AB0302 Profile of Joint Involvement over Time in Rheumatoid Arthritis and Psoriatic Arthritis Patients Treated with Anti-TNF in A Real-World Setting

Background:Evidence on the efficacy of biologics in the treatment of psoriatic arthritis (PsA) patients with axial manifestations affecting 30-70% of PsA patients is limited. Secukinumab (SEC) has provided significant and sustained improvement in the signs and symptoms of active PsA and ankylosing spondylitis.Objectives:This study aims to analyze the experience of using SEC for PsA patients with axial involvement in real-world setting.Methods:Multicentric observational, longitudinal, retrospective study conducted in a tertiary hospital between January 2016 and December 2019. Patients with PsA (CASPAR criteria) and clinical and/or image diagnosis of axial involvement receiving at least one dose of SEC were included. Patients with non-pathological sacroiliacs x-ray and MRI had to have spinal pain VAS ≥4/10 after failure to NSAIDs, prior to the onset of SEC, to be included. Medical records were reviewed to collect demographic and clinical data, features of PsA (manifestations, treatments and activity assessment). Descriptive statistics and then a comparative analysis with the Studentt-test to analyze the effectiveness of SEC were performed.Results:Of 98 PsA patients treated with SEC, 58 (59.2%) had axial involvement, of which 41 (71%) female. Mean age was 54 y.o (SD 10) and average duration of the disease was 10 years (SD 8). All 58 patients had peripheral disease (33% joint erosions), 55 (95%) had psoriasis, 20 (34%) showed dactilitis and 39 (67%) had enthesitis. Sacroiliacs x-ray was damaged in 38 (66%) patients (grade I-IV) and 23 (40%) pathological MRI, with HLAB27+ at 8 (14%) patients. Average BMI was 29 (SD 8), with an obesity rate of 33% (19 pt). Observed comorbidities were hypertension (27 pt, 47%), diabetes mellitus (6 pt, 10%), dyslipidemia (23 pt, 40%), active smoking (18 pt, 31%) and malignancy (6 pt, 10%). Regarding previous treatments, 90% had received cDMARDs, particularly methotrexate (86%) and 40 (69%) had been exposed to at least one bDMARD (15 pt to one, 9 to two, 6 to three and 10 to four or more). 7 patients were on 300 mg dose and 51 patients on 150 mg dose (dose escalation to 300 mg was performed in 16 patients and 44% respond and maintain SEC). Average drug survival time was 1.4 (SD 1) years. At 6 months of SEC therapy, tender and swollen joint count, spinal pain VAS, CRP, ASDAS-CRP and DAPSA had significantly decreased (Table 1). 29 (50%) patients suspended SEC during follow-up due to primary ineffectiveness (8), secondary ineffectiveness (16), adverse events (3), latex allergy (1) and remission (1). Adverse events do not differ from those reported in clinical trials.Table 1.Disease activity assessment at 6 months of secukinumab therapy.Baseline6 months after SECMean differenceP valueSJC4,8±5,41,9±3,1-2,8 (IC95% -3,9 a -1,7)p<0,0001TJC7,7±5,83,9±4,1-3,8 (IC95% -5,1 a -2,4)p<0,0001Spinal pVAS6,1±3,24,2±2,9-1,9 (IC95% -2,4 a -1,4)p<0,0001CRP (mg/L)7,7±9,94,9±5,9-2,9 (IC95% -4,5 a -1,2)p=0,0009ASDAS-CRP2,5±1,91,8±1,3-0,7 (IC95% -0,9 a -0,4)p<0,0001DAPSA27,7±12,116,7±10,4-11 (IC95% -15,3 a -6,8)p<0,0001SJC: swollen joint count, TJC: tender joint count, Spinal pVAS: spinal pain visual analog scale, CRP: C-reactive protein, SEC: secukinumab.Conclusion:Secukinumab in real-world setting provided improvements in the axial and peripheral manifestations of PsA, using both the 150 mg and 300 mg doses.Disclosure of Interests:MARIA MARTIN LOPEZ: None declared, Beatriz Joven-Ibáñez Speakers bureau: Abbvie, Celgene, Janssen, Merck Sharp & Dohme, Novartis, Pfizer, José Luis Pablos: None declared

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POS0495 LARGE JOINT DISEASE IN RHEUMATOID ARTHRITIS AND THE ROLE OF RHEUMATOID FACTOR. RESULTS FROM THE EARLY RHEUMATOID ARTHRITIS STUDY

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-eular.3626 ◽

2021 ◽

Vol 80 (Suppl 1) ◽

pp. 480-480

Author(s):

S. S. Zhao ◽

E. Nikiphorou ◽

A. Young ◽

P. Kiely

Keyword(s):

Rheumatoid Arthritis ◽

Rheumatoid Factor ◽

Treatment Strategies ◽

Treat To Target ◽

Joint Involvement ◽

Aggressive Treatment ◽

Joint Surgery ◽

Large Joint ◽

Significant Difference ◽

Over Time

Background:Rheumatoid arthritis (RA) is classically described as a symmetric small joint polyarthritis with additional involvement of large joints. There is a paucity of information concerning the time course of damage in large joints, such as shoulder, elbow, hip, knee and ankle, from early to established RA, or of the influence of Rheumatoid Factor (RF) status. There is a historic perception that patients who do not have RF follow a milder less destructive course, which might promote less aggressive treatment strategies in RF-negative patients. The historic nature of the Ealy Rheumatoid Arthritis Study (ERAS) provides a unique opportunity to study RA in the context of less aggressive treatment strategies.Objectives:To examine the progression of large joint involvement from early to established RA in terms of range of movement (ROM) and time to joint surgery, according to the presence of RF.Methods:ERAS was a multi-centre inception cohort of newly diagnosed RA patients (<2 years disease duration, csDMARD naive), recruited from 1985-2001 with yearly follow-up for up to 25 (median 10) years. First line treatment was csDMARD monotherapy with/without steroids, favouring sulphasalazine for the majority. Outcome data was recorded at baseline, at 12 months and then once yearly. Patients were deemed RF negative if all repeated assessments were negative. ROM of individual shoulder, elbow, wrist, hip, knee, ankle and hindfeet joints was collected at 3, 5, 9 and 12-15 years. The rate of progression from normal to any loss of ROM, from years 3 to 14 was modelled using GEE, adjusting for confounders. Radiographs of wrists taken at years 0, 1, 2, 3, 5, 7, 9 were scored according to the Larsen method. Change in the Larsen wrist damage score was modelled using GEE as a continuous variable, while the erosion score was dichotomised into present/absent. Surgical procedure data were obtained by linking to Hospital Episodes Statistics and the National Joint Registry. Time to joint surgery was analysed using multivariable Cox models.Results:A total of 1458 patients from the ERAS cohort were included (66% female, mean age 55 years) and 74% were RF-positive. The prevalence of any loss of ROM, from year 3 through to 14 was highest in the wrist followed by ankle, knee, elbow and hip. The proportion of patients at year 9 with greater than 25% loss of ROM was: wrist 30%, ankle 12%, elbow 7%, knee 7% and hip 5%. Odds of loss of ROM increased over time in all joint regions, at around 7 to 13% per year from year 3 to 14. There was no significant difference between RF-positive and RF-negative patients (see Figure 1). Larsen erosion and damage scores at the wrists progressed in all patients; annual odds of developing any erosions were higher in RF-positives OR 1.28 (95%CI 1.24-1.32) than RF-negatives OR 1.17 (95%CI 1.09-1.26), p 0.013. Time to surgery was similar according to RF-status for the wrist and ankle, but RF-positive cases had a lower hazard of surgery at the elbow (HR 0.37, 0.15-0.90), hip (HR 0.69, 0.48-0.99) and after 10 years at the knee (HR 0.41, 0.25-0.68). Adjustment of the models for Lawrence assessed osteoarthritis of hand and feet radiographs did not influence these results.Figure 1.Odds of progression to any loss of ROM (from no loss of ROM) per year in the overall population and stratified by RF status.Conclusion:Large joints become progressively involved in RA, most frequently affecting the wrist followed by ankle, which is overlooked in some composite disease activity indices. We confirm a higher burden of erosions and damage at the wrists in RF-positive patients, but have not found RF-negative patients to have a better prognosis over time with respect to involvement of other large joints. In contrast RF-negative patients had more joint surgery at the elbow, hip, and knee after 10 years. There is no justification to adopt a less aggressive treatment strategy for RF-negative RA. High vigilance and treat-to-target approaches should be followed irrespective of RF status.Disclosure of Interests:None declared

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FRI0009 Infliximab in the treatment of rheumatoid arthritis (ra): referral patterns, response to treatment, and adverse events in a real world setting

10.1136/annrheumdis-2001.1138 ◽

2001 ◽

Author(s):

Y Yazici ◽

D Erkan ◽

I Kulman ◽

L Leff ◽

J Markenson ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Adverse Events ◽

Real World ◽

Response To Treatment ◽

Referral Patterns ◽

Real World Setting

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SAT0153 Effectiveness of low and high dose methotrexate in combination with adalimumab in a real world setting: results from the corrona rheumatoid arthritis registry

10.1136/annrheumdis-2017-eular.1525 ◽

2017 ◽

Author(s):

D Pappas ◽

J Griffith ◽

CA Schlacher ◽

Y Shan ◽

C Karki ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Real World ◽

High Dose ◽

High Dose Methotrexate ◽

Real World Setting ◽

Dose Methotrexate

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Tofacitinib and risk of cardiovascular outcomes: results from the Safety of TofAcitinib in Routine care patients with Rheumatoid Arthritis (STAR-RA) study

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-221915 ◽

2022 ◽

pp. annrheumdis-2021-221915

Author(s):

Farzin Khosrow-Khavar ◽

Seoyoung C Kim ◽

Hemin Lee ◽

Su Been Lee ◽

Rishi J Desai

Keyword(s):

Rheumatoid Arthritis ◽

Real World ◽

Fixed Effects ◽

Safety Concern ◽

Specific Effect ◽

Routine Care ◽

Cardiovascular Outcomes ◽

The Real ◽

Real World Setting ◽

Increased Risk

ObjectivesRecent results from ‘ORAL Surveillance’ trial have raised concerns regarding the cardiovascular safety of tofacitinib in patients with rheumatoid arthritis (RA). We further examined this safety concern in the real-world setting.MethodsWe created two cohorts of patients with RA initiating treatment with tofacitinib or tumour necrosis factor inhibitors (TNFI) using deidentified data from Optum Clinformatics (2012–2020), IBM MarketScan (2012–2018) and Medicare (parts A, B and D, 2012–2017) claims databases: (1) A ‘real-world evidence (RWE) cohort’ consisting of routine care patients and (2) A ‘randomised controlled trial (RCT)-duplicate cohort’ mimicking inclusion and exclusion criteria of the ORAL surveillance trial to calibrate results against the trial findings. Cox proportional hazards models with propensity score fine stratification weighting were used to estimate HR and 95% CIs for composite outcome of myocardial infarction and stroke and accounting for 76 potential confounders. Database-specific effect estimates were pooled using fixed effects models with inverse-variance weighting.ResultsIn the RWE cohort, 102 263 patients were identified of whom 12 852 (12.6%) initiated tofacitinib. The pooled weighted HR (95% CI) comparing tofacitinib with TNFI was 1.01 (0.83 to 1.23) in RWE cohort and 1.24 (0.90 to 1.69) in RCT-duplicate cohort which aligned closely with ORAL-surveillance results (HR: 1.33, 95% CI 0.91 to 1.94).ConclusionsWe did not find evidence for an increased risk of cardiovascular outcomes with tofacitinib in patients with RA treated in the real-world setting; however, tofacitinib was associated with an increased risk of cardiovascular outcomes, although statistically non-significant, in patients with RA with cardiovascular risk factors.Trial registration numberNCT04772248.

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