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

Näytönastekatsaus | Julkaistu: 08.10.2024 Tulosta
Aleksi Raudasoja

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

Näytönastekatsaukset
Aleksi Raudasoja
8.10.2024

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. Bimekizum...»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. Bimeki...»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
  1. 16mg
  2. 160mg
  3. Loading dose 320mg and 160mg afterwards
  4. 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. Bimekizum...»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. Bimekizum...»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. Bimeki...»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. Bimekizum...»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. Bimekizum...»1 431/281 16 weeks 268 (62%) 67 (24%) OR 5.25 (3.8-7.4)
«Ritchlin CT, Kavanaugh A, Merola JF, et al. Bimeki...»2 42/41 12 weeks 30 (73%) 8 (19%) OR 11.0 (3.9-31.0)
«Merola JF, Landewé R, McInnes IB, et al. Bimekizum...»3 267/133 16 weeks 179 (67%) 21 (16%) OR 10.8 (6.4-18.5)
Level of evidence: high

I= intervention; C=comparison; CI=confidence interval

Table 4. ACR50
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. Bimekizum...»1 431/281 16 weeks 189 (44%) 28 (10%) OR 7.1 (4.6-10.9)
«Ritchlin CT, Kavanaugh A, Merola JF, et al. Bimeki...»2 42/41 12 weeks 17 (41%) 3 (7%) OR 8.1 (2.3-28.7)
«Merola JF, Landewé R, McInnes IB, et al. Bimekizum...»3 267/133 16 weeks 116 (43%) 9 (7%) OR 11.1 (5.4-23.0)
Level of evidence: high

I= intervention; C=comparison; CI=confidence interval

Table 5. ACR70
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. Bimekizum...»1 431/281 16 weeks 105 (24%) 12 (4%) 7.2 (3.9-13.4)
«Ritchlin CT, Kavanaugh A, Merola JF, et al. Bimeki...»2 42/41 12 weeks 8 (20%) 2 (5%) 4.1 (0.9-17.9)
«Merola JF, Landewé R, McInnes IB, et al. Bimekizum...»3 267/133 16 weeks 71 (27%) 1 (1%) -
Level of evidence: high

I= intervention; C=comparison; CI=confidence interval

Table 6. Serious adverse events
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. Bimekizum...»1 431/281 16 weeks 7 (2%) 3 (1%) -
«Ritchlin CT, Kavanaugh A, Merola JF, et al. Bimeki...»2 42/43 12 weeks 1 (2%) 1 (2%) -
«Merola JF, Landewé R, McInnes IB, et al. Bimekizum...»3 267/133 16 weeks 5 (2%) 0 -
Level of evidence: low
The quality of evidence is downgraded 2 levels due to very serious imprecision.

I= intervention; C=comparison; CI=confidence interval

Table 7. Treatment emergent adverse events
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. Bimekizum...»1 431/281 16 weeks 258 (60%) 139 (49%) 1.21 (1.05-1.39)
«Ritchlin CT, Kavanaugh A, Merola JF, et al. Bimeki...»2 42/43 12 weeks 19 (44%) 24 (57%) -
«Merola JF, Landewé R, McInnes IB, et al. Bimekizum...»3 267/133 16 weeks 108 (40%) 44 (33%) 1.22 (0.92-1.62)
Level of evidence: moderate
Downgraded due to serious imprecision.

I= intervention; C=comparison; CI=confidence interval

References

  1. 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). Lancet 2023;401(10370):25-37 «PMID: 36493791»PubMed
  2. 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. Lancet 2020;395(10222):427-440 «PMID: 32035552»PubMed
  3. 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, double-blind, placebo-controlled, phase 3 trial (BE COMPLETE). Lancet 2023;401(10370):38-48 «PMID: 36495881»PubMed
Article ID: nak09967 (050.062)
© 2025 The Finnish Medical Society Duodecim

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