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The Journal of Investigative Dermatology Aug 2013The time necessary for a treatment to become effective is crucial for patients and physicians but has been largely neglected in the reporting and comparison of clinical... (Comparative Study)
Comparative Study Meta-Analysis Review
The time necessary for a treatment to become effective is crucial for patients and physicians but has been largely neglected in the reporting and comparison of clinical trials in dermatology. The aim of this systematic review is to determine the time until the onset of action (TOA) of systemic agents approved for moderate-to-severe psoriasis. Primary outcome is the TOA defined as the weighted mean time until 25% of the patients achieved a psoriasis area and severity index (PASI) 75 response. Among the biologics, infliximab has the shortest TOA (3.5 weeks), followed by ustekinumab (high dose 4.6/low dose 5.1 weeks/not weight adapted), adalimumab (4.6 weeks), etanercept (high dose 6.6/low dose 9.5 weeks), and alefacept (high dose 15.4 weeks/low dose: no data). Among the conventional treatments, good data are available for cyclosporine A (CsA; TOA: 6.0 weeks) and limited data are found for methotrexate (MTX; TOA: high dose 3.2/low dose 9.9 weeks). No data are available for fumaric acid esters and retinoids. This systematic review provides clinically relevant information on the onset of action of antipsoriatic agents, although the data currently available allow only a limited assessment. Psoriasis trials should consider including TOA as an additional outcome measure.
Topics: Anti-Inflammatory Agents; Antirheumatic Agents; Dermatologic Agents; Humans; Psoriasis; Time Factors
PubMed: 23426133
DOI: 10.1038/jid.2013.78 -
Journal of Drugs in Dermatology : JDD Aug 2012Nail psoriasis appears to be an important source of psoriatic morbidity through physical impairment, pain, and cosmetic disturbances. Conventional treatment is often... (Review)
Review
Nail psoriasis appears to be an important source of psoriatic morbidity through physical impairment, pain, and cosmetic disturbances. Conventional treatment is often unsatisfactory. A systematic review of studies reporting the effect of TNF-α inhibitors and related drugs on nail psoriasis using the Nail Psoriasis Severity Index (NAPSI) as the outcome measure was therefore made. Data are available from randomized controlled trials (RCT) where NAPSI has been studied as a secondary outcome, as well as from case-series in which NAPSI has been the primary outcome studies suggest that adalimumab, briakinumab, etanercept, golimumab, infliximumab, and ustekinumab all improve NAPSI scores. No direct comparative RCTs are available in which NAPSI scores have been reported. The data further suggest that changes in NAPSI mirror changes in disease severity of other psoriatic manifestations, that is, in psoriatic arthritis and skin psoriasis. The effect only appears to be delayed due to the rate of growth of the nail plate.
Topics: Adalimumab; Alefacept; Anti-Inflammatory Agents; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Dermatologic Agents; Humans; Infliximab; Interleukin-12; Interleukin-23; Nail Diseases; Psoriasis; Recombinant Fusion Proteins; Severity of Illness Index; Tumor Necrosis Factor-alpha; Ustekinumab
PubMed: 22859238
DOI: No ID Found -
Psoriasis (Auckland, N.Z.) 2022The quality of life in psoriatic patients is significantly impaired. Since this century, there have been biologics as a treatment for psoriasis. These biologics reduce... (Review)
Review
BACKGROUND
The quality of life in psoriatic patients is significantly impaired. Since this century, there have been biologics as a treatment for psoriasis. These biologics reduce symptoms, but more knowledge is needed about potential improvements in quality of life. As a result, biological therapy may be more valuable for patients who experience a lot of burden from their chronic skin condition in daily life. The aim of this systematic review was to investigate the possible improvement of the Dermatology Life Quality Index (DLQI) in psoriatic patients using biologics.
MATERIALS AND METHODS
An online search was performed in the PubMed database to identify relevant articles. Inclusion criteria for studies were psoriatic patients, a measurement of DLQI with biologics and without biologics. Exclusion criteria for studies were abstracts not written in English, publications before 2012, full text unavailable, quality of life measurements other than DLQI. Results from the studies with different biologics were combined into the outcome measure: ≥5 points of improvement in the DLQI score. Results of the studies in which biologics were compared with (conventional) systemic therapy were combined in the outcome measure: improvement of the DLQI score is better with biologics than with systemic therapy.
RESULTS
There were nine included articles with a total of 19.926 patients. Adalimumab, alefacept, etanercept, infliximab, ustekinumab and secukinumab were included biologics. Six studies measured the change in DLQI of different biologics in number of points. Of these six studies, 22 sub-analyses were performed and 20 of them showed a DLQI improvement of ≥5 points. The improvement in DLQI was better with biologics than with systemic therapy in two of the three measured studies.
CONCLUSION
Quality of life of psoriatic patients will be improved by the studied biologics. In the future, more research is needed into biologics on patient and quality of life characteristics.
PubMed: 35637943
DOI: 10.2147/PTT.S356568 -
Frontiers in Medicine 2021Herpes zoster (HZ) has raised public concern. An increasing incidence of HZ can be seen in the immunocompromised population, such as the psoriasis patients taking...
Herpes zoster (HZ) has raised public concern. An increasing incidence of HZ can be seen in the immunocompromised population, such as the psoriasis patients taking biologics. Real-world evidences are still needed to investigate the risks of HZ among patients receiving different biologics treatments. This study aims to summarize the findings from cohort studies. Herein, we performed a meta-analysis of cohort studies. We included studies referred to seven biologics (adalimumab, alefacept, efalizumab, etanercept, infliximab, rituximab, and ustekinumab) as well as methotrexate for psoriasis. We estimated summary relative risks (RRs) for HZ using pairwise and network meta-analysis. Overall, five studies were included for analysis. A total of 32827.6 patient-years were observed. The result of the meta-analysis showed that the pooled HZ incidence rate of adalimumab, which accounts for the most patient-years in our analysis, is 2.6 per 1,000 patient-years. Our analysis based on several cohorts showed an insignificant difference among the patients receiving adalimumab, alefacept, efalizumab, etanercept, infliximab, rituximab, ustekinumab, and methotrexate. Based on this analysis, the type of mono-biologic treatment contributes little to the risk of HZ among psoriasis patients. Of note, the negative findings of our study do not mean the unnecessity of vaccination. More efforts must be taken to further determine HZ risk of different therapeutic strategies.
PubMed: 34150802
DOI: 10.3389/fmed.2021.665559 -
The British Journal of Dermatology May 2024Primary endpoint measures in clinical trials are typically measures of disease severity, with patient reported outcome measures (PROMs) relegated as secondary endpoints....
BACKGROUND
Primary endpoint measures in clinical trials are typically measures of disease severity, with patient reported outcome measures (PROMs) relegated as secondary endpoints. However validation of some PROMs may be more rigorous than that of disease severity measures, arguing for a primary role for PROMs.
OBJECTIVES
This study reports on 24 peer reviewed journal articles that used the Dermatology Life Quality Index (DLQI) as primary outcome, derived from a systematic review of randomised controlled trials (RCTs) utlising DLQI covering all diseases and interventions.
MATERIALS AND METHOD
The study protocol was prospectively published on the PROSPERO database, and the study followed PRISMA guidelines. Searches were made with Medline, Cochrane library, EMBASE, Web of Science, SCOPUS, CINAHL(EBSCO) and PsycINFO databases and records combined into an Endnote database. Records were filtered for duplicates and selected by study inclusion/exclusion criteria. Full text articles were sourced and data was extracted by two reviewers into a bespoke REDCap database, with a third reviewer adjudicating differences. The Jadad scoring method was used to determine risk of bias.
RESULTS
Of the 3,220 publications retrieved from online searching, 457 articles met eligibility criteria and included 198,587 patients. DLQI scores were primary outcomes in 24 (5.3%) of these studies comprising 15 different diseases and 3,436 patients. Most study interventions (17/24 studies, 68%) were systemic drugs with biologics (liraglutide, alefacept, secukinumab, ustekinumab, adalimumab) accounting for five out of 25 pharmacological interventions (20%). Topical treaments comprised 32% (8 studies) whereas non-pharmacological interventions (8) were 24% of the total interventions (33). Three studies used non-traditional medicines. Eight studies were multicentred (33.3%), with trials conducted in at least 14 different countries, and four (16.7%) were conducted in multiple countries. The Jadad risk of bias scale showed that bias was uncertain or low, as 87.5% of studies had Jadad scores of ≥3.
CONCLUSIONS
This study provides evidence for use of the DLQI as primary outcome in clinical trials to inform researchers' and clinicians' decisions for its further use.
PubMed: 38819233
DOI: 10.1093/bjd/ljae228