Näytönastekatsaukset

Bimekizumab in adults with active psoriatic arthritis: effectiveness and safety compared to placebo

Näytönastekatsaukset

8.10.2024

Aleksi Raudasoja

Level of evidence: A

Bimekizumab reduces symptoms of psoriatic arthritis and is safe to use. In the intervention group, 62-67% of participants achieved 20% reduction in symptom score (ACR20), compared to 16-20% in the control group.

There was some inconsistency in the study results, but likely explained by different study populations, therefore we did not rate down for inconsistency.

Bimekizumab increased treatment-emergent adverse events in 12-16 weeks follow-up, RR 1.21 (1.05-1.39) in the largest trial and the results were consistent between the trials. The increase was mainly driven by non-serious (e.g. fungal) infections. For serious adverse events, event rates were too low to form conclusions, pooled event rates were 13/740 in the intervention group and 4/457 in the control group.

Table 1. Description of the included studies
Reference	Study type	Population	Intervention and comparison	Outcomes	Risk of bias
«McInnes IB, Asahina A, Coates LC, et al. Bimekizumab in patients with psoriatic arthritis, naive to biologic treatment: a randomised, double-blind, placebo-controlled, phase 3 trial (BE OPTIMAL). Lanc»1	RCT	Adult patients with active psoriatic arthritis. Patients with current or previous exposure to biological treatments were excluded.	Bimekizumab 160mg every 4 weeks versus placebo	Primary outcome: ACR50 Secondary outcomes: ACR20/70, PASI75/90/100, HAQ-DI, SF-36 PCS, SAEs TEAEs at 16 weeks	Low
«Ritchlin CT, Kavanaugh A, Merola JF, et al. Bimekizumab in patients with active psoriatic arthritis: results from a 48-week, randomised, double-blind, placebo-controlled, dose-ranging phase 2b trial. »2	RCT	Adult patients with active psoriatic arthritis, symptoms lasting at least 6 months. Previous exposure to biological treatments was permitted but current users were excluded.	Bimekizumab 16mg 160mg Loading dose 320mg and 160mg afterwards 320mg every four weeks versus placebo	Primary outcome: ACR50 Secondary outcomes: ACR20/70, PASI75/90/100, HAQ-DI, SAEs TEAEs, MASES at 12 weeks	Low
«Merola JF, Landewé R, McInnes IB, et al. Bimekizumab in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor-α inhibitors: a randomised, d»3	RCT	Adult patients with active psoriatic arthritis and inadequate response or intolerance to previous biological treatment	Bimekizumab 160mg every four weeks versus placebo	Primary outcome: ACR50 Secondary outcomes: ACR20/70, PASI75/90/100, HAQ-DI, SF-36 PCS, SAEs, TEAEs at 16 weeks	Low

RCT=randomized controlled trial; SR=systematic review; MA=meta-analysis; HAQ-DI = Health Assessment Questionnaire-Disability Index; SF-36 PCS = Short Form 36-item Health Survey Physical Component Summary; TEAEs = treatment-emergent adverse events; SAEs = serious adverse events; MASES = the Maastricht Ankylosing Spondylitis Enthesitis Score.

Table 2. Additional comments for included studies
Reference	Comments
«McInnes IB, Asahina A, Coates LC, et al. Bimekizumab in patients with psoriatic arthritis, naive to biologic treatment: a randomised, double-blind, placebo-controlled, phase 3 trial (BE OPTIMAL). Lanc»1	Adequate randomization, blinding of study participants/outcome assessors. About 5% missing data across study arms. Active psoriatic arthritis was defined as arthritis with a tender joint count of three or more, swollen joint count of three or more, and one or more active psoriatic lesions or a documented history of psoriasis.
«Ritchlin CT, Kavanaugh A, Merola JF, et al. Bimekizumab in patients with active psoriatic arthritis: results from a 48-week, randomised, double-blind, placebo-controlled, dose-ranging phase 2b trial. »2	Dose-response study. Adequate randomization, blinding of study participants/outcome assessors. 13/206 dropped out. Only placebo versus 160mg dose used in this evidence summary.
«Merola JF, Landewé R, McInnes IB, et al. Bimekizumab in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor-α inhibitors: a randomised, d»3	Adequate randomization, blinding of study participants/outcome assessors. 12/400 dropped out.

Results

Table 3. ACR20
Reference	Number of studies and number of patients (I/C)	Follow-up time	Absolute number of events (%) I	Absolute number of events (%) C	Relative effect (95% CI)
«McInnes IB, Asahina A, Coates LC, et al. Bimekizumab in patients with psoriatic arthritis, naive to biologic treatment: a randomised, double-blind, placebo-controlled, phase 3 trial (BE OPTIMAL). Lanc»1	431/281	16 weeks	268 (62%)	67 (24%)	OR 5.25 (3.8-7.4)
«Ritchlin CT, Kavanaugh A, Merola JF, et al. Bimekizumab in patients with active psoriatic arthritis: results from a 48-week, randomised, double-blind, placebo-controlled, dose-ranging phase 2b trial. »2	42/41	12 weeks	30 (73%)	8 (19%)	OR 11.0 (3.9-31.0)
«Merola JF, Landewé R, McInnes IB, et al. Bimekizumab in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor-α inhibitors: a randomised, d»3	267/133	16 weeks	179 (67%)	21 (16%)	OR 10.8 (6.4-18.5)
Level of evidence: high