Patient acceptable symptom state in scleroderma: results from the tocilizumab compared with placebo trial in active diffuse cutaneous systemic sclerosis.

Objectives: Patient acceptable symptom state (PASS) as an absolute state of well-being has shown promise as an outcome measure in many rheumatologic conditions. We aimed to assess whether PASS may be effective in active diffuse cutaneous SSc differentiating active from placebo. Methods: Data from the phase 2 Safety and Efficacy of Subcutaneous Tocilizumab in Adults with Systemic Sclerosis (faSScinate) trial were used, which compared tocilizumab (TCZ) vs placebo over 48 weeks followed by an open-label TCZ period to 96 weeks. Three different types of PASS questions were evaluated at weeks 8, 24, 48 and 96, including if a current state would be acceptable over time as a yes vs no response and Likert scales about how acceptable a current state is if remaining over time. Additional outcomes assessed included modified Rodnan skin score, HAQ disability index (HAQ-DI), physician and patient global assessments on a visual analogue scale, CRP and ESR. Results: The placebo group consisted of 44 patients and the TCZ group had 43 patients. At baseline, 33% achieved a PASS for all three PASS questions, with the proportion increasing to 69, 71 and 78%, respectively, at 96 weeks. Changes in PASS scores showed a moderately negative correlation with HAQ-DI and patient and physician global assessments visual analogue scales, which indicates expected improvements as PASS improved. The PASS question, 'Considering all of the ways your scleroderma has affected you, how acceptable would you rate your level of symptoms?' showed significant correlations with patient-reported outcomes and differentiating placebo vs TCZ at 48 weeks (P = 0.023). Conclusion: PASS may be used as a patient-centred outcome in SSc, especially as a 7-point Likert scale. Further validation is required to determine the utility as an outcome measure in trials and clinical practice.

Are there differences between young- and older-onset early inflammatory arthritis and do these impact outcomes? An analysis from the CATCH cohort.

OBJECTIVE: The aim of this study was to determine the impact of age on disease and remission in suspected early RA (ERA). METHODS: Data from the Canadian Early Arthritis Cohort (CATCH) were examined at baseline, 6 and 12 months. Patients were divided into three groups based on age. Analysis of variance (ANOVA) and regression models were performed to determine the impact of age on the 28-joint DAS (DAS28) and remission at 12 months. RESULTS: A total of 1809 patients were initially assessed: 442 (24.4%) young (<42 years), 899 (49.7%) middleaged (542<64 years) and 468 (25.9%) old (564 years); 72.9% female; 63.8% met 2010 ACR/European League Against Rheumatism (EULAR) classification criteria for RA; symptom duration at first visit 186.0 days; DAS28 4.9; HAQ 1.0; 25.3% had baseline erosions. A significant correlation existed between older age and a lower percentage of females, less positive RF and CCP, fewer meeting RA criteria, shorter symptom duration, more erosions at first visit, higher DAS28 and HAQ at baseline and 12 months and fewer DAS28 remission at 12 months (all P<0.003). The age group did not affect the change in DAS28 and HAQ from 0 to 12 months. Co-morbidities increased with age; more DMARDs, including MTX and steroids, and fewer biologics were used in older age. Age and female had a lesser chance of remission in the regression model. CONCLUSION: In suspected ERA, older-onset patients start and end their first year worse in terms of DAS28 and HAQ, with fewer meeting RA criteria, less remission, more DMARDs and steroids use but less biologics use. However, there were no differences between age groups in the change in DAS28.