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BackgroundThe COVID-19 pandemic has taken a toll on the mental health of the general population. Patients with systemic lupus erythematosus (SLE) were particularly exposed due to many uncertainties linked to the virus and their immunosuppression as well as difficulties to access medical care and their treatment (eg, hydroxychloroquine) during the early pandemic.ObjectivesTo evaluate the difficulties encountered by SLE patients during the early COVID-19 pandemic, and evaluate their impact on patient mental health.MethodsWe conducted a nationwide survey including SLE patients from France metropolitan and overseas territories, recruited by their treating specialist or through a patient association (AFL+). The survey was administered online or in paper form between November 2020 and April 2021, and included questions aiming at evaluating the difficulties encountered during the early COVID-19 pandemic (March to August 2020). The impact on mental health was evaluated using Hospital Anxiety and depression scale (HADS) and post-traumatic stress disorder (PTSD) Checklist for DSM-5 (PCL-5).Results536 SLE patients (91.9% women) of mean age 50 (±14.1) years responded to the survey. The main reported difficulties were issues to access medical care (n = 136, 25.4%) or to obtain hydroxychloroquine treatment (n = 98/389, 25.2%), the loss of employment (n = 85/349, 24.4%) and financial difficulties (n = 75/536, 11%). Hydroxychloroquine shortage was responsible for difficulties in obtaining the drug for 25.2% (98/389) of HCQ-treated patients, and 57 had to interrupt HCQ treatment for a median of 7 days (IQR: 3-17). In the 342 patients with complete assessment, 161 (47.2%) screened positive for anxiety, 141 (41.2%) for depressive syndrome and 128 (38.7%) for PTSD. Multivariate analysis showed that female sex (OR=4.29 [95%CI: 1.39-13.24]), financial issues (OR=2.57 [1.27-5.22]), difficulties to access medical care (OR=2.15 [1.26-3.69]), or to obtain hydroxychloroquine treatment (OR=1.90 [1.06-3.40]) were independently associated with a positive screening for PTSD.ConclusionThe COVID-19 pandemic resulted in a severe burden in SLE patients, including difficulties in access to care and treatment along with high psychological distress. Better understanding these difficulties will allow better prevention and care in times of crisis.Table 1.Factors associated with the development of anxiety, depression or PTSD. Odds ratio (CI95%) using multivariate logistic regression are shown.Patient and pandemic-associated factorsOdds ratio (95%CI) for anxietyOdds ratio (95%CI) for depressionOdds ratio (95%CI) for PTSDFemale sex2.25 (0.97-5.25), p = 0.058ns4.29 (1.39-13.24)p = 0.01Financial difficultiesns2.59 (1.31-5.11)p = 0.0062.57 (1.27-5.22)p = 0.009Difficulties to obtain HCQ1.70 (0.97-2.98)p = 0.065ns1.90 (1.06-3.40)p = 0.03Difficulties to access medical care1.94 (1.15 3.25)p = 0.0122.57 (1.53-4.33)p < 0.00012.15 (1.26-3.69)p = 0.005AcknowledgementsAntonin Folliasson for his help.Disclosure of InterestsMarc SCHERLINGER: None declared, naimah zein: None declared, Jacques-Eric Gottenberg: None declared, Marianne Riviere: None declared, Jean François Kleinmann: None declared, Jean Sibilia: None declared, Laurent Arnaud Speakers bureau: Alexion, Amgen, Astra-Zeneca, Abbvie, Biogen, BMS, Boehringer-Ingelheim, Cêmka, Kezar, GSK, Grifols, Janssen, LFB, Lilly, Menarini France, Medac, Novartis, Oséus, Pfizer, Roche-Chugaï, Sêmeia, UCB., Consultant of: consultant for Alexion, Amgen, Astra-Zeneca, Abbvie, Biogen, BMS, Boehringer-Ingelheim, Cêmka, Kezar, GSK, Grifols, Janssen, LFB, Lilly, Menarini France, Medac, Novartis, Oséus, Pfizer, Roche-Chugaï, Sêmeia, UCB.

BackgroundThe low prevalence of systemic autoimmune diseases and the diversity of their clinical manifestations make complex to conduct randomised clinical trials to assess the potential efficacy of targeted treatments.ObjectivesTo assess the tolerance and efficacy of targeted therapies prescribed off-label in refractory autoimmune diseases.MethodsThe TATA registry (TArgeted Therapy in Autoimmune Diseases) is a prospective, observational, national and independent cohort follow-up. The inclusion criteria in the registry are as follows: age > 18 years; rare systemic autoimmune disease (systemic lupus erythematosus, Sjögren’s syndrome, systemic scleroderma, inflammatory myopathy, vasculitis) or other refractory rheumatism treated with off-label drugs started after 1st January 2019.ResultsHundred (100) patients (79 females) were enrolled. The median age was 52.5 years [49;56], the median disease duration before enrolment was 5 years [3;7]. The targeted therapies at enrolment were as follows: JAK/STAT inhibitors (44%), anti-IL6R (22%), anti-IL12/23, anti-IL23 and anti-IL17 (9%), anti-BAFF (5%), abatacept (5%), other targeted treatments (9%), and combination of targeted treatments (6%). 73% of patients were receiving corticosteroid therapy at enrolment (median dose 10 mg/day). The current median follow-up time is 9 months [8;10].Safety: 11 serious infections (incidence rate of 14.8 /100 patient-years) and 1 cancer (1.3 cancers/100 patient-years) were observed. Two patients died from severe COVID-19 (2.7 deaths/100 patient-years).Efficacy: The targeted treatment was considered effective by the clinician in 56% of patients and allowed in responders a median reduction of oral corticosteroids of 15 [9-21] mg/day.ConclusionThese initial results of the TATA registry confirm the diversity of targeted treatments prescribed off-label in refractory autoimmune diseases and their corticosteroid-sparing effect when effective. Tolerance was acceptable in these refractory patients with a long history of treatment with immunosuppressive drugs.References[1]B. Terrier et al., Safety and efficacy of rituximab in systemic lupus erythematosus: results from 136 patients from the French AutoImmunity and Rituximab registry. Arthritis Rheum 62, 2458-2466 (2010).[2]J. E. Gottenberg et al., Efficacy of rituximab in systemic manifestations of primary Sjogren’s syndrome: results in 78 patients of the AutoImmune and Rituximab registry. Ann Rheum Dis 72, 1026-1031 (2013).[3]J. E. Gottenberg et al., Risk factors for severe infections in patients with rheumatoid arthritis treated with rituximab in the autoimmunity and rituximab registry. Arthritis Rheum 62, 2625-2632 (2010).[4]F. R. S. S. S. C. I. consortium, contributors, Severity of COVID-19 and survival in patients with rheumatic and inflammatory diseases: data from the French RMD COVID-19 cohort of 694 patients. Ann Rheum Dis, (2020).[5]R. Felten et al., B-cell targeted therapy is associated with severe COVID-19 among patients with inflammatory arthritides: a 1-year multicentre study in 1116 successive patients receiving intravenous biologics. Ann Rheum Dis 81, 143-145 (2022).[6]D. J. Wallace et al., Baricitinib for systemic lupus erythematosus: a double-blind, randomised, placebo-controlled, phase 2 trial. Lancet 392, 222-231 (2018).[7]J. J. Paik et al., Study of Tofacitinib in Refractory Dermatomyositis: An Open-Label Pilot Study of Ten Patients. Arthritis Rheumatol 73, 858-865 (2021).[8]S. Cole et al., Integrative analysis reveals CD38 as a therapeutic target for plasma cell-rich pre-disease and established rheumatoid arthritis and systemic lupus erythematosus. Arthritis Res Ther 20, 85 (2018).[9]S. J. Bowman et al., Safety and efficacy of subcutaneous ianalumab (VAY736) in patients with primary Sjogren’s syndrome: a randomised, double-blind, placebo-controlled, phase 2b dose-finding trial. Lancet 399, 161-171 (2022).AcknowledgementsFrench networks (FAI2R, CRI, IMIDIATE, SFR, SNFMI) focused on rare systemic autoimmune diseases contributed this work by the contribution of network-affiliated physicians.Disclosure of InterestsJacques-Eric Gottenberg Consultant of: Abbvie, BMS, Gilead, Galapagos, Novartis, Lilly Roche Chugai, Sanofi, Janssen, Pfizer, Grant/research support from: BMS.Lilly and Pfizer for this register (with no access to data)., Aurore Chaudier: None declared, Yves Allenbach: None declared, Arsene Mekinian: None declared, Zahir Amoura: None declared, Patrice cacoub: None declared, Divi Cornec: None declared, Eric Hachulla: None declared, Pierre Quartier: None declared, isabelle melki: None declared, Christophe Richez: None declared, Raphaèle Seror: None declared, Benjamin Terrier: None declared, Valerie Devauchelle-Pensec: None declared, Julien Henry: None declared, MARC GATFOSSE: None declared, LAURENCE BOUILLET: None declared, Emeline GAIGNEUX: None declared, Vincent ANDRE: None declared, Gildas BAULIER: None declared, Aurélie SAUNIER: None declared, Marie Desmurs: None declared, Antoine POULET: None declared, Mathieu ETE: None declared, Marie-Elise Truchetet: None declared, Martin Michaud: None declared, Claire Larroche: None declared, AZEDDINE DELLAL: None declared, Amelie LEURS: None declared, Sebastien Ottaviani: None declared, Hubert NIELLY: None declared, Guillaume VIAL: None declared, Roland JAUSSAUD: None declared, Benedicte ROUVIERE: None declared, Pierre-Yves JEANDEL: None declared, Aurelien GUFFROY: None declared, Anne-Sophie Korganow: None declared, Mathieu JOUVRAY: None declared, alain meyer: None declared, Emmanuel Chatelus: None declared, Christelle Sordet: None declared, Renaud FELTEN: None declared, Jean Sibilia: None declared, Samira AHMED YAHIA: None declared, Jean François Kleinmann: None declared, Xavier Mariette Consultant of: BMS, Galapagos, GSK, Janssen, Novartis, Pfizer, Sanofi, UCB

Background The benefit/risk ratio of infliximab in refractory patient with Takayasu arteritis (TA) is assumed to be favorable, based on retrospective studies with limited sample size [1, 2] in which infliximab has been prescribed off-label. Since 2013, the French Temporary Recommendation of Use (RTU) provides a temporary framework allowing the use of infliximab originator in “TA patients refractory to conventional treatment” during a 3-year period. Objectives The aim of the study was to evaluate the real-life efficacy and safety of infliximab originator in TA patients initiating or with ongoing infliximab treatment. Methods Prospective, multicenter, observational, open-label, study of TA patients treated with infliximab originator. Results As of 2016 (2 years of follow-up), the study included 14 patients (13/14 were female; median age 32 [range 12–56] years) with TA (diagnosis according to Ishikawa criteria). At study entry, the median TA duration was 4.7 (0.4–16) years, 12 patients were already treated with infliximab originator (for a median duration of 34 [1–78] months) and 11 patients were receiving corticosteroids (CS). Infliximab originator was administered at a median dose of 5 (3–6) mg/kg with a median interval of 8 (2–67) weeks between each infusion. Seven patients had an improvement in at least 1 of the NIH disease activity criteria for TA [3] after a median follow-up time of 2 (0.4–11) months), 4 had smoldering disease and 1 patient worsened. The median daily dose of CS decreased from 13 (5–35) mg/day of prednisone or equivalent at baseline to 7 (5–10) mg/day at 6 months, to 5 (5–6) mg/day at 12 months, and remained stable up to 22 months of follow-up. Infliximab was discontinued in 6 patients due to inefficacy (n=3), prior to pregnancy (n=2), or remission of TA (n=1). Two adverse events (1 disease flare and 1 spontaneous miscarriage) were reported, without infliximab interruption. Conclusions Infliximab originator appears to provide an effective and favourable benefit:risk treatment option to refractory TA patients. References Mekinian et al, Efficacy of Biological-Targeted Treatments in Takayasu Arteritis: Multicenter, Retrospective Study of 49 Patients, Circulation 132(18) (2015) 1693–700. Mekinian et al, Efficacy and tolerance of infliximab in refractory Takayasu arteritis: French multicentre study, Rheumatology (Oxford) 51(5) (2012) 882–6. Kerr and al. Takayasu arteritis. Ann Intern Med. 1994; 120: 919–29. Acknowledgements The patients were included by AP-HP Cochin (Dr X Puechal), CHU Angers (Dr C Lavigne), CHU Tours (Pr E Diot), CHU Besancon (Pr N Magy, Dr H Gil), CHU Lille (Pr E Hachulla, Pr M Lambert, Dr H Maillard), AP-HP Kremlin-Bicetre (Pr I Kone-Paut), AP-HM Marseille (Pr JR Harle, Dr N Schleinitz), HEGP Pompidou (Dr JE Kahn), CH Royan (Dr A Bonnin), CHU Strasbourg (Pr T Martin, Dr V Poindron), CHU Bordeaux (Pr J Constans). Disclosure of Interest J.-F. Kleinmann Consultant for: MSD, L. Arnaud: None declared, E. Sauleau Consultant for: MSD, N. Gouyette Employee of: MSD, R. Tajima: None declared, J. Sibilia Consultant for: MSD