BIMZELX® ▼ (bimekizumab): The opportunity for complete, fast and lasting skin clearance2,3

The following data is for patients with Plaque Psoriasis 

 

- 68.2% (n=238/349) achieved PASI 100 at week 16¥3 (placebo n=1/86)

- 75.9% (n=265/349) of patients achieved PASI 75 at week 4¥3 (placebo n=1/86)

- 82% (n=147) of week 16 PASI 100 responders maintained this response up to 3 years2

 

BIMZELX®▼ (bimekizumab) was well tolerated, the most frequently reported adverse reactions were: upper respiratory tract infections (14.5%, 14.6%, in plaque psoriasis (PSO), and psoriatic arthritis (PsA) respecively) and oral candidiasis (7.3%, 2.3% in PSO and PsA respectively).1 Other common reported adverse reactions include Tinea infections, Ear infections, Herpes simplex infections, Oropharyngeal candidiasis, Gastroenteritis, Folliculitis, Headache, Rash, Dermatitis, Eczema, Acne, Injection site reactions, and Fatigue.

 

Refer to the SmPC for the full list of adverse events.

 

¥co-primary endpoints PASI 90 and IGA 0/1 at Week 16 were met.

*secondary endpoints

 

 

Click here to see the Clinical Trials Study Design

 

THESE ARE FOUR SEPARATE STUDIES AND SHOULD NOT BE DIRECTLY COMPARED

 

Co-primary endpoints for BE READY, BE VIVID, and BE SURE powered to show the statistical superiority of BIMZELX were the proportion of patients achieving PASI 90, and an IGA response of 0 or 1.3,5,6 BIMZELX was non-inferior and superior to secukinumab with respect to complete clearance of psoriatic lesions through 48 weeks of treatment.7

 

† Primary endpoint PASI 90

‡ Complete skin clearance defined as PASI 100.3,5–7

 

The opportunity to achieve complete clearance in specific sites1,11-13

BIMZELX: reduction of itch symptoms versus ustekinumab, adalimumab, and secukinumab.13

 

Significance value not reported.

Adapted from the BIMZELX Summary of Product Characteristics. 2023.

BIMZELX enabled more patients to achieve reduction of itch by Week 16 vs placebo, ustekinumab, and adalimumab.1,5

 

Significance value not reported3

Adapted from Gottlieb AB et al. 2022.

BIMZELX enabled more patients to have complete resolution of itch over the course of a year vs secukinumab.3

Data presented is a pooled analysis of Q4W/Q8W dosing. Q4W dosing after WEEK 16 does not reflect the licensed dosing regimen for patients <120kg. Please consult the SmPC for full details.1

BIMZELX: reduction of pain symptoms versus ustekinumab, adalimumab, and secukinumab.13

* p<0.0001

THESE ARE FOUR SEPARATE STUDIES AND SHOULD NOT BE DIRECTLY COMPARED

 

Significance value not reported.

Adapted from the BIMZELX Summary of Product Characteristics. 2022.

Complete resolution indicated by a Psoriasis Symptoms and Impacts Measure (P-SIM) score of 0.13

BIMZELX enabled more patients to achieve a reduction in pain by Week 16 vs placebo, ustekinumab, and adalimumab1

Significance value not reported

Adapted from Gottlieb AB et al. 2022. 

Complete resolution indicated by a Psoriasis Symptoms and Impacts Measure (P-SIM) score of 0.13 BIMZELX enabled more patients to have complete resolution of pain vs secukinumab over the course of a year.

Data presented is a pooled analysis of Q4W/Q8W dosing. Q4W dosing after WEEK 16 does not reflect the licensed dosing regimen for patients <120kg. Please consult the SmPC for full details.1

BIMZELX enabled more patients to have complete resolution of pain vs secukinumab over the course of a year.13

BIMZELX: reduced effect of psoriasis symptoms on patient-reported Quality of Life compared to ustekinumab, adalimumab, secukinumab, and placebo.1,12

THESE ARE FOUR SEPARATE STUDIES AND SHOULD NOT BE DIRECTLY COMPARED

 

Adapted from the BIMZELX Summary of Product Characteristics. 2022.

No impact of psoriasis on QoL defined as a Dermatology Life Quality Index (DLQI) absolute score of 0 or 1.1

 

 

Significance value not reported.

Adapted from Augustin, M., et al. Poster 31669. 2022.

Complete skin clearance defined by BSA=0%. No impact of psoriasis on quality of life defined by DLQI=0/1.11 Week 16 data are for the intention-to-treat (ITT) population. Week 48 data are for the maintenance set (patients who received ≥1 dose of study treatment at Week 16 or later).12 Q4W dosing after Week 16 does not reflect the licensed dosing regimen for patients <120 kg. Please consult the SmPC for full details.1

With BIMZELX, more patients reported no impact of psoriasis on their quality of life vs placebo, ustekinumab, adalimumab, and secukinumab at Week 16. ¶1,12

 

¶ Pain reduction defined as a decrease of ≥4 from baseline to Week 16 on the Psoriasis Symptoms and Impacts Measure (P-SIM) scale.1

 

 

 

 

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IE-BK-2300047
Date of preparation: October 2023

Abbreviations:

ACI, acitretin; ADA, adalimumab; APRE, apremilast; BIME, bimekizumab; BRODA, brodalumab; BSA, body-surface area; CERTO, certolizumab pegol; CI, confidence interval; CICLO, ciclosporin; DEUCRAVA, deucravacitinib; DLQI, Dermatology Life Quality Index; ETA, etanercept; FUM, fumaric acid; GUSEL, guselkumab; IFX, infliximab; IGA, investigator global assessment; ITT, intention to treat; IXE, ixekizumab; mNAPSI, modified nail psoriasis severity index; MTX, methotrexate; NETA, netakimab; RSI, non-responder imputation; OLE, open-label extension; PASI, Psoriasis Area and Severity Index; Pbo, placebo; P-SIM, psoriasis symptoms and impacts measures; Q12W, once every 12 weeks; Q1W, every week; Q2W, every 2 weeks; Q4W, every 4 weeks; Q8W, every 8 weeks; QoL, quality of life; RISAN, risankizumab; SAE, serious adverse event; SECU, secukinumab; SmPC, Summary of Product Characteristics; SONELO, sonelokimab; SUCRA, surface under the cumulative ranking curve; TILDRA, tildrakizumab; USK, ustekinumab.

References

  1. BIMZELX (bimekizumab) Summary of product characteristics.
  2. Strober, B., et al. Br J Dermatol. 2023; 188(6): 749-759.
  3. Gordon, K.B., et al. Lancet. 2021; 397(10273): 475-486.
  4. Strober, B., et al. Presentation 34321. Presented at AAD 2022. Boston, USA.
  5. Reich, K., et al. Lancet. 2021; 397(10273): 487-498.
  6. Warren, R.B., et al. N Engl J Med. 2021; 385(2): 130-141
  7. Reich, K., et al. N Eng J Med. 2021; 385(2): 142-251.
  8. NICE TA723. Bimekizumab for treating moderate to severe plaque psoriasis. Available online from: https://www.nice.org.uk/guidance/ta723/. Accessed November 2023.
  9. Sbidian, E., et al. Cochrane Database Syst Rev. 2023;7:CD011535.
  10. Armstrong, A., et al. Dermatol Ther (Heidelb). 2022; 12(8): 177-1792.
  11. Merola, J.F., et al. Poster 1467. EADV Meeting 2022. Milan, Italy.
  12. Augustin, M., et al. Poster 31069. Presented at AAD 2022. Boston, USA.
  13. Gottlieb, A.B., et al. Presentation 34356. Presented at AAD 2022. Boston, USA.