Background: Methotrexate (MTX) is the anchor and most prescribed disease-modifying anti-rheumatic drug (DMARD) for inflammatory rheumatic diseases (IRDs). MTX can be very efficacious but can also have serious, life-threatening side effects. Adequate education and follow-up of patients/carers are therefore essential, and dedicated rheumatology nurse consultations are an important part of this. However, many patients across European countries lack access to nurse consultations, and there are no agreed-upon, defined standards of care for this topic. Objectives: To develop points to consider (PtC), based on the best available evidence and experts’ opinion, on the nursing education of patients (or carers) with IRDs taking MTX. Methods: A task force of adult and pediatric nurses (n=19) from 16 European countries, one rheumatologist, one pharmacist, and three patient-representatives, was established by the Portuguese Association of Health Professionals in Rheumatology. The group convened virtually to discuss the protocol for developing the PtC, including the research questions for a scoping review and for a European survey to collect patients’/careers’, nurses’ and rheumatologists’ experiences and perceptions about MTX education. The results from these studies informed the development of the PtC statements, which were discussed and voted on in two virtual meetings and one online questionnaire. EULAR Standard Operating Procedures for the development of recommendations/PtC were followed. Results: The consensus resulted in three overarching principles and six PtC. All PtC were based on available scientific evidence, and all obtained high levels of agreement (>8/10). These PtC emphasize the need for continuous, tailored education by trained nurses, the availability of diverse educational methods, and the support for self-management and adherence strategies. Conclusion: A set of PtC has been developed to improve the quality of care provided to patients with IRDs and their carers regarding the education and support nurses should provide on MTX use. The ultimate goal is to optimize MTX intake, improve efficacy, reduce side effects and ensure adherence to treatment. A plan is underway for the European implementation of these PtC, recognizing the crucial relevance of multi-professional rheumatology teamwork.

Background: Novel follow-up strategies such as Remote Monitoring and Patient-initiated Care may allow for more targeted and efficient use of health-care resources compared to conventional prescheduled face-to-face outpatient visits. However, knowledge regarding the effectiveness of these strategies is scarce. This is the first randomized clinical trial assessing novel follow-up strategies, Remote Monitoring and Patient-initiated Care, versus Usual Care, in axial spondyloarthritis (axSpA). Objectives: To determine whether (i) Remote Monitoring or (ii) Patient-initiated Care for axSpA were non-inferior to (iii) Usual Care in maintaining low disease activity (Ankylosing Spondylitis Disease Activity Score (ASDAS) <2.1) over 18 months. Methods: ReMonit is a three-armed, single-center, parallel-group, randomized, controlled, open-label non-inferiority trial assessing patients with axSpA in low disease activity on stable treatment with a tumor necrosis factor inhibitor (TNFi). Patients were randomized 1:1:1 to Usual Care with face-to-face hospital visits every six months, Remote Monitoring with monthly digital reporting of patient-reported outcomes (PROs) and no prescheduled visits, or Patient-initiated Care with self-monitoring and no prescheduled visits during the 18-months follow-up. In Remote Monitoring, patients were contacted if the PROs exceeded a pre-defined value (Bath Ankylosing Disease Activity Index ≥4), and were offered a consultation. Patients in all groups could contact the study nurse and request a consultation. The primary endpoint was low disease activity (ASDAS <2.1) evaluated at three timepoints, at 6, 12, as well as 18 months for each patient. Secondary outcomes included other measures of disease activity (ASDAS continuous, C-reactive protein), physical function (Bath Ankylosing Spondylitis Functional Index), patient satisfaction with care, and number of consultations and telephone calls with a rheumatologist or a rheumatology nurse. Mixed effect logistic regression was used to estimate the group-specific marginal probability of ASDAS <2.1 across 6, 12 and 18 months. The non-inferiority of Remote Monitoring vs. Usual Care, and Patient-initiated Care vs. Usual Care was assessed for the between-group differences in the probability of ASDAS <2.1, using a family-wise error rate of 2.5% and a non-inferiority (NI) margin of 15%. If Patient-initiated Care was shown to be non-inferior to Usual Care, it was predefined to assess non-inferiority of Patient-initiated Care vs. Remote Monitoring [1]. ClinicalTrials.gov no. NCT06211322. Results: Of 346 screened patients, 242 were enrolled between September 2021 and June 2022 and randomly allocated to the 3 study arms (Usual Care: n=82, Remote Monitoring: n=79, Patient-initiated Care: n=81). The mean age was 44 years (SD 12), 182 (75%) were males, and mean ASDAS was 1.0 (SD 0.5) at baseline, with balanced study groups. No significant between group differences in ASDAS<2.1 were seen, and upper boundary of 95% CI was well below NI-margin (Figure 1). Both Remote Monitoring and Patient-initiated Care were deemed non-inferior to Usual Care, and Patient-initiated Care to Remote Monitoring. Secondary endpoints on disease activity and function were comparable (Figure 2). Patient satisfaction with care was similar across the three study arms at all timepoints with >90% reporting to be satisfied or very satisfied with the follow-up. The number of consultations were higher in Usual Care than in Remote Monitoring and Patient-initiated Care, but number of telephone calls was higher in Remote Monitoring than Usual Care and Patient Initiated Care (Figure 2). Conclusion: In this study, Remote Monitoring and Patient-initiated Care were both non-inferior to Usual Care in maintaining low disease activity in axial spondyloarthritis over an 18-month period. Patient-initiated Care was also non-inferior to Remote Monitoring. The results indicate that such follow-up strategies could be implemented in patients with axSpA in low disease activity, as an alternative to regular outpatient visits to optimize health care recourses. REFERENCES: [1] Berg et al. JMIR Res Protoc. 2023 Dec 27;12:e52872. Acknowledgements: NIL. Disclosure of Interests: Inger Jorid Berg Has received fees from Novartis in 2019 outside the submitted work, Joseph Sexton: None declared, Eirik Kristianslund: None declared, Anne Therese Tveter: None declared, Gunnstein Bakland From UCB, outside the submitted work, Laure Gossec grants or personal fees from AbbVie, Amgen, Biogen, BMS, Celltrion, Galapagos, Janssen, Lilly, MSD, Novartis, Pfizer, Sandoz, Stada and UCB outside the submitted work, Espen A Haavardsholm speaker or consultant fees from Pfizer, AbbVie, UCB Pharma, Eli Lilly, Novartis, and Boehringer Ingelheim outside the submitted work, speaker or consultant fees from Pfizer, AbbVie, UCB Pharma, Eli Lilly, Novartis, and Boehringer Ingelheim outside the submitted work, Sarah Hakim: None declared, Gary J. Macfarlane: None declared, Ellen Moholt: None declared, Sella Aarrestad Provan speaker or consultant fees from Pfizer and Boehringer Ingelheim outside the submitted work, research grant from Boehringer Ingelheim outside the submitted work, Emil Eirik Kvernberg Thomassen: None declared, Annette de Thurah: None declared, Siri Lillegraven: None declared, Nina Osteras: None declared.

Background: Tapering of tumor necrosis factor inhibitor (TNFi) treatment in patients who have reached sustained remission is debated in current guidelines, and further data are needed regarding the long-term consequences of such strategies. Objectives: To assess the 3-year effects of tapering and withdrawal of TNFi versus continuing stable TNFi on disease activity flare, radiographic joint damage and remission status among RA patients in sustained remission. Methods: ARCTIC REWIND was a randomized, multicenter, open-label, non-inferiority trial including RA patients in sustained remission for ≥12 months on stable TNFi therapy, with no swollen joints at inclusion. Patients were randomized 1:1 to tapering to withdrawal of TNFi (four months half-dose, thereafter withdrawal) or continue stable TNFi therapy, with scheduled visits every four months for 3 years. Full-dose TNFi therapy was reinstated if a flare occurred. The primary endpoint of the current study was flare in disease activity over 3 years. A flare was defined as a combination of DAS>1.6 (loss of remission status), an increase in DAS ≥0.6 units (change above minimal detectable change) and ≥2 swollen joints, or if the physician and patient agreed that a clinically significant flare had occurred. Secondary endpoints included remission status (ACR/EULAR Boolean 2.0 and DAS), 3-year change in radiographic joint damage assessed by van der Heijde modified Sharp Score, medication use and adverse events (AE). Data were analysed in the per protocol population adjusting for center as a stratification factor. Flare-free survival was evaluated by Kaplan-Meier and risk of flare by Cox regression, remission status and radiographic change by logistic and linear regression. Results: Of 99 randomised patients, 92 received the allocated therapy, and 80 (87%) completed 3-year follow-up. Mean baseline DAS (SD) was 0.8 (0.3) in the tapering TNFi group, and 0.9 (0.4) in the stable TNFi group. csDMARD co-medication was used by 89% in the tapering group and 91% in the stable group. After 3 years, 25% (95% CI: 13 to 38) remained flare-free in the tapering TNFi group compared to 85% (70 to 93) in the stable TNFi group (Figure 1), with corresponding hazard ratio for flare of 9.4 (3.9 to 22.8), p<0.0001. Most patients regained DAS remission within the next visit after a flare (84% in the tapering group, 67% in the stable group). We observed significantly lower Boolean 2.0 remission rates in the tapering TNFi group than the stable TNFi group throughout the study period (Figure 2), adjusted risk difference 0-36 months -24% (-33 to -15), p<0.0001 (Boolean 1.0 revealed similar results). The median radiographic changes after 3 years were minimal; 0.5 (95% CI: 0.0 to 2.0) in the tapering group versus 0.5 (0.0 to 1.5) in the stable group, with no significant difference between groups, p-value=0.6. Systemic glucocorticoids (≥1 treatment period during the study) were used by 23% in the tapering TNFi group and 13% in the stable TNFi group during the study, while 10% switched to other types of TNFi or JAK inhibitor treatment in the tapering group, and 11% in the stable group. AE/serious AE occurred in 81%/21% of the patients in the tapering group, and 87%/11% of the patients in the stable group. Conclusion: A large majority of RA patients in remission tapering TNFi to withdrawal experienced a flare within three years, while a minority of patients receiving stable TNFi treatment flared over the same time period. Even though most patients regained remission within the next visit after a flare, TNFi tapering was associated with significantly lower Boolean 2.0 remission rates throughout the study. These findings do not support tapering of TNFi treatment among RA patients in sustained remission. REFERENCES: NIL. Acknowledgements: NIL. Disclosure of Interests: Kaja E. Kjørholt: None declared, Nina Paulshus Sundlisæter: None declared, Anna-Birgitte Aga AbbVie, Lilly, Novartis, Pfizer, Joe Sexton: None declared, Inge C. Olsen Dilafor AB, EU Commission, Åse Lexberg: None declared, Tor Magne Madland Boehringer 2022, Hallvard Fremstad: None declared, Christian A. Høili: None declared, Gunnstein Bakland UCB (Organizing meeting), Cristina Spada Advisory board UCB, Hilde Haukeland Advisory borad for UCB Pharma x2 in 2022., Inger M. Hansen: None declared, Ellen Moholt: None declared, Karen Holten: None declared, Till Uhlig Lilys, Galapagos, Pfizer and UCB, Lilly, Galapagos, Pfizer and UCB, Tore K. Kvien Grünenthal, Janssen, Sandoz, AbbVie, Galapagos, Gilead, Janssen, Novartis, Pfizer, Sandoz, UCB, AbbVie, BMS, Novartis, Pfizer, UCB, Daniel H. Solomon Royalties on several UpToDate chapters on NSAIDs and coxibs. CARRA; unpaid board member., CorEvitas, Horizon, Janssen, Moderna and Novartis provide research support through contracts with Brigham and Women's Hospital for unrelated work., Désirée van der Heijde Director of Imaging Rheumatology, AbbVie, BMS, Galapagos, Glaxo-Smith-Kline, Janssen, Lilly, Novartis, Pfizer, Takeda UCB Pharma., Espen A. Haavardsholm Pfizer, UCB, AbbVie, Participation on a Data Safety Monitoring Board or Advisory Board for Pfizer, AbbVie, Boehringer, Ingelheim, Eli Lilly, Galapagos, Gilead, Novartis, Siri Lillegraven: None declared.

Background Methotrexate (MTX) is the first-line drug in the treatment of rheumatoid arthritis (RA) and many other rheumatic and musculoskeletal diseases (RMDs). It is widely recognized that patients prescribed with this, or other similar drugs, should be properly educated, namely by rheumatology nurses,[1] to better understand why and how to take it, the possible side effects and how to prevent and manage them. However, high disparities may exist across European countries regarding patient education (PE) and support about MTX. Objectives To assess patients’ and clinicians’ perspectives and experiences on education and support received about MTX treatment in Europe. Methods A survey was developed by a team of international researchers and clinicians, including rheumatology nurses (from adult and paediatric care), a pharmacist, a rheumatologist, and patient representatives. Common and sample-specific questions were conceived for adult patients or carers (≥18 years) of children/young with RMDs, nurses, and physicians working in rheumatology in Europe. The survey was available in English and, for patients, in 12 additional languages, disseminated between May and December 2022. Ethics committee approval was obtained (116_CEIPC/2022_IPC). Results Complete responses were obtained from 1536 patients (52% with RA), 154 careers, 335 nurses, and 299 physicians (96% rheumatologists), from 24 European Countries, mainly from Northern (nurses) and Southern Europe (patients and physicians) (Table 1). Only 28% of patients had a specific nurse consultation when they started oral MTX, slightly increasing when the subcutaneous form was prescribed (42%), with variations across Europe, being higher in the Western (43%) and Northern (39%) and lower in Eastern (29%) and Southern (11%). These patients’ perspectives are somewhat in line with physicians’ perspectives, although according to nurses the access to them is higher, independent of the form of prescription (Table 1). Clinicians perceive higher opportunities to discuss patients’ MTX concerns than the patients themselves (Table 1). Patients had more opportunities to voice their concerns (≥7 on a scale from 0 to 10) about MTX before starting it, in Western (57%) and Northern (42%) than in Southern (36%) and Eastern (31%) Europe. According to 47% of nurses, PE occurs on the same day of prescription, with the consultation lasting between 10-30 minutes in 50% of cases or even less than 10’ (15%). 37% of nurses do not perform MTX-related follow-up appointments. Only half of the nurses (49%) received specific training to advise patients about MTX (data not shown). The priority ranking of topics to be addressed was also assessed, with agreement on the top one (side effects and their management) (Figure 1). Around 77% of patients had/have concerns about potential unpleasant side effects, which were discussed with health professionals (mainly with rheumatologists) in 68% of the cases, despite not being clarified 46% of the times. Conclusion PE and support about MTX are unequal across Europe and can be improved by providing opportunities to clarify concerns, namely by providing patients with more access to nursing consultations. There is an overall agreement between patients and clinicians regarding key information areas of education, although a tailored approach is required. Reference [1]Bech B, et al. Annals Rheum Diseases 2020;79:61-68. Acknowledgements This study was funded by an unrestricted grant from medac, without any involvement in the scientific work. Disclosure of Interests Cristiano Matos: None declared, Andrea Marques: None declared, Khadija El Aoufy: None declared, Kristina Buerki: None declared, Ágnes Ágoston-Szabó: None declared, Darja Batšinskaja: None declared, Jana Melicharová: None declared, Marie-Louise Karlsson Speakers bureau: Novartis, Grant/research support from: Novartis, Karlien Claes: None declared, Ana Isabel Rodriguez Vargas: None declared, Ellen Moholt: None declared, Ane Ludvigsen: None declared, Una Martin: None declared, Ulrike Erstling: None declared, Angela Camon: None declared, Ana Pais: None declared, Mikaella Konstantinou: None declared, Myrto Nikoloudaki: None declared, Souzi Makri: None declared, Elena Nikiphorou Speakers bureau: Celltrion, Pfizer, Sanofi, Gilead, Galapagos, AbbVie, Lilly, Fresenius, Paid instructor for: Celltrion, Pfizer, Sanofi, Gilead, Galapagos, AbbVie, Lilly, Fresenius, Grant/research support from: Lilly, Pfizer, Claudia Paiva: None declared, Polly Livermore Consultant of: Nordic Pharma, Grant/research support from: GOSH NIHR BRC and NIHR Personal Fellowship, Ricardo J. O. Ferreira Speakers bureau: Sanofi, MSD, Paid instructor for: UCB, Consultant of: medac, abbvie, roche, Sanofi, Amgen, Grant/research support from: Abbvie.

Background Tapering of disease modifying antirheumatic drugs (DMARDs) to achieve drug-free remission is a goal for the growing group of rheumatoid arthritis (RA) patients in remission. However, the long-term effects of tapering or withdrawal of DMARDs remain unclear. Objectives To compare the 3-year clinical and radiographic outcomes of three conventional synthetic DMARD (csDMARD) treatment strategies (continued stable treatment, half-dose treatment and tapering to withdrawal) among patients in sustained RA remission. Methods ARCTIC REWIND was a randomized, multicenter, open-label, clinical trial enrolling 160 RA patients in sustained remission for ≥1 year on stable csDMARD therapy from 10 different Norwegian rheumatology departments.(1) At baseline, patients were randomized 2:1:1 to stable csDMARDs, half-dose csDMARDs, or half-dose csDMARDs for one year, followed by withdrawal of all csDMARDs (“tapering to withdrawal”). The primary endpoint was absence of disease activity flare over the 3-year study period. A flare was defined as a combination of disease activity score (DAS)>1.6, an increase in DAS ≥0.6 units since the previous visit and ≥2 swollen joints, or if the physician and patient agreed that a clinically significant flare had occurred. Full-dose csDMARD treatment was reinstated upon flare. Secondary endpoints included remission (DAS, ACR/EULAR Boolean) at 1, 2 and 3 years, and 3-year change in radiographic joint damage evaluated by van der Heijde-Sharp score (vdHSS). Data were analyzed using Kaplan-Meier, Mann-Whitney test, Cox and mixed effect logistic regression, with stratification or adjustment for study center. Results Of 156 patients who received the allocated treatment strategy, 139 patients completed 3-years follow-up without major protocol violation. Mean baseline methotrexate dose/week was 19.0 mg in the stable group, 19.4 mg in half-dose, and 19.5 mg in the withdrawal group, and mean DAS at baseline was 0.8 in all groups. During the 3-year study period, 80.1% remained flare-free in the stable csDMARD group, 59.5% in the half-dose and 40.8% in the withdrawal group (Figure 1), with corresponding adjusted hazard ratio (aHR) for flare of 2.7 (95% CI: 1.3 to 5.5) in the half-dose group and 4.1 (2.1 to 8.0) in the withdrawal group, compared to stable csDMARD. The aHR was 1.5 (0.8 to 3.0) in the withdrawal group compared to the half-dose group. For all groups, a majority were in remission at 1, 2 and 3 years (Table 1), with the only significant group difference for ACR/EULAR Boolean remission at 3 years, with risk difference for withdrawal vs stable dose -25% (-45 to -6). Mean/median change in vdHSS after 3 years were 0.3/0.0 in the stable group, 1.0/0.5 in the half-dose group, and 0.7/0.0 in the tapering to withdrawal group, with significant difference between the stable and half-dose group, p<0.01. Sensitivity analyses in the full analysis population gave similar results. Conclusion These 3-year data show that 41% of patients in the tapering to withdrawal arm achieved long-term drug-free remission, indicating that this is a realistic option for some RA patients in sustained remission. The two tapering strategies were associated with an increased risk of flares compared to full-dose csDMARD, and the half-dose group had more radiographic change. However, there were no differences in DAS-remission at the end of the study period. Further research identifying prognostic factors for successful tapering is needed. Reference [1]Lillegraven S et al. JAMA 2021 Acknowledgements: NIL. Disclosure of Interests Kaja Kjørholt: None declared, Nina Paulshus Sundlisæter: None declared, Anna-Birgitte Aga Speakers bureau: AbbVie, Eli Lilly, Novartis, Pfizer, Consultant of: AbbVie, Eli Lilly, Novartis, Pfizer, Joseph Sexton: None declared, Inge Olsen: None declared, Hallvard Fremstad: None declared, Cristina Spada Consultant of: Advisory board UCB November 2022, Tor Magne Madland Speakers bureau: Cellgene (2017), Novartis (2018), Boehringer (2022), Christian A. Høili: None declared, Gunnstein Bakland Consultant of: Consultant fee from UCB, Åse Lexberg: None declared, Inger Johanne Widding Hansen: None declared, Inger M. Hansen: None declared, Hilde Haukeland Consultant of: Advisory board for UCB Pharma 2x in 2022, NovartisNorge 2017 and 2018, Abbot 2012, Maud-Kristine A Ljosa Consultant of: Advisory Board for Abbvie i 2022, Ellen Moholt: None declared, Till Uhlig Speakers bureau: Lilly, Galapagos, Pfizer, UCB, Consultant of: Lilly, Galapagos, Pfizer, UCB, Tore K. Kvien Speakers bureau: Grünenthal, Sandoz, UCB, Consultant of: AbbVie, Amgen, Celltrion, Gilead, Novartis, Pfizer, Sandoz, UCB, Grant/research support from: AbbVie, Amgen, BMS, Galapagos, Novartis, Pfizer, UCB, Daniel Solomon Grant/research support from: Abbvie, Amgen, CorEvitas, Moderna, and Janssen, Désirée van der Heijde Consultant of: AbbVie, Bayer, BMS, Cyxone, Eisai, Galapagos, Gilead, Glaxo-Smith-Kline, Janssen, Lilly, Novartis, Pfizer, UCB Pharma Director of Imaging Rheumatology bv, Espen A Haavardsholm Speakers bureau: Pfizer, UCB, Consultant of: AbbVie, Boehringer Ingelheim, Eli Lilly, Gilead, Siri Lillegraven Grant/research support from: Boehringer Ingelheim.Table 1Remission at 12, 24 and 36 monthsStable doseHalf-doseTapered to withdrawal*DAS remission12 months71/77 (92%)34/39 (87%)29/36 (81%)24 months64/73 (88%)33/37 (89%)33/35 (94%)36 months64/67 (96%)34/36 (94%)31/34 (91%)ACR/EULAR 2011 Boolean remission12 months56/77 (73%)25/39 (64%)22/36 (61%)24 months47/73 (64%)21/37 (57%)20/35 (57%)36 months55/67 (82%)25/36 (69%)19/34 (56%)*12 months half-dose, thereafter withdrawal

Background: Remission is the preferred treatment target in rheumatoid arthritis (RA), and many patients require biologic DMARDs to reach this state. It is debated whether tapering of tumor necrosis factor inhibitor (TNFi) treatment to discontinuation should be considered in RA patients who sustain remission on treatment (1). Objectives: The primary study objective was to assess the effect of tapering and withdrawal of TNFi on the risk of flares in RA patients in clinical remission. Methods: In the non-inferiority ARCTIC REWIND trial, RA patients in remission for at least 12 months on stable TNFi therapy were randomly assigned to continued stable TNFi or tapering (half-dose TNFi for 4 months, thereafter withdrawal of TNFi), with visits every four months. csDMARD co-medication was kept stable in both arms. Patients had to be in DAS remission at inclusion with 0/44 swollen joints. The primary endpoint was the proportion of patients with disease flare during the 12-month study period (defined as DAS>1.6, change in DAS>0.6 and 2 or more swollen joints, or the physician and patient agreed that a clinically significant flare had occurred). Full-dose TNFi was reinstated in case of flares in the tapering arm. The non-inferiority margin was 20%, with a predefined superiority test if non-inferiority was not shown. The inferiority null-hypothesis was tested in the per-protocol population by mixed effect logistic regression. Radiographs were scored by van der Heijde modified Sharp score (0 and 12 months, average of two readers, progression: ≥1 unit change). Clinicaltrials NCT01881308 . Results: We randomised 99 patients, 92 received the allocated treatment strategy, 84 were included in the per-protocol population. Baseline characteristics, clinical and ultrasound disease activity were balanced (Table). csDMARD co-medication was used by 93% in the stable and 88% in the tapering arm. In the primary analysis, 5% of patients in the stable TNFi arm experienced a flare during 12 months, compared to 63% in the tapering TNFi arm. The risk difference (95% CI) was 58% (42% to 74%, Fig 1), with stable treatment being deemed superior to tapering. 90% in the stable and 81% in the tapering arm did not show progression of radiographic joint damage, difference (95% CI) -9% (-24%, 6%). At 12 months, DAS scores, DAS remission and function were similar between groups (Fig 2). The numbers of adverse events (AE)/serious AE in the stable and tapering arm were 57/2 and 50/3, respectively, with 26 and 15 infections. Conclusion: In a randomised clinical trial assessing patients in prolonged and deep RA remission, we observed a large increase in the flare rate in patients who tapered and discontinued TNFi. Patients responded well to reinstated treatment and remission rates in the two study arms were comparable at 12 months. References: [1]Smolen et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update. ARD 2020 Table 1. Baseline values – n (%), mean (SD), or median (IQR) Stable, n=45 Tapering, n=47 Age, yrs 57 (11) 58 (13) Female 30 (67%) 25 (53%) ACPA+ 35 (78%) 36 (77%) Symptom duration, yrs 10 (7) 12 (7) DAS 0.9 (0.4) 0.8 (0.3) CRP mg/L 1 (1 – 2) 1 (1 – 3) No ulttrasound power Doppler signal in any of 32 joints 42 (96%) 44 (94%) Disclosure of Interests: Siri Lillegraven: None declared, Nina Paulshus Sundlisæter: None declared, Anna-Birgitte Aga: None declared, Joe Sexton: None declared, Inge Olsen: None declared, Åse Lexberg: None declared, Tor Magne Madland: None declared, Hallvard Fremstad: None declared, Christian A. Høili Consultant of: Novartis, Gunnstein Bakland Consultant of: Novartis, UCB, Cristina Spada: None declared, Hilde Haukeland Consultant of: Novartis, Inger M. Hansen: None declared, Ellen Moholt: None declared, Till Uhlig Consultant of: Lilly, Pfizer, Speakers bureau: Grünenthal, Novartis, Daniel Solomon Grant/research support from: Funding from Abbvie and Amgen unrelated to this work, Désirée van der Heijde Consultant of: AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eisai, Eli-Lilly, Galapagos, Gilead Sciences, Inc., Glaxo-Smith-Kline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, UCB Pharma; Director of Imaging Rheumatology BV, Tore K. Kvien Grant/research support from: Received grants from Abbvie, Hospira/Pfizer, MSD and Roche (not relevant for this abstract)., Consultant of: Have received personal fees from Abbvie, Biogen, BMS, Celltrion, Eli Lily, Hospira/Pfizer, MSD, Novartis, Orion Pharma, Roche, Sandoz, UCB, Sanofi and Mylan (not relevant for this abstract)., Paid instructor for: Have received personal fees from Abbvie, Biogen, BMS, Celltrion, Eli Lily, Hospira/Pfizer, MSD, Novartis, Orion Pharma, Roche, Sandoz, UCB, Sanofi and Mylan (not relevant for this abstract)., Speakers bureau: Have received personal fees from Abbvie, Biogen, BMS, Celltrion, Eli Lily, Hospira/Pfizer, MSD, Novartis, Orion Pharma, Roche, Sandoz, UCB, Sanofi and Mylan (not relevant for this abstract)., Espen A Haavardsholm Grant/research support from: AbbVie, UCB Pharma, Pfizer Inc, MSD Norway, Roche Norway, Consultant of: Pfizer, AbbVie, Janssen-Cilag, Gilead, UCB Pharma, Celgene, Lilly, Paid instructor for: UCB Pharma, Speakers bureau: Pfizer, AbbVie, UCB Pharma, Celgene, Lilly, Roche, MSD

Background: Non-adherence to medication and non-pharmacological interventions precludes reaching an optimal outcome. 30 to 80% of patients with rheumatic and musculoskeletal diseases (RMDs) do not adhere to their recommended treatment regimens. Objectives: The objective of this EULAR task force was to establish recommendations/points to consider (PtC) for the detection, assessment and management of non-adherence in people with RMDs. Methods: A EULAR task force (TF) was established, and the EULAR standardised operating procedures for the development of PtCs were followed. The TF included rheumatologists, health professionals in rheumatology (HPRs), and patient-representatives from 12 countries. A systematic literature review of reviews was conducted in advance to support the TF in formulating the PtC. Agreement was obtained by Delphi technique in three rounds (0-10 rating scale). Results: A definition of adherence, 4 overarching principles and 9 PtC were formulated (table). Conclusion: The PtCs can help health-care providers to support people with RMDs to adhere to the agreed treatment plan. Table. Overarching principles and points to consider. Definition of Adherence Adherence is defined as the extent to which a person’s behaviour corresponds with the agreed prescription. Overarching principles Agreement 1 Adherence impacts the outcomes of people with RMDs. 99 2 Shared decision making is key, since adherence is a behaviour following an agreed prescription. 96 3 Adherence is influenced by multiple factors. 98 4 Adherence is a dynamic process that requires continuous evaluation. 96 Points to consider Agreement 1 All HCPs involved in the management of people with RMDs should take responsibility for promoting adherence. 99 2 Effective patient-health professional communication should be applied to enhance adherence. 99 3 Barriers and facilitators of adherence of a specific patient to a specific prescription should be appropriately evaluated. 95 4 Patient education should be provided for people with RMDs as an integral part of standard care. 96 5 Care should be tailored to patient preferences and goals to enhance adherence. 98 6 Adherence should be discussed regularly based on open questions and particularly when disease is not well controlled. 99 7 The HCP should explore which factors might negatively influence adherence, including: opportunity (e.g., availability or cost), capability, (e.g., memory problems), motivation (e.g., concerns). 94 8 Together with the patient, the HCP should tailor the approach to overcome individual barriers to adherence, e.g., 98 - simplifying the regimen, - using reminders, - providing education, - discussing the patient’s beliefs on treatments. 9 When specific expertise or interventions for adherence are needed, they should be made available to patients. 98 HCP, health-care providers; RMDs, rheumatic and musculoskeletal diseases Disclosure of Interests: Valentin Ritschl: None declared, Tanja Stamm Grant/research support from: AbbVie, Roche, Consultant of: AbbVie, Sanofi Genzyme, Speakers bureau: AbbVie, Roche, Sanofi, Daniel Aletaha Grant/research support from: AbbVie, Novartis, Roche, Consultant of: AbbVie, Amgen, Celgene, Lilly, Medac, Merck, Novartis, Pfizer, Roche, Sandoz, Sanofi Genzyme, Speakers bureau: AbbVie, Celgene, Lilly, Merck, Novartis, Pfizer, Sanofi Genzyme, UCB, Johannes WJ Bijlsma Grant/research support from: Roche, Speakers bureau: Roche, Lilly, Peter Boehm: None declared, Razvan Dragoi Speakers bureau: MSD, AbbVie, Novartis, Roche, Pfizer, Myllan, Sandoz, Emma Dures Grant/research support from: Independent Learning Grant from Pfizer, combined funding for a research fellow from Celgene, Abbvie and Novartis, Paid instructor for: A fee from Novartis to deliver training to nurses., Fernando Estévez-López: None declared, Laure Gossec Grant/research support from: Lilly, Mylan, Pfizer, Sandoz, Consultant of: AbbVie, Amgen, Biogen, Celgene, Janssen, Lilly, Novartis, Pfizer, Sandoz, Sanofi-Aventis, UCB, Annamaria Iagnocco Grant/research support from: Abbvie, MSD and Alfasigma, Consultant of: AbbVie, Abiogen, Alfasigma, Biogen, BMS, Celgene, Eli-Lilly, Janssen, MSD, Novartis, Sanofi and Sanofi Genzyme, Speakers bureau: AbbVie, Alfasigma, BMS, Eli-Lilly, Janssen, MSD, Novartis, Sanofi, Michal Nudel: None declared, Andrea Marques: None declared, Ellen Moholt: None declared, Bart van den Bemt Grant/research support from: UCB, Pfizer and Abbvie, Consultant of: Delivered consultancy work for UCB, Novartis and Pfizer, Speakers bureau: Pfizer, AbbVie, UCB, Biogen and Sandoz., Kirsten Viktil: None declared, Marieke Voshaar Grant/research support from: part of phd research, Speakers bureau: conducting a workshop (Pfizer), Annette de Thurah Grant/research support from: Novartis (not relevant for the present study)., Speakers bureau: Lily (not relevant for the present study)., Loreto Carmona Grant/research support from: Novartis Farmaceutica, SA, Pfizer, S.L.U., Merck Sharp & Dohme España, S.A., Roche Farma, S.A, Sanofi Aventis, AbbVie Spain, S.L.U., and Laboratorios Gebro Pharma, SA (All trhough institution)

Background: Sustained remission is the goal of rheumatoid arthritis (RA) care, and more patients reach and maintain this state on conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs) with treat-to-target strategies. The knowledge about whether csDMARDs can be tapered in RA remission is limited. Objectives: The primary objective of the study was to assess the effect of tapering of csDMARDs on the risk of flares in RA patients in sustained clinical remission. Methods: In the open, phase 4, non-inferiority ARCTIC REWIND trial, RA patients in clinical remission for ≥ 12 months on stable csDMARD therapy were randomised to continued stable csDMARD or half dose csDMARD. Patients had to be in DAS remission at inclusion with no swollen joints (of 44). The primary endpoint was the proportion of patients with a disease flare during 12 months (defined as a combination of DAS >1.6, change in DAS >0.6 and ≥2 swollen joints, or the physician and patient agreed that a clinically significant flare had occurred). Patients attended visits every 4 months, with extra visits in case of flares. The non-inferiority margin was 20%, with a predefined superiority test if non-inferiority was not shown. Mixed effect logistic regression was used to test the inferiority null-hypothesis in the per-protocol population. Radiographs at 0 and 12 months were scored by van der Heijde Sharp score (average score of two readers, progression: ≥1 unit change/year). Clinicaltrials.gov NCT01881308 . Results: We enrolled 160 patients, 155 received the allocated treatment strategy. Baseline characteristics were overall well balanced (Table). 78% of patients in the stable csDMARD arm and 84% in the half-dose csDMARD arm used methotrexate monotherapy. In the primary analysis, we observed flares in 6% of patients on stable csDMARD, compared to 25% in the half-dose csDMARD arm, giving a risk difference (95% CI) of 18.3% (7.2% to 29.3%, Fig 1). Non-inferiority could not be claimed, with the results showing superiority of the stable arm over the half-dose arm (Fig 1). Similar results were found in methotrexate monotherapy users. In the stable arm, 2/5 (40%) escalated DMARD medication following the flares, compared to 18/19 (95%) in the tapering arm. No progression of radiographic joint damage was observed in 79.5% of patients on stable DMARDs and 62.7% of those tapering, difference (95% CI) -17.7% (-33.0%, -2.3%, Fig 2E). At 12 months, 92% of patients in the stable and 85% of patients in the tapered arm were in DAS remission (Fig 2C). The frequency of adverse events was 75 in the stable arm and 53 in the tapered arm, with serious adverse events in 2 (2.6%) of patients in the stable and 4 (5.1%, including two serious infections) patients in the tapered arm. Conclusion: In RA patients in sustained remission on csDMARDs, continued csDMARD therapy with stable dosage led to significantly fewer disease activity flares and less frequent radiographic joint damage progression than tapered csDMARD treatment. Table. Baseline values; mean (SD), n (%) or median (IQR) Stable, n=78 Tapering, n=78 Age, yrs 55 (12) 56 (12) Female 50 (64%) 54 (69%) ACPA+ 57 (73%) 63 (81%) Symptom dur., yrs 3.7 (1.8) 3.4 (1.4) DAS 0.8 (0.4) 0.8 (0.3) CRP mg/L 2 (1, 3) 2.0 (1,3) MTX monotherapy 61 (78%) 65 (84%) Disclosure of Interests: Siri Lillegraven: None declared, Nina Paulshus Sundlisæter: None declared, Anna-Birgitte Aga: None declared, Joe Sexton: None declared, Inge Olsen: None declared, Hallvard Fremstad: None declared, Cristina Spada: None declared, Tor Magne Madland: None declared, Christian A. Høili Consultant of: Novartis, Gunnstein Bakland Consultant of: Novartis, UCB, Åse Lexberg: None declared, Inger Johanne Widding Hansen: None declared, Inger M. Hansen: None declared, Hilde Haukeland Consultant of: Novartis, Maud-Kristine A Ljosa: None declared, Ellen Moholt: None declared, Till Uhlig Consultant of: Lilly, Pfizer, Speakers bureau: Grünenthal, Novartis, Daniel Solomon Grant/research support from: Funding from Abbvie and Amgen unrelated to this work, Désirée van der Heijde Consultant of: AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eisai, Eli-Lilly, Galapagos, Gilead Sciences, Inc., Glaxo-Smith-Kline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, UCB Pharma; Director of Imaging Rheumatology BV, Tore K. Kvien Grant/research support from: Received grants from Abbvie, Hospira/Pfizer, MSD and Roche (not relevant for this abstract)., Consultant of: Have received personal fees from Abbvie, Biogen, BMS, Celltrion, Eli Lily, Hospira/Pfizer, MSD, Novartis, Orion Pharma, Roche, Sandoz, UCB, Sanofi and Mylan (not relevant for this abstract)., Paid instructor for: Have received personal fees from Abbvie, Biogen, BMS, Celltrion, Eli Lily, Hospira/Pfizer, MSD, Novartis, Orion Pharma, Roche, Sandoz, UCB, Sanofi and Mylan (not relevant for this abstract)., Speakers bureau: Have received personal fees from Abbvie, Biogen, BMS, Celltrion, Eli Lily, Hospira/Pfizer, MSD, Novartis, Orion Pharma, Roche, Sandoz, UCB, Sanofi and Mylan (not relevant for this abstract)., Espen A Haavardsholm Grant/research support from: AbbVie, UCB Pharma, Pfizer Inc, MSD Norway, Roche Norway, Consultant of: Pfizer, AbbVie, Janssen-Cilag, Gilead, UCB Pharma, Celgene, Lilly, Paid instructor for: UCB Pharma, Speakers bureau: Pfizer, AbbVie, UCB Pharma, Celgene, Lilly, Roche, MSD

BackgroundAccording to ”EULAR recommendations for the role of the nurse in the management of chronic inflammatory arthritis”1, patients with rheumatic diseases should get access to nurse-led telephone service. Patients call if they have a flare and need an appointment with the rheumatologist, have questions regarding their disease, medical treatment, infections or side-effects. Patients experience with calling a nurse need further investigation.ObjectivesThe objective for this study was to explore and describe the patients’ experience with the nurse-led telephone service in an outpatient clinic at a rheumatology department.MethodsThe helpline is open 2 hours daily during the week, and served by 2–3 nurses. Patients at the outpatient-clinic between 01.10.17 and 29.12.17, were invited to answer a questionnaire about the nurse-led telephone service. The questions were about access to a nurse, if they got the help they needed, if they had confidence in the nurse’s knowledge, understanding her information, if the helpline was important in their lives with a chronic disease and if the nurse-led telephone service gives comfort or makes them feel secure. They could choose between 5 different answers: not at all, to a small degree, to some degree, to a large degree or to a very large degree. It was also possible to write comments. All the answered phone calls were registered.ResultsThe nurse-led telephone service answered mean (min–max) 3019–48 phone calls every day, and in total 1875 calls during the period of 3 months. Only 29% of these patients needed and got an appointment with a rheumatologist. 341 patients answered the questionnaire. 68 commented regarding long time to wait, or a need for extended time for the telephone service. However, concerning how easy the access to a nurse on helpline was, 70% answered to a large or a very large degree, as shown in table 1. 89% answered that they to a large or a very large degree got the information or help they needed from the nurse. 90% answered that they to a large or a very large degree trusted the nurse’s professional skills. The nurse spoke to them so they could to a large or a very large degree understand her according to 92% of the respondents. There was some variation in the answers about the helpline’s importance in their life with a chronic disease, but 44% answered to a very large degree and only 4.7% answered not at all. 66% answered that access to a nurse on helpline provides a very large degree of security.ConclusionsThis study shows that calling a nurse-led telephone service is valuable for patients with a rheumatic disease. Although there can be some time to wait, almost 90% got the help they needed, understood the nurse and had confidence in the nurse’s knowledge. Only 13.5% answered that nurse-led telephone service has not at all or a small degree of importance in their lives with a chronic disease. The nurse-led telephone service was important to a large or very large degree to feel secure and confident for 87% of the participants in this study.Reference[1] van Eijk-Hustings Y, et al. Ann Rheum Dis2012Disclosure of InterestNone declared

Background Pain is the symptom people with rheumatoid arthritis (RA) have prioritized highest for improvement [1]. Treating to target and aiming for remission in early RA may reduce pain, but there is limited knowledge about the impact of modern treatment strategies on pain in RA patients classified using the 2010 ACR/EULAR criteria. Objectives The objective of this study was to explore and describe changes in the levels of pain in early RA during the first two years after starting DMARD treatment. Methods Patients with symptom duration of less than 2 years from first swollen joint who fulfilled the 2010 ACR/EULAR classification criteria for RA, and were DMARD naïve with indication for DMARD treatment were recruited from 11 rheumatology centres and followed for 2 years in the ARCTIC trial. The treatment target was remission, and DMARDs were prescribed using an algorithm developed according to international recommendations. Swollen joints and joints with ultrasound power Doppler synovitis were injected with intra-articular corticosteroids. Pain was recorded on a Visual Analogue Scale (VAS 0–100 mm) at every visit, and categorised according to Jensen et al. with cut points for no pain set at 0–4 mm, mild 5–44 mm, moderate 45–74 mm and severe pain 75–100 mm [2]. Short Form-36 (SF-36) bodily pain was recorded, and transformed to a scale from 0–100, with high scores indicating low bodily pain. Results A total of 205 early RA patients were included: 61.5% female, 82.4% ACPA positive, and mean (SD) age 52.2 (13.4) years. At initiation of DMARD treatment the mean (SD) 44-swollen joint count was 10.2 (7.2), Ritchie Articular Index 8.14 (6.5), ESR 24 (19) mm/hr and Patient Global Assessment 49 (24) mm. The mean (SD) DAS value was 3.4 (1.1); 20.1% were in low disease activity, 47.1% in moderate disease activity and 32.8% in high disease activity according to DAS. VAS pain at baseline was median (IQR) 45 (27–68) mm, and decreased to 12 (4–27) mm after 1 month, after 1 year to 6 (2–20) mm and after 2 years VAS pain was 7 (2–23) mm; see figure for details. Mean (SD) SF-36 bodily pain at baseline was 40 (21), and increased after 12 months to 73 (23) and 24 months to 74 (24). At baseline less than 3% of the patients reported no pain, after 3/6/12/24 months this proportion increased to 27/32/41/41%, respectively. In the interval 12 to 24 months more than 87% of patients reported exclusively either no or mild pain. Conclusions In this cohort of early DMARD-naïve RA patients treated according to modern treatment strategies aiming for remission, there was a substantial and significant reduction of pain after 1 month. Pain levels decreased further during the first year, and this reduction was sustained during the first 2 years of follow-up. Early intervention and treating to target in this population fulfils the patients9 prioritised goal of minimising pain, leading to a decreased burden of pain in RA. References Heiberg, T. et al. Arthritis Care Res 2002. Jensen, M.P. et al. The Journal of Pain, 2003. Disclosure of Interest E. Moholt: None declared, A.-B. Aga: None declared, I. Olsen: None declared, H. Hammer: None declared, T. Uhlig: None declared, A. Kongtorp: None declared, H. Lunøe: None declared, E. Styrmoe: None declared, S. Lillegraven: None declared, T. Kvien: None declared, E. Haavardsholm Grant/research support from: AbbVie, Pfizer Inc, MSD, Roche Pharmaceuticals, UCB

OBJECTIVES The use of electronic health records (EHR) is an essential part of modern health care, and electronic data capture (EDC) has become essential for managing clinical trials. Usually, these two entities are independent of each other, and transfer from one system to another is done manually. Our aim was to develop a method to capture data directly from the EHR system and transfer them into an EDC system for the NORwegian Disease-Modifying Anti-Rheumatic Drugs (NOR-DMARD) registry. METHODS All rheumatology departments contributing to NOR-DMARD had implemented a structured EHR system. Data are extracted locally and securely transferred to the study data management once a month. The study data management then parse the data into a readable format for the EDC and import the data. Once the data is in the EDC, they are available to all authorized researchers and downloadable in a preferred format. RESULTS From May 2012 to August 2014 almost 6400 visits in 3400 patients treated with biologics have been successfully registered in the EDC system. Previously, NOR-DMARD used standard paper-based case report forms (CRFs), with a substantial cost for data entry. Setting up and maintaining the EDC system required some investments, but the amount saved from avoiding paper handling has made the shift into EDC profitable. In addition to this, gains have been made in administration and data quality. CONCLUSIONS The transition from paper and pencil format to a fully electronic data management system in NOR-DMARD has had obvious advantages regarding feasibility, cost, data quality and accessibility of the data.

Background The NORwegian Disease Modifying Anti-Rheumatic Drugs (NOR-DMARD) registry has since 2000 been registering DMARD use and response in five different Norwegian rheumatology departments (ref). Almost 5,000 biologic treatment courses in 3,500 patients have been included so far, together contributing with 19,000 study visits. Clinical information was previously recorded on paper, but from May 2012 an electronic data capture (EDC) system has been implemented. Objectives To enable transfer of clinical data from a structured electronic health record to an electronic case report form. Methods A commercial EDC system, Viedoc™, has been set up in order to capture study data using electronic case report forms (e-CRFs). All centers have implemented a structured electronic health record (EHR), GoTreatIt™, which facilitates the export of un-identified source data. The workflow of a new patient is as follows: 1. The patient is included into the EDC system with patient information such as patient initial, date of birth and biologic treatment, and a visit is initiated with some information not collected in the EHR. 2. The EDC system generates a unique patient number, which is then registered in the EHR. This key enables the transfer from one system to the other. 3. Study data are then registered in the EHR, both by the treating physician/nurse (e.g. DAS28, ASDAS) and the patient (e.g. MHAQ, RAID). Once a month each center extracts data in an XML-format from the site9s EHR system. The contents of the extracted data are pre-specified and in accordance with the study protocol and e-CRF. The trial data manager uses a SAS program to parse the XML-files to a flat file format readable in the EDC system. The SAS program also runs a validation check against patient numbers, dates of birth and visit dates. We then import the flat files into the EDC system using the system9s import routine, merging by patient number. The system facilitates an audit trail, so any changes are registered. A patient9s e-CRF with all collected data is then accessible for both site and trial data management. Results From May 2012 to June 2013, 1697 patients on biologic treatment have been successfully included into the EDC system. A Contract Research Organization (CRO) NOK handled the previous paper-CRF system at a price of 115 NOK (20 USD) per visit/CRF. The money saved from this contract has already made the shift into EDC profitable, taken the set-up and licensing costs of the EDC system into consideration. In addition to this, the paper CRF system required considerable manual resources at each participating center, including entering, copying and mailing of completed CRFs and administration of inclusion IDs. Conclusions We have developed a novel methodology where we gather electronic health records from five different centers into a central trial database. We avoid time-consuming handling of paper-CRFs and eliminate data entry errors since we import source data directly into the study database. Compared to a standard e-CRF solution we gain efficacy effects because we avoid redundant registration, i.e. both in the patient journal and in the e-CRF system. Disclosure of Interest : None declared DOI 10.1136/annrheumdis-2014-eular.4195