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Comparison of ixekizumab with ustekinumab in moderate-to-severe psoriasis: 24-week results from IXORA-S, a phase III study.
Br J Dermatol. 2017 Oct; 177(4):1014-1023.BJ

Abstract

BACKGROUND

It has been shown that the interleukin (IL)-23/IL-17 axis is critical in the pathogenesis of psoriasis.

OBJECTIVES

To present the primary end point (week 12) and safety and efficacy data up to week 24 from a head-to-head trial (IXORA-S) of the IL-17A inhibitor ixekizumab (IXE) vs. the IL-12/23 inhibitor ustekinumab (UST).

METHODS

Randomized patients received IXE (160-mg starting dose, then 80 mg every 2 weeks for 12 weeks, then 80 mg every 4 weeks, n = 136) or UST (45 mg or 90 mg weight-based dosing per label, n = 166). The primary end point was the proportion of patients reaching ≥ 90% Psoriasis Area and Severity Index improvement (PASI 90). Hommel-adjusted key secondary end points at week 12 included PASI 75, PASI 100, static Physician's Global Assessment (sPGA) score of 0 or 1, sPGA score of 0, Dermatology Life Quality Index (DLQI) score of 0 or 1, ≥ 4-point reduction on the itch numerical rating scale (NRS) and changes in itch NRS and skin pain visual analogue scale.

RESULTS

At week 12, IXE (n = 99, 72·8%) was superior to UST (n = 70, 42·2%) in PASI 90 response (response difference 32·1%, 97·5% confidence interval 19·8-44·5%, P < 0·001). Response rates for PASI 75, PASI 100 and sPGA (0,1) were significantly higher for IXE than for UST (adjusted P < 0·05). At week 24, IXE-treated patients had significantly higher response rates than UST-treated patients for PASI, sPGA and DLQI (unadjusted P < 0·05). No deaths were reported, and the treatments did not differ with regard to overall incidences of adverse events (P = 0·299).

CONCLUSIONS

The superior efficacy of IXE demonstrated at week 12 persisted up to week 24. The safety profiles were consistent with those previously reported for both treatments.

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Authors+Show Affiliations

Reich K
Dermatologikum Hamburg, Stephansplatz 5, 20354, Hamburg, Germany. Georg-August-University, Göttingen, Germany.
Pinter A
Department of Dermatology, Venereology, and Allergology, University Clinic Frankfurt, Frankfurt am Main, Germany.
Lacour JP
Department of Dermatology, University Hospital of Nice, Nice, France.
Ferrandiz C
Servicio de Dermatología, Hospital Universitario Germans Trias i Pujol, Universitat Autónoma de Barcelona, Badalona, Barcelona, Spain.
Micali G
Dermatology Clinic, University of Catania, University Hospital Policlinico-Vittorio Emanuele, Catania, Sicily, Italy.
French LE
Department of Dermatology, University of Zurich Hospital, Zurich, Switzerland.
Lomaga M
DermEdge Research, Mississauga, ON, Canada.
Dutronc Y
Eli Lilly and Company, Indianapolis, IN, U.S.A.
Henneges C
Eli Lilly and Company, Indianapolis, IN, U.S.A.
Wilhelm S
Eli Lilly and Company, Indianapolis, IN, U.S.A.
Hartz S
Eli Lilly and Company, Indianapolis, IN, U.S.A.
Paul C
Dermatology Department, CHU, Paul Sabatier University, Toulouse, France.
IXORA-S investigators
No affiliation info available

MeSH

AdultAntibodies, Monoclonal, HumanizedDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleFemaleHumansInjections, SubcutaneousMalePatient Reported Outcome MeasuresPsoriasisTreatment OutcomeUstekinumab

Pub Type(s)

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

Language

eng

PubMed ID

28542874

Citation

Reich, K, et al. "Comparison of Ixekizumab With Ustekinumab in Moderate-to-severe Psoriasis: 24-week Results From IXORA-S, a Phase III Study." The British Journal of Dermatology, vol. 177, no. 4, 2017, pp. 1014-1023.
Reich K, Pinter A, Lacour JP, et al. Comparison of ixekizumab with ustekinumab in moderate-to-severe psoriasis: 24-week results from IXORA-S, a phase III study. Br J Dermatol. 2017;177(4):1014-1023.
Reich, K., Pinter, A., Lacour, J. P., Ferrandiz, C., Micali, G., French, L. E., Lomaga, M., Dutronc, Y., Henneges, C., Wilhelm, S., Hartz, S., & Paul, C. (2017). Comparison of ixekizumab with ustekinumab in moderate-to-severe psoriasis: 24-week results from IXORA-S, a phase III study. The British Journal of Dermatology, 177(4), 1014-1023. https://doi.org/10.1111/bjd.15666
Reich K, et al. Comparison of Ixekizumab With Ustekinumab in Moderate-to-severe Psoriasis: 24-week Results From IXORA-S, a Phase III Study. Br J Dermatol. 2017;177(4):1014-1023. PubMed PMID: 28542874.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparison of ixekizumab with ustekinumab in moderate-to-severe psoriasis: 24-week results from IXORA-S, a phase III study. AU - Reich,K, AU - Pinter,A, AU - Lacour,J P, AU - Ferrandiz,C, AU - Micali,G, AU - French,L E, AU - Lomaga,M, AU - Dutronc,Y, AU - Henneges,C, AU - Wilhelm,S, AU - Hartz,S, AU - Paul,C, AU - ,, Y1 - 2017/07/19/ PY - 2017/05/09/accepted PY - 2017/5/26/pubmed PY - 2018/6/19/medline PY - 2017/5/26/entrez SP - 1014 EP - 1023 JF - The British journal of dermatology JO - Br J Dermatol VL - 177 IS - 4 N2 - BACKGROUND: It has been shown that the interleukin (IL)-23/IL-17 axis is critical in the pathogenesis of psoriasis. OBJECTIVES: To present the primary end point (week 12) and safety and efficacy data up to week 24 from a head-to-head trial (IXORA-S) of the IL-17A inhibitor ixekizumab (IXE) vs. the IL-12/23 inhibitor ustekinumab (UST). METHODS: Randomized patients received IXE (160-mg starting dose, then 80 mg every 2 weeks for 12 weeks, then 80 mg every 4 weeks, n = 136) or UST (45 mg or 90 mg weight-based dosing per label, n = 166). The primary end point was the proportion of patients reaching ≥ 90% Psoriasis Area and Severity Index improvement (PASI 90). Hommel-adjusted key secondary end points at week 12 included PASI 75, PASI 100, static Physician's Global Assessment (sPGA) score of 0 or 1, sPGA score of 0, Dermatology Life Quality Index (DLQI) score of 0 or 1, ≥ 4-point reduction on the itch numerical rating scale (NRS) and changes in itch NRS and skin pain visual analogue scale. RESULTS: At week 12, IXE (n = 99, 72·8%) was superior to UST (n = 70, 42·2%) in PASI 90 response (response difference 32·1%, 97·5% confidence interval 19·8-44·5%, P < 0·001). Response rates for PASI 75, PASI 100 and sPGA (0,1) were significantly higher for IXE than for UST (adjusted P < 0·05). At week 24, IXE-treated patients had significantly higher response rates than UST-treated patients for PASI, sPGA and DLQI (unadjusted P < 0·05). No deaths were reported, and the treatments did not differ with regard to overall incidences of adverse events (P = 0·299). CONCLUSIONS: The superior efficacy of IXE demonstrated at week 12 persisted up to week 24. The safety profiles were consistent with those previously reported for both treatments. SN - 1365-2133 UR - https://www.unboundmedicine.com/medline/citation/28542874/Comparison_of_ixekizumab_with_ustekinumab_in_moderate_to_severe_psoriasis:_24_week_results_from_IXORA_S_a_phase_III_study_ L2 - https://doi.org/10.1111/bjd.15666 DB - PRIME DP - Unbound Medicine ER -
Grapherence [↓54]

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