PMID- 28270933
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20191120
IS  - 2056-5933 (Print)
IS  - 2056-5933 (Electronic)
IS  - 2056-5933 (Linking)
VI  - 3
IP  - 1
DP  - 2017
TI  - No impact of concomitant methotrexate use on serious adverse event and serious 
      infection risk in patients with rheumatoid arthritis treated with bDMARDs: a 
      systematic literature review and meta-analysis.
PG  - e000352
LID - 10.1136/rmdopen-2016-000352 [doi]
LID - e000352
AB  - OBJECTIVES: To compare the risk of serious adverse events, serious infections and 
      death caused by methotrexate and biological disease-modifying antirheumatic drug 
      (bDMARD) combination therapy versus a bDMARD prescribed as monotherapy in 
      rheumatoid arthritis (RA). METHODS: A systematic literature review was conducted 
      until February 2016 in PubMed, Embase and Cochrane Library databases by selecting 
      randomised controlled trials comparing methotrexate and bDMARD combination 
      therapy to bDMARD monotherapy in RA. The meta-analysis compared the occurrence of 
      (1) serious adverse events, (2) serious infections and (3) death among these 
      groups by the Mantel-Haenszel method. RESULTS: The literature review selected 16 
      controlled trials comparing methotrexate and bDMARD combination therapy to bDMARD 
      monotherapy. After meta-analysis comparing patients under monotherapy to those 
      under combination therapy: (1) the risk of occurrence of serious adverse events 
      was comparable in 12 trials: RR (95% CI) 0.92 (0.78 to 1.08). (2) No significant 
      difference was observed in the risk of occurrence of serious infections in 13 
      trials: RR (95% CI) 1.15 (0.84 to 1.58). We noted a trend, although 
      insignificant, towards a high risk of the occurrence of tuberculosis in 10 
      studies: RR (95% CI) 1.78 (0.63 to 4.99). (3) The risk of death was comparable in 
      12 trials: RR (95% CI) 0.73 (0.40 to 1.35). CONCLUSIONS: The results showed no 
      significant difference between the two groups, confirming that the use of 
      methotrexate and bDMARD combination therapy in RA does not cause an increased 
      risk of serious adverse events or serious infections or death compared with 
      bDMARD monotherapy.
FAU - Baradat, Claire
AU  - Baradat C
AD  - Rheumatology Center, Purpan Teaching Hospital, CHU of Toulouse, Toulouse, France; 
      Paul Sabatier University, Toulouse, France.
FAU - Degboe, Yannick
AU  - Degboe Y
AD  - Rheumatology Center, Purpan Teaching Hospital, CHU of Toulouse, Toulouse, France; 
      Paul Sabatier University, Toulouse, France; Inserm, UMR 1043, Toulouse, France.
FAU - Constantin, Arnaud
AU  - Constantin A
AD  - Rheumatology Center, Purpan Teaching Hospital, CHU of Toulouse, Toulouse, France; 
      Paul Sabatier University, Toulouse, France; Inserm, UMR 1043, Toulouse, France.
FAU - Cantagrel, Alain
AU  - Cantagrel A
AD  - Rheumatology Center, Purpan Teaching Hospital, CHU of Toulouse, Toulouse, France; 
      Paul Sabatier University, Toulouse, France; Inserm, UMR 1043, Toulouse, France.
FAU - Ruyssen-Witrand, Adeline
AU  - Ruyssen-Witrand A
AD  - Rheumatology Center, Purpan Teaching Hospital, CHU of Toulouse, Toulouse, France; 
      Paul Sabatier University, Toulouse, France; Inserm, UMR 1027, Toulouse, France.
LA  - eng
PT  - Journal Article
DEP - 20170222
PL  - England
TA  - RMD Open
JT  - RMD open
JID - 101662038
PMC - PMC5337718
OTO - NOTNLM
OT  - DMARDs (biologic)
OT  - Methotrexate
OT  - Rheumatoid Arthritis
COIS- Competing interests: None declared.
EDAT- 2017/03/09 06:00
MHDA- 2017/03/09 06:01
PMCR- 2017/02/22
CRDT- 2017/03/09 06:00
PHST- 2016/08/24 00:00 [received]
PHST- 2016/11/02 00:00 [revised]
PHST- 2016/11/07 00:00 [accepted]
PHST- 2017/03/09 06:00 [entrez]
PHST- 2017/03/09 06:00 [pubmed]
PHST- 2017/03/09 06:01 [medline]
PHST- 2017/02/22 00:00 [pmc-release]
AID - rmdopen-2016-000352 [pii]
AID - 10.1136/rmdopen-2016-000352 [doi]
PST - epublish
SO  - RMD Open. 2017 Feb 22;3(1):e000352. doi: 10.1136/rmdopen-2016-000352. eCollection 
      2017.