Impact of tumour necrosis factor inhibitor treatment on radiographic progression in rheumatoid arthritis patients in clinical practice: results from the nationwide Danish DANBIO registry
- Lykke Midtbøll Ørnbjerg1,
- Mikkel Østergaard1,
- Pernille Bøyesen2,
- Niels Steen Krogh3,
- Anja Thormann1,
- Ulrik Tarp4,
- Uta Engling Poulsen5,
- Jakob Espesen6,
- Vibeke Stevenius Ringsdal7,
- Niels Graudal8,
- Gina Kollerup9,
- Dorte Vendelbo Jensen10,
- Ole Rintek Madsen11,
- Bente Glintborg12,
- Torben Christensen13,
- Hanne Lindegaard14,
- Ditte Dencker15,
- Annette Hansen11,
- Anne Rødgaard Andersen16,
- Merete Lund Hetland1
- 1DANBIO registry and Department of Rheumatology, Copenhagen University Hospital Glostrup, Glostrup, Denmark
- 2Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway
- 3Zitelab Aps, Copenhagen, Denmark
- 4Department of Rheumatology, Aarhus University Hospital, Aarhus, Denmark
- 5Rheumatism Hospital, University of Southern Denmark, Gråsten, Denmark
- 6Department of Internal Medicine, Lillebælt Hospital, Vejle, Denmark
- 7Department of Rheumatology, Århus University Hospital, Aalborg, Denmark
- 8Department of Rheumatology, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark
- 9Department of Rheumatology, Copenhagen University Hospital Frederiksberg, Copenhagen, Denmark
- 10Department of Rheumatology, Helsingør Hospital, Helsingør, Denmark
- 11Department of Medicine/Rheumatology, Copenhagen University Hospital Gentofte, Gentofte, Denmark
- 12Department of Medicine, Holbæk Hospital, Holbæk, Denmark
- 13Department of Rheumatology, Copenhagen University Hospital Slagelse, Slagelse, Denmark
- 14Department of Rheumatology, Odense University Hospital, Odense, Denmark
- 15Department of Medicine, Hospital of South West Jutland, Esbjerg, Denmark
- 16Department of Rheumatology, Copenhagen University Hospital Glostrup, Glostrup, Denmark
- Correspondence to Lykke Midtbøll Ørnbjerg, DANBIO, Copenhagen University Hospital Glostrup, Department of Rheumatology, Nordre Ringvej 57, 2600 Glostrup, Denmark;
Contributors All co-authors fulfilled criteria for co-authorship according to the Vancouver protocol.
- Accepted 8 March 2012
- Published Online First 24 April 2012
Objectives To compare radiographic progression during treatment with disease-modifying antirheumatic drugs (DMARD) and subsequent treatment with tumour necrosis factor α inhibitors (TNF-I) in rheumatoid arthritis (RA) patients in clinical practice.
Methods Conventional radiographs (x-rays) of hands and wrists were obtained ∼2 years before start (prebaseline), at baseline and ∼2 years after start (follow-up) of TNF-I. Clinical data were obtained from the DANBIO registry and the patient files. x-Rays were scored blinded to chronology according to the Sharp/van der Heijde method. Annual radiographic progression rates during the DMARD (prebaseline to baseline x-ray) and TNF-I (baseline to follow-up x-ray) periods were calculated.
Results 517 RA patients (76% women, 80% IgM rheumatoid factor positive, 65% anticyclic citrullinated peptide positive, 40% current smokers, age 54 years (range 21–86), median disease duration 5 years (range 0–57)) were included. Patients were treated with infliximab (61%), etanercept (15%) or adalimumab (24%). During the DMARD period 85% of patients received methotrexate, 51% sulphasalazine and 78% prednisolone. The median DMARD period was 733 days (IQR 484–1002) and the median TNF-I period was 562 days (IQR 405–766). The median radiographic progression rate decreased from 0.7 (IQR 0–2.9) total Sharp score units/year (dTSS) in the DMARD period to 0 (0–0.9) units/year in the TNF-I period (p<0.0001, Wilcoxon). Corresponding mean dTSS values were 2.1 (SD 3.7) versus 0.7 (SD 2.3) units/year (p<0.0001, paired t test). 305 patients progressed (dTSS >0) in the DMARD period compared with 158 patients in the TNF-I period (p<0.0001, χ2).
Conclusion This nationwide observational study of RA patients documented significantly reduced radiographic progression during TNF-I treatment compared with the previous period of DMARD treatment.
Funding Danish Regions (ie, the hospital owners) gave financial support to DANBIO. Janssen Biologics (formerly Centocor) supported the present study with an unrestricted grant, while Abbott, Pfizer (formerly Wyeth) and MSD (formerly Schering-Plough) (since 2004), Bristol-Myers Squibb and Roche (since 2006), and UCB-Nordic (since 2007) have supported DANBIO with unrestricted grants. Janssen Biologics were allowed to comment on the work, but the authors had the full right to accept or refuse these comments. Except for this, the sponsors have had no influence on data collection, analysis or publication.
Competing interests MØ has received consulting fees, speaking fees or research grants from Abbott, Amgen, Bristol-Myers Squibb, Centocor/Janssen, Genmab, Glaxo-Smith-Kline, Mundipharma, Novo, Pfizer, Roche, Schering-Plough, UCB and Wyeth. UT has received consulting fees, speaking fees or research grants from Roche, Schering-Plough, Abbott and MSD. GK has received consulting fees, speaking fees or research grants from MSD. ORM has received consulting fees, speaking fees and research grants from Abbott, MSD, Pfizer, UCB, BMS, Amgen and Roche. HL has received consulting fees, speaking fees or research grants from Roche. AH has received consulting fees, speaking fees or research grants from Abbott, MSD and BMS. MLH has received consulting fees, speaking fees or research grants from Abbott, Bristol-Myers Squibb, Centocor/Janssen, Glaxo-Smith-Kline, MSD/Schering-Plough, Pfizer/Wyeth, Roche and UCB The remaining authors had no completing interests.
Ethics approval The study was based on data from the nationwide Danish DANBIO registry. DANBIO has been approved by The Danish Data Registry since the year 2000 (j.nr. 2007-58-0014 and j.nr. 2007-58-0006), and since October 2006 as a national quality registry by the National Board of Health (j.nr. 7-201-03-12/1). According to Danish law, informed consent and ethics approval were not required for the present study.
Provenance and peer review Not commissioned; externally peer reviewed.