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. 2019 Nov;78(11):1536-1544.
doi: 10.1136/annrheumdis-2019-215427. Epub 2019 Aug 20.

Treatment response and drug retention rates in 24 195 biologic-naïve patients with axial spondyloarthritis initiating TNFi treatment: routine care data from 12 registries in the EuroSpA collaboration

Lykke Midtbøll Ørnbjerg  1   2 , Cecilie Heegaard Brahe  3   2 , Johan Askling  4 , Adrian Ciurea  5 , Herman Mann  6 , Fatos Onen  7 , Eirik Klami Kristianslund  8 , Dan Nordström  9 , Maria Jose Santos  10 , Catalin Codreanu  11 , Juan Gómez-Reino  12 , Ziga Rotar  13 , Bjorn Gudbjornsson  14 , Daniela Di Giuseppe  4 , Michael J Nissen  15 , Karel Pavelka  6 , Merih Birlik  7 , Tore Kvien  8 , Kari Kalervo Eklund  16 , Anabela Barcelos  17 , Ruxandra Ionescu  11 , Carlos Sanchez-Piedra  12 , Matija Tomsic  13 , Árni Jón Geirsson  18 , Anne Gitte Loft  2 , Irene van der Horst-Bruinsma  19 , Gareth Jones  20 , Florenzo Iannone  21 , Lise Hyldstrup  1 , Niels Steen Krogh  22 , Merete Lund Hetland  1   23 , Mikkel Østergaard  1   23
Affiliations

Treatment response and drug retention rates in 24 195 biologic-naïve patients with axial spondyloarthritis initiating TNFi treatment: routine care data from 12 registries in the EuroSpA collaboration

Lykke Midtbøll Ørnbjerg et al. Ann Rheum Dis. 2019 Nov.

Abstract

Objective: To study drug retention and response rates in patients with axial spondyloarthritis (axSpA) initiating a first tumour necrosis factor inhibitor (TNFi).

Methods: Data from 12 European registries, prospectively collected in routine care, were pooled. TNFi retention rates (Kaplan-Meier statistics), Ankylosing Spondylitis Disease Activity Score (ASDAS) Inactive disease (<1.3), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) <40 mm and Assessment of SpondyloArthritis International Society responses (ASAS 20/40) were assessed at 6, 12 and 24 months.

Results: A first TNFi was initiated in 24 195 axSpA patients. Heterogeneity of baseline characteristics between registries was observed. Twelve-month retention was 80% (95% CI 79% to 80%), ranging from 71% to 94% across registries. At 6 months, ASDAS Inactive disease/BASDAI<40 rates were 33%/72% (LUNDEX-adjusted: 27%/59%), ASAS 20/40 response rates 64%/49% (LUNDEX-adjusted 52%/40%). In patients initiating first TNFi after 2009, 6097 patients was registered to fulfil ASAS criteria for axSpA, 2935 was registered to fulfil modified New York Criteria for Ankylosing Spondylitis and 1178 patients was registered as having non-radiographic axSpA. In nr-axSpA patients, we observed lower 12-month retention rates (73% (70%-76%)) and lower 6-month LUNDEX adjusted response rates (ASDAS Inactive disease/BASDAI40 20%/50%, ASAS 20/40 45%/33%). For patients initiating first TNFi after 2014, 12-month retention rate, but not 6-month response rate, was numerically higher compared with patients initiating TNFi in 2009-2014.

Conclusion: A large European database of patients with axSpA initiating a first TNFi treatment in routine care, demonstrated that 27% of patients achieved ASDAS inactive disease after 6 months, while 59% achieved BASDAI <40. Four of five patients continued treatment after 1 year.

Keywords: DMARDS (biologic); anti-TNF; epidemiology; outcomes research; spondyloarthritis.

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Conflict of interest statement

Competing interests: LMØ: Novartis; CHB: Novartis; JA: has entered into agreements with Abbvie, BMS, Lilly, Merck, Pfizer, Roche, Samsung Bioepis, and UCB, mainly for safety monitoring via the Swedish ARTIS system, and received a travel reimbursement from Novartis. Karolinska Institutet has received remuneration for JA’s participation in meetings arranged by Pfizer and by Lilly; AC: AbbVie, Celgene, Eli Lilly, Janssen-Cilag, MSD, Novartis, Pfizer and UCB; HM: AbbVie, MSD, Novartis, Pfizer, Sanofi; FO: Abbvie, Novartis, Pfizer, Roche, UCB; EKK: none; DN: AbbVie, BMS, Lilly, MSD, Novartis, Pfizer, Roche, Sandoz, UCB; MJS: Abbvie, Biogen, Roche, Lilly, Pfizer, Novartis; Catalin Codreanu: AbbVie, Amgen, Angellini, Astra Zeneca, BMS, Egis, MSD, Pfizer, Richter, Roche, Sanofi, Servier, Teva, UCB, Zentiva; JGR: none; ZR: speaker or consulting fees from Abbvie, Amgen, Biogen, CellGen, Eli-Lilly, Jansen, Medis, MSD, Novartis, Pfizer, and Roche. BioRx.si has received funding for clinical research paid to Društvo za razvoj revmatologije from AbbVie, Celgene, Celtrion, Eli Lilly, Johnson & Johnson, Medis, MSD, Novartis, Pfizer and Roche; BG: Amgen, Novartis, Pfizer; MJN: Abbvie, Lilly, Pfizer, Novartis; KP: AbbVie, Roche, Pfizer, Amgen, Sanofi, Egis, BMS, UCB, MSD, Eli Lilly; TKK: AbbVie, Biogen, BMS, Celltrion, Egis, Eli Lilly, MSD, Mylan, Novartis, Oktal, Orion Pharma, Hospira/Pfizer, Roche, Sandoz, Sanofi and UCB; AB: Abbvie, Lilly, MSD, Novartis, Pfizer; MT: Abbvie, Amgen, Biogen, CellGen, Eli-Lilly, Jansen, Medis, MSD, Novartis, Pfizer, and Roche; FI: BMS, Pfizer, Abbvie, UCB, Roche, Celgene, Eli-Lilly, Hospira, Janssen, Merck; LHH: Novartis; MØ: Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli-Lilly, Hospira, Janssen, Merck, Novartis, Orion, Pfizer, Regeneron, Roche, UCB; MLH: Abbvie, Biogen, BMS, CellTrion, MSD, Novartis, Orion, Pfizer, Samsung, UCB.

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