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The purpose of the study was to estimate the clinical profile of naïve biological patients with rheumatoid arthritis (RA) starting adalimumab through 3-year calendar periods and their clinical outcomes such as drug survival and global clinical disease control (GCDC). RA patients starting adalimumab as first biological drug between 2003 and 2012 were subdivided in 3-year calendar periods. Survival on therapy was estimated using the Kaplan-Meier analysis. One and 2-year clinical response was assessed by calculating percentage of patients attaining GCDC (28-joint Disease Activity Score (DAS28) ≤ 2.6 + Health Assessment Questionnaire (HAQ) ≤ 0.5), low disease activity (DAS28 ≤ 3.2), remission (DAS28 ≤ 2.6) and good European League Against Rheumatism (EULAR) response. Multivariate regression models were used to assess baseline predictors of drug discontinuation or achievement of clinical remission. We recruited 1695 RA patients. Overall drug persistence at 3 years was 40.6 %, while the global rate of nonswitching patients was 54.7 %. Compared to 2003-2005, initiators in more recent years had a significantly lower 3-year crude drug retention rate (log rank, p < 0.0001) and a significantly higher rate of switching to alternative biologics (log rank, p < 0.0001). No difference in adverse events or effectiveness rate among the calendar periods was found. A substantial proportion of patients (up to 27 %) achieved GCDC at 2 years, regardless of the calendar period. In real-life setting, RA patients starting adalimumab in more recent years had a higher rate of drug discontinuation not related to ineffectiveness or side effects but to switching, probably due to a wider availability of biologics. A meaningful proportion of patients attained GCDC without any difference across calendar periods.

Objectives Although neuropsychiatric involvement in Systemic Lupus Erythematosus (NPSLE) is one of the most complex and troubling manifestations of the disease, validated outcome instruments to be used as sensitive endpoints in controlled clinical trials are lacking. We set out a systematic literature review (SLR) to identify outcome measurement instruments and domains used to assess NPSLE. Methods The Preferred Reporting Items for systematic reviews and Meta-analysis (PRISMA) guidelines were used. Articles available in English (1967-2020), listed in PubMed, EMBASE, PsycINFO, Cochrane Library and EULAR outcome measures library were screened. All domains and outcome measurement instruments were characterized according to the OMERACT Filter 2.1, considering core areas (manifestations/abnormalities, life impact, death/lifespan, societal/resource use) and contextual factors. Results Of 3,392 abstracts evaluated, 83 studies were included in the SLR (15,974 patients, females 89.9%). Eligible studies included domains and instruments pertinent to all core areas defined by OMERACT, except for “societal/resource use”. The most common core areas were “manifestations/abnormalities”, covering 10 domains pertinent to laboratory and instrumental markers, indexes and neuropsychiatric dimension (cognitive, neurologic and psychiatric field), and “life impact”, covering 7 domains related to physical function (from both the perspective of the patient and the physician), pain and quality of life. Conclusion Our study revealed great heterogeneity in the instruments derived from populations with NPSLE and none of these had high-quality evidence. This supports the need to develop and further validate a core domain set and outcome measurement instruments to promote clinical research in this field, enhancing comparability across studies.

BackgroundAccording to international task force recommendations, primary goal of rheumatoid arthritis (RA) treatment is to achieve control of symptoms, prevent structural damage and normalize functional status.Simultaneous achievement of DAS28 PCR remission <2.6, HAQ DI <0.5 and change from baseline in modified Total Sharp Score (SHS)<0.5, has recently defined as comprehensive disease control (CDC). Residual sub-clinical synovitis on ultrasonography/power doppler (US-PD) examination is one of the major driver of radiographic progression, but US-PD evaluation has not been yet included in definition of CDC.ObjectivesTo analyze the achievement of CDC in an Early Rheumatoid Arthritis (ERA) Cohort after 1 year from diagnosis and to evaluate if this status was also associated to absence of US subclinical active synovitis. Compared US status in patients who achieved CDC with those achieving DAS 28 PCR-REM but not CDC.MethodsERA patients fulfilling 2010 ACR/EULAR who consecutively attended our Early Arthritis Clinic between 2009–2014 were retrospectively analyzed. Patients with available follow-up of 1 year were included. Standardized therapeutic approach has been performed according to EULAR T2T guidelines. Disease activity and functional disability has been evaluated using DAS28 PCR and HAQ DI every 3 months and after 12 months (T12) from diagnosis. Being more easily applicable in daily practice activity, radiographic progression has been assessed using Simple Erosion Narrowing Score (SENS). Therefore we considered as radiographic non progressors those patients who showed no change in SENS score at 12 months, from baseline (assimilated to <0.5 point change in mHSS). Patients were stratified in CDC-achievers and CDC non-achievers. Among those patients who reached DAS28-REM alone were identified. All patients were evaluated by US-PD of both wrists and II and III metacarpophalangeal. US-PD assessment was drawn at T12, considering as active subclinical synovitis a PD signal ≥1 in more than 1 Joint.Results125 patients out of 323 met the inclusion criteria. After 12 month from diagnosis, 30% were CDC-achievers (n=38) and 70% CDC non-achievers (n=87); of this last group, 38,4% (n=48) achieved REM. 81,2% (39/48) of patients in REM didn't achieved CDC because of radiographic progression. When comparing US-PD findings in both CDC-achievers and REM 6/38 (15.7%) and 12/48 (25%) respectively showed residual US-PD synovitis. In REM 10/12 (83%) of those with residual synovitis didn't achieve CDC because of radiographic progression.ConclusionsIn our Cohort a significant proportion of patients achieved CDC one year after diagnosis and a T2T therapeutic strategy. As already known our findings confirm that clinical remission is not fully protective against radiographic progression in ERA since 83% of those with residual US-PD synovitis did radiographically progress.However, the meaning of residual synovitis observed also in our CDC-achievers patients, although to a lesser amount (15.7%), is still unknown and has to be ascertained in a pro...

BackgroundRemission is the optimal therapeutic goal in treating rheumatoid arthritis to target but low disease activity could constitute a valuable alternative goal especially in patients with long standing disease. Few data exist about the different clinical and functional implications of the two disease activity conditions especially in Early Rheumatoid Arthritis (ERA).ObjectivesTo investigate whether aiming a state of remission yields some benefit when compared with low disease activity as regard to functional outcomes in an Early Rheumatoid Arthritis cohort of patients.MethodsERA patients fulfilling 2010 ACR/EULAR who consecutively attended our Early Arthritis Clinic between 2009-2014 were retrospectively analyzed. Patients with available follow-up of at least 1 year were included. Disease activity and functional disability has been evaluated using DAS28 and HAQ after 6 (T6) and 12 (T12) months from diagnosis. Standardized therapeutic approach has been performed according to EULAR guidelines. At T6 and T12 HAQ was compared between patients with different levels of disease activity according to the DAS28: remission (REM-DAS28<2.6) and low disease activity (LDA-DAS28≤3.2). Data were analysed by using t student test.ResultsOne hundred and thirty-nine patients completed the 1-year follow up. At baseline DAS28 and HAQ were respectively 4.59±1.1 and 0.95±0,7. At T6 81 (58%) patients achieved DAS28 remission and had an HAQ of 0.27±0.41, 22 (16%) patients were in DAS28 LDA with an HAQ of 0.49±0.5. At T12 83 (60%) patients achieved DAS28 REM and 27 (19%) DAS28 LDA with an HAQ respectively of 0.22±0.35 and 0.75±0.61. At both time points, HAQ resulted significally lower (p<0.05) in REM groups compared to that in LDA. Within the period of observation (from T6 to T12) 11 patients changed from LDA to REM. When investigating the change in physical function in these patients we saw improvement of HAQ from 0.48±0.55 to 0.21±0.29. 13 patients moved from REM to LDA and HAQ deteriorated significantly (REM 0.33±0.3, LDA 0.74±0.49, p=0.01).ConclusionsEven though LDA constitutes an alternative goal especially in patients with long standing disease, our analyses revealed that aiming a state of clinical REM within the first months of the disease, is much better also in term of physical function. Reaching early a good physical function not only will benefit the patient but also will improved major socioeconomic consequences of Rheumatoid Arthritis.ReferencesH Radner, JS Smolen, D Aletaha. Remission in rheumatoid arthritis: benefit over low disease activity in patient-reported outcomes and costs. Arthritis Research & Therapy 2014;16:R56.Disclosure of InterestNone declared