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Efficacy of biological disease-modifying antirheumatic drugs: a systematic literature review informing the 2016 update of the EULAR recommendations for the management of rheumatoid arthritis
  1. Jackie L Nam1,2,
  2. Kaoru Takase-Minegishi3,
  3. Sofia Ramiro4,
  4. Katerina Chatzidionysiou5,
  5. Josef S Smolen6,7,
  6. Désirée van der Heijde4,
  7. Johannes W Bijlsma8,
  8. Gerd R Burmester9,
  9. Maxime Dougados10,
  10. Marieke Scholte-Voshaar11,12,
  11. Ronald van Vollenhoven13,14,
  12. Robert Landewé13,15
  1. 1Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK
  2. 2NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust, Leeds, UK
  3. 3Center for Rheumatic Diseases, Yokohama City University Medical Center, Yokohama, Japan
  4. 4 
  5. 5Unit for Clinical Therapy Research, Inflammatory Diseases (ClinTRID), The Karolinska Institute, Stokholm, Sweden
  6. 6Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria
  7. 7Department of Medicine, Hietzing Hospital, Vienna, Austria
  8. 8Department of Rheumatology, University Medical Center Utrecht, Utrecht, The Netherlands
  9. 9Department of Rheumatology, Charité University Medicine Berlin, Berlin, Germany
  10. 10Department of Rheumatology, Paris Descartes University, Cochin Hospital, Assistance Publique-Hôpitaux de Paris, INSERM (U1153): Clinical Epidemiology and Biostatistics, Paris, France
  11. 11Department of Psychology, Health and Technology, University of Twente, Enschede, The Netherlands
  12. 12EULAR Standing Committee of People with Arthritis/Rheumatism in Europe
  13. 13Department of Clinical Immunology & Rheumatology, Amsterdam Rheumatology Center, Amsterdam, The Netherlands
  14. 14Department of Rheumatology, Amsterdam Rheumatology Center, Amsterdam, The Netherlands
  15. 15Department of Rheumatology, Zuyderland Medical Center, Heerlen, The Netherlands
  1. Correspondence to Dr Jackie L Nam, Department of Rheumatology, Second Floor, Chapel Allerton Hospital, Chapeltown Road, Leeds LS7 4SA, UK; J.Nam{at}


Objectives To update the evidence for the efficacy of biological disease-modifying antirheumatic drugs (bDMARDs) in patients with rheumatoid arthritis (RA) to inform European League Against Rheumatism (EULAR) Task Force treatment recommendations.

Methods MEDLINE, EMBASE and Cochrane databases were searched for phase III or IV (or phase II, if these studies were lacking) randomised controlled trials (RCTs) published between January 2013 and February 2016. Abstracts from the American College of Rheumatology and EULAR conferences were obtained.

Results The RCTs confirmed greater efficacy with a bDMARD+conventional synthetic DMARD (csDMARD) versus a csDMARDs alone (level 1A evidence). Using a treat-to-target strategy approach, commencing and escalating csDMARD therapy and adding a bDMARD in cases of non-response, is an effective approach (1B). If a bDMARD had failed, improvements in clinical response were seen on switching to another bDMARD (1A), but no clear advantage was seen for switching to an agent with another mode of action. Maintenance of clinical response in patients in remission or low disease activity was best when continuing rather than stopping a bDMARD, but bDMARD dose reduction or ‘spacing’ was possible, with a substantial proportion of patients achieving bDMARD-free remission (2B). RCTs have also demonstrated efficacy of several new bDMARDs and biosimilar DMARDs (1B).

Conclusions This systematic literature review consistently confirmed the previously reported efficacy of bDMARDs in RA and provided additional information on bDMARD switching and dose reduction.

  • Anti-TNF
  • DMARDs (biologic)
  • Rheumatoid Arthritis
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  • Correction notice This article has been corrected since it published Online First. Reference 8 has been updated.

  • Contributors JLN and KT extracted the data for the SLR. All coauthors contributed to the writing of the manuscript.

  • Competing interests JS: Amgen, Abbvie, Astra-Zeneca, Astro, BMS, Celgene, Glaxo, ILTOO, Janssen, Merck-Serono, MSD, Novartis-Sandoz, Pfizer, Roche-Chugai, Samsung, UCB. DvdH: AbbVie, Amgen, Astellas, AstraZeneca, BMS, Celgene, Daiichi, Eli-Lilly, Galapagos, Gilead, Merck, Novartis, Pfizer, Roche, Sanofi-Aventis, UCB, 5, Director of Imaging Rheumatology BV. JWB: Roche, AbbVie, Bristol-Myers Squibb, Merck Sharp & Dohme, Pfizer, UCB. GB: UCB, AbbVie, BMS, Hexal, Janssen, Lilly, MSD, Medimmune, Novartis, Pfizer, Sanofi, Roche. MD, AbbVie, Pfizer, Novartis, MSD. RvV: AbbVie, Bristol-Myers Squibb, GlaxoSmithKline, Pfizer, Roche, UCB Pharma, Biotest, Janssen, Eli-Lilly, Merck, Vertex. RL: AbbVie, Amgen, Centocor, Novartis, Pfizer, Roche, Schering-Plough, UCB, Pfizer, Ablynx, Amgen, Astra-Zeneca, Bristol Myers Squibb, Celgene, Janssen (formerly Centocor), Galapagos, Glaxo-Smith-Kline, Novartis, Novo-Nordisk, Merck, TiGenix, Rheumatology Consultancy BV.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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