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Abstract Number: 1261

The Impact of Remission and Low Disease Activity Attainment on Health-related Quality of Life in Two Phase III Clinical Trials of Belimumab in Systemic Lupus Erythematosus

Sharzad Emamikia1, Shereen Oon2, Alvaro Gomez1, Julius Lindblom1, Alexander Borg1, Yvonne Enman1, Eric Morand3, David Grannas4, Ronald van Vollenhoven5, Mandana Nikpour6 and Ioannis Parodis7, 1Division of Rheumatology, Department of Medicine Solna, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden, 2Department of Rheumatology, St Vincent's Hospital, Fitzroy, Australia, 3School of Clinical Sciences at Monash Health, Monash University Faculty of Medicine, Nursing and Health Sciences, Monash Medical Centre Clayton, Melbourne, Australia, 4Divison of Biostatistics, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden, Stockholm, Sweden, 5Department of Rheumatology and Clinical Immunology, Amsterdam University Medical Center, Amsterdam Rheumatology Center, Amsterdam, Netherlands, 6University of Melbourne at St Vincent's Hospital, Melbourne, Australia, 7Division of Rheumatology, Department of Medicine Solna, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden and Department of Rheumatology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden

Meeting: ACR Convergence 2021

Keywords: Outcome measures, quality of life, Systemic lupus erythematosus (SLE)

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Session Information

Date: Monday, November 8, 2021

Session Title: SLE – Diagnosis, Manifestations, & Outcomes Poster III: Outcomes (1257–1303)

Session Type: Poster Session C

Session Time: 8:30AM-10:30AM

Background/Purpose: Health-related quality of life (HRQoL) is considered one of the most important outcomes in clinical trials of systemic lupus erythematosus (SLE), along with reduction in disease activity and safety. We studied the duration and consecutiveness of remission or low disease activity throughout a 52-week long period on standard therapy plus belimumab or placebo in relation to HRQoL outcome.

Methods: We analysed pooled 52-week data from the BLISS-52 (N=865) and BLISS-76 (N=819) phase III trials. We determined remission using the prevailing Definitions of Remission in SLE (DORIS) definition (1) and low disease activity using the Lupus Low Disease Activity State (LLDAS) (2). Remission required clinical (c)SLEDAI-2K=0, PhGA (0–3) <0.5, and prednisone ≤5 mg/day. LLDAS required SLEDAI-2K ≤4, PhGA (0–3) ≤1, and prednisone ≤7.5 mg/day. HRQoL was measured with the SF-36 physical and mental component summary (PCS and MCS), and EQ-5D-3L. Minimal clinically important difference (MCID) at week 52 for PCS and MCS was set to 2.5, and for EQ-5D-3L utility index to 0.040. Associations were assessed using quantile regression analysis. Adjustments for demographics, disease duration, organ damage and baseline status were incorporated.

Results: The minimum cumulative attainment of remission to achieve a benefit in PCS ≥MCID at week 52 was four visits (corresponding to 16 weeks) (β=0.63), while 7 visits (28 weeks) were required for MCS differences ≥MCID (β=0.37). Correspondingly, 9 visits in LLDAS (36 weeks) were required for achieving differences ≥MCID in both PCS (b=0.28) and MCS (β=0.29). Table 1 shows 95% confidence intervals and p values. When analysing the impact of sustained remission and LLDAS, four consecutive visits in remission (16 weeks) were required for PCS ≥MCID (b=0.70), whereas six visits (24 weeks) were required for MCS ≥MCID (b=0.46). Sustained LLDAS for nine consecutive visits (36 weeks) was needed for PCS and MCS ≥MCID (b=0.31 and 0.31, respectively). For EQ-5D ≥MCID to be reached, a cumulative total of seven visits (28 weeks) in remission (b=0.006), or eight visits (32 weeks) in LLDAS (b=0.005) was required, whereas if sustained, remission for six visits (24 weeks; b=0.008) or LLDAS for seven visits (28 weeks; b=0.006) were sufficient.

Conclusion: Attainment of remission or LLDAS in the BLISS-52 and BLISS-76 trials of belimumab was associated with improved HRQoL. Less time was required in remission than in LLDAS to achieve clinically important differences in multiple HRQoL aspects. Clinically important differences in HRQoL required shorter total time if the remission or LLDAS was sustained. Clinically important differences in mental aspects of HRQoL required longer time in remission than physical aspects. The impact of cumulative and sustained remission or LLDAS on HRQoL adds evidence on the clinical importance of these treat-to-target endpoints.

References
1) van Vollenhoven R. et al. Ann Rheum Dis. 2017
2) Franklyn K. et al. Ann Rheum Dis. 2016


Disclosures: S. Emamikia, None; S. Oon, None; A. Gomez, None; J. Lindblom, None; A. Borg, None; Y. Enman, None; E. Morand, Amgen, 2, AbbVie, 2, Biogen, 2, Bristol Myers Squibb, 2, 5, AstraZeneca, 2, 5, 6, Genentech, 2, Servier, 2, Capella Biosciences, 2, Eli Lilly, 5, 6, EMD Serono, 5, 6, Janssen, 2, 5, UCB, 2, GlaxoSmithKline, 2, 5; D. Grannas, None; R. van Vollenhoven, Bristol Myers Squibb, 2, 5, Eli Lilly, 5, UCB, 2, 5, 6, Pfizer, 2, 6, 12, Support for educational programs; institutional grants, Roche, 12, Support for educational programs; institutional grants, Janssen, 2, 6, AbbVie, 2, 6, AstraZeneca, 2, Biotest, 2, GlaxoSmithKline, 2, 6, Biogen, 2, Galapagos, 2, 6, Gilead, 2, Sanofi, 2, Servier, 2, Vielabio, 2; M. Nikpour, None; I. Parodis, Amgen, Elli Lilly and Company, and Gilead Sciences., 5, 6, GlaxoSmithKline and Novartis., 5, 6.

To cite this abstract in AMA style:

Emamikia S, Oon S, Gomez A, Lindblom J, Borg A, Enman Y, Morand E, Grannas D, van Vollenhoven R, Nikpour M, Parodis I. The Impact of Remission and Low Disease Activity Attainment on Health-related Quality of Life in Two Phase III Clinical Trials of Belimumab in Systemic Lupus Erythematosus [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 9). https://acrabstracts.org/abstract/the-impact-of-remission-and-low-disease-activity-attainment-on-health-related-quality-of-life-in-two-phase-iii-clinical-trials-of-belimumab-in-systemic-lupus-erythematosus/. Accessed January 30, 2023.
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