UCB presented new long-term data on bimekizumab in psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA) at EULAR 2023.
The company presented data from three Phase 3 studies: BE COMPLETE (including its long-term extension study), BE MOBILE 1, and BE MOBILE 2. These studies evaluated the efficacy and safety of bimekizumab in adults with active PsA, non-radiographic axSpA (nr-axSpA), and ankylosing spondylitis (AS). The results showed sustained clinical responses for up to one year in multiple disease manifestations and patient populations.
For patients with PsA who had an inadequate response to tumor necrosis factor inhibitors (TNFi-IR), bimekizumab demonstrated sustained joint and skin clearance responses at week 52. Over 60% of patients continuously treated with bimekizumab achieved complete skin clearance, and nearly 50% had minimal disease activity at week 52. The results highlight the consistent and sustained response of bimekizumab in both biologic-naïve and TNF inhibitor-experienced PsA patients.
In the spectrum of axSpA, bimekizumab showed a sustained reduction of inflammatory lesions in the sacroiliac joints and spine, as well as improvements in peripheral manifestations of the disease at week 52 in Phase 3, BE MOBILE 1 and BE MOBILE 2 studies. Approximately 50% of patients with baseline inflammation achieved remission in the sacroiliac joints and the spine.
In the BE MOBILE 1 study, after 52 weeks of treatment in patients with inflammation at baseline, 80% of patients treated with bimekizumab and 57.1% of patients who switched to bimekizumab from placebo at week 16 achieved remission in inflammation of the sacroiliac joints.
Regarding spine inflammation, in the BE MOBILE 1 imaging sub-study, 40% of patients with inflammation at baseline received continuous bimekizumab, and 27.3% of patients who moved to bimekizumab from placebo at week 16 achieved remission. In the BE MOBILE 2 study, 76.7% of patients receiving continuous bimekizumab and 62.5% of patients who moved to bimekizumab at week 16 achieved remission.
Regarding enthesitis, in the BE MOBILE 1 study, 54.3% of patients receiving continuous bimekizumab and 44.6% of patients who moved to bimekizumab at week 16 achieved resolution. In the BE MOBILE 2 study, 50.8% of patients receiving continuous bimekizumab and 46.3% moved to bimekizumab from placebo at week 16 achieved a resolution of enthesitis.
Rinvoq demonstrated positive results in the Phase 2 Study for Systemic Lupus Erythematosus patients.
AbbVie announced the successful outcomes of the Phase 2 SLEek study of Rinvoq in systemic lupus erythematosus (SLE) patients, which evaluated the efficacy of Rinvoq (upadacitinib) alone and in combination with ABBV-599 high dose (elsubrutinib 60 mg and upadacitinib 30 mg) in adults with moderately to severely active systemic lupus erythematosus (SLE) who were already receiving standard lupus therapies.
The study demonstrated significant improvements in disease activity and reduced steroid use while maintaining a favorable safety profile.
At week 24, a higher percentage of patients treated with upadacitinib 30 mg or ABBV-599 high dose achieved the primary endpoint of SLE Responder Index (SRI-4) and a steroid dose of less than or equal to 10 mg prednisone equivalent once per day, compared to placebo. At week 48, 32% of placebo, 45.2% of patients on Rinvoq 30 mg, and 51.5% on ABBV-599 HD achieved SRI-4 and steroid dose ≤ 10 mg.
At week 48, 25.3% of patients on placebo, 53.2% on Rinvoq 30 mg, and 48.5% on ABBV-599 HD achieved BICLA response.
18% of patients on a placebo, 50% on Rinvoq 30 mg, and 39.7% on ABBV-599 HD achieved Lupus Low Disease Activity State (LLDAS) response at week 48.
No new safety signals were observed beyond the known safety profile of upadacitinib. The adverse events reported with ABBV-599 high dose were similar to those reported for patients treated with upadacitinib alone.
The Janssen presented new data from clinical trials highlighting the long-lasting benefits of Tremfya (guselkumab) in individuals with active psoriatic arthritis (PsA).
The Phase 3b COSMOS trial demonstrated sustained improvements in all minimal disease activity (MDA) domains up to week 48, while a separate analysis of the Phase 3 DISCOVER-1 and DISCOVER-2 trials revealed prompt and persistent enhancements in critical determinants. Tremfya, the first fully human selective interleukin (IL)-23 inhibitor therapy, has been approved for treating adults with active psoriatic arthritis.
The overall response rates at week 24 and week 48 demonstrated substantial improvements in multiple domains, with physician-reported domains (LEI, PASI, and SJC) showing faster achievement than patient-driven domains. At weeks 24 and 48, the Psoriasis Area and Severity Index (PASI) responses were 66.8% and 81.5%; Leeds Enthesitis Index (LEI) responses were 74.5% and 79.8%; swollen joint count (SJC) response rates were 46.2% and 63.0%.
Tremfya demonstrated rapid and sustained improvements, including patient-reported pain, health-related quality of life, and fatigue.
With the new data at EULAR, Janssen aims to demonstrate the sustained and multifaceted benefits of Tremfya (guselkumab) in individuals with active PsA.