Evidence map›Paper›PMID 28190255›Full record

Trial reportJournal of the European Academy of Dermatology and Venereology : JEADV2017

Continuous dosing versus interrupted therapy with ixekizumab: an integrated analysis of two phase 3 trials in psoriasis.

A Blauvelt, K A Papp, H Sofen, M Augustin, G Yosipovitch, N Katoh, U Mrowietz, M Ohtsuki, Y Poulin, D Shrom and 4 more

Erratum issuedAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of the European Academy of Dermatology and Venereology : JEADV, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 24 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 6 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 6 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Trial
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  12. Article
  13. Article
  14. Review
  15. The Relapse of Psoriasis: Mechanisms and Mysteries.JID innovations : skin science from molecules to population health · 2022
    Review
  16. Review
  17. Article
  18. Article
  19. Review
  20. Should biologics for psoriasis be interrupted in the era of COVID-19?Journal of the American Academy of Dermatology · 2020
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors.

A BlauveltOregon Medical Research Center, Portland, OR, USA.
K A PappProbity Medical Research and K. Papp Clinical Research, Waterloo, ON, Canada.
H SofenDepartment of Medicine (Dermatology), David Geffen School of Medicine, Los Angeles, CA, USA.
M AugustinInstitute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg, Hamburg, Germany.
G YosipovitchDepartment of Dermatology, Miller School of Medicine, University of Miami, Miami, FL, USA.
N KatohDepartment of Dermatology, Kyoto Prefectural University of Medicine Graduate School of Medical Science, Kyoto, Japan.
U MrowietzPsoriasis-Center, Department of Dermatology, University Medical Center Schleswig-Holstein, Campus Kiel, Germany.
M OhtsukiDepartment of Dermatology, Jichi Medical University, Shimotsuke, Tochigi, Japan.
Y PoulinDepartment of Medicine, Université Laval, Hôpital Hôtel-Dieu de Québec, Quebec, QC, Canada.
D ShromEli Lilly and Company, Indianapolis, IN, USA.
R BurgeEli Lilly and Company, Indianapolis, IN, USA.
K SeeEli Lilly and Company, Indianapolis, IN, USA.
L MallbrisEli Lilly and Company, Indianapolis, IN, USA.
K B GordonDepartment of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundContinuous treatment is recommended for patients with moderate-to-severe psoriasis; however, treatment may need to be interrupted in routine clinical practice.

objectiveTo assess outcomes in patients continuously treated with ixekizumab versus those who interrupted therapy and were subsequently retreated with ixekizumab (IXE).

methodsThis analysis used data pooled from two phase 3 trials, UNCOVER-1 and UNCOVER-2. Patients were randomized to placebo (PBO), IXE every 4 (Q4W) or IXE every 2 weeks (Q2W) for 12 weeks. Patients with a static Physician's Global Assessment (sPGA) 0, 1 at Week 12 were rerandomized to IXEQ4W, IXE every 12 weeks (not presented) or PBO. We examined outcomes in patients who were continuously treated (IXEQ2W/IXEQ4W; IXEQ4W/IXEQ4W) or withdrawn (IXEQ2W/PBO; IXEQ4W/PBO), and in patients who were withdrawn and retreated with IXEQ4W for 24 weeks after disease relapse (sPGA ≥3).

resultsA total of 1226 treated patients achieved an sPGA 0, 1 at Week 12 and entered the maintenance phase; of these patients, 402 and 416 were rerandomized to PBO and IXEQ4W, respectively. Among patients interrupting treatment, 157 (82.2%) of IXEQ4W/PBO and 176 (83.4%) of IXEQ2W/PBO had an sPGA ≥3 by Week 60; median time to relapse was approximately 20 weeks irrespective of induction dose. At Week 60, continuously treated patients maintained high levels of PASI and sPGA responses (90.0% PASI 75 IXEQ2W/IXEQ4W; 81.9% sPGA 0, 1 IXEQ2W/IXEQ4W, non-responder imputation). After 24 weeks of retreatment with IXEQ4W (IXEQ2W/PBO/IXEQ4W and IXEQ4W/PBO/IXEQ4W), 87.0% (107 of 123) and 95.1% (97 of 102) (observed), respectively, of patients recaptured PASI 75 and 70.7% (104 of 147) and 82.3% (107 of 130) (observed) recaptured an sPGA 0, 1. Overall, adverse events in continuously treated and retreated patients were comparable.

conclusionHigh levels of response were sustained with continuous ixekizumab treatment through 60 weeks. Most patients who were withdrawn experienced disease relapse, and most of those patients recaptured response after 24 weeks of retreatment.

Indexed as

Antibodies, Monoclonal, HumanizedDouble-Blind MethodHumansPlacebosPsoriasisAntibodies, Monoclonal, HumanizedixekizumabPlacebos

Identifiers

PMID28190255
PMCPMC5485049

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.