title: Risk of Serious Infections in Patients with Psoriasis on Biologic Therapies: A Systematic Review and Meta-Analysis.
abstract: A comprehensive evaluation of the risk of serious infections in biologic therapies for psoriasis is lacking. We performed a systematic review and meta-analysis of randomized controlled trials (RCTs) and prospective cohort studies reporting serious infections in people taking any licensed biologic therapy for psoriasis compared with those taking placebo, nonbiologic therapy, or other biologic therapies. The quality of the studies was assessed using Grading of Recommendations Assessment, Development and Evaluation criteria. No significant heterogeneity was detected in data from 32 RCTs (n = 13,359 participants) and one cohort study (n = 4,993 participants). In adults, low- to very-low-quality RCT data showed no significant difference between any biologic therapy and placebo at weeks 12-16 (overall pooled Peto odds ratio = 0.71, 95% confidence interval = 0.36-1.41) and weeks 20-30 (odds ratio = 2.27, 95% confidence interval = 0.45-11.49). No significant differences were found in any of the other comparisons in underpowered RCT data. Prospective cohort study data of low quality suggests that only adalimumab (adjusted hazard ratio [adjHR] = 2.52, 95% confidence interval = 1.47-4.32) was associated with a significantly higher risk of serious infection compared with retinoid and/or phototherapy in adults. No association between biologic therapies and serious infections in patients with psoriasis who were eligible for RCTs was detected. Further observational studies are needed to inform the uncertainty around this risk in the real world.
authors.affiliation: Dermatology Centre, Salford Royal NHS Foundation Trust, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK; Centre for Pharmacoepidemiology and Drug Safety, Manchester Pharmacy School, The University of Manchester, Manchester, UK.
authors.forename: Zenas Z N
authors.initials: ZZN
authors.lastname: Yiu
authors.affiliation: British Association of Dermatologists, London, UK.
authors.forename: Lesley S
authors.initials: LS
authors.lastname: Exton
authors.affiliation: Department of Dermatology, Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle, UK.
authors.forename: Zarif
authors.initials: Z
authors.lastname: Jabbar-Lopez
authors.affiliation: British Association of Dermatologists, London, UK.
authors.forename: M Firouz
authors.initials: MF
authors.lastname: Mohd Mustapa
authors.affiliation: National Clinical Guideline Centre, Royal College of Physicians of London, London, UK.
authors.forename: Eleanor J
authors.initials: EJ
authors.lastname: Samarasekera
authors.affiliation: Department of Dermatology, Western Infirmary, Glasgow, UK.
authors.forename: A David
authors.initials: AD
authors.lastname: Burden
authors.affiliation: Sheffield University Teaching Hospitals and Sheffield Children's Hospitals, Sheffield, UK.
authors.forename: Ruth
authors.initials: R
authors.lastname: Murphy
authors.affiliation: Department of Dermatology, East Lancashire Hospitals NHS Trust, Royal Blackburn Hospital, Blackburn, Lancashire, UK.
authors.forename: Caroline M
authors.initials: CM
authors.lastname: Owen
authors.affiliation: Department of Dermatology, Royal Liverpool and Broadgreen University Hospitals Trust, Liverpool, UK.
authors.forename: Richard
authors.initials: R
authors.lastname: Parslew
authors.affiliation: Department of Dermatology, Oxford University Hospitals Foundation Trust, Oxford, UK.
authors.forename: Vanessa
authors.initials: V
authors.lastname: Venning
authors.affiliation: Centre for Pharmacoepidemiology and Drug Safety, Manchester Pharmacy School, The University of Manchester, Manchester, UK.
authors.forename: Darren M
authors.initials: DM
authors.lastname: Ashcroft
authors.affiliation: Dermatology Centre, Salford Royal NHS Foundation Trust, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.
authors.forename: Christopher E M
authors.initials: CEM
authors.lastname: Griffiths
authors.affiliation: St John's Institute of Dermatology, Guy's and St. Thomas' NHS Foundation Trust, London, UK. Electronic address: catherine.smith@kcl.ac.uk.
authors.forename: Catherine H
authors.initials: CH
authors.lastname: Smith
authors.affiliation: Dermatology Centre, Salford Royal NHS Foundation Trust, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK. Electronic address: richard.warren@manchester.ac.uk.
authors.forename: Richard B
authors.initials: RB
authors.lastname: Warren
mesh_terms: D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized; D001688:Biological Products / Q000627:therapeutic use*; D001691:Biological Therapy; D006801:Humans; D007239:Infections / Q000150:complications*; D008727:Methotrexate / Q000627:therapeutic use; D016017:Odds Ratio; D010789:Phototherapy / Q000379:methods; D016016:Proportional Hazards Models; D011565:Psoriasis / Q000150:complications* / Q000628:therapy*; D016032:Randomized Controlled Trials as Topic; D012176:Retinoids / Q000627:therapeutic use; D012307:Risk Factors; D013997:Time Factors; D000069549:Ustekinumab / Q000627:therapeutic use
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D001688:Biological Products; D012176:Retinoids; C555450:secukinumab; D000069549:Ustekinumab; D008727:Methotrexate