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Objectives To apply the lupus low disease activity state (LLDAS) definition within a large cohort of patients and to assess the agreement between the LLDAS and the physician’s subjective evaluation of lupus activity. Methods We conducted a cross-sectional analysis of a prospective multicentre study of SLE patients. We applied the LLDAS and assessed whether there was agreement with the clinical status according to the physician’s opinion. Results A total of 508 patients [92% women; mean age 50.4 years (s.d. 3.7)] were recruited and 304 (62.7%) patients were in the LLDAS. According to physician assessment, 430 (86.1%) patients were classified as remission or low activity. Overall agreement between both evaluations was 71.4% (95% CI: 70.1, 70.5) with a Cohen’s κ of 0.3 [interquartile range (IQR) 0.22–0.37]. Most cases (96.1%) in the LLDAS were classified as remission or low activity by the expert. Of the patients who did not fulfil the LLDAS, 126 (70.4%) were classified as having remission/low disease activity. The main reasons for these discrepancies were the presence of new manifestations compared with the previous visit and a SLEDAI 2K score >4, mainly based on serological activity. Conclusions Almost two-thirds of SLE patients were in the LLDAS. There was a fair correlation between the LLDAS and the physician’s evaluation. This agreement improves for patients fulfilling the LLDAS criteria. The discordance between both at defining lupus low activity, the demonstrated association of the LLDAS with better outcomes and the fact that the LLDAS is more stringent than the physician’s opinion imply that we should use the LLDAS as a treat-to-target goal.

Aims Adalimumab is a biological therapy used to treat different chronic inflammatory diseases. At present, there is an increasing number of adalimumab biosimilars. To assume the acceptability of interchangeability between reference adalimumab and biosimilars, there should be evidence about efficacy and safety of this switching. Regulation of this practice falls under the authority of individual European Union Member States. The aim of this study is to systematically review the evidence on the efficacy, safety and immunogenicity of switching between reference adalimumab and biosimilars in different chronic immune-mediated inflammatory diseases. Methods Studies presenting data about switching between reference adalimumab and biosimilars were identified by sensitive search strategies in Medline and EMBASE from 1 January 2004 to 30 June 2021. Results A total of 471 references were obtained and 21 finally included in the analysis (total number of patients switching: 2802). Eight different adalimumab biosimilars were tested after receiving reference adalimumab. Eight articles included rheumatoid arthritis (RA), one miscellaneous rheumatic disease, six psoriasis (PSO) and six inflammatory bowel disease (IBD) patients. Overall, the efficacy results in the switching groups were comparable to those obtained in the arms of continuous biosimilar and continuous reference adalimumab. There were no significant differences in treatment emergent adverse events, anti-drug or neutralising antibodies among the three groups. Conclusions Switching between reference adalimumab and biosimilars has no impact on efficacy, safety and immunogenicity in patients with RA, PSO and IBD. This finding was consistent for the different adalimumab biosimilars analysed. These conclusions could probably be extended to other rheumatic diseases such as psoriatic arthritis and ankylosing spondylitis.

Objective SLE can affect any part of the gastrointestinal (GI) tract. GI symptoms are reported to occur in >50% of SLE patients. To describe the GI manifestations of SLE in the RELESSER (Registry of SLE Patients of the Spanish Society of Rheumatology) cohort and to determine whether these are associated with a more severe disease, damage accrual and a worse prognosis. Methods We conducted a nationwide, retrospective, multicentre, cross-sectional cohort study of 3658 SLE patients who fulfil ≥4 ACR-97 criteria. Data on demographics, disease characteristics, activity (SLEDAI-2K or BILAG), damage (SLICC/ACR/DI) and therapies were collected. Demographic and clinical characteristics were compared between lupus patients with and without GI damage to establish whether GI damage is associated with a more severe disease. Results From 3654 lupus patients, 3.7% developed GI damage. Patients in this group (group 1) were older, they had longer disease duration, and were more likely to have vasculitis, renal disease and serositis than patients without GI damage (group 2). Hospitalizations and mortality were significantly higher in group 1. Patients in group 1 had higher modified SDI (SLICC Damage Index). The presence of oral ulcers reduced the risk of developing damage in 33% of patients. Conclusion Having GI damage is associated with a worse prognosis. Patients on a high dose of glucocorticoids are at higher risk of developing GI damage which reinforces the strategy of minimizing glucocorticoids. Oral ulcers appear to decrease the risk of GI damage.

Muscular symptoms, which may be due to multiple causes, are one of the most common early complaints in a rheumatology practice. Musculoskeletal symptoms in rheumatic conditions are very varied, ranging from mechanical problems to muscular symptoms derived from inflammatory and systemic autoimmune diseases. Several drugs commonly used by different specialists and certain drugs used in rheumatology can also cause a wide variety of muscle symptoms. A description of different systemic autoimmune diseases follows to describe the different forms of involvement of the musculoskeletal system that they cause, as well as the main causes with which a differential diagnosis should be made. In this chapter, we will try to give some clues to reach an early diagnosis using clinical criteria, particularly based on a directed anamnesis and physical examination, discussing possible guidelines for the complimentary tests that may be required in patients with muscle complaints.

To analyze the influence of tobacco smoking on systemic lupus erythematosus (SLE) clinical features and damage. Cross-sectional and retrospective, case-control study comparing SLE patients with and without tobacco exposure. Cumulative clinical data and comorbidities were collected, and severity (Katz index) and damage (SLICC/ACR damage index) (SDI) indices were calculated. Pack-years (PY) was used to estimate lifetime tobacco exposure. A logistic regression was carried out to explore the impact of tobacco use on retinal damage. 216 patients were included. The mean age was 49 years (± 12.7), 93% were females, and median disease duration was 17 years [interquartile range (IQR):9-25]. Fifty-three percent of patients were smokers at some point. The median PY was 13 (IQR: 6-20.5). Only 54.8% of active smokers recalled having been informed of the negative effects of smoking, versus 83.3% of never smokers ( 0.001). In a bivariant analysis, an association between tobacco use at any time and discoid lupus [OR: 3.5(95%CI 1.5-8.9); p = 0.002] photosensitivity [OR: 2.06(95%CI 1.16-3.7); p = 0.01] and peripheral arteriopathy (p = 0.007) was found. Considering SDI item by item, a significant association with retinal damage, adjusted for age [OR: 1.03(95%CI 1-1.07); p = 0.04], was found. Using PYs, an association was found with discoid lupus (p = 0.01), photosensitivity (p = 0.03) and peripheral arteriopathy (p = 0.01), global SDI 0 (p = 0.002) and retinal damage (p = 0.02). In a multivariate analysis exploring factors associated with retinal damage, any previous smoking history and SDI remained associated with retinal damage. Tobacco smoking is associated with cutaneous manifestations and damage and is an independent predictor of retinal damage in SLE patients.

Background: Renal involvement in systemic lupus erythematosus (SLE) is the most frequent severe manifestation and carries a bad prognosis. Objectives: To analyze the outcome of lupus nephritis (LN) in terms of chronic kidney disease development (CKD). Methods: Design: multicentre restrospective observational study. Patients: SLE patients (ACR97) with biopsy proven LN attending to three South European Rheumatology departments. Variables: demographics, SLE related variables, including global activity (SLEDAI-2K), renal flares, therapies, ACR response criteria and CKD. Statistical analysis: descriptive bivariate and multivariate analysis exploring factors associated to CKD. Results: Seventy-six patients with biopsy-proven LN were included, 90,7% female; mean age: 33 years; mean disease: duration 14 years; mean follow-up time (since LN diagnosis): 8,5 years. LN class III, IV and V were present in 22%, 75% and 3% of the cases, respectively. At LN diagnosis 68 (89%) patients had a severe renal flare. Forty-one (56.1%) and 49 (64.4%) had HTA and nephrotic syndrome, respectively. The mean 24h proteinuria levels at LN diagnosis was 4,6g. Mean SLEDAI-2K at the time of flare was 20.3, with 69 (65.7%) patients having an extrarenal flare. The treatments used to induce remission were: glucocorticoids (100%): pulses M-prednisolone in 49 (64%) and oral prednisone (mean starting dose): 43 mg/day (±20.6); intravenous cyclophosphamide in 42 (55%) patients; mycophenolate mofetil (MMF) in 21 (27%) patients; calcineurin inhibitors in 5 (11%) patients; rituximab in 4 (5.2%) patients; and oral cyclophosphamide in 4 (5,2%) patients. Forty-eight (63%) patients were receiving hydroxychloroquine. MMF was the immunosuppressant (IS) more frequently used (52%) as maintenance therapy. At 3, 6 and 12th months, the mean proteinuria was 2.3g/24h, 1.53g/24h, 1.1g/24h, respectively (p In the bivariate study, the following variables were significantly associated with CKD: male sex, hypertension, ACEI drugs, severe infection after LN, temporal dyalisis, non ACR renal response, non use of hydroxychloroquine, time to achieve 10mg/day of prednisone, previous creatinine to LN, maximum creatinine at LN, hyperlipidemia at 3 months of LN, active urinary sediment at 12 months, creatinine at 6 and 12 months, proteinuria at 6 and 12 months. In the logistic regression model, using genetic algorithms, we found that proteinuria at 6 months was significantly associated with CKD (OR:2.95; 95%CI 1.19,9.29, p= 0.03). Hypertension and male sex were marginally associated (p=0.06, both). Conclusion: A considerable percentage of LN patients developed renal chronic failure (21,9%). A high percentage of ACR response was achieved using medium dose (40mg) of glucocorticoids for induction. A significative reduction of proteinuria was achieved at 3 months, but proteinuria at 6 months was the only factor finally associated with CKD. Disclosure of Interests: Irene Altabas Gonzalez: None declared, Jose M Pego-Reigosa: None declared, Jose Maria Gonzalez: None declared, Francisco Rubino: None declared, Chiara Stagnaro: None declared, Chiara Tani: None declared, Carlos Rodriguez-Lozano: None declared, Maria Celia Erausquin: None declared, Juan Carlos Quevedo-Abeledo: None declared, Inigo Hernandez: None declared, Marta Mosca Paid instructor for: GlaxoSmithKline, Lilly, UCB, Inigo Rua-Figueroa: None declared

Background Remission and Low Disease activity state (LDAS) are physician assessed treat to target-T2T outcomes for Systemic Lupus Erythematosus (SLE). Lupus Impact Tracker (LIT), a ten-item unidimensional patient reported tool has good psychometric properties and responds to patient reported changes in health, physician based disease activity (DA) and composite response Index (SRI). Herein we report responsiveness of LIT to changes in physician (T2T) and patient assessed outcomes (DA by SLAQ and health status (EQ5D)) among SLE patients from the largest European SLE registry- cohort. Methods One-year longitudinal, observational, multi-center data from 1364 adult patients with SLE meeting 1997 ACR criteria were obtained from baseline and year 1 visit. This included demographics, patient reported tools (LIT, EQ5D VAS, SLAQ), SLE (activity-SLEDAI) and medications. Remission off therapy (ROFT) was defined as SLEDAI=0 without prednisone or Immunosuppressive/s. Remission on-therapy (RONT) was SLEDAI=0 and a prednisone dose 5 mg/day and/or Immunosuppressive/s (maintenance dose). LDAS (modified) was defined as SLEDAI 4, prednisone dose 9 mg/day and/or maintenance immunosuppressive/s. Non-optimal (NO) disease status was SLEDAI >4 and/or prednisone dose >9 mg/day and/or immunosuppressive/s in induction dose. Use of hydroxychloroquine was permitted in all groups. LIT values were compared using mixed models. Responsiveness was evaluated by standard response means (SRM) in groups with changes in DA (T2T, SLAQ) and EQ5D VAS as anchors. We did not have enough observations for stratified analysis for SLE patients with fibromyalgia. Results 1232/1364 (90%) were women, and 95% were Caucasian. Mean (SD) SLEDAI and SDI were 2.6 (3.5) and 0.7 (1.1) respectively. As (i) DA was low (median 2) in LDAS, (ii) steroid use was more prevalent in RONT than LDAS, we combined RONT and LDAS into one category to analyse patient relevant differences in LIT. LIT was responsiveness in the appropriate direction with improvement and worsening in disease activity (T2T and SLAQ) and health status (EQ5D VAS) over time. Mean LIT changes to and from NO to RONT/LDAS ranged from 3–5 (table 1), while it declined by over 8.5 with change from NO to ROFT. We had limited observations for ROFT to NO change. Mean change in LIT ranged from −3 to 3 with improvement and worsening in SLAQ, and from −7.6 to 6 with improvement and worsening in EQ5D VAS. Conclusions LIT responds appropriately in both directions to changes in physician (T2T) as well as patient relevant (DA and health status) outcomes among Spanish SLE patients. Funding Source(s): None