ACR 2022 Blockbuster: Bimekizumab Treats Patients with Active Psoriatic Arthritis with Amazing Results!

Background and purpose: Bimekizumab (BKZ) is an IgG1 monoclonal antibody that selectively inhibits IL-17F and IL-17A
.
In the Phase 3 BE OPTIMAL study of patients with the biologics DMARD (bDMARD)-naïve, BKZ was superior to placebo (PBO) in the treatment of joint and skin diseases, and data on drug efficacy and safety for up to 52 weeks are presented here
.

Methods: BE OPTIMAL (NCT03895203) included 16 weeks double-blind, PBO control and 36 weeks treatment blind
.
Patients with bDMARD-naïve were eligible, adults were included, active PsA met PsA classification criteria for ≥ 6 months, ≥ 3 tender and ≥ 3 swollen joints, ≥ 1 active psoriasis lesion and/or history
of psoriasis.
Patients were randomized to 3:2:1: subcutaneous injection of BKZ 160 mg every 4 weeks; PBO； Reference group (adalimumab [ADA] 40 mg every 2 weeks).

Starting at week 16, patients with PBO received BKZ 160 mg Q4W (PBO/BKZ).

Results: 821/852 (96.
4%) patients completed a 16-week double-blind trial; 761 people (89.
3%) completed the entire 52-week trial
.
There were basically no differences in baseline (BL) characteristics between groups (randomized group): mean age 48.
7 years; BMI 29.
2 kg/m²; Diagnosed 5.
9 years; 46.
8% male; The body surface area (BSA) of psoriasis was ≥3% in 49.
9%
of patients.
Patients who achieved ACR 50 at 52 weeks: 53.
0% PBO/BKZ, 54.
5% BKZ, 50.
0% ADA; Complete skin clearance (psoriasis area and severity index [PASI] 100) in patients with BL psoriasis (BSA≥3%): 65.
0% PBO/BKZ, 60.
8% BKZ, 48.
5% ADA; Patients with minimal disease activity: 53.
7% PBO/BKZ, 55.
0% BKZ, 52.
9% ADA (Figure 1).

The clinical joint and cutaneous therapeutic response of BKZ continued to increase from 16 to 52 weeks; Patients who switched to BKZ at week 16 had improved efficacy outcomes compared with week 52 (table).

Overall radiographic progress by 52 weeks was minimal
.
Patients with no progression in imaging (van der Heijde-modified total Sharp score ≤0.
5 change from baseline) at 52 weeks): 87.
3% PBO/BKZ, 89.
3% BKZ, 94.
1% ADA (imaging group; in the case of observation)
.
The cumulative probability of radiographic progress is shown in Figure 2
.

By 52 weeks, 555/702 (79.
1%) patients had ≥1 treatment-emergency adverse event (TEAE) while receiving BKZ; There are 113/140 (80.
7%)
in ADA.
The three most common TEAEs in BKZ: nasopharyngitis (BKZ: 12.
0% of patients; ADA 8.
6% of patients), upper respiratory tract infection (BKZ: 7.
1%; ADA: 5.
7%) and urinary tract infections (BKZ: 6.
1%; ADA: 3.
6%)
。 Patients discontinued for TEAE: 21 (3.
0%) BKZ; 7 (5.
0%)ADA
。 Candida infection was reported in 7.
7% of patients with BKZ and 0.
7% in ADA
.
All are mild/moderate with no systemic lesions
.
One case of oral Candida infection led to discontinuation
.
By 52 weeks, 3 patients treated with BKZ had malignancy (excluding non-melanoma skin cancer), 4 had major adverse cardiac events, 2 had definite IBD (ulcerative colitis), and 1 death was reported (motorcycle accident).

No cases of uveitis have been reported
.

Figure 1 Responders of ACR50, PASI100 and MDA at week 52 [NRI]

Figure 2 Change in vdHmTSS cumulative probability plot from baseline to week 16 and week 52

Table Efficacy endpoints at weeks 16 and 52

Conclusion:

At week 16, BKZ showed clinically significant improvement in the treatment of patients with bDMARD-naïve with active PsA and continued improvement until week
52.
BKZ was well tolerated and no new medication safety issues
were observed.

Original source:

Christopher Ritchlin, Laura Coates, Iain McInnes, et al.
Bimekizumab Treatment in Biologic DMARD-Naïve Patients with Active Psoriatic Arthritis: 52-Week Efficacy and Safety Results from a Phase 3, Randomized, Placebo-Controlled, Active Reference Study.
ACR Convergence 2022.
October 18, 2022.