Background: In reported systematic reviews and meta-analyses of randomized controlled trials (RCTs) assessing treatments for psoriasis, the proportion of serious adverse events (SAEs) did not differ between treatments and placebo. Including cases of psoriasis worsening as SAEs may explain the lack of difference.
Objectives: This systematic review and meta-analysis aimed to explore this possibility.
Methods: Among the 140 RCTs included in the Living Network Cochrane Review (last search on 8 May 2019), we selected those comparing a biologic treatment against placebo. The primary outcome was the numbers of SAEs in the treatment and placebo arms after excluding cases of psoriasis worsening. Secondary outcomes were the number of adverse events (AEs) of special interest. The trial was registered on PROSPERO (CRD42019124495).
Results: We analysed 51 RCTs. Of these, 21 included at least one anti-tumour necrosis factor (TNF)-α arm, 15 one anti-interleukin (IL)-17 arm, 11 one anti-IL-23 arm and nine one anti-IL-12/23 arm. With cases of psoriasis worsening included, the risk of occurrence of SAEs between biologic treatments and placebo did not differ: risk ratio (RR) 1·09, 95% confidence interval (CI) 0·88-1·36. After excluding cases of psoriasis worsening, the RR became significant (RR 1·30, 95% CI 1·02-1·65). By drug class, the RRs were for anti-TNF-α, 1·68 (95% CI 1·11-2·54; no missing data); anti-IL-17, 1·28 (95% CI 0·88-1·85; no missing data); anti-IL-23, 0·95 (95% CI 0·59-1·52; no missing data) and anti-IL-12/23, 1·18 (95% CI 0·72-1·94; no missing data). We were unable to examine potential differences in AEs of special interest between biologic treatments and placebo arms because of the small number of events.
Conclusions: On excluding cases of worsening psoriasis, the risk of occurrence of SAEs is higher in the biologic than in the placebo arm. Given the rare events, we could not highlight whether this higher risk of SAEs was related to AEs of special interest. Reporting of SAEs in clinical trials has to be changed to provide more transparency through the separate reporting of disease flares leading to hospital admission and other SAEs.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1111/bjd.19244 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Harlequin ichthyosis is a rare skin disorder affecting newborns characterized by a scaly skin, flexed limbs, ectropium, and eclabium. The overall incidence of HI is 1 in 300,000 births, with approximately only 200 cases reported worldwide. Some studies uncovered a TH17 immune skewing in patients with HI, which is also seen in psoriasis.
View Article and Find Full Text PDFTularemia in a Psoriasis Patient on Biologic Therapy After Relocation to Western South Dakota.
S D Med
December 2024
Department of Internal Medicine, University of South Dakota Sanford School of Medicine.
Background: Francisella tularensis is an aerobic, gram negative coccobacillus bacterium that causes tularemia. F. tularensis spreads primarily through ticks, biting flies, droplet inhalation, contaminated mud or water, or infected animal bites, and it can survive in animal carcasses with the most common mode of transmission occurring via inoculation into the skin and inhalation/ingestion.
View Article and Find Full Text PDF2024 British Association for Sexual Health and HIV (BASHH) UK national guideline on the management of vulval conditions.
Int J STD AIDS
January 2025
Genitourinary and HIV Medicine and BASHH Clinical Effectiveness Group, Central North West London NHS Foundation Trust, London, UK.
Background: The management of vulval disorders in Genitourinary Medicine (GUM) clinics requires targeted approaches due to the wide range of conditions affecting the vulva. Vulval diseases encompass various aetiologies, including dermatoses, pain syndromes, and pre-malignant conditions, necessitating specialized care often involving multidisciplinary collaboration.
Purpose: This guideline aims to provide evidence-based recommendations for the diagnosis and management of specific vulval conditions that may present in GUM clinics.
Adverse events associated with IL-23 and IL-12/23 inhibitors in the clinical management of psoriasis: a comprehensive pharmacovigilance analysis.
BMC Pharmacol Toxicol
January 2025
Clinical Research Unit, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Background: Interleukin-23 (IL-23) inhibitors and the IL-12/23 inhibitor ustekinumab constitute a pivotal class of therapeutic agents employed in the clinical management of Psoriasis, a chronic immune-mediated skin disorder. Notwithstanding their therapeutic efficacy, concerns have arisen due to the emergence of multiple adverse events (AEs) associated with their usage. This study aims to provide a comprehensive examination of the distribution and characteristics of these AEs concerning IL-23 and IL-12/23 inhibitors, with a specific focus on guselkumab, tildrakizumab, risankizumab, and ustekinumab.
View Article and Find Full Text PDFRecalcitrant Pediatric Facial Vitiligo Successfully Treated with Roflumilast Cream 0.3% Once Daily.
J Clin Aesthet Dermatol
January 2025
Dr. Warren and Ms. Sanchez are with Derm Texas in Dallas, Texas.
Vitiligo is an autoimmune disorder that causes melanocyte damage and pigment loss. The clinical presentation of vitiligo consists of patchy areas of lighter skin and results from a loss of functioning melanocytes and may be more visible in darker skin toned patients. Vitiligo affects approximately 2 percent of children and adolescents in the United States, with half of the affected cases undiagnosed.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!