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Efficacy, Safety, and Patient-Reported Outcomes in Patients with Moderate-to-Severe Plaque Psoriasis Treated with Brodalumab for 5 Years in a Long-Term, Open-Label, Phase II Study.
Am J Clin Dermatol. 2019 Dec; 20(6):863-871.AJ

Abstract

BACKGROUND

Chronic inflammatory diseases such as psoriasis require treatment options that maintain efficacy and tolerability during extended treatment.

OBJECTIVE

The aim of the study was to assess the long-term efficacy and safety of brodalumab, a fully human anti-interleukin-17 receptor A monoclonal antibody, in patients with moderate-to-severe plaque psoriasis.

METHODS

Patients who completed a 12-week, phase II, dose-ranging clinical trial received brodalumab 210 mg every 2 weeks in an open-label extension study. Efficacy was assessed by static physician's global assessment (sPGA) and psoriasis area and severity index (PASI). Quality of life, assessed by dermatology life quality index (DLQI), and safety were also evaluated.

RESULTS

Overall, 181 patients received brodalumab for a median of 264 weeks. Brodalumab treatment resulted in rapid improvements in sPGA, PASI, and DLQI that were maintained through week 264. Achieving PASI 90 to < 100 or PASI 100 at weeks 12, 240, and 264 was associated with greater likelihood for DLQI 0 or 1 compared with achieving PASI 75 to < 90. Over 5 years, one adverse event of suicidal ideation was reported, no suicides occurred, and no new safety signals emerged.

CONCLUSIONS

Brodalumab demonstrated skin clearance and improved quality of life, with an acceptable safety profile, throughout 5 years of treatment. CLINICALTRIALS.

GOV IDENTIFIER

NCT01101100.

Links

PMC Free PDF

Authors+Show Affiliations

Lebwohl MG
Icahn School of Medicine at Mount Sinai, 5 East 98th Street, 5th Floor, New York, NY, 10029, USA. Lebwohl@aol.com.
Blauvelt A
Oregon Medical Research Center, 9495 SW Locust Street, Suite G, Portland, OR, 97223, USA.
Menter A
Baylor Scott & White, 3900 Junius Street, Suite 145, Dallas, TX, 75246, USA.
Papp KA
Probity Medical Research and K. Papp Clinical Research, 135 Union Street East, Waterloo, ON, N2J 1C4, Canada.
Guenthner S
The Dermatology Center of Indiana, 1100 Southfield Drive, Suite 1240, Plainfield, IN, 46168, USA.
Pillai R
Bausch Health Americas, 1330 Redwood Way #A, Petaluma, CA, 94954, USA.
Israel RJ
Bausch Health US, LLC, 400 Somerset Corporate Boulevard, Bridgewater, NJ, 08807, USA.
Jacobson A
Ortho Dermatologics, 400 Somerset Corporate Boulevard, Bridgewater, NJ, 08807, USA.

MeSH

AdolescentAdultAgedAntibodies, Monoclonal, HumanizedDermatologic AgentsFemaleHumansInterleukin-17Long-Term CareMaleMiddle AgedPatient Reported Outcome MeasuresPsoriasisQuality of LifeSeverity of Illness IndexSkinSuicidal IdeationTime FactorsTreatment OutcomeYoung Adult

Pub Type(s)

Clinical Trial, Phase II
Journal Article

Language

eng

PubMed ID

31493163

Clinical Trial Links

Clinical trial which this article describes

Citation

Lebwohl, Mark G., et al. "Efficacy, Safety, and Patient-Reported Outcomes in Patients With Moderate-to-Severe Plaque Psoriasis Treated With Brodalumab for 5 Years in a Long-Term, Open-Label, Phase II Study." American Journal of Clinical Dermatology, vol. 20, no. 6, 2019, pp. 863-871.
Lebwohl MG, Blauvelt A, Menter A, et al. Efficacy, Safety, and Patient-Reported Outcomes in Patients with Moderate-to-Severe Plaque Psoriasis Treated with Brodalumab for 5 Years in a Long-Term, Open-Label, Phase II Study. Am J Clin Dermatol. 2019;20(6):863-871.
Lebwohl, M. G., Blauvelt, A., Menter, A., Papp, K. A., Guenthner, S., Pillai, R., Israel, R. J., & Jacobson, A. (2019). Efficacy, Safety, and Patient-Reported Outcomes in Patients with Moderate-to-Severe Plaque Psoriasis Treated with Brodalumab for 5 Years in a Long-Term, Open-Label, Phase II Study. American Journal of Clinical Dermatology, 20(6), 863-871. https://doi.org/10.1007/s40257-019-00466-2
Lebwohl MG, et al. Efficacy, Safety, and Patient-Reported Outcomes in Patients With Moderate-to-Severe Plaque Psoriasis Treated With Brodalumab for 5 Years in a Long-Term, Open-Label, Phase II Study. Am J Clin Dermatol. 2019;20(6):863-871. PubMed PMID: 31493163.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy, Safety, and Patient-Reported Outcomes in Patients with Moderate-to-Severe Plaque Psoriasis Treated with Brodalumab for 5 Years in a Long-Term, Open-Label, Phase II Study. AU - Lebwohl,Mark G, AU - Blauvelt,Andrew, AU - Menter,Alan, AU - Papp,Kim A, AU - Guenthner,Scott, AU - Pillai,Radhakrishnan, AU - Israel,Robert J, AU - Jacobson,Abby, PY - 2019/9/8/pubmed PY - 2020/4/21/medline PY - 2019/9/8/entrez SP - 863 EP - 871 JF - American journal of clinical dermatology JO - Am J Clin Dermatol VL - 20 IS - 6 N2 - BACKGROUND: Chronic inflammatory diseases such as psoriasis require treatment options that maintain efficacy and tolerability during extended treatment. OBJECTIVE: The aim of the study was to assess the long-term efficacy and safety of brodalumab, a fully human anti-interleukin-17 receptor A monoclonal antibody, in patients with moderate-to-severe plaque psoriasis. METHODS: Patients who completed a 12-week, phase II, dose-ranging clinical trial received brodalumab 210 mg every 2 weeks in an open-label extension study. Efficacy was assessed by static physician's global assessment (sPGA) and psoriasis area and severity index (PASI). Quality of life, assessed by dermatology life quality index (DLQI), and safety were also evaluated. RESULTS: Overall, 181 patients received brodalumab for a median of 264 weeks. Brodalumab treatment resulted in rapid improvements in sPGA, PASI, and DLQI that were maintained through week 264. Achieving PASI 90 to < 100 or PASI 100 at weeks 12, 240, and 264 was associated with greater likelihood for DLQI 0 or 1 compared with achieving PASI 75 to < 90. Over 5 years, one adverse event of suicidal ideation was reported, no suicides occurred, and no new safety signals emerged. CONCLUSIONS: Brodalumab demonstrated skin clearance and improved quality of life, with an acceptable safety profile, throughout 5 years of treatment. CLINICALTRIALS. GOV IDENTIFIER: NCT01101100. SN - 1179-1888 UR - https://www.unboundmedicine.com/medline/citation/31493163/Efficacy_Safety_and_Patient_Reported_Outcomes_in_Patients_with_Moderate_to_Severe_Plaque_Psoriasis_Treated_with_Brodalumab_for_5_Years_in_a_Long_Term_Open_Label_Phase_II_Study_ DB - PRIME DP - Unbound Medicine ER -