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 language | English (US) |
|---|---|
| Pages (from-to) | 1318-1328 |
| Number of pages | 11 |
| Journal | New England Journal of Medicine |
| Volume | 373 |
| Issue number | 14 |
| DOIs | |
| State | Published - Oct 1 2015 |
| Externally published | Yes |
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ASJC Scopus subject areas
- Medicine(all)
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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 journal › Article
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TY - JOUR
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
AB - 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
UR - http://www.scopus.com/inward/record.url?scp=84942876148&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84942876148&partnerID=8YFLogxK
U2 - 10.1056/NEJMoa1503824
DO - 10.1056/NEJMoa1503824
M3 - Article
C2 - 26422722
AN - SCOPUS:84942876148
VL - 373
SP - 1318
EP - 1328
JO - New England Journal of Medicine
JF - New England Journal of Medicine
SN - 0028-4793
IS - 14
ER -