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Bimekizumab versus Secukinumab in Plaque Psoriasis.
N Engl J Med. 2021 Jul 08; 385(2):142-152.NEJM

Abstract

BACKGROUND

Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits both interleukin-17A and interleukin-17F. The efficacy and safety of bimekizumab as compared with secukinumab, which selectively inhibits interleukin-17A alone, in patients with moderate-to-severe plaque psoriasis have not been extensively examined.

METHODS

In this phase 3b trial, we randomly assigned patients with moderate-to-severe plaque psoriasis, in a 1:1 ratio, to receive bimekizumab subcutaneously at a dose of 320 mg every 4 weeks or secukinumab subcutaneously at a dose of 300 mg weekly to week 4, followed by every 4 weeks to week 48. At week 16, patients receiving bimekizumab underwent rerandomization, in a 1:2 ratio, to receive maintenance dosing every 4 weeks or every 8 weeks to week 48. The primary end point was 100% reduction from baseline in the Psoriasis Area and Severity Index (PASI) score at week 16. The primary analysis was first tested for the noninferiority of bimekizumab to secukinumab at a margin of -10 percentage points and then tested for superiority.

RESULTS

A total of 1005 patients were screened and 743 were enrolled; 373 patients were assigned to receive bimekizumab and 370 to receive secukinumab. At week 16, a total of 230 patients (61.7%) in the bimekizumab group and 181 (48.9%) in the secukinumab group had a 100% reduction from baseline in the PASI score (PASI 100) (adjusted risk difference, 12.7 percentage points; 95% confidence interval [CI], 5.8 to 19.6); bimekizumab was shown to be noninferior and superior to secukinumab (P<0.001 for noninferiority and superiority). At week 48, a total of 250 patients (67.0%) treated with bimekizumab had a PASI 100 response, as compared with 171 patients (46.2%) treated with secukinumab (adjusted risk difference, 20.9 percentage points; 95% CI, 14.1 to 27.7; P<0.001). At the week 4 time point, 265 patients (71.0%) in the bimekizumab group had 75% or greater reduction from baseline in the PASI score, as compared with 175 patients (47.3%) in the secukinumab group (adjusted risk difference, 23.7; 95% CI, 17.0 to 30.4; P<0.001). Oral candidiasis occurred more often with bimekizumab (72 patients, 19.3%) than with secukinumab (11 patients, 3.0%).

CONCLUSIONS

In patients with moderate-to-severe psoriasis, treatment with bimekizumab resulted in greater skin clearance than treatment with secukinumab over 16 and 48 weeks but was associated with oral candidiasis (predominantly mild or moderate as recorded by the investigator). Longer and larger trials are required to determine the comparative effect and risks of interleukin-17 inhibitors in psoriasis. (Funded by UCB Pharma; BE RADIANT ClinicalTrials.gov number, NCT03536884.).

Authors+Show Affiliations

From the Center for Translational Research in Inflammatory Skin Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany (K.R.); the Dermatology Centre, Salford Royal NHS Foundation Trust, Manchester NIHR Biomedical Research Centre, University of Manchester, Manchester, United Kingdom (R.B.W.); the Icahn School of Medicine at Mount Sinai, New York (M.L.); the SKiN Centre for Dermatology, Probity Medical Research, Peterborough, and Queen's University, Kingston, ON (M.G.), and Dalhousie University, Halifax, NS (R.G.L.) - all in Canada; Yale University, New Haven, and Central Connecticut Dermatology Research, Cromwell - both in Connecticut (B.S.); Paul Sabatier University, Toulouse, France (C.P.); UCB Pharma, Brussels (D.D.C., V.V.); UCB Pharma, Raleigh, NC (C.M., C.C., L.P.); and the Oregon Medical Research Center, Portland (A.B.).From the Center for Translational Research in Inflammatory Skin Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany (K.R.); the Dermatology Centre, Salford Royal NHS Foundation Trust, Manchester NIHR Biomedical Research Centre, University of Manchester, Manchester, United Kingdom (R.B.W.); the Icahn School of Medicine at Mount Sinai, New York (M.L.); the SKiN Centre for Dermatology, Probity Medical Research, Peterborough, and Queen's University, Kingston, ON (M.G.), and Dalhousie University, Halifax, NS (R.G.L.) - all in Canada; Yale University, New Haven, and Central Connecticut Dermatology Research, Cromwell - both in Connecticut (B.S.); Paul Sabatier University, Toulouse, France (C.P.); UCB Pharma, Brussels (D.D.C., V.V.); UCB Pharma, Raleigh, NC (C.M., C.C., L.P.); and the Oregon Medical Research Center, Portland (A.B.).From the Center for Translational Research in Inflammatory Skin Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany (K.R.); the Dermatology Centre, Salford Royal NHS Foundation Trust, Manchester NIHR Biomedical Research Centre, University of Manchester, Manchester, United Kingdom (R.B.W.); the Icahn School of Medicine at Mount Sinai, New York (M.L.); the SKiN Centre for Dermatology, Probity Medical Research, Peterborough, and Queen's University, Kingston, ON (M.G.), and Dalhousie University, Halifax, NS (R.G.L.) - all in Canada; Yale University, New Haven, and Central Connecticut Dermatology Research, Cromwell - both in Connecticut (B.S.); Paul Sabatier University, Toulouse, France (C.P.); UCB Pharma, Brussels (D.D.C., V.V.); UCB Pharma, Raleigh, NC (C.M., C.C., L.P.); and the Oregon Medical Research Center, Portland (A.B.).From the Center for Translational Research in Inflammatory Skin Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany (K.R.); the Dermatology Centre, Salford Royal NHS Foundation Trust, Manchester NIHR Biomedical Research Centre, University of Manchester, Manchester, United Kingdom (R.B.W.); the Icahn School of Medicine at Mount Sinai, New York (M.L.); the SKiN Centre for Dermatology, Probity Medical Research, Peterborough, and Queen's University, Kingston, ON (M.G.), and Dalhousie University, Halifax, NS (R.G.L.) - all in Canada; Yale University, New Haven, and Central Connecticut Dermatology Research, Cromwell - both in Connecticut (B.S.); Paul Sabatier University, Toulouse, France (C.P.); UCB Pharma, Brussels (D.D.C., V.V.); UCB Pharma, Raleigh, NC (C.M., C.C., L.P.); and the Oregon Medical Research Center, Portland (A.B.).From the Center for Translational Research in Inflammatory Skin Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany (K.R.); the Dermatology Centre, Salford Royal NHS Foundation Trust, Manchester NIHR Biomedical Research Centre, University of Manchester, Manchester, United Kingdom (R.B.W.); the Icahn School of Medicine at Mount Sinai, New York (M.L.); the SKiN Centre for Dermatology, Probity Medical Research, Peterborough, and Queen's University, Kingston, ON (M.G.), and Dalhousie University, Halifax, NS (R.G.L.) - all in Canada; Yale University, New Haven, and Central Connecticut Dermatology Research, Cromwell - both in Connecticut (B.S.); Paul Sabatier University, Toulouse, France (C.P.); UCB Pharma, Brussels (D.D.C., V.V.); UCB Pharma, Raleigh, NC (C.M., C.C., L.P.); and the Oregon Medical Research Center, Portland (A.B.).From the Center for Translational Research in Inflammatory Skin Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany (K.R.); the Dermatology Centre, Salford Royal NHS Foundation Trust, Manchester NIHR Biomedical Research Centre, University of Manchester, Manchester, United Kingdom (R.B.W.); the Icahn School of Medicine at Mount Sinai, New York (M.L.); the SKiN Centre for Dermatology, Probity Medical Research, Peterborough, and Queen's University, Kingston, ON (M.G.), and Dalhousie University, Halifax, NS (R.G.L.) - all in Canada; Yale University, New Haven, and Central Connecticut Dermatology Research, Cromwell - both in Connecticut (B.S.); Paul Sabatier University, Toulouse, France (C.P.); UCB Pharma, Brussels (D.D.C., V.V.); UCB Pharma, Raleigh, NC (C.M., C.C., L.P.); and the Oregon Medical Research Center, Portland (A.B.).From the Center for Translational Research in Inflammatory Skin Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany (K.R.); the Dermatology Centre, Salford Royal NHS Foundation Trust, Manchester NIHR Biomedical Research Centre, University of Manchester, Manchester, United Kingdom (R.B.W.); the Icahn School of Medicine at Mount Sinai, New York (M.L.); the SKiN Centre for Dermatology, Probity Medical Research, Peterborough, and Queen's University, Kingston, ON (M.G.), and Dalhousie University, Halifax, NS (R.G.L.) - all in Canada; Yale University, New Haven, and Central Connecticut Dermatology Research, Cromwell - both in Connecticut (B.S.); Paul Sabatier University, Toulouse, France (C.P.); UCB Pharma, Brussels (D.D.C., V.V.); UCB Pharma, Raleigh, NC (C.M., C.C., L.P.); and the Oregon Medical Research Center, Portland (A.B.).From the Center for Translational Research in Inflammatory Skin Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany (K.R.); the Dermatology Centre, Salford Royal NHS Foundation Trust, Manchester NIHR Biomedical Research Centre, University of Manchester, Manchester, United Kingdom (R.B.W.); the Icahn School of Medicine at Mount Sinai, New York (M.L.); the SKiN Centre for Dermatology, Probity Medical Research, Peterborough, and Queen's University, Kingston, ON (M.G.), and Dalhousie University, Halifax, NS (R.G.L.) - all in Canada; Yale University, New Haven, and Central Connecticut Dermatology Research, Cromwell - both in Connecticut (B.S.); Paul Sabatier University, Toulouse, France (C.P.); UCB Pharma, Brussels (D.D.C., V.V.); UCB Pharma, Raleigh, NC (C.M., C.C., L.P.); and the Oregon Medical Research Center, Portland (A.B.).From the Center for Translational Research in Inflammatory Skin Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany (K.R.); the Dermatology Centre, Salford Royal NHS Foundation Trust, Manchester NIHR Biomedical Research Centre, University of Manchester, Manchester, United Kingdom (R.B.W.); the Icahn School of Medicine at Mount Sinai, New York (M.L.); the SKiN Centre for Dermatology, Probity Medical Research, Peterborough, and Queen's University, Kingston, ON (M.G.), and Dalhousie University, Halifax, NS (R.G.L.) - all in Canada; Yale University, New Haven, and Central Connecticut Dermatology Research, Cromwell - both in Connecticut (B.S.); Paul Sabatier University, Toulouse, France (C.P.); UCB Pharma, Brussels (D.D.C., V.V.); UCB Pharma, Raleigh, NC (C.M., C.C., L.P.); and the Oregon Medical Research Center, Portland (A.B.).From the Center for Translational Research in Inflammatory Skin Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany (K.R.); the Dermatology Centre, Salford Royal NHS Foundation Trust, Manchester NIHR Biomedical Research Centre, University of Manchester, Manchester, United Kingdom (R.B.W.); the Icahn School of Medicine at Mount Sinai, New York (M.L.); the SKiN Centre for Dermatology, Probity Medical Research, Peterborough, and Queen's University, Kingston, ON (M.G.), and Dalhousie University, Halifax, NS (R.G.L.) - all in Canada; Yale University, New Haven, and Central Connecticut Dermatology Research, Cromwell - both in Connecticut (B.S.); Paul Sabatier University, Toulouse, France (C.P.); UCB Pharma, Brussels (D.D.C., V.V.); UCB Pharma, Raleigh, NC (C.M., C.C., L.P.); and the Oregon Medical Research Center, Portland (A.B.).From the Center for Translational Research in Inflammatory Skin Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany (K.R.); the Dermatology Centre, Salford Royal NHS Foundation Trust, Manchester NIHR Biomedical Research Centre, University of Manchester, Manchester, United Kingdom (R.B.W.); the Icahn School of Medicine at Mount Sinai, New York (M.L.); the SKiN Centre for Dermatology, Probity Medical Research, Peterborough, and Queen's University, Kingston, ON (M.G.), and Dalhousie University, Halifax, NS (R.G.L.) - all in Canada; Yale University, New Haven, and Central Connecticut Dermatology Research, Cromwell - both in Connecticut (B.S.); Paul Sabatier University, Toulouse, France (C.P.); UCB Pharma, Brussels (D.D.C., V.V.); UCB Pharma, Raleigh, NC (C.M., C.C., L.P.); and the Oregon Medical Research Center, Portland (A.B.).From the Center for Translational Research in Inflammatory Skin Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany (K.R.); the Dermatology Centre, Salford Royal NHS Foundation Trust, Manchester NIHR Biomedical Research Centre, University of Manchester, Manchester, United Kingdom (R.B.W.); the Icahn School of Medicine at Mount Sinai, New York (M.L.); the SKiN Centre for Dermatology, Probity Medical Research, Peterborough, and Queen's University, Kingston, ON (M.G.), and Dalhousie University, Halifax, NS (R.G.L.) - all in Canada; Yale University, New Haven, and Central Connecticut Dermatology Research, Cromwell - both in Connecticut (B.S.); Paul Sabatier University, Toulouse, France (C.P.); UCB Pharma, Brussels (D.D.C., V.V.); UCB Pharma, Raleigh, NC (C.M., C.C., L.P.); and the Oregon Medical Research Center, Portland (A.B.).From the Center for Translational Research in Inflammatory Skin Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany (K.R.); the Dermatology Centre, Salford Royal NHS Foundation Trust, Manchester NIHR Biomedical Research Centre, University of Manchester, Manchester, United Kingdom (R.B.W.); the Icahn School of Medicine at Mount Sinai, New York (M.L.); the SKiN Centre for Dermatology, Probity Medical Research, Peterborough, and Queen's University, Kingston, ON (M.G.), and Dalhousie University, Halifax, NS (R.G.L.) - all in Canada; Yale University, New Haven, and Central Connecticut Dermatology Research, Cromwell - both in Connecticut (B.S.); Paul Sabatier University, Toulouse, France (C.P.); UCB Pharma, Brussels (D.D.C., V.V.); UCB Pharma, Raleigh, NC (C.M., C.C., L.P.); and the Oregon Medical Research Center, Portland (A.B.).

Pub Type(s)

Clinical Trial, Phase III
Comparative Study
Equivalence Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

33891380

Citation

Reich, Kristian, et al. "Bimekizumab Versus Secukinumab in Plaque Psoriasis." The New England Journal of Medicine, vol. 385, no. 2, 2021, pp. 142-152.
Reich K, Warren RB, Lebwohl M, et al. Bimekizumab versus Secukinumab in Plaque Psoriasis. N Engl J Med. 2021;385(2):142-152.
Reich, K., Warren, R. B., Lebwohl, M., Gooderham, M., Strober, B., Langley, R. G., Paul, C., De Cuyper, D., Vanvoorden, V., Madden, C., Cioffi, C., Peterson, L., & Blauvelt, A. (2021). Bimekizumab versus Secukinumab in Plaque Psoriasis. The New England Journal of Medicine, 385(2), 142-152. https://doi.org/10.1056/NEJMoa2102383
Reich K, et al. Bimekizumab Versus Secukinumab in Plaque Psoriasis. N Engl J Med. 2021 Jul 8;385(2):142-152. PubMed PMID: 33891380.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Bimekizumab versus Secukinumab in Plaque Psoriasis. AU - Reich,Kristian, AU - Warren,Richard B, AU - Lebwohl,Mark, AU - Gooderham,Melinda, AU - Strober,Bruce, AU - Langley,Richard G, AU - Paul,Carle, AU - De Cuyper,Dirk, AU - Vanvoorden,Veerle, AU - Madden,Cynthia, AU - Cioffi,Christopher, AU - Peterson,Luke, AU - Blauvelt,Andrew, Y1 - 2021/04/23/ PY - 2021/4/24/pubmed PY - 2021/7/21/medline PY - 2021/4/23/entrez SP - 142 EP - 152 JF - The New England journal of medicine JO - N Engl J Med VL - 385 IS - 2 N2 - BACKGROUND: Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits both interleukin-17A and interleukin-17F. The efficacy and safety of bimekizumab as compared with secukinumab, which selectively inhibits interleukin-17A alone, in patients with moderate-to-severe plaque psoriasis have not been extensively examined. METHODS: In this phase 3b trial, we randomly assigned patients with moderate-to-severe plaque psoriasis, in a 1:1 ratio, to receive bimekizumab subcutaneously at a dose of 320 mg every 4 weeks or secukinumab subcutaneously at a dose of 300 mg weekly to week 4, followed by every 4 weeks to week 48. At week 16, patients receiving bimekizumab underwent rerandomization, in a 1:2 ratio, to receive maintenance dosing every 4 weeks or every 8 weeks to week 48. The primary end point was 100% reduction from baseline in the Psoriasis Area and Severity Index (PASI) score at week 16. The primary analysis was first tested for the noninferiority of bimekizumab to secukinumab at a margin of -10 percentage points and then tested for superiority. RESULTS: A total of 1005 patients were screened and 743 were enrolled; 373 patients were assigned to receive bimekizumab and 370 to receive secukinumab. At week 16, a total of 230 patients (61.7%) in the bimekizumab group and 181 (48.9%) in the secukinumab group had a 100% reduction from baseline in the PASI score (PASI 100) (adjusted risk difference, 12.7 percentage points; 95% confidence interval [CI], 5.8 to 19.6); bimekizumab was shown to be noninferior and superior to secukinumab (P<0.001 for noninferiority and superiority). At week 48, a total of 250 patients (67.0%) treated with bimekizumab had a PASI 100 response, as compared with 171 patients (46.2%) treated with secukinumab (adjusted risk difference, 20.9 percentage points; 95% CI, 14.1 to 27.7; P<0.001). At the week 4 time point, 265 patients (71.0%) in the bimekizumab group had 75% or greater reduction from baseline in the PASI score, as compared with 175 patients (47.3%) in the secukinumab group (adjusted risk difference, 23.7; 95% CI, 17.0 to 30.4; P<0.001). Oral candidiasis occurred more often with bimekizumab (72 patients, 19.3%) than with secukinumab (11 patients, 3.0%). CONCLUSIONS: In patients with moderate-to-severe psoriasis, treatment with bimekizumab resulted in greater skin clearance than treatment with secukinumab over 16 and 48 weeks but was associated with oral candidiasis (predominantly mild or moderate as recorded by the investigator). Longer and larger trials are required to determine the comparative effect and risks of interleukin-17 inhibitors in psoriasis. (Funded by UCB Pharma; BE RADIANT ClinicalTrials.gov number, NCT03536884.). SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/33891380/Bimekizumab_versus_Secukinumab_in_Plaque_Psoriasis_ DB - PRIME DP - Unbound Medicine ER -