Phase 3 studies comparing brodalumab with ustekinumab in psoriasis

M. Lebwohl, B. Strober, A. Menter, K. Gordon, J. Weglowska, L. Puig, K. Papp, L. Spelman, D. Toth, F. Kerdel, A. W. Armstrong, G. Stingl, A. B. Kimball, H. Bachelez, J. J. Wu, J. Crowley, R. G. Langley, T. Blicharski, C. Paul, J. P. LacourS. Tyring, L. Kircik, S. Chimenti, K. C. Duffin, J. Bagel, J. Koo, G. Aras, J. Li, W. Song, C. E. Milmont, Y. Shi, N. Erondu, P. Klekotka, B. Kotzin, A. Nirula

Research output: Contribution to journalArticle

311 Citations (Scopus)

Abstract

BACKGROUND Early clinical studies suggested that the anti-interleukin-17 receptor A monoclonal antibody brodalumab has efficacy in the treatment of psoriasis. METHODS In two phase 3 studies (AMAGINE-2 and AMAGINE-3), patients with moderate-tosevere psoriasis were randomly assigned to receive brodalumab (210 mg or 140 mg every 2 weeks), ustekinumab (45 mg for patients with a body weight ≤100 kg and 90 mg for patients >100 kg), or placebo. At week 12, patients receiving brodalumab were randomly assigned again to receive a brodalumab maintenance dose of 210 mg every 2 weeks or 140 mg every 2 weeks, every 4 weeks, or every 8 weeks; patients receiving ustekinumab continued to receive ustekinumab every 12 weeks, and patients receiving placebo received 210 mg of brodalumab every 2 weeks. The primary aims were to evaluate the superiority of brodalumab over placebo at week 12 with respect to at least a 75% reduction in the psoriasis area-and-severity index score (PASI 75) and a static physician's global assessment (sPGA) score of 0 or 1 (clear or almost clear skin), as well as the superiority of brodalumab over ustekinumab at week 12 with respect to a 100% reduction in PASI score (PASI 100). RESULTS At week 12, the PASI 75 response rates were higher with brodalumab at the 210-mg and 140-mg doses than with placebo (86% and 67%, respectively, vs. 8% [AMAGINE-2] and 85% and 69%, respectively, vs. 6% [AMAGINE-3]; P

Original languageEnglish (US)
Pages (from-to)1318-1328
Number of pages11
JournalNew England Journal of Medicine
Volume373
Issue number14
DOIs
StatePublished - Oct 1 2015
Externally publishedYes

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Psoriasis
Placebos
Interleukin-17 Receptors
Ustekinumab
brodalumab
Monoclonal Antibodies
Body Weight
Physicians
Skin

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Lebwohl, M., Strober, B., Menter, A., Gordon, K., Weglowska, J., Puig, L., ... Nirula, A. (2015). Phase 3 studies comparing brodalumab with ustekinumab in psoriasis. New England Journal of Medicine, 373(14), 1318-1328. https://doi.org/10.1056/NEJMoa1503824

Phase 3 studies comparing brodalumab with ustekinumab in psoriasis. / Lebwohl, M.; Strober, B.; Menter, A.; Gordon, K.; Weglowska, J.; Puig, L.; Papp, K.; Spelman, L.; Toth, D.; Kerdel, F.; Armstrong, A. W.; Stingl, G.; Kimball, A. B.; Bachelez, H.; Wu, J. J.; Crowley, J.; Langley, R. G.; Blicharski, T.; Paul, C.; Lacour, J. P.; Tyring, S.; Kircik, L.; Chimenti, S.; Duffin, K. C.; Bagel, J.; Koo, J.; Aras, G.; Li, J.; Song, W.; Milmont, C. E.; Shi, Y.; Erondu, N.; Klekotka, P.; Kotzin, B.; Nirula, A.

In: New England Journal of Medicine, Vol. 373, No. 14, 01.10.2015, p. 1318-1328.

Research output: Contribution to journalArticle

Lebwohl, M, Strober, B, Menter, A, Gordon, K, Weglowska, J, Puig, L, Papp, K, Spelman, L, Toth, D, Kerdel, F, Armstrong, AW, Stingl, G, Kimball, AB, Bachelez, H, Wu, JJ, Crowley, J, Langley, RG, Blicharski, T, Paul, C, Lacour, JP, Tyring, S, Kircik, L, Chimenti, S, Duffin, KC, Bagel, J, Koo, J, Aras, G, Li, J, Song, W, Milmont, CE, Shi, Y, Erondu, N, Klekotka, P, Kotzin, B & Nirula, A 2015, 'Phase 3 studies comparing brodalumab with ustekinumab in psoriasis', New England Journal of Medicine, vol. 373, no. 14, pp. 1318-1328. https://doi.org/10.1056/NEJMoa1503824
Lebwohl M, Strober B, Menter A, Gordon K, Weglowska J, Puig L et al. Phase 3 studies comparing brodalumab with ustekinumab in psoriasis. New England Journal of Medicine. 2015 Oct 1;373(14):1318-1328. https://doi.org/10.1056/NEJMoa1503824
Lebwohl, M. ; Strober, B. ; Menter, A. ; Gordon, K. ; Weglowska, J. ; Puig, L. ; Papp, K. ; Spelman, L. ; Toth, D. ; Kerdel, F. ; Armstrong, A. W. ; Stingl, G. ; Kimball, A. B. ; Bachelez, H. ; Wu, J. J. ; Crowley, J. ; Langley, R. G. ; Blicharski, T. ; Paul, C. ; Lacour, J. P. ; Tyring, S. ; Kircik, L. ; Chimenti, S. ; Duffin, K. C. ; Bagel, J. ; Koo, J. ; Aras, G. ; Li, J. ; Song, W. ; Milmont, C. E. ; Shi, Y. ; Erondu, N. ; Klekotka, P. ; Kotzin, B. ; Nirula, A. / Phase 3 studies comparing brodalumab with ustekinumab in psoriasis. In: New England Journal of Medicine. 2015 ; Vol. 373, No. 14. pp. 1318-1328.
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abstract = "BACKGROUND Early clinical studies suggested that the anti-interleukin-17 receptor A monoclonal antibody brodalumab has efficacy in the treatment of psoriasis. METHODS In two phase 3 studies (AMAGINE-2 and AMAGINE-3), patients with moderate-tosevere psoriasis were randomly assigned to receive brodalumab (210 mg or 140 mg every 2 weeks), ustekinumab (45 mg for patients with a body weight ≤100 kg and 90 mg for patients >100 kg), or placebo. At week 12, patients receiving brodalumab were randomly assigned again to receive a brodalumab maintenance dose of 210 mg every 2 weeks or 140 mg every 2 weeks, every 4 weeks, or every 8 weeks; patients receiving ustekinumab continued to receive ustekinumab every 12 weeks, and patients receiving placebo received 210 mg of brodalumab every 2 weeks. The primary aims were to evaluate the superiority of brodalumab over placebo at week 12 with respect to at least a 75{\%} reduction in the psoriasis area-and-severity index score (PASI 75) and a static physician's global assessment (sPGA) score of 0 or 1 (clear or almost clear skin), as well as the superiority of brodalumab over ustekinumab at week 12 with respect to a 100{\%} reduction in PASI score (PASI 100). RESULTS At week 12, the PASI 75 response rates were higher with brodalumab at the 210-mg and 140-mg doses than with placebo (86{\%} and 67{\%}, respectively, vs. 8{\%} [AMAGINE-2] and 85{\%} and 69{\%}, respectively, vs. 6{\%} [AMAGINE-3]; P",
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T1 - Phase 3 studies comparing brodalumab with ustekinumab in psoriasis

AU - Lebwohl, M.

AU - Strober, B.

AU - Menter, A.

AU - Gordon, K.

AU - Weglowska, J.

AU - Puig, L.

AU - Papp, K.

AU - Spelman, L.

AU - Toth, D.

AU - Kerdel, F.

AU - Armstrong, A. W.

AU - Stingl, G.

AU - Kimball, A. B.

AU - Bachelez, H.

AU - Wu, J. J.

AU - Crowley, J.

AU - Langley, R. G.

AU - Blicharski, T.

AU - Paul, C.

AU - Lacour, J. P.

AU - Tyring, S.

AU - Kircik, L.

AU - Chimenti, S.

AU - Duffin, K. C.

AU - Bagel, J.

AU - Koo, J.

AU - Aras, G.

AU - Li, J.

AU - Song, W.

AU - Milmont, C. E.

AU - Shi, Y.

AU - Erondu, N.

AU - Klekotka, P.

AU - Kotzin, B.

AU - Nirula, A.

PY - 2015/10/1

Y1 - 2015/10/1

N2 - BACKGROUND Early clinical studies suggested that the anti-interleukin-17 receptor A monoclonal antibody brodalumab has efficacy in the treatment of psoriasis. METHODS In two phase 3 studies (AMAGINE-2 and AMAGINE-3), patients with moderate-tosevere psoriasis were randomly assigned to receive brodalumab (210 mg or 140 mg every 2 weeks), ustekinumab (45 mg for patients with a body weight ≤100 kg and 90 mg for patients >100 kg), or placebo. At week 12, patients receiving brodalumab were randomly assigned again to receive a brodalumab maintenance dose of 210 mg every 2 weeks or 140 mg every 2 weeks, every 4 weeks, or every 8 weeks; patients receiving ustekinumab continued to receive ustekinumab every 12 weeks, and patients receiving placebo received 210 mg of brodalumab every 2 weeks. The primary aims were to evaluate the superiority of brodalumab over placebo at week 12 with respect to at least a 75% reduction in the psoriasis area-and-severity index score (PASI 75) and a static physician's global assessment (sPGA) score of 0 or 1 (clear or almost clear skin), as well as the superiority of brodalumab over ustekinumab at week 12 with respect to a 100% reduction in PASI score (PASI 100). RESULTS At week 12, the PASI 75 response rates were higher with brodalumab at the 210-mg and 140-mg doses than with placebo (86% and 67%, respectively, vs. 8% [AMAGINE-2] and 85% and 69%, respectively, vs. 6% [AMAGINE-3]; P

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