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UCB Presents Number Needed to Treat Analysis for Bimekizumab in Moderate to Severe Plaque Psoriasis at AMCP Nexus

Update: Bimzelx (bimekizumab-bkzx) Now FDA Approved - October 17, 2023

October 22, 2021 -- UCB today announced new data from a network meta-analysis (NMA) demonstrating that bimekizumab was associated with the lowest number needed to treat (NNT) to achieve Psoriasis Area and Severity Index (PASI) 90 and PASI 100 skin clearance levels compared with 12 other approved biologic therapies used for moderate to severe plaque psoriasis within 16 weeks. These results were presented at the Academy of Managed Care Pharmacy (AMCP) Nexus 2021, October 18-21.

The efficacy and safety of bimekizumab have not been established. Bimekizumab is an investigational product and not approved by the U.S. Food and Drug Administration (FDA). It is currently under review by the U.S. FDA for the treatment of moderate to severe plaque psoriasis in adults.

About the Studies†
While the number of therapies available for the treatment of plaque psoriasis has increased over the last 5 to 10 years, data from head-to-head comparisons are limited.1 To address this limitation, UCB conducted an NMA. While it does not replace head-to-head clinical trials, it can facilitate the comparison of multiple treatments by simultaneously analyzing the direct evidence of treatment comparisons and also indirect comparisons of treatments through a common comparator.2 Results from the NMA were presented at the International Society of Pharmacoeconomic Research (ISPOR), May 17-20, 2021.3

NNT was also calculated as part of the NMA analysis, which is an analytical approach often used in immunology to provide information on the relative benefit of therapies. It refers to the number of individuals that need to be treated with a given therapy in order to achieve the desired outcome in an additional individual. An ideal NNT is 1, indicating that only one patient needs to be treated to receive an additional benefit. As NNT increases, the less effective the intervention will be. Indirect comparisons produced from NMAs and NNTs do not imply superiority, nor do they replace randomized clinical trials. These data do not assess safety and therefore, conclusions regarding safety of any therapeutic agent cannot be made.

The objective of the analysis was to assess the NNT to achieve completely clear skin (PASI 100) or almost clear skin (PASI 90) in the short term (10-16 weeks) for bimekizumab and other approved biologics for the treatment of moderate to severe plaque psoriasis.4,5 The NNT values of biologic treatments compared to placebo to achieve one additional PASI 90 or PASI 100 response were calculated as the reciprocal of the corresponding absolute risk differences obtained from the NMA.4,5

Bimekizumab was Associated with the Lowest NNT to Achieve Completely Clear Skin or Almost Clear Skin within 16 Weeks
Using placebo as the reference group, the calculated NNT values were as follows:

NNT Values4,5†

PASI 90*

PASI 100

bimekizumab 320 mg

1.22

1.74

risankizumab 150 mg

1.40

2.26

brodalumab 210 mg

1.42

2.30

ixekizumab 80 mg

1.45

2.65

guselkumab 100 mg

1.52

3.08

secukinumab 300 mg

1.62

3.11

adalimumab 40 mg

2.29

5.78

ustekinumab 45-90 mg

2.30

5.72

tildrakizumab 100 mg

2.80

7.61

etanercept 50 mg

4.61

16.77

“We are pleased to share the results of UCB’s analysis highlighting the utility of bimekizumab for decision makers seeking optimal outcomes for their psoriasis patients,” said Eddie Lee, Head of HEOR Strategy U.S., UCB. “UCB is committed to generating relevant and impactful data to supplement our clinical trials, which may help formulary decision makers evaluate treatment options for psoriasis.”

These results were also presented at the 2021 Fall Clinical Dermatology Conference, October 21-24.

About Psoriasis
Psoriasis is a common, chronic inflammatory disease with primary involvement of the skin.6 This skin condition affects men and women of all ages and ethnicities.1 Psoriasis signs and symptoms can vary but may include red patches of skin covered with silvery scales; dry, cracked skin that may bleed; and thickened, pitted or ridged nails.7 Psoriasis also has a considerable psychological and quality-of-life impact, potentially affecting work, recreation, relationships, sexual functioning, family and social life.8

Unmet needs remain in the treatment of psoriasis. A population-based survey identified that approximately one in three psoriasis patients reported that their primary goals of therapy, including keeping symptoms under control, reducing itching and decreasing flaking, were not met with their current treatment.5,6,9

About bimekizumab
Bimekizumab is an investigational humanized IgG1 monoclonal antibody that is designed to selectively and directly inhibit both IL-17A and IL-17F, two key cytokines driving inflammatory processes.10,11,12 Selective inhibition of IL-17F in addition to IL-17A has been shown to suppress inflammation to a greater extent than IL-17A inhibition alone.9,10,11

The efficacy and safety of bimekizumab have not been established. Bimekizumab is an investigational product and not approved by the U.S. Food and Drug Administration (FDA). It is currently under review by the U.S. FDA for the treatment of moderate to severe plaque psoriasis in adults.

†Please see the individual package inserts for each product for specific safety information. These data are not reflective of head-to-head comparisons. The NMA included phase 2 and phase 3 clinical trials for each product that met the inclusion criteria. The NMA analyses were conducted to include PASI data in the short-term at 10-16 weeks, as these timepoints encompass the range of stated primary endpoint timepoints across the included studies.

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  1. Wright E, Yasmeen N, Malottki K, et al. Assessing the Quality and Coherence of Network Meta-Analyses of Biologics in Plaque Psoriasis: What Does All This Evidence Synthesis Tell Us? Dermatol Ther (Heidelb). 2021;11(1):181-220
  2. Laupacis A, Sackett DL, Roberts RS. An assessment of clinically useful measures of the consequences of treatment. N Engl J Med. 1988;318(26):1728-1733.
  3. Armstrong A, Reich K, Warren RB, et. Al. Comparative Efficacy of Bimekizumab for the Treatment of Moderate to Severe Plaque Psoriasis- A Network Meta-Analysis. 2021-05, ISPOR 2021, Montreal, Canada Value in Health, Volume 24, Issue 5, S1 May 2021.
  4. Leonardi C, Fahrbah K, Neupane B, et al. Number Needed to Treat among Therapies for Patients with Moderate-to-Severe Plaque Psoriasis: Results from a Network Meta-Analysis. Poster presented at: AMCP Nexus 2021; October 18–21, 2021; Denver, Colorado, USA.
  5. Leonardi C, Fahrbah K, Neupane B, et al. Number Needed to Treat among Therapies for Patients with Moderate-to-Severe Plaque Psoriasis: Results from a Network Meta-Analysis. Poster presented at: Fall Clinical Dermatology Conference (FC21); October 21 – 24, 2021; Las Vegas, Nevada, USA.
  6. National Psoriasis Foundation. About Psoriasis webpage. Available at: https://www.psoriasis.org/about-psoriasis/ Last accessed September 2021.
  7. Mayo Clinic. Psoriasis: Symptoms & Causes. Available at: https://www.mayoclinic.org/diseases-conditions/psoriasis/symptoms-causes/syc-20355840. Last accessed September 2021.
  8. Moon HS, Mizara A, McBride SR. Psoriasis and psycho-dermatology. Dermatol Ther (Heidelb). 2013;3(2):117-130.
  9. Lebwohl MG, Kavanaugh A, Armstrong AW, et al. US Perspectives in the Management of Psoriasis and Psoriatic Arthritis: Patient and Physician Results from the Population-Based Multinational Assessment of Psoriasis and Psoriatic Arthritis (MAPP) Survey. Am J Clin Dermatol. 2016;17(1):87-97.
  10. Warren RB, Blauvelt A, Bagel J, et al. Bimekizumab versus adalimumab in plaque psoriasis. N Engl J Med. 2021;385(2):130-141.
  11. Reich K, Papp KA, Blauvelt A, et al. Bimekizumab versus ustekinumab for the treatment of moderate to severe plaque psoriasis (BE VIVID): efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo-controlled phase 3 trial. Lancet. 2021;397(10273):487-498.
  12. Gordon KB, Foley P, Krueger JG, et al. Bimekizumab efficacy and safety in moderate to severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomised withdrawal phase 3 trial. Lancet. 2021;397(10273):475-486.

Source: UCB

Posted: October 2021

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