PMID- 35738803
OWN - NLM
STAT- MEDLINE
DCOM- 20220627
LR  - 20220716
IS  - 2056-5933 (Electronic)
IS  - 2056-5933 (Linking)
VI  - 8
IP  - 2
DP  - 2022 Jun
TI  - Risk of malignancy in rheumatoid arthritis patients initiating biologics: an 
      historical propensity score matched cohort study within the French nationwide 
      healthcare database.
LID - 10.1136/rmdopen-2021-002139 [doi]
LID - e002139
AB  - OBJECTIVE: To compare the risk of malignancy between patients with rheumatoid 
      arthritis (RA) initiating their first biological disease-modifying antirheumatic 
      drug (bDMARD) and those continuing conventional synthetic DMARDs (csDMARDs). 
      METHODS: Nine-year historical Propensity Score (PS) matched cohort study within 
      the French national healthcare database (87% of the French population; ~57 
      million people), including adults RA without malignancy. Exposures started with 
      the first use of any systemic treatment (csDMARDs and/or bDMARDs). Incident users 
      of bDMARDs were matched on a dynamic PS to patients continuing csDMARDs. Their 
      risk of malignancy was compared by Cox model. RESULTS: From 1 January 2007 to 31 
      December 2014, 83 706 patients with RA started their first systemic treatment (63 
      837 remained on csDMARDs and 19 869 initiated a bDMARD during follow-up). After 
      dynamic PS matching, 19 727 bDMARD initiators were compared with 19 727 RA 
      remaining on csDMARDs. They did not statistically differ in risk of overall 
      malignancies (HR 0.99 (95% CI 0.86 to 1.14)), solid cancer (HR 0.95 (95% CI 0.82 
      to 1.11)), nor lymphoma (HR 1.35 (95% CI 0.72 to 2.53)). Results were similar 
      when bDMARDs were given as monotherapy or in association with csDMARDs. Analyses 
      restricted to patients starting TNF inhibitor as first bDMARD compared with 
      matched RA remaining on csDMARDs, provided similar results (HR for overall 
      malignancy 1.03 (95% CI 0.88 to 1.21)). Sensitivity analyses, varying carry-over 
      periods (up to 5 years) to define risk periods, provided similar results. 
      CONCLUSIONS: In this historical cohort study within the French nationwide 
      healthcare database, the risk of overall, solid or haematological malignancies 
      did not significantly differ between patients with RA initiating bDMARD and those 
      continuing csDMARDs.
CI  - (c) Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No 
      commercial re-use. See rights and permissions. Published by BMJ.
FAU - Seror, Raphaele
AU  - Seror R
AUID- ORCID: 0000-0002-5523-1856
AD  - Service de Rhumatologie, Assistance Publique - Hopitaux de Paris (AP-HP), Hopital 
      Bicetre, Universite Paris-Saclay, FHU CARE, Le Kremlin-Bicetre, France 
      raphaele.seror@aphp.fr.
AD  - INSERM UMR 1184, Universite Paris-Saclay, Faculte de Medecine, Le 
      Kremlin-Bicetre, France.
FAU - Lafourcade, Alexandre
AU  - Lafourcade A
AD  - Centre de Pharmacoepidemiologie (Cephepi), AP-HP. Sorbonne Universite, Hopital 
      Universitaire Pitie Salpetriere, Paris, France.
FAU - De Rycke, Yann
AU  - De Rycke Y
AD  - Departement Biostatistique Sante Publique et Information Medicale, Centre de 
      Pharmacoepidemiologie (Cephepi), CIC-1901, Sorbonne Universite, Faculte de 
      medecine Sorbonne Universite, AP-HP, Hopital Pitie-Salpetriere, Paris, France.
AD  - Institut Pierre Louis d'epidemiologie, Sorbonne University, INSERM UMR-S 1136, 
      Paris, France.
FAU - Pinto, Sandrine
AU  - Pinto S
AD  - Institut Pierre Louis d'epidemiologie, Sorbonne University, INSERM UMR-S 1136, 
      Paris, France.
FAU - Castaneda, Johann
AU  - Castaneda J
AD  - Centre de Pharmacoepidemiologie (Cephepi), AP-HP. Sorbonne Universite, Hopital 
      Universitaire Pitie Salpetriere, Paris, France.
FAU - Fautrel, Bruno
AU  - Fautrel B
AUID- ORCID: 0000-0001-8845-4274
AD  - Institut Pierre Louis d'epidemiologie, Sorbonne University, INSERM UMR-S 1136, 
      Paris, France.
AD  - Service de Rhumatologie, Sorbonne Universite, AP-HP.Sorbonne Universite, Hopital 
      Pitie Salpetriere, Paris, France.
FAU - Mariette, Xavier
AU  - Mariette X
AUID- ORCID: 0000-0002-4244-5417
AD  - Service de Rhumatologie, Assistance Publique - Hopitaux de Paris (AP-HP), Hopital 
      Bicetre, Universite Paris-Saclay, FHU CARE, Le Kremlin-Bicetre, France.
AD  - INSERM UMR 1184, Universite Paris-Saclay, Faculte de Medecine, Le 
      Kremlin-Bicetre, France.
FAU - Tubach, Florence
AU  - Tubach F
AD  - Departement Biostatistique Sante Publique et Information Medicale, Centre de 
      Pharmacoepidemiologie (Cephepi), CIC-1901, Sorbonne Universite, Faculte de 
      medecine Sorbonne Universite, AP-HP, Hopital Pitie-Salpetriere, Paris, France.
AD  - Institut Pierre Louis d'epidemiologie, Sorbonne University, INSERM UMR-S 1136, 
      Paris, France.
AD  - delete this affiliaton, Paris, France.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - RMD Open
JT  - RMD open
JID - 101662038
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Biological Factors)
RN  - 0 (Biological Products)
SB  - IM
MH  - Adult
MH  - *Antirheumatic Agents/adverse effects
MH  - *Arthritis, Rheumatoid/drug therapy/epidemiology
MH  - Biological Factors/therapeutic use
MH  - *Biological Products/adverse effects
MH  - Cohort Studies
MH  - Delivery of Health Care
MH  - Humans
MH  - *Neoplasms/epidemiology
MH  - Propensity Score
PMC - PMC9226991
OTO - NOTNLM
OT  - antirheumatic agents
OT  - arthritis, rheumatoid
OT  - biological therapy
OT  - epidemiology
COIS- Competing interests: BF received research grants from AbbVie, Lilly, MSD and 
      Pfizer, and consultancy fees from AbbVie, Amgen, Biogen, BMS, Celgene, Celltrion, 
      Fresenius Kabi, Gilead, Janssen, Lilly, Medac, MSD, Mylan, NORDIC Pharma, 
      Novartis, Pfizer, Roche, Sandoz, Sanofi-Genzyme, SOBI, UCB. FT is head of the 
      Centre de Pharmacoepidemiologie (Cephepi) of the Assistance Publique-Hopitaux de 
      Paris and of the Clinical Research Unit of Pitie-Salpetriere hospital, both these 
      structures have received research funding and grants for the research projects 
      handled and fees for consultant activities from a large number of pharmaceutical 
      companies, that have contributed indiscriminately to the salaries of its 
      employees. FT is not employed by these structures and did not receive any 
      personal remuneration from these companies. RS received honorarium from Amgen, 
      BMS, Fresenius Kabi, Boerhinger, GSK, Jansen, Pfizer, Roche. XM received 
      honorarium from BMS, Galapagos, Gilead, GSK, Jansen, Pfizer, Sanofi, UCB.
EDAT- 2022/06/24 06:00
MHDA- 2022/06/28 06:00
PMCR- 2022/06/22
CRDT- 2022/06/23 21:07
PHST- 2021/12/02 00:00 [received]
PHST- 2022/05/22 00:00 [accepted]
PHST- 2022/06/23 21:07 [entrez]
PHST- 2022/06/24 06:00 [pubmed]
PHST- 2022/06/28 06:00 [medline]
PHST- 2022/06/22 00:00 [pmc-release]
AID - rmdopen-2021-002139 [pii]
AID - 10.1136/rmdopen-2021-002139 [doi]
PST - ppublish
SO  - RMD Open. 2022 Jun;8(2):e002139. doi: 10.1136/rmdopen-2021-002139.