October 12, 2023
Bimekizumab Demonstrates High Clinical Response Rates in Hidradenitis Suppurativa, Phase 3 Data Reveals
UCB has unveiled promising findings from a pooled analysis of Phase 3 bimekizumab studies, BE HEARD I and BE HEARD II, involving patients with moderate to severe hidradenitis suppurativa (HS).
Primary Endpoint Success: Patients treated with bimekizumab exhibited higher response rates in the primary endpoint, HiSCR50, at Week 16 when compared to the placebo group.
Notably, the response rates were 58 percent for those receiving bimekizumab every two weeks (Q2W), 55.9 percent for those on Q2W/Q4W dosing, and 56.1 percent for Q4W/Q4W dosing, as opposed to 33.4 percent for the placebo group
Sustained Improvement: The positive response observed at Week 16 continued to increase for patients who remained in the study through Week 48.
Approximately 8 in 10 patients who initially achieved HiSCR50 maintained this response up to Week 48.
Stringent Endpoints: The analysis also included more stringent HiSCR75, HiSCR90, and HiSCR100 endpoints. Bimekizumab-treated patients displayed improved responses through Week 48
Safety Profile: The safety profile of bimekizumab remained consistent with previous studies
These results indicate that bimekizumab has the potential to represent a substantial breakthrough in the management of hidradenitis suppurativa.
Late-Breaking Data Reveals Amlitelimab's Promising Potential in Atopic Dermatitis
Findings from the late-breaking Phase 2b study of amlitelimab were presented at the European Academy of Dermatology and Venereology (EADV) 2023 Congress, shedding light on the drug's potential as a best-in-class treatment for atopic dermatitis.
Amlitelimab, an innovative treatment, demonstrated remarkable results in adults with moderate-to-severe atopic dermatitis.
Patients treated with amlitelimab experienced significant improvements, with up to a 61.5% reduction in the Eczema Area and Severity Index (EASI) score at week 16 compared to placebo, a key primary endpoint.
Impressively, these improvements continued to progress up to week 24.
The study also revealed substantial enhancements in all critical secondary endpoints at week 16, persisting through week 24. Among these secondary endpoints, the Investigator Global Assessment response of 0 (clear) or 1 (almost clear skin) (IGA 0/1) was particularly notable. Patients receiving the highest dose experienced a 22.1% improvement at week 16, which grew to an impressive 45.5% by week 24.
Treatment | IGA 0/1 Response Rate at Week 16 | IGA 0/1 Response Rate at Week 24 |
Amlitelimab 250 mg + LD | 22.1% | 45.5% |
Placebo | 5.1% | 11.4% |
Amlitelimab's safety profile remained reassuring, with no new safety concerns arising. Treatment-emergent adverse event rates were 67.4% for amlitelimab and 60.3% for the placebo.
October 11, 2023
BMS presented long-term data of Sotyktu in psoriasis patients.
Bristol Myers Squibb has released new findings from a three-year study on Sotyktu (deucravacitinib) treatment for adults with moderate-to-severe plaque psoriasis. The study demonstrates the drug's enduring efficacy and consistent safety profile.
The long-term extension (LTE) trial, known as POETYK PSO, revealed that clinical response rates remained robust after 148 weeks of continuous Sotyktu treatment.
Specifically, the Psoriasis Area and Severity Index (PASI) 75 response rate was steady at 73.2%, PASI 90 at 48.1%, and static Physician's Global Assessment (sPGA) 0/1 at 54.1%.
Summary or Sotyktu psoriasis trial outcomes
| PASI 75 | PASI 90 | sPGA 0/1 |
Week 16 | 61.1% | 35.2% | 57.5% |
Week 52 | 72.6% | 45.6% | 58.1% |
Week 148 | 73.2% | 48.1% | 54.1% |
October 11, 2023
AbbVie Unveils Extended Findings Supporting Rinvoq's Efficacy and Safety in Moderate to Severe Atopic Dermatitis.
AbbVie has presented compelling long-term data affirming the efficacy and safety of Rinvoq (upadacitinib) in adults and adolescents with moderate to severe atopic dermatitis. This validation arises from three ongoing Phase 3 studies, which were randomized, double-blind, and multicenter, spanning 140 weeks.
Across these studies, patients who received Rinvoq consistently demonstrated promising response rates for the co-primary endpoints, EASI 75 and vIGA-AD 0/1, as well as for secondary endpoints, EASI 90 and itch reduction (WP-NRS 0/1), beginning as early as week 16 and sustaining these improvements through week 140.
Measure Up 1 trial outcomes
| EASI 75 at week 140 | vIGA-AD 0/1 at week 140 |
Rinvoq 15 mg | 88.8% | 63.4% |
Rinvoq 30 mg | 90.3% | 65.5% |
Measure Up 2 trial outcomes
| EASI 75 at Week 140 | vIGA-AD 0/1 at Week 140 |
Rinvoq 15 mg | 82.0% | 49.2% |
Rinvoq 30 mg | 92.7% | 63.2% |
The safety aspect of these findings is that they align with the known safety profile of upadacitinib. Importantly, no new safety concerns emerged during the study, further solidifying the drug's safety record.
AbbVie Reports Positive Results in Phase 2 Vitiligo Trial or Rinvoq, Advancing to Phase 3
AbbVie has shared encouraging news from its Phase 2b clinical study evaluating upadacitinib, also known as Rinvoq, in adults with non-segmental vitiligo (NSV). The study successfully met its primary endpoint, which measured the percent change from baseline in the Facial Vitiligo Area Scoring Index (F-VASI) at week 24 for patients receiving 11 mg and 22 mg doses of upadacitinib, compared to a placebo.
Furthermore, at week 52, the percent reduction from baseline in F-VASI showed even more promising results for all the upadacitinib dosages, surpassing the outcomes observed at week 24.
These positive results in the clinical program of upadacitinib in vitiligo have led to its advancement to Phase 3 trials.
The primary endpoint of F-VASI at week 24 measures re-pigmentation of the face. Higher response rates were also observed with upadacitinib, particularly with F-VASI 75 (indicating a ≥75% reduction from baseline in F-VASI) at week 24 for both the 11 mg and 22 mg doses, and Total Vitiligo Area Scoring Index (T-VASI) 50 (indicating a ≥50% reduction from baseline in T-VASI) at week 24 for the 22 mg dose.
Notably, the mean percent reduction from baseline F-VASI at week 52 surpassed the results seen at week 24 for all the upadacitinib dose groups. Response rates for F-VASI 75 and T-VASI 50 at week 52 were notably higher than those at week 24 for all upadacitinib dose groups, indicating sustained improvements over time.
The safety profile of upadacitinib remained consistent with its established safety record. No new safety signals emerged during the study. The upadacitinib 22 mg group showed numerically higher rates of severe treatment-emergent adverse events, leading to discontinuation of the study drug compared to other groups.