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BE OPTIMAL and BE COMPLETE: 52-week post-hoc analysis of patients with BSA ≥3% and ≥10%
During the European Academy of Dermatology and Venereology Congress (EADV) 2023 Congress, Thaçi presented a post-hoc analysis of two phase III trials, BE OPTIMAL (NCT03895203) and BE COMPLETE (NCT03896581), of bimekizumab in patients with psoriatic arthritis (PsA). The analysis focused on the 52-week safety and efficacy of bimekizumab versus placebo in patients with PsA and psoriasis with ≥3% body surface area (BSA) affected at baseline.
The study design and baseline patient characteristics have been previously reported on the Psoriasis and Psoriatic Arthritis Hub.
Results
Safety
The safety outcomes for patients treated with bimekizumab 160 mg every 4 weeks are shown in Table 1. The most frequent treatment-emergent adverse events were nasopharyngitis and coronavirus infection in BE OPTIMAL and BE COMPLETE, respectively.
Table 1. Adverse events*
|
TEAE, treatment-emergent adverse event. |
||
|
TEAE, % |
BE OPTIMAL (N = 356) |
BE COMPLETE (N = 255) |
|---|---|---|
|
Any TEAE |
75.0 |
55.7 |
|
Severe TEAEs |
3.4 |
4.7 |
|
Study discontinuation due to TEAEs |
2.8 |
3.5 |
|
Drug-related TEAEs |
25.3 |
20 |
|
Serious TEAEs |
5.1 |
5.9 |
|
Deaths |
0.3 |
0.4 |
|
Serious infections |
0.6 |
2.0 |
Efficacy
Key efficacy outcomes, including 50% improvement in American College of Rheumatology response criteria, Swollen Joint Count ≤1, and Psoriasis Area and Severity Index ≤1, in patients with a BSA ≥3% and ≥10% are shown in Figure 1.
Figure 1. Patients achieving A ACR50, B SJC ≤1, and C PASI ≤1*
ACR50, 50% improvement in American College of Rheumatology response criteria; BSA, body surface area; PASI, Psoriasis Area and Severity Index; SJC, Swollen Joint Count.
*Data from Thaçi.1
†Patients randomized to placebo switched to bimekizumab at Week 16.
Conclusion
Week-52 results from BE OPTIMAL and BE COMPLETE demonstrated positive efficacy and safety outcomes with bimekizumab for patients with PsA and severe skin symptoms (BSA ≥3% and ≥10%). Similar response rates were seen across patients who were originally randomized to bimekizumab and those who switched from placebo to bimekizumab at Week 16.
References
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