Tags

Type your tag names separated by a space and hit enter

Safety and efficacy of brodalumab for psoriasis after 120 weeks of treatment.
J Am Acad Dermatol. 2014 Dec; 71(6):1183-1190.e3.JA

Abstract

BACKGROUND

Brodalumab (anti-interleukin-17-receptor antibody) was effective in treating moderate to severe psoriasis in a 12-week, dose-ranging, placebo-controlled trial.

OBJECTIVE

We sought to evaluate efficacy and safety of long-term brodalumab treatment.

METHODS

In this interim analysis at week 120 of an open-label extension study, patients received brodalumab 210 mg every 2 weeks. Protocol amendments reduced the dose (140 mg) in patients weighing 100 kg or less and subsequently increased the dose (210 mg) in patients with inadequate responses. Efficacy was measured by static physician global assessment and 75% or greater, 90% or greater, or 100% improvement in Psoriasis Area and Severity Index score (PASI-75, PASI-90, and PASI-100, respectively).

RESULTS

Of 181 patients, 144 completed week 120. Static physician global assessment scores of clear/almost clear and clear were achieved by 90% and 63% of patients, respectively, at week 12 and by 72% and 51% at week 120. The PASI-75, PASI-90, and PASI-100 response rates at week 12 (95%/85%/63%) were sustained through week 120 (86%/70%/51%). Most commonly reported adverse events were nasopharyngitis (26.5%), upper respiratory tract infection (19.9%), arthralgia (16.0%), and back pain (11.0%). Four patients had grade-2 absolute neutrophil count.

LIMITATIONS

There was no control group in this open-label extension.

CONCLUSION

Brodalumab demonstrated sustained clinical response and an acceptable safety profile through 120 weeks in patients with moderate to severe psoriasis.

Links

Publisher Full Text (DOI)

Authors+Show Affiliations

Papp K
Probity Medical Research, Waterloo, Ontario, Canada. Electronic address: kapapp@probitymedical.com.
Leonardi C
Saint Louis University, Saint Louis, Missouri.
Menter A
Baylor University Medical Center, Dallas, Texas.
Thompson EH
Amgen Inc, Thousand Oaks, California.
Milmont CE
Amgen Inc, Thousand Oaks, California.
Kricorian G
Amgen Inc, Thousand Oaks, California.
Nirula A
Amgen Inc, Thousand Oaks, California.
Klekotka P
Amgen Inc, Thousand Oaks, California.

MeSH

AdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedControlled Clinical Trials as TopicDermatologic AgentsDose-Response Relationship, DrugFemaleHumansMaleMiddle AgedPsoriasisReceptors, Interleukin-17Severity of Illness IndexTreatment Outcome

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25313095

Clinical Trial Links

Clinical trial which this article describes
Study to Assess the Long-term Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Psoriasis

Citation

Papp, Kim, et al. "Safety and Efficacy of Brodalumab for Psoriasis After 120 Weeks of Treatment." Journal of the American Academy of Dermatology, vol. 71, no. 6, 2014, pp. 1183-1190.e3.
Papp K, Leonardi C, Menter A, et al. Safety and efficacy of brodalumab for psoriasis after 120 weeks of treatment. J Am Acad Dermatol. 2014;71(6):1183-1190.e3.
Papp, K., Leonardi, C., Menter, A., Thompson, E. H., Milmont, C. E., Kricorian, G., Nirula, A., & Klekotka, P. (2014). Safety and efficacy of brodalumab for psoriasis after 120 weeks of treatment. Journal of the American Academy of Dermatology, 71(6), 1183-e3. https://doi.org/10.1016/j.jaad.2014.08.039
Papp K, et al. Safety and Efficacy of Brodalumab for Psoriasis After 120 Weeks of Treatment. J Am Acad Dermatol. 2014;71(6):1183-1190.e3. PubMed PMID: 25313095.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and efficacy of brodalumab for psoriasis after 120 weeks of treatment. AU - Papp,Kim, AU - Leonardi,Craig, AU - Menter,Alan, AU - Thompson,Elizabeth H Z, AU - Milmont,Cassandra E, AU - Kricorian,Greg, AU - Nirula,Ajay, AU - Klekotka,Paul, Y1 - 2014/10/11/ PY - 2014/07/03/received PY - 2014/08/19/revised PY - 2014/08/21/accepted PY - 2014/10/15/entrez PY - 2014/10/15/pubmed PY - 2015/2/5/medline KW - anti–interleukin-17 therapy KW - brodalumab KW - clinical trial KW - efficacy KW - long-term treatment KW - open-label extension KW - psoriasis KW - safety SP - 1183 EP - 1190.e3 JF - Journal of the American Academy of Dermatology JO - J Am Acad Dermatol VL - 71 IS - 6 N2 - BACKGROUND: Brodalumab (anti-interleukin-17-receptor antibody) was effective in treating moderate to severe psoriasis in a 12-week, dose-ranging, placebo-controlled trial. OBJECTIVE: We sought to evaluate efficacy and safety of long-term brodalumab treatment. METHODS: In this interim analysis at week 120 of an open-label extension study, patients received brodalumab 210 mg every 2 weeks. Protocol amendments reduced the dose (140 mg) in patients weighing 100 kg or less and subsequently increased the dose (210 mg) in patients with inadequate responses. Efficacy was measured by static physician global assessment and 75% or greater, 90% or greater, or 100% improvement in Psoriasis Area and Severity Index score (PASI-75, PASI-90, and PASI-100, respectively). RESULTS: Of 181 patients, 144 completed week 120. Static physician global assessment scores of clear/almost clear and clear were achieved by 90% and 63% of patients, respectively, at week 12 and by 72% and 51% at week 120. The PASI-75, PASI-90, and PASI-100 response rates at week 12 (95%/85%/63%) were sustained through week 120 (86%/70%/51%). Most commonly reported adverse events were nasopharyngitis (26.5%), upper respiratory tract infection (19.9%), arthralgia (16.0%), and back pain (11.0%). Four patients had grade-2 absolute neutrophil count. LIMITATIONS: There was no control group in this open-label extension. CONCLUSION: Brodalumab demonstrated sustained clinical response and an acceptable safety profile through 120 weeks in patients with moderate to severe psoriasis. SN - 1097-6787 UR - https://www.unboundmedicine.com/medline/citation/25313095/Safety_and_efficacy_of_brodalumab_for_psoriasis_after_120_weeks_of_treatment_ DB - PRIME DP - Unbound Medicine ER -