OP0109 CO-MEDICATION WITH A CONVENTIONAL SYNTHETIC DMARD IN PATIENTS WITH AXIAL SPONDYLOARTHRITIS IS ASSOCIATED WITH IMPROVED RETENTION OF TNF INHIBITORS: RESULTS FROM THE EUROSPA COLLABORATION
Authors: M. Nissen, B. Delcoigne, D. DI Giuseppe, L. T. H. Jacobsson, K. Fagerli, A. G. Loft, A. Ciurea, D. Nordström, Z. Rotar, F. Iannone, M. J. Santos, M. Pombo-Suarez, B. Gudbjornsson, H. Mann, N. Akkoc, C. Codreanu, I. Van der Horst-Bruinsma, B. Michelsen, G. Macfarlane, M. L. Hetland, M. Tomsic, B. Moeller, P. Ávila-Ribeiro, C. Sánchez-Piedra, H. Relas, A. J. Geirsson, L. Nekvindova, G. Yildirim Cetin, R. Ionescu, N. Steen Krogh, J. Askling, B. Glintborg, U. Lindström
Journal: Annals of the Rheumatic Diseases (2020)

Background: Axial spondylarthritis (axSpA) patients treated with a tumour necrosis factor inhibitor (TNFi) may receive a concomitant conventional synthetic disease-modifying anti-rheumatic drug (csDMARD), although the value of combination therapy remains unclear. Objectives: Describe the proportion and phenotype of patients with axSpA initiating their first TNFi as monotherapy compared to TNFi+csDMARD combination therapy, and to compare the 1-year TNFi retention between the two groups. Methods: Data from 13 European registries was collected. Two exposure treatment groups were defined: TNFi monotherapy at baseline (=TNFi start date) and TNFi+csDMARD combination therapy. TNFi retention rates were assessed with Kaplan-Meier curves for each country and combined. Hazard ratios (HR, 95% CI) for discontinuing the TNFi were obtained with Cox models: (i) crude; adjusted for (ii) country, and (iii) country, sex, age, calendar year, disease duration and BASDAI. Participating countries were dichotomized into two strata, depending on their 1-year retention rate being above (stratum A) or below (stratum B) the average retention rate across all countries. Results: 22,196 axSpA patients were included with 34% on TNFi+csDMARD combination therapy. Baseline characteristics are presented in table 1. Overall, the crude TNFi retention rate was marginally longer in the combination therapy group (80% (79-81%)) compared to the monotherapy group (78% (77-79%)) and was primarily driven by differences in stratum B (fig. 1). TNFi retention rates varied significantly across countries (range:-11.0% to +11.3%), with a clear distinction between the 2 strata. The HRs for discontinuation over 1-year (reference=TNFi monotherapy) in the 3 models were: (i) 0.88 (0.82-0.93), (ii) 0.87 (0.82-0.92), (iii) 0.88 (0.82-0.93). Table 1 Baseline characteristics All patients (n=22196) Country stratum A Country stratum B TNFi mono (n=4940) csDMARD + TNFi (n=2547) TNFi mono (n=9693) csDMARD + TNFi (n=5016) Age (years), mean (SD) 42.6 (12.5) 43.4 (12.0) 42.8 (12.2) 41.6 (12.7) 43.7 (12.7) Females, % 41.1 37.7 38.2 42.0 44.2 Disease duration (yrs), mean (SD) 5.7 (8.0) 6.2 (7.7) 6.7 (7.4) 4.9 (8.2) 6.1 (8.2) Enthesitis, % 50.3 16.7 33.9 57.8 59.7 SJC-28, median (IQR) 0 (0-1) 0 (0-0) 0 (0-2) 0 (0-0) 0 (0-2) VAS pain (0-100), mean (SD) 60.9 (24.5) 63.3 (26.5) 67.8 (23.3) 60.2 (23.4) 57.2 (24.3) CRP (mg/L), median (IQR) 8 (3-20) 7.8 (2-20) 18 (6.7-32.6) 6.0 (2.7-15) 8.0 (3-22) BASDAI (0-10), mean (SD) 5.7 (2.1) 5.7 (2.2) 6.2 (2.1) 5.6 (2.0) 5.4 (2.2) BASFI (0-10), mean (SD) 4.4 (2.5) 4.4 (2.6) 4.9 (2.5) 4.3 (2.4) 4.2 (2.9) ASDAS, mean (SD) 3.5 (1.1) 3.7 (1.0) 4.0 (1.0) 3.3 (1.0) 3.3 (1.1) On Infliximab, % 25.7 21 22 24 36 Baseline csDMARD use, % -Methotrexate 0 45 0 63 -Sulfasalazine 0 68 0 33 -Leflunomide 0 8 0 1 Conclusion: Considerable differences were observed across countries in the use of combination therapy and TNFi retention in axSpA patients. The overall 1-year TNFi retention was higher with csDMARD co-therapy compared to TNFi monotherapy. TNFi monotherapy had a 12-13% higher risk of treatment discontinuation. Acknowledgments: Novartis Pharma AG and IQVIA MN and BD participated equally Disclosure of Interests: Michael Nissen Grant/research support from: Abbvie, Consultant of: Novartis, Lilly, Abbvie, Celgene and Pfizer, Speakers bureau: Novartis, Lilly, Abbvie, Celgene and Pfizer, Bénédicte Delcoigne: None declared, Daniela Di Giuseppe: None declared, Lennart T.H. Jacobsson Consultant of: AbbVie, Eli Lilly, Janssen, Novartis and Pfizer, Karen Fagerli: None declared, Anne Gitte Loft Grant/research support from: Novartis, Consultant of: AbbVie, MSD, Novartis, Pfizer and UCB, Speakers bureau: AbbVie, MSD, Novartis, Pfizer and UCB, Adrian Ciurea Consultant of: Consulting and/or speaking fees from AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Merck Sharp &amp; Dohme, Novartis and Pfizer., Dan Nordström Consultant of: Abbvie, Celgene, Lilly, Novartis, Pfizer, Roche and UCB., Speakers bureau: Abbvie, Celgene, Lilly, Novartis, Pfizer, Roche and UCB., Ziga Rotar Consultant of: Speaker and consulting fees from Abbvie, Amgen, Biogen, Eli Lilly, Medis, MSD, Novartis, Pfizer, Roche, Sanofi., Speakers bureau: Speaker and consulting fees from Abbvie, Amgen, Biogen, Eli Lilly, Medis, MSD, Novartis, Pfizer, Roche, Sanofi., Florenzo Iannone Consultant of: Speaker and consulting fees from AbbVie, Eli Lilly, Novartis, Pfizer, Roche, Sanofi, UCB, MSD, Speakers bureau: Speaker and consulting fees from AbbVie, Eli Lilly, Novartis, Pfizer, Roche, Sanofi, UCB, MSD, Maria Jose Santos Speakers bureau: Novartis and Pfizer, Manuel Pombo-Suarez Consultant of: Janssen, Lilly, MSD and Sanofi., Speakers bureau: Janssen, Lilly, MSD and Sanofi., Björn Gudbjornsson Speakers bureau: Novartis and Amgen, Heřman Mann: None declared, Nurullah Akkoc: None declared, Catalin Codreanu Consultant of: Speaker and consulting fees from AbbVie, Accord Healthcare, Alfasigma, Egis, Eli Lilly, Ewopharma, Genesis, Mylan, Novartis, Pfizer, Roche, Sandoz, UCB, Speakers bureau: Speaker and consulting fees from AbbVie, Accord Healthcare, Alfasigma, Egis, Eli Lilly, Ewopharma, Genesis, Mylan, Novartis, Pfizer, Roche, Sandoz, UCB, Irene van der Horst-Bruinsma Grant/research support from: AbbVie, Novartis, Eli Lilly, Bristol-Myers Squibb, MSD, Pfizer, UCB Pharma, Consultant of: AbbVie, Novartis, Eli Lilly, Bristol-Myers Squibb, MSD, Pfizer, UCB Pharma, Brigitte Michelsen: None declared, Gary Macfarlane: None declared, Merete L. Hetland Grant/research support from: BMS, MSD, AbbVie, Roche, Novartis, Biogen and Pfizer, Consultant of: Eli Lilly, Speakers bureau: Orion Pharma, Biogen, Pfizer, CellTrion, Merck and Samsung Bioepis, Matija Tomsic: None declared, Burkhard Moeller: None declared, Pedro Ávila-Ribeiro Grant/research support from: Novartis, Carlos Sánchez-Piedra: None declared, Heikki Relas Grant/research support from: Abbvie., Consultant of: Abbvie, Celgene, and Pfizer., Speakers bureau: Abbvie, Celgene, and Pfizer., Arni Jon Geirsson: None declared, Lucie Nekvindova: None declared, Gozde Yildirim Cetin Speakers bureau: AbbVie, Novartis, Pfizer, Roche, UCB, MSD, Ruxandra Ionescu Consultant of: Consulting fees from Abbvie, Eli-Lilly, Novartis, Pfizer, Roche, Sandoz, Speakers bureau: Consulting and speaker fees from Abbvie, Eli-Lilly, Novartis, Pfizer, Roche, Sandoz, Niels Steen Krogh: None declared, Johan Askling Grant/research support from: JA acts or has acted as PI for agreements between Karolinska Institutet and the following entities, mainly in the context of the ARTIS national safety monitoring programme of immunomodulators in rheumatology: Abbvie, BMS, Eli Lilly, Merck, MSD, Pfizer, Roche, Samsung Bioepis, Sanofi, and UCB Pharma, Bente Glintborg Grant/research support from: Grants from Pfizer, Biogen and Abbvie, Ulf Lindström: None declared