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Background: To evaluate the cost-effectiveness of tofacitinib in comparison to vedolizumab for the treatment of moderate-to-severe ulcerative colitis (UC) after failure or intolerance to conventional therapy (bio-naive) or first-line biologic treatment (bio-experienced), from the Spanish National Health System (NHS) perspective. Methods: A lifetime Markov model with eight-week cycles was developed including five health states: remission, response, active UC, remission after surgery, and death. Response and remission probabilities (for induction and maintenance periods) were obtained from a multinomial network meta-analysis. Drug acquisition – biosimilar prices included – (ex-factory price with mandatory deductions), adminis- tration, surgery, patient management, and adverse event management costs (€, year 2019) were considered. A 3% discount rate (cost/outcomes) was applied. Probabilistic and deterministic sensitivity analyses (PSA) were conducted. Results: Tofacitinib was dominant versus vedolizumab (both in bio-naive and bio-experienced patients) entailing total cost savings of €23,816 (bio-naïve) and €11,438 (bio-experienced). Differences in quality- adjusted life-year (QALY) were smaller than 0.1 for both populations. PSA results showed that tofacitinib has a high probability of being cost-effective (bio-naïve: 82.5%; bio-experienced: 90.6%) versus vedolizumab. Conclusions: From the Spanish NHS perspective, tofacitinib could be a dominant treatment (less costly and more effective) in comparison to vedolizumab, with relevant cost savings and similar QALY gains.

There are aspects of Janus kinase (JAK) inhibitors, specifically tofacitinib, that distinguish them from other drugs used in the treatment of ulcerative colitis (UC), such as their oral administration, their short half-life and their lack of immunogenicity. With the available evidence, we can highlight tofacitinib's quick action and flexibility of use, and its efficacy in patients, irrespective of whether or not they have previously been exposed to TNF inhibitors (anti-TNF drugs) and other biologic agents. Moreover, their safety profile is known and manageable, with certain considerations and precautions being factored in before and during treatment. In this review, we have defined various scenarios pertaining to this drug, e.g. its use in the event of failure or intolerance to previous treatment with biologics, when a quick response is required or in patients with other concurrent immune-mediated diseases.

OBJECTIVES 1)To analyze evidence about poor adherence / non-adherence including their prevalences, associated factors, and interventions in ulcerative colitis (UC) patients; 2)To provide a framework to improve poor adherence / non-adherence. METHODS A qualitative approach was applied. A literature review was performed using Medline. Primary searches were performed with Mesh and free texts to identify articles that analyzed prevalence, causes, associated factors, and interventions designed to improve poor adherence/ non-adherence in UC patients. The studies' quality was evaluated using the Oxford scale. The results were presented and discussed in a nominal group meeting, comprising a multidisciplinary committee of six gastroenterologists, one psychologist, one nurse, and one patient. Several overarching principles and recommendations were generated. A consensus procedure was implemented via a Delphi process during which each committee member produced a score ranging from 0 = totally disagree to 10 = totally agree. Agreement was considered if at least 70% of the participants voted ≥7. RESULTS The literature review included 75 articles. Non-adherence rates ranged from 7%-72%. We found a great variability in the methods employed to assess adherence, associated factors, and interventions designed to improve adherence. Overall, eight overarching principles and six recommendations were generated, all of them achieving the pre-established agreement level, including, among others, the identification, classification, and management of non-adherence. CONCLUSIONS Poor adherence / non-adherence are common in UC patients, being a relevant clinical concern. Health professionals should address this issue and actively involve the patients in implementing effective and individualized interventions to improve adherence.

Background and aims Our objective was to define, describe and organize (on the basis of consensus) the patient's preferences in the management of ulcerative colitis (UC), in order to further incorporate them in daily practice and improve patients satisfaction, adherence to the treatment and quality of care. Methods Qualitative study. A narrative literature review in Medline using Mesh and free-text terms was conducted to identify articles on UC patient preferences as well as clinical scenarios that may influence the preferences. The results were presented and discussed in a multidisciplinary nominal group meeting composed of six gastroenterologists, one primary care physician, one nurse practitioner and one expert patient. Key clinical scenarios and patient preferences were then defined, generating a series of points to consider and recommendations. The level of agreement with the final selection of preferences was established following a Delphi process. Results The narrative review retrieved 69 articles of qualitative design and moderate quality. The following key clinical scenarios were identified: diagnosis, follow-up, surgery, and special situations/patients profiles such as adolescents or women. Patient preferences were classified into information, treatment (pharmacological and non-pharmacological), follow-up, relations with health professionals, relations with the health system and administration. Finally, 11 recommendations on patient preferences for UC in relation to its management reached the level of agreement established. Conclusion The consensual description of patient's preferences contribute to identify different areas for improvement in healthcare practice.

Background: Patients with psoriatic arthritis (PsA) experience significant disability and reduced quality of life, resulting from the emotional distress and functional impairment associated with psoriatic skin lesions, as well as joint disease. Patient reported outcomes are important to evaluate healthcare interventions and to reflect the impact of PsA on patients’ lives. Objectives: The aims of the present study were to describe disease characteristics of PsA patients with an acceptable symptoms state (PsAID score Methods: Post-hoc analysis of data from a cross-sectional observational, multicenter study, aimed at evaluating the prevalence of MDA in a Spanish population with PsA, to describe their characteristics and to evaluate the association between MDA and the impact of the disease as assessed by the PsAID questionnaire. The original study included 227 adult patients of both genders diagnosed with PsA according to CASPAR criteria with at least one year of disease evolution and on treatment with biological and/or conventional synthetic disease modifying anti-rheumatic drugs (cDMARD). The PsAID questionnaire reflects the effect of PsA from the patient’s perspective. It is composed of 12 physical and psychological domains. PsAID score Results: 122 patients with a PsAID score A moderate relationship between HAQ Conclusion: There are discrepancies between the treatment goals (MDA) and the impact of disease as assessed by PsAID. Clinical characteristics such as DIP involvement, inflammatory load (PCR) and genetic factors (familial history) seem to be associated with a lower probability of being in an acceptable symptoms state in PsA patients. Disclosure of interests: Ruben Queiro Silva: None declared, Juan D. Canete: None declared, Susana Gomez Employee of: I am a current employee of Pfizer., ana Cabez Employee of: Pfizer

Background The goal of treatment in psoriatic arthritis (PsA) according to the T2T strategy is remission, or at least, a low disease activity state1. Currently there is no clear agreement on how to measure these treatment goals. Objectives To explore the relationship between very low disease activity (VLDA) state, according to the MDA 7/7 criteria2, and DAPSA remission3, as well as its association with the impact of the disease evaluated by the PsAID questionnaire4, in patients with PsA in routine clinical practice. Methods Post-hoc analysis of the MAAPs study5. We included patients who met CASPAR criteria, with at least one year of disease evolution, and treated with biological and/or synthetic DMARDs according to the usual clinical practice in Spain. Patients were considered in VLDA if they met 7/7 of the MDA criteria, and in DAPSA/cDAPSA remission (this last without CRP) if they had a value ≤4. A PsAID Results Of the 227 patients included in the original study, 26 (11.5%), 52 (30.6%), 65 (36.9%) and 125 (55%) were in VLDA, DAPSA remission, cDAPSA remission, and PASS, respectively. There was a moderate agreement between VLDA and DAPSA remission (κ=0.52) or the cDAPSA remission (κ=0.42). Patients in VLDA had a lower impact of the disease measured by PsAID [mean total score (SD): VLDA 1.1 (1.2); DAPSA remission 1.3 (1.5); cDAPSA remission 1.7 (1.6)]. There was a moderate agreement between DAPSA remission or cDAPSA remission and PASS (κ=0.55 and κ=0.58 respectively), while fair agreement was found between VLDA and PASS (κ=0.18). Conclusions About one third of this series reached DAPSA remission, while only 11.5% reached VLDA state. On the other hand, more than half were in PASS situation. Agreement between VLDA and DAPSA was moderate. Although the MDA 7/7 criteria seem to be more stringent criteria for assessing remission, DAPSA remission shows better agreement with PASS. DAPSA and VLDA would be adequate treatment targets in daily practice. References [1] Smolen JS, et al. Treating axial spondyloarthritis and peripheral spondyloarthritis, especially psoriatic arthritis, to target: 2017 update of recommendations by an international task force. Ann Rheum Dis2018;77:3–17. [2] Coates LC, et al. Defining Low Disease Activity States in Psoriatic Arthritis using Novel Composite Disease Instruments. J Rheumatol2016;43:371–375. [3] Schoels MM, et al. Disease activity in psoriatic arthritis (PsA): defining remission and treatment success using the DAPSA score. Ann Rheum Dis2016;75:811–818. [4] Gossec L, et al. A patient-derived and patient-reported outcome measure for assessing psoriatic arthritis: elaboration and preliminary validation of the Psoriatic Arthritis Impact of Disease (PsAID) questionnaire, a 13-country EULAR initiative. Ann Rheum Dis2014;73:1012–1019. [5] Queiro R, et al. Minimal disease activity and impact of disease in psoriatic arthritis: a Spanish cross-sectional multicenter study. Arthritis Res Ther2017;19:72. Disclosure of Interest None declared

Background Some cardiovascular risk factors (CVRF) have been related to poorer responses to biological therapy 1 . We aimed to evaluate the potential link between the MDA response and the presence of CVRF in patients treated with traditional and/or biological DMARDs. Objectives The objective has been to evaluate the potential association beetween classic CVRF and the probability of reaching an MDA response in PsA patients. Methods Cross-sectional study carried out at 25 rheumatology outpatient clinics in patients who fulfilled the Classification for Psoriatic Arthritis (CASPAR) criteria with at least one year disease duration, and treated with biological or conventional synthetic (cs) DMARDs according to routine clinical practice in Spain. Patients were considered in MDA if they met at least 5/7 of the MDA criteria 2 . The relationship between MDA and CVRF was evaluated by uni and multivariate analyses. Results 227 patients were included, 133 (58.6%) were in MDA state (52% on anti-TNFα monotherapy, 24% on csDMARD monotherapy, 24% on anti-TNFα in combination with csDMARD). Among the classic CVRF, tobacco (crude OR: 0.54), sedentary lifestyle (crude OR: 1.95), hyperuricemia (crude OR: 2.01) and obesity (crude OR: 1.54) were related to the likelihood of MDA in the univariate model (p Conclusions Contrary to what has been found in other studies, in this cross-sectional multicenter study we could not find any relationship between traditional CVRF (except for sedentary lifestyle) and MDA. In any case, patients with psoriatic disease should be encouraged to maintain healthy lifestyle habits. References Ogdie A, Eder L. Improving cardiovascular health and metabolic comorbidities in patients with psoriatic arthritis. Int J Clin Rheumatol 2015; 10(6):451–459. Coates LC, Fransen J, Helliwell PS. Defining minimal disease activity in psoriatic arthritis: a proposed objective target for treatment. Ann Rheum Dis 2010; 69(1):48–53. Acknowledgements This study was funded by Pfizer. Disclosure of Interest None declared

Background The target of treatment in psoriatic arthritis (PsA) should be remission or inactive disease. A potential definition that would fit with the Treat-to-Target Recommendations would be MDA meeting all 7 criteria 1 , proposed as a definition of very low disease activity (VLDA) in PsA. Patient reported outcomes (PROs), such as those provided by the novel PsAID questionnaire 2 , are also important to evaluate healthcare interventions and to reflect the impact of PsA on patients9 lives. Objectives The aims of the present study were to evaluate the prevalence of VLDA in patients with PsA and how much residual active disease is still present, so as to determine whether PsAID could be an additional useful tool to assess PsA interventions in clinical practice. Methods This was a post-hoc analysis of data from a cross-sectional observational and multicenter study (MAAPS), aimed at evaluating the prevalence of MDA in a Spanish population with PsA, to describe their characteristics and to evaluate the association between MDA and the impact of the disease as assessed by the PsAID questionnaire in routine clinical practice The original study included adult patients of both genders diagnosed with PsA according to CASPAR criteria with at least one year of evolution time of disease and on treatment with biological and/or conventional synthetic disease modifying anti-rheumatic drugs (cDMARD). Patients were considered in VLDA when they met all the MDA criteria 1 : tender joint count ≤1, swollen joint count ≤1, Psoriasis Area Severity index (PASI) score ≤1 or body surface area ≤3%, patient pain visual analog scale (VAS) score ≤15, patient global disease activity VAS score ≤20, Health Assessment Questionnaire (HAQ) score ≤0.5, and tender entheseal points ≤1. Patient acceptable symptoms state (PASS) has been defined as a PsAID value Results 227 patients were included, 133 (58.6%) in MDA state and 58 (25.6%) in VLDA state. VLDA patients suffered from a mild impact of the disease according to PsAID: the majority (82.5%) had a PsAID score Conclusions 26% of Spanish PsA patients achieve VLDA state in routine clinical practice. PsA patients who reached this state also had a very low impact of disease according to PsAID. VLDA state could represent a situation of clinical remission in PsA. References Coates LC, Fransen J, Helliwell PS. Ann Rheum Dis 2010;69(1):48–53. Gossec L, de WM, Kiltz U, Braun J, Kalyoncu U, Scrivo R et al. Ann Rheum Dis 2014;73(6):1012–1019. Acknowledgements MAAPS (Minimal Activity in Psoriatic Arthritis) study group:. J.C. Torre Alonso; J.A Roman Ivorra; J. Sanz; J. Salvatierra; J. Calvo Alen; A. Sellas; F.J. Rodriguez; A. Bermudez; M.Romero; M. Riesco; J.C Cobeta; F.Medina; A. Aragόn; ML. Garcia; A. Urruticoechea; CM. Gonzalez; E. Judez; B. Gonzalez; P. Fernandez; L. Pantoja; R. Morla. This study was funded by Pfizer. Disclosure of Interest None declared

Objectives The aims were to evaluate the prevalence of anti-drug antibodies (ADA) in patients with RA or SpA experiencing secondary failure to anti-TNF therapy and to correlate ADA presence with anti-TNF concentration and clinical response. Methods This was a cross-sectional, observational study of patients with active RA or SpA experiencing secondary failure to etanercept (ETN), infliximab (INF) or adalimumab (ADL). Concomitant non-biologic DMARDs were permitted. Serum anti-TNF and ADA levels were measured with two-site ELISA. Results Among 570 evaluable patients, those with RA (n = 276) were mostly female (80 vs 39%), older (56 vs 48 years), received concomitant DMARDs (83 vs 47%) and had maintained good clinical disease control for longer (202 vs 170 weeks) compared with patients with SpA (n = 294). ADA were found in 114/570 (20.0%) patients; 51/188 (27.1%) against INF and 63/217 (29.0%) against ADL; none against ETN. Of these 114 patients, 92 (81%) had no detectable serum drug concentrations. Proportionately more patients with SpA (31.3%) had anti-INF antibodies than those with RA (21.1%; P = 0.014). A significantly lower proportion of patients receiving concomitant DMARDs (16.5%) developed ADA than those on monotherapy (26.4%; P < 0.05). Conclusion In patients with RA or SpA and secondary failure, the development of ADA against ADL or INF, but not ETN, appears to be one of the main reasons for secondary treatment failure, but not the only one. Further investigations are needed to determine other causes of anti-TNF failure.

Background Biological therapies have greatly improved the management of psoriatic arthritis (PsA). Minimal disease activity (MDA) has become the optimal target in the treatment of PsA, waiting for a standardized definition of remission. Knowing the proportion of PsA patients in the MDA state could inform on the quality of management of these patients. Objectives To determine the prevalence of MDA (Coates et al.) in patients with PsA in Spain as well as its potential predictors. To evaluate the association between MDA and the impact of disease, as evaluated by the PsA Impact of Disease questionnaire (PsAID). Methods This was a non-interventional, cross-sectional, multicenter study, which aimed to evaluate the prevalence of MDA in a Spanish population with PsA. The study was carried out at 25 rheumatology outpatient clinics between May/2014 and Feb/2015. A total of 238 adult patients diagnosed with PsA (CASPAR criteria) with at least one year disease duration and treated with biological and non-biological DMARDS were included. Finally, 227 were considered evaluable. Clinical, demographic, treatment data, physical function (HAQ) and quality of life (PsAID) were obtained. According to the latter, the patient acceptable symptoms state (PASS) has been defined as a PsAID value Results Overall, 133 out of 227 (58.6%) subjects achieved MDA at study entry. Seventy-seven (37.9%) and 137 (64.4%) patients reached joint and skin remission, respectively. However, a fair relationship between MDA and joint remission (k=0.390) and a slight relationship between MDA and skin remission (k=0.178) were observed. Patients in MDA state had better functional capacity by HAQ (0.35 ± 0.47) vs non-MDA patients (0.79 ± 0.63), p Conclusions MDA was achieved by nearly 60% of patients in this study reflecting clinical practice in agreement with results from earlier studies. These patients had better functional state and most of them reached an acceptable symptoms state according to the PsAID. Our results of predictors to achive MDA should be confirmed in further prospective studies. References Coates LC, Fransen J, Helliwell PS. Defining minimal disease activity in psoriatic arthritis: a proposed objective target for treatment. Ann Rheum Dis. 2010 Jan;69(1):48–53. Perrotta FM, Marchesoni A, Lubrano E. Minimal Disease Activity and Remission in Psoriatic Arthritis Patients Treated with Anti-TNF-alpha Drugs. J Rheumatol. 2015 Dec 15. pii: jrheum.150805. Haddad A, Thavaneswaran A, Ruiz-Arruza I, Pellett F, Chandran V, Cook RJ et al. Minimal disease activity and anti-tumor necrosis factor therapy in psoriatic arthritis. Arthritis Care Res (Hoboken) 2015;67(6):842–847. Acknowledgement This work has been funded by Pfizer Disclosure of Interest None declared