ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 0369

The Longitudinal Measurement Properties and Clinical Application of the PROMIS Fatigue 13a and 10a in Lupus

Paul Kamudoni1, Alexandra Lauer1, Oliver Guenther1, Cristina Vazquez Mateo2 and Karon Cook3, 1the healthcare business of Merck KGaA, Darmstadt, Germany, 2Global Clinical Development, EMD Serono, an affiliate of Merck KGaA, Darmstadt, Germany, 3Feral Scholars, Broaddus, TX

Meeting: ACR Convergence 2022

Keywords: ,

Session Information

Date: Saturday, November 12, 2022

Title: SLE – Treatment Poster I

Session Type: Poster Session A

Session Time: 1:00PM-3:00PM

Background/Purpose: Fatigue is among the most prevalent symptoms of systemic lupus erythematosus (SLE) and is associated with patient distress, work dysfunction, and worse overall health status. The National Institutes of Health (NIH) PROMIS Fatigue item bank and related short forms have advanced the measurement of fatigue across rheumatologic and other chronic conditions. The aims of this study were to evaluate the responsiveness of the PROMIS Fatigue 13a and 10a scores and to establish minimal important difference (MID) estimates in SLE populations.

Methods: Pooled data across treatment arms from a 52-week Phase II, placebo-controlled, randomized clinical trial evaluating evobrutinib in SLE were used in this post-hoc analysis (MS200527-0018; NCT02975336). Study participants met at least 4 of 11 American College of Rheumatology SLE criteria and had an SLE Disease Activity Index (SLEDAI-2K) score of ≥6. Responsiveness and MID were analyzed based on score change from baseline to week 52, using an anchor-based approach.

Results: At baseline, study participants (n=466) had a mean (standard deviation, SD) age of 40 (12.3) years and 94% were female. Mean (SD) scores at baseline were 55.5 (8.03), and 55.9 (7.99) for the PROMIS Fatigue 10a and 13a, respectively. Six suitable anchors were identified and used in the responsiveness analyses. The PROMIS Fatigue 13a and 10a scores were highly sensitive to both worsening and improvements in fatigue over 52 weeks (standardized response mean >0.3 on all six anchors for worsening and on five anchors for improvement). Score changes of 2.6–4.7 (2.2–5.4) on the PROMIS Fatigue 13a and 2.5–4.4 (2.5–5.6) on the PROMIS Fatigue 10a are proposed as MID criteria for worsening (improvement) in fatigue over 52 weeks.

Conclusion: This research extends the evidence underpinning the applicability of the PROMIS Fatigue 13a and 10a in SLE routine clinical practice and research. The MID estimates established will aid the integration of PROMIS Fatigue scores into clinical decision-making and facilitate clinician-patient communication.

Disclosures: P. Kamudoni, the healthcare business of Merck KGaA, Darmstadt, Germany; A. Lauer, the healthcare business of Merck KGaA, Darmstadt, Germany; O. Guenther, the healthcare business of Merck KGaA, Darmstadt, Germany; C. Vazquez Mateo, EMD Serono, Billerica, MA, USA; K. Cook, the healthcare business of Merck KGaA, Darmstadt, Germany, AppliedVR.

To cite this abstract in AMA style:

Kamudoni P, Lauer A, Guenther O, Vazquez Mateo C, Cook K. The Longitudinal Measurement Properties and Clinical Application of the PROMIS Fatigue 13a and 10a in Lupus [abstract]. Arthritis Rheumatol. 2022; 74 (suppl 9). https://acrabstracts.org/abstract/the-longitudinal-measurement-properties-and-clinical-application-of-the-promis-fatigue-13a-and-10a-in-lupus/. Accessed .

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