OMERACT 2023 Systemic Lupus Erythematosus Special Interest Group: Winnowing and Binning Preliminary Candidate Domains for the Core Outcome Set.

BACKGROUND

The Outcome Measures in Rheumatology (OMERACT) Systemic Lupus Erythematosus (SLE) Working Group held a Special Interest Group (SIG) at the OMERACT 2023 conference in Colorado Springs where SLE collaborators reviewed domain sub-themes generated through qualitative research and literature review.

OBJECTIVE

The objective of the SIG and the subsequent meetings of the SLE Working Group was to begin the winnowing and binning of candidate domain sub-themes into a preliminary list of candidate domains that will proceed to the consensus Delphi exercise for the SLE COS.

METHODS

Four breakout groups at the SLE SIG in Colorado Springs winnowed and binned 132 domain sub-themes into candidate domains, which was continued with a series of virtual meetings by an advisory group of SLE patient research partners (PRPs), members of the OMERACT SLE Working Group Steering Committee, and other collaborators.

RESULTS

The 132 domain sub-themes were reduced to a preliminary list of 20 candidate domains based on their clinical and research relevance for clinical trials and research studies.

CONCLUSION

A meaningful and substantial winnowing and binning of candidate domains for the SLE COS was achieved resulting in a preliminary list of 20 candidate domains.

Informations de copyright

Copyright © 2024. Published by Elsevier Inc.

Déclaration de conflit d'intérêts

Declaration of competing interest Wils Nielsen, Lee Simon, Maya Desai, Yvonne Enman, Daniel Wallace, Cynthia Aranow, Meggan Mackay, Kimberly Trotter, Ali Duarte Garcia, John A Reynolds, Danaë Papachristos, Sandra Navarra, Amita Aggarwal, Chi Chiu Mok, Keishi Fujio, Rosalind Ramsey-Goldman, Aaron Howe, Behdin Nouwrouzi-Kia, Dennisse Bonilla, Julian Thumboo, Martin Aringer, Sindhu R. Johnson, Zahi Touma: None. Vibeke Strand:All support for the present manuscript (e.g., funding, provision of study materials, medical writing, article processing charges, etc.): I am a founding member of the executive committee of Outcome Measures in Rheumatology (OMERACT) [1992 – present], an international consensus organization that develops and validates outcome measures in rheumatology randomized controlled trials and longitudinal observational studies and has received arms-length funding from as many as 36 sponsors. Grants or Contracts from any entity: I am a founding member of the executive committee of Outcome Measures in Rheumatology (OMERACT) [1992 – present], an international consensus organization that develops and validates outcome measures in rheumatology randomized controlled trials and longitudinal observational studies and has received arms-length funding from as many as 36 sponsors. Ioannis Parodis:All support for the present manuscript (e.g., funding, provision of study materials, medical writing, article processing charges, etc.): I have received research funding from Amgen, I have received research funding from GlaxoSmithKline, I have received research funding from Astra-Zeneca, I have received research funding from Janssen Pharmaceuticals, I have received research funding from Aurinia Pharmaceuticals, I have received research funding from Novartis, I have received research funding from Elly Lilly and Company, I have received research funding from Otsuka Pharmaceutical, I have received research funding from Gilead Sciences, I have received research funding from F. Hoffmann-La Roche AG Payment or Honoraria for lectures, presentations, speakers, bureaus, manuscript writing or educational events: I have received research funding from Amgen, I have received research funding from GlaxoSmithKline, I have received research funding from Astra-Zeneca, I have received research funding from Janssen Pharmaceuticals, I have received research funding from Aurinia Pharmaceuticals, I have received research funding from Novartis, I have received research funding from Elly Lilly and Company, I have received research funding from Otsuka Pharmaceutical, I have received research funding from Gilead Sciences, I have received research funding from F. Hoffmann-La Roche AG Alfred Kim:Grants or Contracts from any entity: Rheumatology Research Foundation – Institution, National Multiple Sclerosis Society – Institution, GlaxoSmithKline – Institution, Novartis – Institution, NIH/NIAMS P30AR073752 – Institution, BMS – Institution Consulting Fees: Alexion Pharmaceuticals – Self, ANI Pharmaceuticals – Self, AstraZeneca – Self, Aurinia Pharmaceuticals – Self, Kypha Inc – Self, Pfizer Inc – Self Payment or Honoraria for lectures, presentations, speakers, bureaus, manuscript writing or educational events: GlaxoSmithKline – Self, Exagen Diagnostics – Self, UpToDate – Self Patents planned, issued, or pending: Kypha US Patent 1102931882 Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid: Lupus Foundation of America-Heartland Chapter – Unpaid, St Louis Rheumatology Association – Unpaid, Rheumatology Research Foundation – Unpaid, Lupus Research Alliance – Unpaid Daniel Wallace:Payment or Honoraria for lectures, presentations, speakers, bureaus, manuscript writing or educational events: Speakers bureau GSK, Merck-Serono, Astra Zeneca Yashaar Chaichian:Grants or Contracts from any entity: Lupus Therapeutics, LLC - Payments made to institution, Eli Lilly & Company - Payments made to institution, Amgen Inc. - Payments made to institution, Stanford University, Discovery Innovation Fund in Basic Biomedical Sciences - Payments made to institution Support for attending meetings and/or travel: Lupus Therapeutics, LLC (provided support to attend the 2022 and 2023 LuCIN Community Meeting) -Payments made to institution Oshrat Tayer-Shifman:Consulting Fees: Astra-Zeneca – Payed to me, Abbvie – Payed to me Support for attending meetings and/or travel: Astra-Zeneca – Payment made to institution Lai Shan Tam:Consulting Fees: Janssen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Janssen, Pfizer, and Sanofi – me Payment or Honoraria for lectures, presentations, speakers, bureaus, manuscript writing or educational events: Pfizer, Abbvie, Janssen – me Support for Attending Meetings and/or travel: abbvie – other institutions Participation on a Data Safety Monitoring Board or Advisory Board: Pfizer, Abbvie, Janssen, AstraZeneca – me Leasdership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid: Convenor of the APLAR Academy – unpaid Other financial and non-financial interests: Unrestricted grant from Amgen, Boehringer Ingelheim, GSK, Janssen, Novartis, and Pfizer - To the Chinese University of Hong Kong Manuel F. Ugarte-Gil:Grants or Contracts: Janssen, GSK – Payments were made to my institution Consulting Fees: Astra-Zeneca Payment or Honoraria for lectures, presentations, speakers, bureaus, manuscript writing or educational events: Astra-Zeneca, GSK Guillermo Pons-Estel:Grants of Contracts from any entity: I received grant from Janssen – Payment was made to GLADEL (Latin American Group for the Study of Lupus) Payment or Honoraria for lectures, presentations, speakers, bureaus, manuscript writing or educational events: I received honoraria from GSK for lectures - Payment was made to myself, I received honoraria from Werfen for lectures - Payment was made to myself, I received honoraria from Novartis for lectures - Payment was made to myself, I received honoraria from Pfizer for lectures - Payment was made to myself, I received honoraria from Janssen for lectures - Payment was made to myself. Support for Attending Meetings and/or travel: I received support from ABBVIE to attend to the ACR 2021, I received support from Pfizer to attend to the EULAR 2023 Participation on a Data Safety Monitoring Board or Advisory Board: I received honoraria from Janssen for Advisory Board - Payment was made to myself, I received honoraria from Astra Zeneca for Advisory Board - Payment was made to myself, I received honoraria from GSK for Advisory Board - Payment was made to myself, I received honoraria from Novartis for Advisory Board - Payment was made to myself Mandana Nikpour:Grants of Contracts from any entity: Research grants from Janssen to support the ongoing research of the Australian Scleroderma Cohort Study - Payments made to my institution Consulting Fees: I have consulted for Janssen, Boehringer Ingelheim and Astra Zeneca - Payments made to me Payment or Honoraria for lectures, presentations, speakers, bureaus, manuscript writing or educational events: I have presented for Janssen, Boehringer Ingelheim, Astra Zeneca and GSK - Payments made to me Support for Attending Meetings and/or travel: Support from Boehringer Ingelheim to attend the EULAR Conference in 2023 - No payment made to me or my institution Alberta Hoi:Grants or Contracts from any entity: Arthritis Australia - I was grant recipient, AstraZeneca - Sponsorship of the Australian Lupus Registry and Biobank and Asia Pacific Lupus Collaboration, and also contract research on unmet needs in Australian lupus patients, Perpetual IMPACT - fund I was grant recipient, BMS, Merck Serono, GSK, Eli Lilly, UCB - Sponsored Asia Pacific Lupus Collaboration, for which I contribute data towards, Janssen - Contracted the Asia Pacific Lupus Collaboration to conduct a research study on medication use Consulting Fees: UCB Advisory Board Payment or Honoraria for lectures, presentations, speakers, bureaus, manuscript writing or educational events: Novartis Speaker Fee, Janssen honoraria for chairing Juanita Romero-Diaz:Consulting Fees: Novartis, Biogen Support for Attending Meetings and/or travel: Boehringer Participation on a Data Safety Monitoring Board or Advisory Board: Biogen Marta Mosca:Consulting Fees: Astra Zeneca, GSK, Lilly, UCB, BMS, Idorsia, Otsuka, Abbvie Payment or Honoraria for lectures, presentations, speakers, bureaus, manuscript writing or educational events: Atra Zeneca, GSK, Otsuka, Janssen, UCB, Abbvie Support for Attending Meetings and/or travel: Janssen to attend the European Lupus Meeting in 2022 Participation on a Data Safety Monitoring Board or Advisory Board: Idorsia Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid: EMA liaison for EULAR Receipt of equipment, materials, drugs, medical writing, gifts or other services: I have received Anifrolumab as for compassionate use from Astra Zeneca Aaron Drucker:Grants of Contracts from any entity: National Eczema Association, Eczema Society of Canada, Canadian Dermatology Foundation, CIHR, NIH, PSI Foundation Consulting Fees: Canadian Agency for Drugs and Technologies in Health Payment or Honoraria for lectures, presentations, speakers, bureaus, manuscript writing or educational events: British Journal of Dermatology, American Academy of Dermatology, National Eczema Association, Canadian Dermatology Today Eric Morand:Grants of Contracts from any entity: grant/research support from: AbbVie, Amgen, AstraZeneca, Biogen, Bristol Myers Squibb, Eli Lilly and Company, EMD Serono, Genentech, GlaxoSmithKline, Janssen, and UCB Pharma – Research grants to institution Consulting Fees: Consulting fees from AbbVie, AstraZeneca, Biogen, Bristol Myers Squibb, Eli Lilly and Company, EMD Serono, Genentech, GlaxoSmithKline, Janssen, Novartis, Servier, Wolf, Zenas Payment or Honoraria for lectures, presentations, speakers, bureaus, manuscript writing or educational events: Honoraria from AstraZeneca, Biogen, Bristol Myers Squibb, EMD Serono, Gilead Support for Attending Meetings and/or travel: Travel support from AstraZeneca Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid: Board Director, Rare Voices Australia – Not for Profit, Board Directory, Exosome Biosciences Ian Bruce:Grants of Contracts from any entity: Janssen Research - Grant to institution, Astra Zeneca - Research Grant to institution, GSK - Research Grant to institution Consulting Fees: GSK - Speaker fees to institution, Astra Zeneca - Speaker fees to institution, Janssen - Speaker fees to institution Participation on a Data Safety Monitoring Board or Advisory Board: AstraZeneca and Merck Serono - INB has served on boards for AstraZeneca and Merck Serono