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Abstract Number: L09

A Multicenter Randomized Study in Early Rheumatoid Arthritis to Compare Active Conventional Therapy versus Three Biological Treatments: 24 Week Efficacy and Safety Results of the NORD-STAR Trial

Merete Lund Hetland1, Espen A Haavardsholm 2, Anna Rudin 3, Dan Nordström 4, Mike Nurmohamed 5, Bjorn Gudbjornsson 6, Jon Lampa 7, Kim Hørslev-Petersen 8, Till Uhlig 9, Gerdur Grondal 10, Mikkel Østergaard 11, Marte Heiberg 2, Jos Twisk 12, Kristina Lend 7, Simon Krabbe 13, Joakim Lindqvist 7, Anna-Karin Ekwall 14, Kathrine Lederballe Grøn 15, Meliha Kapetanovic 16, Francesca Faustini 7, Riitta Tuompo 17, Tove Lorenzen 18, Giovanni Cagnotto 19, Eva Baecklund 20, Oliver Hendricks 21, Daisy Vedder 22, Tuulikki Sokka-isler 23, Tomas Husmark 24, Maud-Kristine Aga Ljoså 25, Eli Brodin 26, Torkell Ellingsen 27, Annika Söderbergh 28, Milad Rizk 29, Åsa Reckner 30, Line Uhrenholt 31, Per Larsson 32, Soeren Just 33, David Stevens 34, Trine Laurberg 35, Gunnstein Bakland 36, Inge Christoffer Olsen 37, Ronald van Vollenhoven 38 and The NORD-STAR Study Group 39, 1DANBIO and Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre of Head and Orthopaedics, Rigshospitalet, Copenhagen, Denmark, 2Diakonhjemmet Hospital, Oslo, Norway, 3Dept Rheumatology and Inflammation Research, Sahlgrenska Academy at University of Gothenburg, Göteborg, Sweden, 4Department of Medicine, ROB-FIN, Helsinki University Hospital and Helsinki University, Helsinki, Finland., Helsinki, Finland, 5Amsterdam Rheumatology and immunology Center location Reade and Amsterdam UMC location VU medical center, Amsterdam, Netherlands, 6Centre for Rheumatology Research, Landspitali and Faculty of Medicine, University of Iceland, Reykjavik, Iceland, 7Karolinska Institutet, Stockholm, Sweden, 8Department of Rheumatology, King Christian X's Hospital for Rheumatic Diseases Graasten, Denmark, Graasten, Denmark, 9Diakonhjemmet Hospital, Dept. of Rheumatology / University of Oslo, Faculty of Medicine, Oslo, Norway, 10Department of Rheumatology, Landspitali and Centre for Rheumatology Research, Landspitali, Reykjavík, Iceland, 11Copenhagen Center for Arthritis Research, University of Copenhagen, Copenhagen, Denmark, 12Department of Epidemiology and Biostatistics, Amsterdam UMC, Amsterdam, Netherlands, 13Rigshospitalet, København, Denmark, 14University of Gothenburg, Kullavik, Sweden, 15Rigshospitalt Glostrup, Glostrup, Denmark, 16Lund University, Skane University Hospital, Department of Clinical Sciences Lund, Section of Rheumatology, Lund and Malmö, Sweden, Lund, Sweden, 17Helsinki University Hospital, Helsinki, Finland, 18Reumatologi, Regionshospitalet Silkeborg, Kolding, Denmark, 19Lund University, Malmö, Sweden, 20Uppsala University, Uppsala, Sweden, 21Danish Hospital for Rheumatic Diseases, Sønderborg, Denmark, 22Amsterdam Rheumatology & immunology Center / Reade, Amsterdam, Netherlands, 23Jyvaskyla Central Hospital, Jyvaskyla, Finland, 24Rheumatology Clinic, Falun, Sweden, 25Ålesund Hospital Helse Møre og Romsdal HF, Ålesund, Norway, 26Haukeland University Hospital, Bergen, Norway, 27Department of Rheumatology, Odense University Hospital, Denmark, Odense, Syddanmark, Denmark, 28Örebro University Hospital, Ôrebro, Sweden, 29Västmanlands Hospital, Västerås, Sweden, 30Rheumatology Department, Linkoping, Sweden, 31Aalborg Universitetshospital, Aalborg, Denmark, 32Center for Rheumatology, Academic Specialist Center, Stockholm Health Services, Stockholm, Sweden, Stockholm, Stockholms Lan, Sweden, 33Odense University Hospital, Odense, 34St. Olav's University Hospital, Trondheim, Norway, 35Aarhus University Hospital, Aarhus, Denmark, 36University Hospital of North Norway, Tromsø, Norway, 37Oslo University Hospital, Oslo, Norway, 38Amsterdam Rheumatology and immunology Center, Netherlands., Amsterdam, Netherlands, 39Site investigators in all participating countries, Stockholm, Sweden

Meeting: 2019 ACR/ARP Annual Meeting

Date of first publication: October 23, 2019

Keywords: Abatacept, certolizumab pegol, drug treatment, Late-Breaking 2019, Tocilizumab

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Session Information

Date: Tuesday, November 12, 2019

Title: Late-Breaking Abstracts ePoster

Session Type: Late-Breaking Abstract Poster Session

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

Background/Purpose: The optimal first-line treatment of patients (pts) with early rheumatoid arthritis (RA) is yet to be established. The primary aim was to assess and compare the proportion of pts who achieved remission with active conventional therapy (ACT) and with three different biologic therapies after 24 wks. Secondary aims were to assess and compare other efficacy measures and safety.

Methods: The investigator-initiated NORD-STAR trial (NCT01491815) was conducted in Sweden, Denmark, Norway, Finland, The Netherlands and Iceland. In this multicenter, randomized, open-label, blinded-assessor, phase 4 study pts with early RA (ACR/EULAR 2010 criteria, 18+ years old, < 24 months’ symptom duration, disease activity score (C-reactive protein, CRP (DAS28)) >3.2, ≥2 (of 66) swollen and ≥2 (68) tender joints, rheumatoid factor (RF) or anti-citrullinated protein antibody (ACPA) positive or CRP >10mg/L)) were recruited and randomized 1:1:1:1 (stratified by country, gender and ACPA). All received methotrexate (25 mg/week after one month). To this was added: Arm 1 (ACT): either oral prednisolone (tapered from 20 mg/d to 5 mg/d in 9 wks); or: sulphasalazine (2 g/day), hydroxychloroquine (35mg/kg/wk) and mandatory intra-articular (IA) triamcinolone hexacetonide (TCH) in ≤4 swollen joints (≤80 mg/visit up to wk 20); Arm 2 (CZP): certolizumab (CZP) 200 mg EOW SC (400 mg at 0, 2 and 4 wks); Arm 3 (ABA): abatacept 125 mg/wk SC; Arm 4 (TCZ): tocilizumab 8 mg/kg/4wks IV or 162 mg/wk SC. IA TCH was allowed in all arms up to wk 20. Primary outcome was clinical disease activity index remission (CDAI≤2.8) at wk 24 (ITT analysis). Dichotomous outcomes were analyzed by adjusted (stratification variables, age, body mass index (BMI) and baseline DAS28) logistic regression with non-responder imputation (NRI). Non-inferiority analyses (per protocol population) had a pre-specified margin of 15%.

Results: In total, 812 pts were randomized. At baseline age was 54.3±14.7 yrs (mean±SD), 31.2% were male, DAS28 5.0±1.1, 74.9% were RF positive and 81.9% ACPA positive, BMI 26.2±5.1 kg/m2, time since diagnosis 7 (1-18) days (median, IQR). Crude CDAI remission rates (ITT) were: ACT: 42.0%, CZP: 47.8%, ABA: 52.5%, TCZ: 41.0%. Figure 1 shows the estimated remission rates with 95% CI. Table 1 shows the primary and key secondary outcomes (ITT population). With ACT as the reference, the absolute difference in adjusted remission rate (delta) was 9% (95%CI: 0.1 to 19%) for ABA, 4% (-5 to 13%) for CZP and -1% (-10 to 9%) for TCZ. Differences in remission rates with CZP and TCZ, but not with ABA, remained within the pre-defined non-inferiority margin versus ACT (per-protocol population), Figure 2. Total numbers of (serious) adverse events (SAEs/total AEs) across ACT, CZP, ABA, TCZ were 13/552, 20/530, 10/527, 10/653, respectively.

Conclusion: High remission rates were found across all four treatment arms at 24 wks. Higher CDAI remission rate was observed for ABA versus ACT (delta 9%) and for CZP (4%), but not for TCZ (-1%). With the predefined 15% margin, ACT was non-inferior to CZP and TCZ, but not to ABA. These results underscore the efficacy and safety of active conventional therapy based on MTX combined with glucocorticoids and may guide future treatment strategies for early RA.

Figure 1.

Figure 2.


Disclosure: 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; E. Haavardsholm, None; A. Rudin, None; D. Nordström, AbbVie, 5, 8, BMS, 5, 8, Celgene, 5, 8, Lilly, 5, 8, MSD, 2, 4, 8, Novartis, 5, 8, Pfizer, 2, 5, 8, Roche, 2, 5, 8, UCB, 5, 8; M. Nurmohamed, AbbVie, 2, 8, BMS, 2, 8, Celgene, 2, 8, Eli Lilly, 2, 8, Janssen, 2, 8, Merck, 2, 8, Pfizer, 2, 8, Roche, 2, 8, UCB, 2, 8; B. Gudbjornsson, Actavis, 8, Amgen, 8, Novartis, 8, Pfizer, 8; J. Lampa, None; K. Hørslev-Petersen, AbbVie, 2, Pfizer, 9; T. Uhlig, None; G. Grondal, None; 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. Heiberg, None; J. Twisk, None; K. Lend, None; S. Krabbe, None; J. Lindqvist, None; A. Ekwall, AbbVie, 1, Pfizer, 1; K. Lederballe Grøn, BMS, 1; M. Kapetanovic, Abbvie, 5, Pfizer, 2; F. Faustini, None; R. Tuompo, Roche, 1, Novartis, 1; T. Lorenzen, None; G. Cagnotto, Novartis, 1; E. Baecklund, None; O. Hendricks, LILLY, 1, ABBVIE, 1, Novartis, 1; D. Vedder, None; T. Sokka-isler, None; T. Husmark, None; M. Ljoså, None; E. Brodin, None; T. Ellingsen, None; A. Söderbergh, None; M. Rizk, AbbVie, 1; Å. Reckner, None; L. Uhrenholt, None; P. Larsson, None; S. Just, None; D. Stevens, None; T. Laurberg, Abbvie, 1, UCB Nordic, 1; G. Bakland, Novartis, 1; I. Olsen, None; R. van Vollenhoven, None.

To cite this abstract in AMA style:

Lund Hetland M, Haavardsholm E, Rudin A, Nordström D, Nurmohamed M, Gudbjornsson B, Lampa J, Hørslev-Petersen K, Uhlig T, Grondal G, Østergaard M, Heiberg M, Twisk J, Lend K, Krabbe S, Lindqvist J, Ekwall A, Lederballe Grøn K, Kapetanovic M, Faustini F, Tuompo R, Lorenzen T, Cagnotto G, Baecklund E, Hendricks O, Vedder D, Sokka-isler T, Husmark T, Ljoså M, Brodin E, Ellingsen T, Söderbergh A, Rizk M, Reckner Å, Uhrenholt L, Larsson P, Just S, Stevens D, Laurberg T, Bakland G, Olsen I, van Vollenhoven R, NORD-STAR Study Group. A Multicenter Randomized Study in Early Rheumatoid Arthritis to Compare Active Conventional Therapy versus Three Biological Treatments: 24 Week Efficacy and Safety Results of the NORD-STAR Trial [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/a-multicenter-randomized-study-in-early-rheumatoid-arthritis-to-compare-active-conventional-therapy-versus-three-biological-treatments-24-week-efficacy-and-safety-results-of-the-nord-star-trial/. Accessed .
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