Author(s): Arnold M.; Khanna D.; Denton C.; Lin C.; Van Laar J.; Frech T.; Anderson M.; Baron M.; Chung L.; Fierlbeck G.; Allanore Y.; Riemekasten G.; Steen V.; Muller-Ladner U.; Burke L.; Spotswood H.; Jahreis A.; Siegel J.; Furst D.; Pope J.
Source: Journal of Rheumatology; 2017; vol. 44 (no. 6); p. 881
Publication Date: 2017
Publication Type(s): Conference Abstract
Available in print at Edge Hill Aintree LIRC – from JOURNAL OF RHEUMATOLOGY
Abstract:Objectives: Patient Acceptable Symptom State (PASS) as an absolute state of well-being and has shown promise as an outcome measure in many rheumatologic conditions. We assessed whether PASS may be an effective in active diffuse cutaneous SSc. Methods: Data from the faSScinate trial were used, which compared tocilizumab vs placebo over 48 weeks followed by an open-label tocilizumab period to 96 weeks. Three different types of PASS questions were evaluated at weeks 8, 24, 48 and 96 including would a current state be acceptable over time as yes vs no response, and Likert scales about how acceptable a current state is if remaining over time. Additional outcomes assessed included mRSS, HAQ-DI, MD and Pt global VAS, CRP and ESR. PASS question #1: “Considering all of the ways your scleroderma has affected you over the last week, how acceptable would you rate your level of symptoms?” PASS question #2: “Think about all the ways that your scleroderma has affected you during the last week. If you were to remain for the next few months as you were in the last week, would this be acceptable to you?” PASS question #3: “Has there been a change in how you would describe your level of functional impairment since you started the study?” Results: At baseline, the placebo group consisted of 44 patients, and tocilizumab group had 43 patients. At baseline, 33% achieved 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, Pt and MD global VAS. PASS asking “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 tocilizumab at 48 weeks (P = 0.023). Conclusion: PASS may be used as patient-centered outcome in SSc especially as a 7-point Likert scale. Further validation through larger clinical trials is required before being able to apply this concept to clinical practice.