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Ixekizumab provides superior efficacy compared with ustekinumab over 52 weeks of treatment: Results from IXORA-S, a phase 3 study.
J Am Acad Dermatol. 2019 Jan; 80(1):70-79.e3.JA

Abstract

BACKGROUND

Biologics targeting interleukin 17A (IL-17A) allow for rapid clearance of psoriatic plaques, with a clinically favorable safety profile.

OBJECTIVES

To compare the safety and efficacy of ixekizumab, an IL-17A antagonist, with the safety and efficacy of the IL-12/23 inhibitor ustekinumab through 52 weeks of treatment in the head-to-head trial IXORA-S.

METHODS

Patients were randomized to ixekizumab (n = 136) or ustekinumab (n = 166) and dosed per the approved labels. After 1 year, efficacy was assessed via improvements in Psoriasis Area and Severity Index (PASI) score (with PASI 90 indicating a 90% or greater improvement from baseline PASI score) and a static Physician's Global Assessment (sPGA) response of either 0 or 0 or 1, with dropouts counted as nonresponders. Safety analyses included treatment-emergent adverse events (AEs).

RESULTS

At week 52, significantly more ixekizumab-treated patients (P < .01) reported PASI 90 (104 [76.5%]), an sPGA response of 0 (72 [52.9%]), or an sPGA response of 0 or 1 (110 [82.1%]) responses than did ustekinumab-treated patients (PASI 90, 98 [59.0%]; sPGA response of 0, 60 [36.1%]; and sPGA response of 0 or 1, 108 [65.1%]). Treatment-emergent AEs, serious AEs, and discontinuation rates were not different between the treatment groups. Injection site reactions occurred more frequently in the ixekizumab-treated group (ixekizumab, 22 [16.3%]; ustekinumab, 2 [1.2%]) (P < .001).

LIMITATIONS

This study was not designed to compare safety end points related to rare events.

CONCLUSIONS

Compared with ustekinumab, ixekizumab showed superior efficacy and comparable safety outcomes through 52 weeks of treatment.

Links

Publisher Full Text (DOI)

Authors+Show Affiliations

Paul C
Dermatology Department, CHU, Paul Sabatier University, Toulouse, France. Electronic address: paul.c@chu-toulouse.fr.
Griffiths CEM
Dermatology Centre, Salford Royal Hospital, University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom.
van de Kerkhof PCM
Department of Dermatology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands.
Puig L
Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain.
Dutronc Y
Eli Lilly and Company, Indianapolis, Indiana.
Henneges C
Eli Lilly and Company, Indianapolis, Indiana.
Dossenbach M
Eli Lilly and Company, Indianapolis, Indiana.
Hollister K
Eli Lilly and Company, Indianapolis, Indiana.
Reich K
Dermatologikum Berlin and Georg-August-University Göttingen, Göttingen, Germany.

MeSH

AdultAntibodies, Monoclonal, HumanizedDermatologic AgentsDouble-Blind MethodFemaleHumansMalePsoriasisTime FactorsTreatment OutcomeUstekinumab

Pub Type(s)

Clinical Trial, Phase III
Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

29969700

Citation

Paul, Carle, et al. "Ixekizumab Provides Superior Efficacy Compared With Ustekinumab Over 52 Weeks of Treatment: Results From IXORA-S, a Phase 3 Study." Journal of the American Academy of Dermatology, vol. 80, no. 1, 2019, pp. 70-79.e3.
Paul C, Griffiths CEM, van de Kerkhof PCM, et al. Ixekizumab provides superior efficacy compared with ustekinumab over 52 weeks of treatment: Results from IXORA-S, a phase 3 study. J Am Acad Dermatol. 2019;80(1):70-79.e3.
Paul, C., Griffiths, C. E. M., van de Kerkhof, P. C. M., Puig, L., Dutronc, Y., Henneges, C., Dossenbach, M., Hollister, K., & Reich, K. (2019). Ixekizumab provides superior efficacy compared with ustekinumab over 52 weeks of treatment: Results from IXORA-S, a phase 3 study. Journal of the American Academy of Dermatology, 80(1), 70-e3. https://doi.org/10.1016/j.jaad.2018.06.039
Paul C, et al. Ixekizumab Provides Superior Efficacy Compared With Ustekinumab Over 52 Weeks of Treatment: Results From IXORA-S, a Phase 3 Study. J Am Acad Dermatol. 2019;80(1):70-79.e3. PubMed PMID: 29969700.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Ixekizumab provides superior efficacy compared with ustekinumab over 52 weeks of treatment: Results from IXORA-S, a phase 3 study. AU - Paul,Carle, AU - Griffiths,Christopher E M, AU - van de Kerkhof,Peter C M, AU - Puig,Lluís, AU - Dutronc,Yves, AU - Henneges,Carsten, AU - Dossenbach,Martin, AU - Hollister,Kristin, AU - Reich,Kristian, Y1 - 2018/06/30/ PY - 2017/12/20/received PY - 2018/06/10/revised PY - 2018/06/26/accepted PY - 2018/7/4/pubmed PY - 2019/3/21/medline PY - 2018/7/4/entrez KW - IXORA-S KW - biologic KW - clinical trial KW - efficacy KW - ixekizumab KW - psoriasis KW - safety KW - ustekinumab SP - 70 EP - 79.e3 JF - Journal of the American Academy of Dermatology JO - J Am Acad Dermatol VL - 80 IS - 1 N2 - BACKGROUND: Biologics targeting interleukin 17A (IL-17A) allow for rapid clearance of psoriatic plaques, with a clinically favorable safety profile. OBJECTIVES: To compare the safety and efficacy of ixekizumab, an IL-17A antagonist, with the safety and efficacy of the IL-12/23 inhibitor ustekinumab through 52 weeks of treatment in the head-to-head trial IXORA-S. METHODS: Patients were randomized to ixekizumab (n = 136) or ustekinumab (n = 166) and dosed per the approved labels. After 1 year, efficacy was assessed via improvements in Psoriasis Area and Severity Index (PASI) score (with PASI 90 indicating a 90% or greater improvement from baseline PASI score) and a static Physician's Global Assessment (sPGA) response of either 0 or 0 or 1, with dropouts counted as nonresponders. Safety analyses included treatment-emergent adverse events (AEs). RESULTS: At week 52, significantly more ixekizumab-treated patients (P < .01) reported PASI 90 (104 [76.5%]), an sPGA response of 0 (72 [52.9%]), or an sPGA response of 0 or 1 (110 [82.1%]) responses than did ustekinumab-treated patients (PASI 90, 98 [59.0%]; sPGA response of 0, 60 [36.1%]; and sPGA response of 0 or 1, 108 [65.1%]). Treatment-emergent AEs, serious AEs, and discontinuation rates were not different between the treatment groups. Injection site reactions occurred more frequently in the ixekizumab-treated group (ixekizumab, 22 [16.3%]; ustekinumab, 2 [1.2%]) (P < .001). LIMITATIONS: This study was not designed to compare safety end points related to rare events. CONCLUSIONS: Compared with ustekinumab, ixekizumab showed superior efficacy and comparable safety outcomes through 52 weeks of treatment. SN - 1097-6787 UR - https://www.unboundmedicine.com/medline/citation/29969700/Ixekizumab_provides_superior_efficacy_compared_with_ustekinumab_over_52_weeks_of_treatment:_Results_from_IXORA_S_a_phase_3_study_ DB - PRIME DP - Unbound Medicine ER -
Grapherence [↓30]

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