Original articleThe risk of infection and malignancy with tumor necrosis factor antagonists in adults with psoriatic disease: A systematic review and meta-analysis of randomized controlled trials
Section snippets
Methods
Based on the Cochrane Handbook for Systemic Reviews of Interventions guidelines,30 we used a predefined, peer-reviewed protocol to perform the study selection, assessment of eligibility criteria, data extraction, and statistical analysis of RCTs of patients with PsO and PsA. This article was prepared in accordance with the PRISMA statement.31 This study was granted an institutional review board exemption by the University of Pennsylvania.
Search results and trial characteristics
Of 820 potentially relevant publications identified through database searching, 20 clinical trials including 6810 adult patients (5427 patients in PsO and 1383 patients in PsA studies) qualified for inclusion (Fig 1). Seven trials specifically included patients with active PsA unresponsive to disease-modifying antirheumatic drugs (DMARD), nonsteroidal anti-inflammatory drugs, or both, although 5 of these trials also required that patients have active psoriatic skin lesions, a documented history
Discussion
Our systematic review and meta-analysis combined data from 20 RCTs of adult patients with PsO and PsA treated with anti–TNF-alfa agents. To our knowledge, this is the largest review to date of RCTs examining the risk of infection and malignancy with the use of anti–TNF-alfa agents in patients with psoriatic disease.
Our study suggests that there may be a small increased risk of overall infection with the short-term use of TNF-alfa antagonists for psoriatic disease. However, 97.6% of reported
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2021, Seminars in Arthritis and RheumatismCitation Excerpt :However, at the time the study was conducted, the number of patients who were taking biologics was small. Overall, during the last few years the majority of studies did not support an elevated risk of malignancy (apart of NMSCs) with either biologics or csDMARDs [19–21,31–35]. Medications were not found to be predictors of malignancy in the present study.
Supported in part by grants K23AR051125 and RC1 ARO58204 from the National Institute of Arthritis, Musculoskeletal, and Skin Diseases (Dr Gelfand), and a National Research Service Award from the National Institute of Health (Dr Dommasch).
Disclosure: Dr Gelfand receives grant support and is an investigator for Amgen, Abbott, Novartis, and Pfizer. He is a consultant for Pfizer, Genentech, Celgene, Amgen, Centocor, Novartis, and Abbott. Dr Dommasch, Dr Abuabara, Mr Shin, Dr Nguyen, and Dr Troxel have no conflicts of interest to declare.