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Background:Rheumatoid arthritis (RA) and spondyloarthropathies (SpA) are chronic rheumatic diseases that can progress to disability if left uncontrolled. Biologic therapies can induce remission in patients with inadequate response or intolerance to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs). Due to the safety and economic concern, updated treatment recommendations now consider biologics discontinuation in patients with persistent remission. However, available data are still limited.Objectives:To evaluate the biologics effectivenss, drug survival, rate of discontinuation in real-life practice and to identify predictors of biologics discontinuation due to remission in RA and SpA.Methods:A total of 87 patients with RA and 49 patients with SpA, starting biologics between January 2005 and October 2020, were recruited from the Rheumatic Disease Prior Authorization (RDPA) registry of Siriraj hospital. Baseline data were recorded. Time-dependent rates in achieving remission were calculated. Cumulative probability of biologics discontinuation and predictive factors of drug discontinuation due to remission were analyzed.Results:The biologics used in RA patients were Etanercept (49.4%), Rituximab (44.8%), and Infliximab (5.7%). The 1- and 5- year remission rates were 8.5% and 23.9%, respectively. Drug survival rates were 33.6% for Etanercept, 40.7% for Rituximab, and 36% for Infliximab at five years. The main reasons for drug discontinuation were disease remission (32.1%), inadequate response (32.1%), and side effects (15.1%). Rituximab had the highest discontinuation rate due to remission (56.4%). There was no predictive factor for biologics discontinuation due to remission.SpA patients were treated with Etanercept (83.6%) and Infliximab (16.4%). The 1- and 5- year remission rates were 67.4% and 66.7%, respectively. Drug survival rates were 50.3% for Etanercept and 0% for Infliximab at five years. Biologics withdrawal due to side effects occurred in 16%, inadequate response in 10%, and disease remission in 10% of patients. The predictive factor for biologics discontinuation due to remission was disease duration < 5 years (Hazard ratio 6.92, 95%CI 1.10, 43.29)Conclusion:Biologic therapies are effective in patients with active RA and SpA despite csDMARDs treatment. The highest drug survival rates are Rituximab in RA and Etanercept in SpA. Infliximab has the shortest drug retention rate in SpA. Drug discontinuation due to remission is more successful in RA patients, particularly in the Rituximab group. The best predictor for biologics discontinuation due to remission in SpA is the disease duration of fewer than five years.Table 1.Effectiveness, Drug Survival and Causes of Biologic Discontinuation in RA and SpARA % (87 cases)BiologicsTotal % (N)5-year Remission rate %5-year Drug survival rate %Discontinuation % (N 53 cases)Total %(53)RemissionInadequate responseSide effectNon-adherence/ ReferDeathEtanercept49.4 (43)23.933.650.9(27)14.8(4)44.4(12)22.2(6)11.1(3)7.4(2)*Infliximab5.7 (5)365.7 (3)0(0)33.3(1)33.3(1)33.3(1)(0)Rituximab44.8 (39)40.743.4 (23)56.5(13)17.4(4)4.3(1)13.0(3)8.7(2)SpA %(49 cases)BiologicsTotal % (N)5-year Remission rate %Drug survival rate%Discontinuation % (N 23 cases)Total % (23)RemissionInadequate responseSide effectNon-adherence/ ReferDeathEtanercept83.6 (41)66.750.378.3(18)22.2(4)22.2(4)33.3(6)22.2(4)0(0)Infliximab16.4 (8)021.7 (5)20(1)20(1)40(2)20(1)0(0)*Cause of death: sudden cardiac death (1), intraabdominal infection (1)Cause of death: pneumonia (1), Lung cancer (1)Disclosure of Interests:None declared

Background JIA is the most common chronic inflammatory rheumatic diseases of childhood. Due to their long-term safety and efficacy, biologic disease modifying antirheumatic drugs (DMARD) are commonly necessary for control of pJIA patients (pts). Objectives To evaluate 6-year (y) safety and 2 y effectiveness profile of Adalimumab with or without methotrexate (ADA±MTX) when used in current clinical practice for the treatment of moderately to severely active pJIA. Methods This is a 6 y interim analysis of an ongoing, multicenter, non-interventional, observational registry of pts with moderately to severely active pJIA with up to10 y safety follow-up. Included pts are treated with either ADA±MTX or MTX alone as part of their routine clinical care enrolled in the US, EU, and Australia. MedDRA observational adverse events (AEs) were recorded from the first day in the registry through last contact, irrespective of the duration of registry treatment. Effectiveness was assessed by 27-joint juvenile arthritis disease activity score (JADAS27), based on CRP. Results As of January 2014, enrollment was complete. As of June 1, 2015 cut-off date, 846 pts (543 in ADA±MTX and 303 in MTX groups) were treated in the registry. There were 39 pts who rolled over from the MTX to the ADA±MTX arm. At registry entry mean pJIA disease duration was 1.4 y and 3.7 y for MTX and ADA±MTX arms, respectively. At baseline (BL), mean AJC71 was 5.8 and 5.3 for MTX and ADA±MTX arms, respectively, and Childhood Health Assessment Questionnaire Disability Index (CHAQ-DI) was 0.6 for both arms. At data cutoff, the mean duration of study exposure was 1.81 y and 2.15 y for MTX and ADA±MTX arms, respectively. Overall, 206 pts (68%) in the MTX and 216 pts (39.8%) in the ADA±MTX arms discontinued registry drug through 6 y. The main reasons for registry drug discontinuation for the MTX arm: pts required additional therapy (32.3%), other (11.9%), lack of efficacy (10.9%), AEs (8.3%), or pts achieved JIA remission (7.6%), and for ADA±MTX arm: lack of efficacy (16%), lost to follow-up (7.2%), other (5.9%), and AEs (5.3%). Frequencies and rates of treatment-emergent AEs were similar to those reported for observational AEs (Table). There were no reports of deaths, malignancies, opportunistic infections, active TB, oral candidiasis, or CHF. Mean JADAS27 (CRP) improved from 12.2 at BL to 9.7, 5.2, 4.4, 3.5, 2.2 at months 1, 6, and 12, 18, 24 for pts in the MTX and from 11.8 at BL to 7.0, 4.-2, 4.2, 3.6, 3.9 in the ADA±MTX arms, respectively (observed data). Conclusions Overall, ADA±MTX was well-tolerated in these pts with pJIA with no new safety signals. Discontinuations from the registry drug were relatively high through 6 y, but greater in the MTX only arm. Acknowledgement AbbVie sponsored the study & contributed with PRINTO & PRCSG to the analysis, review, and approval of the abstract. Xiaolei Leahy & Ashish Deshmukh of AbbVie contributed to the research. Medical writing support was provided by Gaurav Patki, PhD, of AbbVie. Disclosure of Interest N. Ruperto Grant/research support from: AbbVie Inc., AstraZeneca, Bristol-Myers Squibb, Janssen Biologics B.V., Eli Lilly and Co., “Francesco Angelini”, GlaxoSmithKline, Italfgroupaco, Novartis, Pfizer, Roche, Sanofi Aventis, Schwarz Biosciences GmbH, Xoma, and Wyeth Phgroupaceuticals., Employee of: GASLINI Hospital, Speakers bureau: Astellas, AstraZeneca, Bristol-Myers Squibb, Italfarmaco, Janssen Biologics B.V., MedImmune, Roche, and Wyeth/Pfizer, D. J. Lovell Consultant for: AbbVie Inc., AstraZeneca, Centocor, Bristol-Myers Squibb, Pfizer, Regeneron, Hoffman La-Roche, Novartis, UBC, Xoma, and Genentech, Speakers bureau: Wyeth Pharmaceuticals, and served on data and safety monitoring boards for Amgen and Forest Research, C. Wallace Grant/research support from: Pfizer and Amgen, Consultant for: Amgen and Novartis., M. Toth: None declared, I. Foeldvari Consultant for: AbbVie and Novartis, J. Bohnsack Consultant for: Novartis, D. Milojevic Consultant for: Genentech and Novartis, E. Rabinovich Grant/research support from: UCB Pharma, Janssen Research & Development, LLC, Hoffmann-La Roche Inc., and AbbVie, D. Kingsbury Grant/research support from: AbbVie, K. Marzan Grant/research support from: AbbVie., P. Quartier Grant/research support from: AbbVie, Novartis, Consultant for: AbbVie, Novartis, K. Minden Grant/research support from: Pfizer and Abbvie, Consultant for: Pfizer, Abbvie, Roche/Chugai, Novartis, Medac and Pharma-Allergan., E. Chalom Speakers bureau: AbbVie, G. Horneff Grant/research support from: AbbVie, Pfizer, and Roche, Speakers bureau: AbbVie, Novartis, Pfizer, and Roche, R. M. Kuester Grant/research support from: AbbVie Inc. and Wyeth/Pfizer, J. Dare Grant/research support from: AbbVie, AstraZeneca, Bristol-Myers Squibb, Horizon Pharma, Medac, Pfizer, Roche, and UCB, M. Heinrich Shareholder of: AbbVie Inc, Employee of: AbbVie Inc, H. Kupper Shareholder of: AbbVie Inc, Employee of: AbbVie Inc, J. Kalabic Shareholder of: AbbVie Inc, Employee of: AbbVie Inc, A. Martini Grant/research support from: AbbVie Inc., AstraZeneca, Bristol-Myers Squibb, Janssen Biologics B.V., Eli Lilly and Co., “Francesco Angelini”, GlaxoSmithKline, Italfarmaco, Novartis, Pfizer, Roche, Sanofi Aventis, Schwarz Biosciences GmbH, Xoma, and Wyeth Pharmaceuticals, Employee of: GASLINI Hospital, Speakers bureau: Astellas, AstraZeneca, Bristol-Myers Squibb, Italfarmaco, and MedImmune., H. I. Brunner Consultant for: AbbVie Inc., AstraZeneca, Centocor, Bristol-Myers Squibb, Boehringer-Ingelheim, Pfizer, Regeneron, Hoffman La-Roche, Novartis, UCB, and Genentech, Speakers bureau: Genentech Pharmaceuticals.

Background There are limited data describing patterns of discontinuations of biologic therapy for rheumatoid arthritis (RA) in real-world settings. Such information could help clinicians understand real-life treatment patterns and serve as a marker of effectiveness to help inform decisions. Objectives To describe the patterns and reasons for discontinuation of biologics within 1 year after initiation of treatment in the Corrona C omparative E ffectiveness R egistry to study T herapies for A rthritis and I nflammatory Co n ditions (CERTAIN) study. Methods CERTAIN is a prospective, nonrandomized, comparative effectiveness cohort study nested within the US Corrona registry and included adult patients with RA who have at least moderate disease activity (Clinical Disease Activity Index >10) and are starting or switching biologics.1 This descriptive study included all patients who initiated a biologic in CERTAIN and discontinued the biologic or switched to a different biologic before their 12-month follow-up visit. Reasons for discontinuation were evaluated based on physician's report and categorized as efficacy reasons, safety reasons, both and other reasons unrelated to safety or efficacy. Results A total of 2361 patients enrolled in CERTAIN contributed 2809 all-biologic initiations to this analysis, which included 1670 anti–tumor necrosis factor agents (aTNFs) and 1139 non-aTNFs. At the time of the analysis, data were available for 1174 biologic initiations from patients who completed CERTAIN, with 344 initiations still in follow up. Baseline characteristics at the time of biologic initiation were as follows: median age, 57 years; female, 79%; median RA duration, 5 years; and rheumatoid factor (RF) and/or anti-cyclic citrullinated peptide (ACCP) antibody seropositivity, 68%. After excluding those initiations still in follow up, 909 of 2465 initiations (37%) resulted in a discontinuation within 12 months, with reasons for discontinuation available for 635 patients (70%; [Table][1]). A higher proportion of biologics were discontinued by the 3-month follow-up visit due to safety reasons, while a higher proportion of initiations were discontinued after the 3-month follow-up visit due to efficacy reasons ( P

Background The American Academy of Ophthalmology published in 2011 revised recommendations regarding screening for hydroxychloroquine (HCQ) toxicity. Little is known about the implementation of these guidelines in clinical practice Objectives The aim of this study was to assess the implementation of these recommendations by rheumatologists and ophthalmologists in Israel Methods A questionnaire was developed, consisting of 13 questions pertaining to each physician9s routine practice in the follow up of patients treated with HCQ. The questionnaire was distributed among all members of the Israeli societies of Rheumatology and Ophthalmology as a web survey. The study was conducted for a period of 6 months (May to November 2014). Results One hundred and twenty one physicians responded to the questionnaire, 49 rheumatologists and 71 ophthalmologists. Sixty three percent of the rheumatologists prescribed a HCQ dose of not more than 6.5mg/kg and not more than 400mg/d while only 17 ophthlamologists responded to this question of whom only 4 were aware of the dose recommendations. Sixty nine percent of all the responders followed patients treated with HCQ for more than 5 years, 12.4% followed patients on treatment for more than 10 yrs. Only 82.6% recommend a baseline ophthlamologic examination at baseline while 7.4% recommend baseline evaluation only for patients at risk. Forty two percent of all responders postpone initiation of HCQ treatment until completion of a baseline evaluation. Only 0.6% of the rheumatologists and 19% of the ophthalomologists were aware of the recommended ophthalmologic assessments for baseline and follow up evaluation. Thirty percent of the responders recommend red on white visual field (VF) assessment and 14% recommend 24-2 VF, while a similar percentage recommend these tests for follow up (33%,13% respectively). HCQ treatment was discontinued due to abnormal findings in the following tests: red on white VF:19%, 24-2 VF: 7%, fundoscopic findings: 25%, color field: 5%, OCT: 19% and auto-fluorescence: 3%. When an abnormal test was detected 56% recommended cessation of therapy while 23% recommended additional evaluation before treatment arrest. Only 14% of the responders recommend first follow up evaluation after 5 years for patients without risk factors and the remainder recommend more frequent testing. Similarly, 56.2% recommend yearly follow up while the remainder recommend more frequent evaluation. Eighty three percent of the responders were not aware of all of the known risk factors for HCQ toxicity. Conclusions Many physicians in Israel are unaware of the 2011 recommendations regarding baseline and follow up tests, timing of assessments, drug discontinuation strategy and risk factors to be considered regarding HCQ retinal toxicity. Use of inappropriate tests to detect HCQ retinal toxicity may lead to unnecessary cessation of beneficial HCQ treatment while lack of consideration of risk factors may pose patients at risk for toxicity. These results emphasize the importance of implementing the 2011 recommendations for better monitoring of patients using HCQ. References Ophthalmology 2011;118(2):415-422 Disclosure of Interest None declared

Background Anti-TNF therapy (αTNF) has revolutionised rheumatology with undeniable improvements in patients’ care, but also made it an expensive speciality. Humira, Enbrel and Infliximab are independently within the top 10 selling pharmaceutical products 2012 with combined estimated worldwide sales of $9.48, $8.37 and $7.67 billion respectively [1]. Financial accountability is imperative to modern medical practice and this includes minimising drug waste. In much of the UK injectable αTNF is delivered directly to patients’ home, with financial benefits for NHS trusts, however any unused stock is wasted. Objectives We aimed to quantify injectable αTNF waste, reasons for it and explore options for reduction. Methods Patients return unused αTNF to the department as a drug safety measure. Patient details; volume of returned drug; and date are recorded on an Excel database. Returns between October 2011 and October 2012 were identified. Patients’ clinical letters were reviewed to establish the timing, reason and a clinical decision made as to the predictability of drug discontinuation. A questionnaire was completed by clinical staff (7 Consultant, 3 SpR, 4 Clinical Nurse Specialist) regarding clinical scenarios of primary/ secondary failure and significant events requiring αTNF cessation. It explored knowledge of the process of stopping αTNF including its delivery. Results In total 390 patients received injectable αTNF; 25 stopped (4 inefficacy, 12 side effects, 6 new contraindication, 3 other); 2 were deemed predictable. Conclusions Annual un-used αTNF amounted to £35,500 representing 1.4% of our departments £2.5million biologics spend. Whilst this is a small proportion, when dealing with large figures small percentages amount to considerable sums. Wastage was largely unpredictable; simply recognising patients expected to stop is thus unlikely to be beneficial. The questionnaire identified sources of unnecessary drug delivery due to delays in stopping αTNF. Clinical staff need education and a streamlined pathway for αTNF cessation instituted. Currently deliveries are made quarterly; reducing this interval would minimise waste without incurring extra cost to the Trust, but an increased workload preparing and dispensing prescriptions is inevitable. To uncouple any dissociation between decision making and prescribing ‘flagging’ prescription requests prior to assessment points (e.g. 6 months in RA) would ensure criteria are fulfilled and appropriate prescribing. We have identified local actions to reduce αTNF wastage. However, our experience is unlikely to be unique and consequently represents an area for considerable potential cost savings both within the UK and EU. References FiercePharma 9 th October 2012 Disclosure of Interest None Declared