Clinical Predictors of TNF-Inhibitor Free Disease Control in Patients with Rheumatoid Arthritis after Stopping TNFi Treatment: Results from a Dutch Multicentre Pragmatic Open-Label Randomized Controlled Trial.

Marjan Ghiti Moghadam¹, Harald E. Vonkeman², Peter M. ten Klooster^3,4, Femke Lamers-Karnebeek⁵, Janneke Tekstra⁶, Barbara van Schaeybroeck⁷, Ruth Klaasen⁸, Marieke van Onna⁹, Hein J. Bernelot Moens¹⁰, H. Visser¹¹, Annemarie Schilder¹², Mark R. Kok¹³, Robert Landewé¹⁴, Piet L.C.M. van Riel¹⁵, Mart A.F.J. van de Laar¹⁶ and Tim Jansen¹⁷, ¹rheumatology, Arthritis Centre Twente, University of Twente and Medisch Spectrum Twente, Enschede, The Netherlands, Enschede, Netherlands, ²Rheumatology Center Twente, Medisch Spectrum Twente & Twente University, Enschede, Netherlands, ³Psychology, Health & Technology, University of Twente, Enschede, Netherlands, ⁴Arthritis Centre Twente, University of Twente and Medisch Spectrum Twente, Enschede, The Netherlands, Enschede, Netherlands, ⁵rheumatology, RadboudUMC, Nijmegen, Netherlands, ⁶Dept. Rheumatology & Clinical Immunology, University Medical Center Utrecht, Utrecht, Netherlands, ⁷Rheumatology, Albert Schweitzer MC, Dordrecht, Netherlands, ⁸Rheumatology, Meander MC, Amersfoort, Netherlands, ⁹Huispostnummer F4-105, PO Box, AMC medical centre, Amsterdam, Netherlands, ¹⁰rheumatology, Ziekenhuisgroep Twente, Almelo, Netherlands, ¹¹Department of Rheumatolgy, Rijnstate Hospital Arnhem, Arnhem, Netherlands, ¹²Rheumatology, Medisch Centrum Leeuwarden, Leeuwarden, Netherlands, ¹³Rheumatology, Maaststadziekenhuis, Rotterdam, Netherlands, ¹⁴University of Amsterdam, Amsterdam, Netherlands, ¹⁵IQ Health Care, radboudUMC, Nijmegen, Netherlands, ¹⁶Rheymatology, Arthritis Centre Twente, University of Twente and Medisch Spectrum Twente, Enschede, Netherlands, ¹⁷VieCuri Medical Center, Venlo, Netherlands

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: rheumatoid arthritis (RA) and tumor necrosis factor (TNF)

Session Information

Date: Tuesday, November 15, 2016

Title: Rheumatoid Arthritis – Clinical Aspects IV: Managing Patients in Remission

Session Type: ACR Concurrent Abstract Session

Session Time: 2:30PM-4:00PM

Background/Purpose: Tumor Necrosis Factor inhibitor (TNFi) free prolonged acceptable disease control in patients with rheumatoid arthritis (RA), in stable remission or low disease activity (LDA) during treatment with TNFi will benefit the balance between costs and effects. Therefore, using the data from the POET study, we evaluated the available potential clinical predictors of prolonged disease control after discontinuation of TNFi.

Methods: Data of 439 RA patients who were randomized to stop TNFi treatment in the POET study were analyzed post-hoc. The indicator of prolonged acceptable disease control over 12 months was: not restarting TNFi treatment. Available potential clinical predictors were: type of TNFi (antibody vs. receptor antagonist); concomitant conventional systemic DMARD; female sex; Younger age (<60 yrs.); short disease duration (<10 yrs.); RF positive; ACPA positive; erosive disease; normal weight (BMI 18.5 – 25); first TNFi; DAS28 deep remission (DAS28 ≤1.98) and MBDAscore ≤44, all at baseline. Associations between potential clinical predictors and disease relapse versus prolonged acceptable disease control were examined using univariate analysis and multivariate logistic regression.

Results: In the POET study 439 stable controlled RA-patients in remission or low-disease activity stopped their TNFi. During the following 12 months observation 50,1% of patients remained in low disease activity or remission. <span”>Univariate analysis revealed an association of the following predictors: type of TNFi (antibody vs. receptor antagonist) OR: 2.26(1.53–3.34) p<0.0001; Short disease duration OR: 1.88(1.26–2.79) p=0.002; absences of erosions OR: 1.62(1.08–2.44) p=0.020 and MBDA score ≤44 OR: 2.32(1.32–4.05) p=0.003.Multivariate (backward deletion) of potential clinical predictors of prolonged acceptable disease control after TNFi discontinuation are: Type of TNFi (antibody vs. receptor antagonist) OR:2.39(1.57 – 3.65) p<0.0001; Short disease duration (<10 yrs.) OR 2.02 (1.34 – 3.05) p=0.001; and MBDA ≤44 OR: 2.01 (1.11 – 3.65) p= 0.022.

Conclusion: This post hoc analysis in well-controlled RA patients stopping their TNFi during participations in the POET study suggests that patients characterized by the use of an TNFi antibody (predominatly adalumimab but including infliximab, golumimab and certoluzimab) with a short disease duration and a low MBDA score are likely to remain well-controlled (remission or low disease activity) during the following 12 months. Their littermates using a receptor antagonist (etanercept) with a longstanding disease and a high MBDA are most likely to flare. These data allow the well-controlled RA-patient using a TNFi and their attending physician to make an educated shared decision on continuation or stopping this expensive treatment.

Disclosure: M. Ghiti Moghadam, None; H. E. Vonkeman, None; P. M. ten Klooster, None; F. Lamers-Karnebeek, None; J. Tekstra, None; B. van Schaeybroeck, None; R. Klaasen, None; M. van Onna, None; H. J. Bernelot Moens, None; H. Visser, None; A. Schilder, None; M. R. Kok, None; R. Landewé, Abbott, Amgen, Centocor, Novartis, Pfizer, Roche, Schering-Plough, UCB and Wyeth, 2,Abbott/AbbVie, Ablynx, Amgen, Astra-Zeneca, BMS, Janssen (formerly Centocor), GSK, Merck, Novo-Nordisk, Novartis, Pfizer, Roche, Schering-Plough, TiGenics, UCB, and Wyeth, 5,Director of Rheumatology Consultancy BV, 6,Abbott, Amgen, Centocor, Novartis, Pfizer, Roche, Schering-Plough, UCB and Wyeth, 8; P. L. C. M. van Riel, None; M. A. F. J. van de Laar, None; T. Jansen, None.

To cite this abstract in AMA style:

Ghiti Moghadam M, Vonkeman HE, ten Klooster PM, Lamers-Karnebeek F, Tekstra J, van Schaeybroeck B, Klaasen R, van Onna M, Bernelot Moens HJ, Visser H, Schilder A, Kok MR, Landewé R, van Riel PLCM, van de Laar MAFJ, Jansen T. Clinical Predictors of TNF-Inhibitor Free Disease Control in Patients with Rheumatoid Arthritis after Stopping TNFi Treatment: Results from a Dutch Multicentre Pragmatic Open-Label Randomized Controlled Trial. [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/clinical-predictors-of-tnf-inhibitor-free-disease-control-in-patients-with-rheumatoid-arthritis-after-stopping-tnfi-treatment-results-from-a-dutch-multicentre-pragmatic-open-label-randomized-con/. Accessed .

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