Brodalumab, an anti-IL17RA monoclonal antibody, in psoriatic arthritis

Philip J. Mease, Mark C. Genovese, Maria W. Greenwald, Christopher T. Ritchlin, André D. Beaulieu, Atulya (Atul) Deodhar, Richard Newmark, Jing Yuan Feng, Ngozi Erondu, Ajay Nirula

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Abstract

BACKGROUND: We assessed the efficacy and safety of brodalumab, a human monoclonal antibody against interleukin-17 receptor A (IL17RA), in a phase 2, randomized, double-blind, placebo-controlled study involving patients with psoriatic arthritis. METHODS: We randomly assigned patients with active psoriatic arthritis to receive brodalumab (140 or 280 mg subcutaneously) or placebo on day 1 and at weeks 1, 2, 4, 6, 8, and 10. At week 12, patients who had not discontinued their participation in the study were offered open-label brodalumab (280 mg) every 2 weeks. The primary end point was 20% improvement in American College of Rheumatology response criteria (ACR 20) at week 12. RESULTS: Of the 168 patients who underwent randomization (57 in the brodalumab 140-mg group, 56 in the brodalumab 280-mg group, and 55 in the placebo group), 159 completed the double-blind phase and 134 completed 40 weeks of the open-label extension. At week 12, the brodalumab 140-mg and 280-mg groups had higher rates of ACR 20 than the placebo group (37% [P = 0.03] and 39% [P = 0.02], respectively, vs. 18%); they also had higher rates of 50% improvement (ACR 50) (14% [P = 0.05] and 14% [P = 0.05] vs. 4%). Rates of 70% improvement were not significantly higher in the brodalumab groups. Similar degrees of improvement were noted among patients who had received previous biologic therapy and those who had not received such therapy. At week 24, ACR 20 response rates in the brodalumab 140-mg and 280-mg groups were 51% and 64%, respectively, as compared with 44% among patients who switched from placebo to open-label brodalumab; responses were sustained through week 52. At week 12, serious adverse events had occurred in 3% of patients in the brodalumab groups and in 2% of those in the placebo group. CONCLUSIONS: Brodalumab significantly improved response rates among patients with psoriatic arthritis. Larger studies of longer duration are necessary to assess adverse events.

Original languageEnglish (US)
Pages (from-to)2295-2306
Number of pages12
JournalNew England Journal of Medicine
Volume370
Issue number24
DOIs
StatePublished - 2014

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Interleukin-17 Receptors
Psoriatic Arthritis
Monoclonal Antibodies
Placebos
brodalumab
Biological Therapy
Random Allocation

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Mease, P. J., Genovese, M. C., Greenwald, M. W., Ritchlin, C. T., Beaulieu, A. D., Deodhar, A. A., ... Nirula, A. (2014). Brodalumab, an anti-IL17RA monoclonal antibody, in psoriatic arthritis. New England Journal of Medicine, 370(24), 2295-2306. https://doi.org/10.1056/NEJMoa1315231

Brodalumab, an anti-IL17RA monoclonal antibody, in psoriatic arthritis. / Mease, Philip J.; Genovese, Mark C.; Greenwald, Maria W.; Ritchlin, Christopher T.; Beaulieu, André D.; Deodhar, Atulya (Atul); Newmark, Richard; Feng, Jing Yuan; Erondu, Ngozi; Nirula, Ajay.

In: New England Journal of Medicine, Vol. 370, No. 24, 2014, p. 2295-2306.

Research output: Contribution to journalArticle

Mease, PJ, Genovese, MC, Greenwald, MW, Ritchlin, CT, Beaulieu, AD, Deodhar, AA, Newmark, R, Feng, JY, Erondu, N & Nirula, A 2014, 'Brodalumab, an anti-IL17RA monoclonal antibody, in psoriatic arthritis', New England Journal of Medicine, vol. 370, no. 24, pp. 2295-2306. https://doi.org/10.1056/NEJMoa1315231
Mease, Philip J. ; Genovese, Mark C. ; Greenwald, Maria W. ; Ritchlin, Christopher T. ; Beaulieu, André D. ; Deodhar, Atulya (Atul) ; Newmark, Richard ; Feng, Jing Yuan ; Erondu, Ngozi ; Nirula, Ajay. / Brodalumab, an anti-IL17RA monoclonal antibody, in psoriatic arthritis. In: New England Journal of Medicine. 2014 ; Vol. 370, No. 24. pp. 2295-2306.
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abstract = "BACKGROUND: We assessed the efficacy and safety of brodalumab, a human monoclonal antibody against interleukin-17 receptor A (IL17RA), in a phase 2, randomized, double-blind, placebo-controlled study involving patients with psoriatic arthritis. METHODS: We randomly assigned patients with active psoriatic arthritis to receive brodalumab (140 or 280 mg subcutaneously) or placebo on day 1 and at weeks 1, 2, 4, 6, 8, and 10. At week 12, patients who had not discontinued their participation in the study were offered open-label brodalumab (280 mg) every 2 weeks. The primary end point was 20{\%} improvement in American College of Rheumatology response criteria (ACR 20) at week 12. RESULTS: Of the 168 patients who underwent randomization (57 in the brodalumab 140-mg group, 56 in the brodalumab 280-mg group, and 55 in the placebo group), 159 completed the double-blind phase and 134 completed 40 weeks of the open-label extension. At week 12, the brodalumab 140-mg and 280-mg groups had higher rates of ACR 20 than the placebo group (37{\%} [P = 0.03] and 39{\%} [P = 0.02], respectively, vs. 18{\%}); they also had higher rates of 50{\%} improvement (ACR 50) (14{\%} [P = 0.05] and 14{\%} [P = 0.05] vs. 4{\%}). Rates of 70{\%} improvement were not significantly higher in the brodalumab groups. Similar degrees of improvement were noted among patients who had received previous biologic therapy and those who had not received such therapy. At week 24, ACR 20 response rates in the brodalumab 140-mg and 280-mg groups were 51{\%} and 64{\%}, respectively, as compared with 44{\%} among patients who switched from placebo to open-label brodalumab; responses were sustained through week 52. At week 12, serious adverse events had occurred in 3{\%} of patients in the brodalumab groups and in 2{\%} of those in the placebo group. CONCLUSIONS: Brodalumab significantly improved response rates among patients with psoriatic arthritis. Larger studies of longer duration are necessary to assess adverse events.",
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AU - Beaulieu, André D.

AU - Deodhar, Atulya (Atul)

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N2 - BACKGROUND: We assessed the efficacy and safety of brodalumab, a human monoclonal antibody against interleukin-17 receptor A (IL17RA), in a phase 2, randomized, double-blind, placebo-controlled study involving patients with psoriatic arthritis. METHODS: We randomly assigned patients with active psoriatic arthritis to receive brodalumab (140 or 280 mg subcutaneously) or placebo on day 1 and at weeks 1, 2, 4, 6, 8, and 10. At week 12, patients who had not discontinued their participation in the study were offered open-label brodalumab (280 mg) every 2 weeks. The primary end point was 20% improvement in American College of Rheumatology response criteria (ACR 20) at week 12. RESULTS: Of the 168 patients who underwent randomization (57 in the brodalumab 140-mg group, 56 in the brodalumab 280-mg group, and 55 in the placebo group), 159 completed the double-blind phase and 134 completed 40 weeks of the open-label extension. At week 12, the brodalumab 140-mg and 280-mg groups had higher rates of ACR 20 than the placebo group (37% [P = 0.03] and 39% [P = 0.02], respectively, vs. 18%); they also had higher rates of 50% improvement (ACR 50) (14% [P = 0.05] and 14% [P = 0.05] vs. 4%). Rates of 70% improvement were not significantly higher in the brodalumab groups. Similar degrees of improvement were noted among patients who had received previous biologic therapy and those who had not received such therapy. At week 24, ACR 20 response rates in the brodalumab 140-mg and 280-mg groups were 51% and 64%, respectively, as compared with 44% among patients who switched from placebo to open-label brodalumab; responses were sustained through week 52. At week 12, serious adverse events had occurred in 3% of patients in the brodalumab groups and in 2% of those in the placebo group. CONCLUSIONS: Brodalumab significantly improved response rates among patients with psoriatic arthritis. Larger studies of longer duration are necessary to assess adverse events.

AB - BACKGROUND: We assessed the efficacy and safety of brodalumab, a human monoclonal antibody against interleukin-17 receptor A (IL17RA), in a phase 2, randomized, double-blind, placebo-controlled study involving patients with psoriatic arthritis. METHODS: We randomly assigned patients with active psoriatic arthritis to receive brodalumab (140 or 280 mg subcutaneously) or placebo on day 1 and at weeks 1, 2, 4, 6, 8, and 10. At week 12, patients who had not discontinued their participation in the study were offered open-label brodalumab (280 mg) every 2 weeks. The primary end point was 20% improvement in American College of Rheumatology response criteria (ACR 20) at week 12. RESULTS: Of the 168 patients who underwent randomization (57 in the brodalumab 140-mg group, 56 in the brodalumab 280-mg group, and 55 in the placebo group), 159 completed the double-blind phase and 134 completed 40 weeks of the open-label extension. At week 12, the brodalumab 140-mg and 280-mg groups had higher rates of ACR 20 than the placebo group (37% [P = 0.03] and 39% [P = 0.02], respectively, vs. 18%); they also had higher rates of 50% improvement (ACR 50) (14% [P = 0.05] and 14% [P = 0.05] vs. 4%). Rates of 70% improvement were not significantly higher in the brodalumab groups. Similar degrees of improvement were noted among patients who had received previous biologic therapy and those who had not received such therapy. At week 24, ACR 20 response rates in the brodalumab 140-mg and 280-mg groups were 51% and 64%, respectively, as compared with 44% among patients who switched from placebo to open-label brodalumab; responses were sustained through week 52. At week 12, serious adverse events had occurred in 3% of patients in the brodalumab groups and in 2% of those in the placebo group. CONCLUSIONS: Brodalumab significantly improved response rates among patients with psoriatic arthritis. Larger studies of longer duration are necessary to assess adverse events.

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