the GALAXI Phase 2 study at week 48, participants continued in the LTE phase and were divided into three distinct treatment regimens, as randomly assigned:
TREMFYA 100 mg administered subcutaneously (SC) every eight weeks (q8w).
TREMFYA 200 mg administered subcutaneously (SC) every four weeks (q4w).
STELARA® (ustekinumab) 90 mg administered subcutaneously (SC) every eight weeks (q8w).
Outcomes after three years were:
These results signify the potential of TREMFYA as a viable and sustained treatment option for individuals with moderate to severe Crohn's disease, offering hope for long-term disease management.