Evidence map›Paper›PMID 30942952›Full record

Observational studyDermatologic therapy2019

From randomized clinical trials to real life data. An Italian clinical experience with ixekizumab and its management.

Giovanni Damiani, Rosalynn R Z Conic, Paolo D M Pigatto, Nicola L Bragazzi, Alessia Pacifico, Piergiorgio Malagoli, Young Dermatologists Italian Network

Abstract readObservational Study
In one paragraph

Observational study in Dermatologic therapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–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

8 citing papers in PubMed.

  1. Observational
  2. Article
  3. Review
  4. Article
  5. Observational
  6. Article
  7. Article
  8. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Giovanni DamianiDepartment of Biomedical, Surgical and Dental Sciences, University of Milan, Milan, Italy.ORCID 0000-0002-2390-6505
Rosalynn R Z ConicDepartment of Dermatology, Case Western Reserve University, Cleveland, Ohio.
Paolo D M PigattoClinical Dermatology, IRCCS Istituto Ortopedico Galezzi, Milan, Italy.
Nicola L BragazziSchool of Public Health, Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy.
Alessia PacificoSan Gallicano Dermatological Institute, IRCCS, Rome, Italy.ORCID 0000-0003-0348-0620
Piergiorgio MalagoliDermatology Unit, Azienda Ospedaliera San Donato Milanese, Milan, Italy.
Young Dermatologists Italian NetworkYoung Dermatologists Italian Network, GISED, Bergamo, Italy.

Funding

Psoriasis Center of Research TranslationP50AR070590 · NIAMS · CASE WESTERN RESERVE UNIVERSITY · PI COOPER, KEVIN D · 2017 to 2021
$6.5M
TRAINING IN INVESTIGATIVE AND MOLECULAR DERMATOLOGYT32AR007569 · NIAMS · CASE WESTERN RESERVE UNIVERSITY · PI COOPER, KEVIN D · 1991 to 2019
$2.7M
NIAMS NIH HHS P50 AR070590NIAMS NIH HHS T32 AR007569
6 · The paper itself

Abstract

Interleukin(IL)-17 inhibitors display higher efficacy than both TNFi and IL-12/23i, which increased the goal psoriasis area severity index (PASI) from 75 to PASI 90 or even PASI 100. Ixekizumab, a recombinant, humanized IgG4 monoclonal antibody targeting IL-17A displayed a high efficacy and safety in RCTs, namely UNCOVER-2 and UNCOVER-3. However, few studies examined real-life data for these medications, and those which exist highlight discrepancies in efficacy and safety between RCTs and real-life data, likely due to the heterogeneity of patients treated outside of trials. Thus, we performed a single center large prospective observational study (RLSD) that enrolled 47 psoriatic patients followed for 20 weeks and we compared the obtained data with the UNCOVER studies. At week 20 in RLSD versus UNCOVER-3 both PASI-90 and PASI-100 results were similar, whilst at week 12, the RLSD cohort obtained higher PASI 90 (76 vs 69,3%) and PASI-100 (55 vs 39%) than UNCOVER cohorts. Interestingly we also reported higher injection-site related pain that disappeared after week 12. In conclusion, real-life data together with RCTs contribute to enrich the information background available to dermatologists in daily practice.

Indexed as

AdultAntibodies, Monoclonal, HumanizedFemaleHumansInterleukin-17MaleMiddle AgedProspective StudiesPsoriasisRandomized Controlled Trials as TopicSeverity of Illness IndexAntibodies, Monoclonal, HumanizedInterleukin-17ixekizumabDLQIinjection-site painixekizumabPASIpsoriasisreal-lifeUNCOVER-2UNCOVER-3

Identifiers

PMID30942952
PMCPMC6579640

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.