Predictors of DAPSA28 Remission at 6 Months in Bio-Naive Patients with Psoriatic Arthritis Starting a TNF Inhibitor in Clinical Practice– Results from the EuroSpA Collaboration

Lykke Midtbøll Ørnbjerg¹, Stylianos Georgiadis ², Lennart Jacobsson ³, Anne Gitte Loft ⁴, Florenzo Iannone ⁵, Burkhard Moeller ⁶, Joe Sexton ⁷, Herman Mann ⁸, Maria José Santos ⁹, Manuel Pombo-Suarez ¹⁰, Kari K. Eklund ¹¹, Matija Tomsic ¹², Bjorn Gudbjornsson ¹³, Şükran Erten ¹⁴, Catalin Codreanu ¹⁵, Irene van der Horst-Bruinsma ¹⁶, Johan Wallman ¹⁷, Marco Sebastiani ¹⁸, Michael J. Nissen ¹⁹, Eirik Kristianslund ²⁰, Karel Pavelka ⁸, Elsa Vieira-Sousa ²¹, Carlos Sánchez-Piedra ²², Nina Trokovic ²³, Ziga Rotar ²⁴, Thorvardur J Love ²⁵, servet Yolbas ²⁶, Ruxandra IONESCU ²⁷, Marleen van de Sande ¹⁶, Gareth Jones ²⁸, Brigitte Michelsen ²⁹, Mikkel Østergaard ³⁰ and Merete Lund Hetland ¹, ¹DANBIO and Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre of Head and Orthopaedics, Rigshospitalet, Copenhagen, Denmark, ²DANBIO registry and Copenhagen Center for Arthritis Research, Centre for Rheumatology and Spine Diseases, Rigshospitalet, Copenhagen, Denmark, ³Dept of Rheumatology and Inflammation Research, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Sweden,, Gothenburg, Sweden, ⁴Department of Rheumatology, Aarhus University Hospital., Aarhus, Denmark, ⁵Department of Emergency and Transplantation , Rheumatology Unit, University Hospital of Bari, Bari, Italy., Bari, Italy, ⁶University Hospital Bern, Bern, Switzerland, ⁷Diakonhjemmet Hospital, Dept. of Rheumatology, Oslo, Norway, ⁸Institute of Rheumatology, Department of Rheumatology, 1st Faculty of Medicine, Prague, Czech Republic, Prague 2, Czech Republic, ⁹Rheumatology department, Hospital Garcia de Orta, Almada, Portugal, ¹⁰Unit Research, Spanish Society of Rheumatology, Madrid, Spain, ¹¹ROB-FIN registry, Department of Medicine, Helsinki University and University Hospital, Helsinki, Finland, ¹²Department of Rheumatology, University Medical Centre, Ljubjana, Slovenia, ¹³Centre for Rheumatology Research, Landspitali and Faculty of Medicine, University of Iceland, Reykjavik, Iceland, ¹⁴Yıldırım Beyazıt University, Ankara, Turkey, ¹⁵Center of Rheumatic Diseases, University of Medicine and Pharmacy, Bucharest, Romania., Bucharest, Romania, ¹⁶Amsterdam University Medical Center, Amsterdam, Netherlands, ¹⁷Department of Clinical Sciences Lund, Rheumatology Lund University, Lund, Sweden, ¹⁸Rheumatology Unit, Department of Surgery, Medicine, Dentistry and Morphological Sciences with Transplant Surgery, Oncology and Regenerative Medicine Relevance, Azienda Policlinico di Modena, University of Modena and Reggio Emilia, Modena, Italy, ¹⁹University Hospital Geneva, Geneva, Switzerland, ²⁰Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway., Oslo, Norway, ²¹Rheumatology and Metabolic Bone Diseases, Hospital de Santa Maria - Centro Hospitalar Lisboa Norte, EPE | Rheumatology Research Unit, Instituto de Medicina Molecular - Faculty of Medicine, University of Lisbon, Lisbon Academic Medical Centre, Lisbon, Portugal,, Lisbon, Portugal, ²²Research Unit, Spanish Society of Rheumatology, Madrid, Spain, ²³Helsinki University Central Hospital, Helsinki, Finland, ²⁴UMC LJUBLJANA, DPT. OF RHEUMATOLOGY, LJUBLJANA, Slovenia, ²⁵Faculty of Medicine, University of Iceland, Reykjavik, Iceland, ²⁶TURKBIO registry and Celal Bayar University School of Medicin, Division of Rheumatology, Malatya, Turkey, ²⁷SPITALUL CLINIC SFANTA MARIA, Bucharest, ²⁸University of Aberdeen, Aberdeen, United Kingdom, ²⁹EuroSpA Coordinating Center, Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre for Head and Orthopaedics, Rigshospitalet, Glostrup, Glostrup, Denmark, ³⁰Copenhagen Center for Arthritis Research, University of Copenhagen, Copenhagen, Denmark

Meeting: 2019 ACR/ARP Annual Meeting

Keywords: Psoriatic arthritis

Session Information

Date: Tuesday, November 12, 2019

Title: Spondyloarthritis Including Psoriatic Arthritis – Clinical Poster III: Psoriatic Arthritis, Clinical Features

Session Type: Poster Session (Tuesday)

Session Time: 9:00AM-11:00AM

Background/Purpose: Tumor necrosis factor inhibitors (TNFi) have contributed to improved prognosis in patients with psoriatic arthritis (PsA). However, many patients treated with TNFi fail to achieve a treatment target of remission. Hence, the aims of this study were to identify predictors of 6-month Disease Activity in Psoriatic Arthritis in 28 joints (DAPSA28)(1) remission (DAPSA28≤4) in bio-naive PsA patients starting TNFi in clinical practice and investigate the performance of the derived prediction model.

Methods: Pooled data from PsA patients in 13 European registries participating in the EuroSpA Research Collaboration were analyzed(2). Patients with a 6-month follow-up visit (time window 3-9 months) with data allowing for calculation of DAPSA28, were included. The study cohort was divided into a derivation and validation cohort (50% of patients from each registry in each sub-cohort). Logistic regression analyses were applied to identify conventional clinical variables (marked with bold in Table 1) associated with DAPSA28≤4 at 6 months in the derivation cohort. Missing covariate data were imputed with Multiple Imputation with Chained Equations. Variables with a p-value < 0.25 in univariate analyses were included in the initial multivariable model. A priori it was decided to adjust for age, gender and country. Purposeful selection guided removal of variables from the multivariable model. Model fit was tested in the validation cohort by area under the Receiver Operating Curve (ROC) and misclassification error.

Results: Of the 16,230 PsA patients in the EuroSpA database 7,975 patients initiating 1^st TNFi had a registered follow-up visit with registered variables for DAPSA28 calculation and were included in the study. The study cohort had slightly higher baseline disease activity than the patients without DAPSA28 assessment at follow-up (Table 1). At 6 months, 1,956 (24.5%) patients were in DAPSA28 remission. Based on univariate analyses, all tested variables except concomitant csDMARD and time since diagnosis were included in the initial multivariate model. The final multivariate model identified that current or past smoking, treatment start prior to 2009, normal CRP, high 28TJC, high global, fatigue and HAQ scores decreased the probability of DAPSA28 remission at 6 months (Table 2). The regression coefficients of the model were used to derive a prediction index for each patient in the validation cohort, determining their predicted probability of DAPSA28 remission at 6 months. The ability of the model to correctly predict DAPSA28 remission using different cut-offs for predicted probability are shown with the ROC (Figure 1). The fit was deemed reasonable (median area under the curve 0.75, misclassification error 0.22).

Conclusion: A prediction model based on conventional clinical variables correctly predicted DAPSA28 remission status at 6 months in 3 out of 4 patients in a validation cohort. Future studies should investigate the potential of improving the model by addition of imaging and soluble biomarkers.

Acknowledgements:

Novartis Pharma AG and IQVIA for supporting the EuroSpA collaboration.

References:

Michelsen et al. Ann Rheum Dis 2018;77(12):1736-41
Brahe et al. Arthritis Rheum 2018; 70 (suppl 10)

20190604_eurospa_abstract4.1_table1

Table 2_EuroSpA_study4.1_table2

20190603_EuroSpA_abstract4.1_figure1

Disclosure: L. Ørnbjerg, Novartis, 2; S. Georgiadis, Novartis, 2; L. Jacobsson, None; A. Loft, AbbVie, 5, 8, MSD, 5, 8, Novartis, 5, 8, Pfizer, 5, 8, UCB, 5, 8; F. Iannone, AbbVie, 5, 8, BMS, 5, 8, Janssen, 5, 8, lilly, 5, 8, Lilly, 5, 8, MSD, 2, 5, 8, Novartis, 5, 8, Pfizer, 5, 8, Roche, 5, 8, Sanofi, 5, 8, UCB, 5, 8; B. Moeller, AbbVie, 2, 8, Eli Lilly, 2, 8, Janssen, 2, 8, Merck, 2, 8, Novartis, 2, 8, Pfizer, 2, 8, UCB, 2, 9; J. Sexton, None; H. Mann, None; M. Santos, AbbVie, 8, Biogen, 8, Novartis, 8, Pfizer, 8, Roche, 8; M. Pombo-Suarez, None; K. Eklund, None; M. Tomsic, None; B. Gudbjornsson, Actavis, 8, Amgen, 8, Novartis, 8, Pfizer, 8; �. Erten, None; C. Codreanu, AbbVie, 5, 8, Egis, 5, 8, Eli-Lilly, 5, 8, Ewopharma, 5, 8, Mylan, 5, 8, Novartis/Sandoz, 5, 8, Pfizer, 5, 8, Roche, 5, 8, UCB, 5, 8; I. van der Horst-Bruinsma, AbbVie, 2, 5, 8, Bristol Myers-Squibb, 2, 5, 8, MSD, 2, 5, 8, Novartis, 2, 5, 8, Pfizer, 2, 5, 8, UCB Pharma, 2, 5, 8; J. Wallman, AbbVie, 5, Celgene, 5, Eli Lilly, 5, Novartis, 5, UCB Pharma, 5; M. Sebastiani, None; M. Nissen, Abbvie, Celgene, Lilly, MSD, Novartis, Pfizer, 5, 8; E. Kristianslund, None; K. Pavelka, AbbVie, 8, Abbvie, 5, 8, Amgen, 5, 8, BMS, 8, Egis, 5, 8, Lilly, 5, 8, MSD, 8, Novartis, 5, 8, Pfizer, 5, 8, Roche, 5, 8, UCB, 8; E. Vieira-Sousa, None; C. Sánchez-Piedra, None; N. Trokovic, None; Z. Rotar, AbbVie, 9, Amgen, 5, 8, Eli-Lilly, 9, MSD, 5, Novartis, 9, Pfizer, 9, Sanofi, 5; T. Love, None; s. Yolbas, None; R. IONESCU, Abbvie, 5, 8, Amgen, 5, 8, Alpha Sigma, 5, 8, BMS, 5, 8, Ewopharma, 5, 8, Lilly, 5, 8, Mylan, 5, 8, Novartis, 5, 8, MSD, 5, 8, Pfizer, 5, 8, UCB, 5, 8, Roche, 5, 8, Sandoz, 5, 8; M. van de Sande, Novartis, 2, 5, AbbVie, 5, Janssen, 2, Eli Lilly, 2; G. Jones, Celgene, 2; B. Michelsen, Novartis, 2; M. Østergaard, AbbVie, 2, 8, 9, Abbvie, 2, 5, 8, Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, UCB, 5, 8, Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli-Lilly, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, and UCB, 5, 8, Abbvie, Celgene, Centocor, Merck, and Novartis, 2, Abbvie, Celgene, Centocor, Merck, Novartis, 2, BMS, 2, 5, 8, 9, Boehringer Ingelheim, 5, 8, Boehringer-Ingelheim, 2, 8, Boehringer-ingelheim, 9, Celgene, 2, 5, 8, Centocor, 2, Eli Lilly, 5, 8, 9, Eli Lilly and Company, 5, 8, Eli-Lilly, 2, 8, Hospira, 2, 5, 8, Janssen, 2, 5, 8, 9, Merck, 2, 5, 8, 9, Novartis, 2, 5, 8, Novo, 2, 5, 8, Novo Nordisk, 5, 8, Orion, 2, 5, 8, Pfizer, 2, 5, 8, 9, Regeneron, 2, 5, 8, Roche, 2, 5, 8, roche, 9, Sandoz, 2, 8, Sanofi, 2, 8, UCB, 2, 5, 8; M. Lund Hetland, Abbvie, 2, AbbVie, 2, Biogen, 2, BMS, 2, CellTrion, 2, 9, MSD, 2, Novartis, 2, Orion, 2, Pfizer, 2, Samsung, 2, UCB, 2.

To cite this abstract in AMA style:

Ørnbjerg L, Georgiadis S, Jacobsson L, Loft A, Iannone F, Moeller B, Sexton J, Mann H, Santos M, Pombo-Suarez M, Eklund K, Tomsic M, Gudbjornsson B, Erten �, Codreanu C, van der Horst-Bruinsma I, Wallman J, Sebastiani M, Nissen M, Kristianslund E, Pavelka K, Vieira-Sousa E, Sánchez-Piedra C, Trokovic N, Rotar Z, Love T, Yolbas s, IONESCU R, van de Sande M, Jones G, Michelsen B, Østergaard M, Lund Hetland M. Predictors of DAPSA28 Remission at 6 Months in Bio-Naive Patients with Psoriatic Arthritis Starting a TNF Inhibitor in Clinical Practice– Results from the EuroSpA Collaboration [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/predictors-of-dapsa28-remission-at-6-months-in-bio-naive-patients-with-psoriatic-arthritis-starting-a-tnf-inhibitor-in-clinical-practice-results-from-the-eurospa-collaboration/. Accessed .

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