Treatment management of patients with systemic lupus erythematosus: a delphi consensus analysis




Anifrolumab, Consensus, Delphi, Efficacy, Likert scale, Systemic lupus erythematosus


Background: Systemic lupus erythematosus (SLE) is associated with clinical burden for the patient and organ damage. The development of therapies for SLE has been constrained by clinical and biologic heterogeneity. These represent challenges in clinical trial design and endpoint selection.

Objective: To identify the most relevant descriptors for efficacy, endpoints, disease activity, organ damage, quality of life (QoL), and Patient Reported Outcome Measures (PROMs) in the treatment of SLE.

Methods: A Delphi study was conducted using a national expert panel of clinicians in the treatment of SLE. A steering committee composed of 3 opinion leaders with deep expertise in SLE treatment was defined. The steering committee analyzed and appraised the evidence, designed the Delphi study, defined the statements, and analyzed the expert panel responses. A 2-round Delphi survey was conducted. Participants were asked to rate the statements using a five-point Likert scale.

Results: Nine experts participated in the Delphi survey. After the two rounds, the consensus was reached on 18 of the 23 statements: 2 statements were included in the “efficacy” domain, 2 in the “glucocorticoid-sparing” domain, 2 in the “endpoint evaluation” domain, 4 in the “score” domain, 1 in the “disease activity” domain, 1 in the “organ damage” domain, 1 in the “QoL” domain, 2 in the “PROMs” domain, 1 in the “AIFA monitoring” domain and 2 in the “extra” domain. No statements reached consensus within the “onset” domain.

Conclusion: In this Delphi study, 18 statements across 11 domains were agreed upon for the treatment of SLE.


Justiz Vaillant AA, Goyal A, Varacallo M. Systemic Lupus Erythematosus. 2022 Jul 8. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022. PMID 30571026

Maidhof W, Hilas O. Lupus: an overview of the disease and management options. P&T. 2012;37(4):240-249. PMID:22593636

Sebastiani GD, Spinelli FR, Bartoloni E, et al. Baseline characteristics of systemic lupus erythematosus patients included in the Lupus Italian Registry of the Italian Society for Rheumatology. Lupus. 2021;30(8):1233-1243. PMID:33884900 PMID:33884900 DOI:

Sebastiani GD, Prevete I, Iuliano A, et al. Early Lupus Project: one-year follow-up of an Italian cohort of patients with systemic lupus erythematosus of recent onset. Lupus. 2018;27(9):1479-1488. PMID:29779436 PMID:29779436 DOI:

Sebastiani GD, Prevete I, Piga M, et al. Early Lupus Project - A multicentre Italian study on systemic lupus erythematosus of recent onset. Lupus. 2015;24(12):1276-1282. PMID:25979916 PMID:25979916 DOI:

Prevete I, Espinosa G, Bellisai F, et al; Gruppo di Studio SIR sul Lupus Eritematoso Sistemico di recente insorgenza-Early Lupus and Registro Español de pacientes con Lupus Eritematoso Sistémico (RELES), Autoimmune Diseases Study Group (GEAS). Comparative study between two European inception cohorts of patients with early systemic lupus erythematosus. Clin Exp Rheumatol. 2020;38(5):925-932. PMID:31969225 PMID:31969225

Specchia ML, Cadeddu C, Di Pietro ML, et al. Health technology assessment of belimumab: a new monoclonal antibody for the treatment of systemic lupus erythematosus. BioMed Research International. 2014;2014:704207-704215. PMID: 25243173 DOI:

Thong B, Olsen NJ. Systemic lupus erythematosus diagnosis and management. Rheumatology (Oxford). 2017;56(suppl 1):i3-i13. PMID:28013206

Lateef A, Petri M. Unmet medical needs in systemic lupus erythematosus. Arthritis Res Ther. 2012;14(suppl 4):S4. PMID:23281889 DOI:

Gordon C, Amissah-Arthur MB, Gayed M, et al; British Society for Rheumatology Standards, Audit and Guidelines Working Group. The British Society for Rheumatology guideline for the management of systemic lupus erythematosus in adults. Rheumatology (Oxford). 2018;57(1):e1-e45. PMID:29029350 DOI:

Tsioni V, Andreoli L, Meini A, et al. The prevalence and incidence of systemic lupus erythematosus in children and adults: a population-based study in a mountain community in northern Italy. Clin Exp Rheumatol. 2015;33(5):681-687. PMID:26089119

AstraZeneca. Ricerca di mercato 2021. Data on file.

Epidemiology of Systemic Lupus Erythematosus pages in Systemic Lupus Erythematosus. A Companion to Rheumatology. Mosby. 2007;1-18. Online

Zen M, Bassi N, Nalotto L, et al. Disease activity patterns in a monocentric cohort of SLE patients: a seven-year follow-up study. Clin Exp Rheumatol. 2012;30(6):856-863. PMID:22765883

Pons-Estel GJ, Alarcón GS, Scofield L, Reinlib L, Cooper GS. Understanding the epidemiology and progression of systemic lupus erythematosus. Semin Arthritis Rheum. 2010;39(4):257-268. PMID:19136143 DOI:

Deijns SJ, Broen JCA, Kruyt ND et al. The immunologic etiology of psychiatric manifestations in systemic lupus erythematosus: A narrative review on the role of the blood brain barrier, antibodies, cytokines and chemokines. Autoimmun Rev. 2020 Aug;19(8):102592. PMID 32561462 DOI:

Hess EV, Farhey Y. Etiology, environmental relationships, epidemiology, and genetics of systemic lupus erythematosus. Curr Opin Rheumatol. 1995;7(5):371-375. PMID:8519608 DOI:

Aringer M, Costenbader K, Daikh D, et al. 2019 European League Against Rheumatism/American College of Rheumatology Classification Criteria for Systemic Lupus Erythematosus. Arthritis Rheumatol. 2019;71(9):1400-1412.

Furie RA, Petri MA, Wallace DJ, et al. Novel evidence-based systemic lupus erythematosus responder index. Arthritis Rheum. 2009;61(9):1143-1151. DOI:

Mikdashi J, Nived O. Measuring disease activity in adults with systemic lupus erythematosus: the challenges of administrative burden and responsiveness to patient concerns in clinical research. Arthritis Res Ther. 2015;17(1):183. DOI:

Tanaka Y, Mizukami A, Kobayashi A, Ito C, Matsuki T. Disease severity and economic burden in Japanese patients with systemic lupus erythematosus: A retrospective, observational study. Int J Rheum Dis. 2018;21(8):1609-1618. DOI:

Navarra SV, Guzmán RM, Gallacher AE, et al; BLISS-52 Study Group. Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebo-controlled, phase 3 trial. Lancet. 2011;377(9767):721-731. PMID:21296403 DOI:

Furie R, Petri M, Zamani O, et al; BLISS-76 Study Group. A phase III, randomized, placebo-controlled study of belimumab, a monoclonal antibody that inhibits B lymphocyte stimulator, in patients with systemic lupus erythematosus. Arthritis Rheum. 2011;63(12):3918-3930. PMID:22127708 DOI:

Wallace DJ, Kalunian K, Petri MA, et al. Efficacy and safety of epratuzumab in patients with moderate/severe active systemic lupus erythematosus: results from EMBLEM, a phase IIb, randomised, double-blind, placebo-controlled, multicentre study. Ann Rheum Dis. 2014;73(1):183-190. PMID:23313811 DOI:

Piga M, Floris A, Sebastiani GD, et al. Risk factors of damage in early diagnosed systemic lupus erythematosus: results of the Italian multicentre Early Lupus Project inception cohort. Rheumatology (Oxford). 2020;59(9):2272-2281. PMID:31840179 PMID:31840179 DOI:

Polachek A, Gladman DD, Su J, Urowitz MB. Defining Low Disease Activity in Systemic Lupus Erythematosus. Arthritis Care Res (Hoboken). 2017;69(7):997-1003. PMID:27696791 DOI:

Mahieu MA, Strand V, Simon LS, Lipsky PE, Ramsey-Goldman R. A critical review of clinical trials in systemic lupus erythematosus. Lupus. 2016;25(10):1122-1140. PMID:27497257 DOI:

Lupus Research Alliance. Baricitinib Development as a Lupus Treatment Discontinued. Online (Accessed January 2022).

Riggs JM, Hanna RN, Rajan B, et al. Characterisation of anifrolumab, a fully human anti-interferon receptor antagonist antibody for the treatment of systemic lupus erythematosus. Lupus Sci Med. 2018;5(1):e000261. PMID:29644082 DOI:

Lichtman EI, Helfgott SM, Kriegel MA. Emerging therapies for systemic lupus erythematosus--focus on targeting interferon-alpha. Clin Immunol. 2012;143(3):210-221. PMID:22525889 DOI:

Furie RA, Morand EF, Bruce IN et al. Type I interferon inhibitor anifrolumab in active systemic lupus erythematosus (TULIP-1): a randomised, controlled, phase 3 trial. The Lancet Rheumatology 2019;1(4):e219-e219. DOI:

Morand EF, Furie R, Tanaka Y, et al; TULIP-2 Trial Investigators. Trial of Anifrolumab in Active Systemic Lupus Erythematosus. N Engl J Med. 2020;382(3):211-221. PMID:31851795 DOI:

Preedy VR, Watson RR, eds. 5-Point Likert Scale. In: Handbook of Disease Burdens and Quality of Life Measures. Springer; 2010, DOI:

Humphrey-Murto S, Varpio L, Wood TJ, et al. The use of the Delphi and other consensus group methods in medical education research: a review. Acad Med. 2017;92(10):1491-1498. PMID:28678098 DOI:

Schneider P, Evaniew N, Rendon JS, et al; PARITY Investigators. Moving forward through consensus: protocol for a modified Delphi approach to determine the top research priorities in the field of orthopaedic oncology. BMJ Open. 2016;6(5):e011780. PMID:27221129 DOI:

Vogel C, Zwolinsky S, Griffiths C, Hobbs M, Henderson E, Wilkins E. A Delphi study to build consensus on the definition and use of big data in obesity research. Int J Obes. 2019;43(12):2573-2586. PMID:30655580 DOI:

Ab Latif R, Dahlan A, Ab Mulud Z, Mat Nor MZ. The Delphi technique as a method to obtain consensus in health care education research. Educ Med J. 2017;9(3):89-102. DOI:

De Meyer D, Kottner J, Beele H, et al. Delphi procedure in core outcome set development: rating scale and consensus criteria determined outcome selection. J Clin Epidemiol. 2019;111:23-31. PMID:30922885 DOI:

Avella JR. Delphi panels: research design, procedures, advantages, and challenges. Int J Dr Stud. 2016;11:305-321. DOI:

Akins RB, Tolson H, Cole BR. Stability of response characteristics of a Delphi panel: application of bootstrap data expansion. BMC Med Res Methodol. 2005;5(1):37. PMID:16321161 DOI:

Iqbal S, Pipon-Young L. The Delphi method. Psychologist. 2009;22(7):598-601.



How to Cite

Sebastiani GD, Mosca M, Ravasio R, Brambilla P, Raimondo P, Doria A. Treatment management of patients with systemic lupus erythematosus: a delphi consensus analysis. Grhta [Internet]. 2022 Oct. 10 [cited 2023 Dec. 7];9(1):123-32. Available from:



Original Research Articles


Received 2022-07-22
Accepted 2022-08-30
Published 2022-10-10


Most read articles by the same author(s)

1 2 3 4 > >>