Comparison of ixekizumab with ustekinumab in moderate-to-severe psoriasis: 24-week results from IXORA-S, a phase III study.
- Reich K Dermatologikum Hamburg, Stephansplatz 5, 20354, Hamburg, 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.
- 2017-05-26
Published in:
- The British journal of dermatology. - 2017
Adult
Antibodies, Monoclonal, Humanized
Dose-Response Relationship, Drug
Double-Blind Method
Drug Administration Schedule
Female
Humans
Injections, Subcutaneous
Male
Patient Reported Outcome Measures
Psoriasis
Treatment Outcome
Ustekinumab
English
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.
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.
- Language
-
- English
- Open access status
- hybrid
- Identifiers
-
- DOI 10.1111/bjd.15666
- PMID 28542874
- Persistent URL
- https://sonar.ch/global/documents/167786
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