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Ann Rheum Dis. 2017 Feb;76(2):386-391. doi: 10.1136/annrheumdis-2016-209285. Epub 2016 Jun 15.

Risk of invasive melanoma in patients with rheumatoid arthritis treated with biologics: results from a collaborative project of 11 European biologic registers.

Author information

Arthritis Research UK Centre for Epidemiology, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK.
Clinical Epidemiology Unit, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.
Department of Rheumatology, Karolinska University Hospital, Stockholm, Sweden.
Department of Rheumatology, Herlev and Gentofte University Hospital, Hellerup, Denmark.
The Parker Institute, Bispebjerg and Frederiksberg, University of Copenhagen, Copenhagen, Denmark.
The DANBIO registry and Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet Glostrup and second affiliation Hetland: Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Epidemiology Unit, German Rheumatism Research Centre, Berlin, Germany.
Charité University Medicine Berlin, Berlin, Germany.
Rheumatology Department, Université Paris-Sud, AP-HP, Hôpitaux Universitaires Paris-Sud, INSERM U1184, Center for Immunology of Viral Infections and Autoimmune Diseases, Le Kremlin-Bicêtre, France.
Rheumatology Division, University of Geneva, Geneva, Switzerland.
Rheumatology Research Unit, Rheumatology Department, Instituto de Medicina Molecular, Faculdade de Medicina, Universidade de Lisboa, Lisbon Portugal, CHLN- Santa Maria Hospital, CAML, Lisbon, Portugal.
Rheumatology Unit-DIM, University of Bari, Bari, Italy.
Institute of Rheumatology, Prague, Czech Republic.
First Faculty of Medicine, Charles University in Prague, Prague, Czech Republic.
Department of Rheumatology, Teaching Hospital of Lapeyronie and University of Montpellier, Montpellier, France.
Rheumatology Department, National Center for Rare Systemic Autoimmune Diseases, Hôpitaux Universitaires de Strasbourg, CNRS, Institut de Biologie Moléculaire et Cellulaire, Immunopathologie et Chimie Thérapeutique/Laboratory of Excellence Medalis, Université de Strasbourg, Strasbourg, France.
NIHR Manchester Musculoskeletal Biomedical Research Unit, Central Manchester University Hospitals NHS Foundation Trust and University of Manchester Partnership, Manchester, UK.



Some studies have reported a possible association between exposure to tumour necrosis factor (TNF) inhibitors and an increased risk of melanoma. The aim of this study was to investigate the incidence of invasive cutaneous melanomas in patients with rheumatoid arthritis (RA) treated with TNF inhibitors (TNFi), other biologic disease modifying drugs and non-biologic therapy.


Eleven biologic registers from nine European countries participated in this collaborative project. According to predefined exposure definitions, cohorts of patients with RA were selected. Using the country-specific general population of each register as reference, age, sex and calendar year standardised incidence ratios (SIRs) of invasive histology-confirmed cutaneous melanoma were calculated within each register. Pooled SIR and incidence rate ratios (IRRs) comparing biologic cohorts to biologic-naïve were calculated across countries by taking the size of the register into account.


Overall 130 315 RA patients with a mean age of 58 years contributing 579 983 person-years were available for the analysis and 287 developed a first melanoma. Pooled SIRs for biologic-naïve, TNFi and rituximab-exposed patients were 1.1 (95% CI 0.9 to 1.4), 1.2 (0.99 to 1.6) and 1.3 (0.6 to 2.6), respectively. Incidence rates in tocilizumab and abatacept-exposed patients were also not significantly increased. IRR versus biologic-naïve patients were: TNFi 1.1 (95% CI 0.8 to 1.6); rituximab 1.2 (0.5 to 2.9).


This large European collaborative project did not confirm an overall increased risk of melanoma following exposure to TNFi.


Anti-TNF; Epidemiology; Rheumatoid Arthritis

[Indexed for MEDLINE]
Free PMC Article

Conflict of interest statement

JA received grant/research support from AstraZeneca, Merck, Lilly and Pfizer, and has received grant support from Abbvie, Pfizer, Merck, Roche, BMS and UCB for the ARTIS register. LD has received speaking fees from UCB and MSD. AS received speakers fees (<$10 000) from BMS, MSD, Pfizer, Roche, Sanofi-Aventis. AZ received grant/research support from Abbvie, Amgen, BMS, MSD, Roche, Pfizer and UCB for the German biologics register RABBIT and speakers fees (<$10 000) from BMS, MSD, Novartis, Pfizer, Roche, Sanofi and UCB. XM received honorarium (<$10 000) from BMS, Pfizer and UCB. AF received honorarium (<$10 000) from Abbvie, BMS, Pfizer, Roche and UCB. FI received personal fees from Actelion, Celgene, Janssen, Pfizer, AbbVie, UCB and MSD outside the submitted work. JZ received honorarium (<$10 000) from Abbvie and Hospira. JM received <$10 000 for honoraria and consultancies from Roche. J-EG received honorarium (<$10 000) from Abbvie, BMS, MSD, Pfizer, Roche and UCB. KLH received grant/research support from Pfizer and honoraria (<$10 000) from Abbvie and Pfizer. JL received honoraria (<$10 000) from Novartis-Sandoz and Pfizer.

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