The Physician Global Assessment International Standardisation COnsensus in Systemic Lupus Erythematosus (PISCOS) study aimed to obtain an evidence-based and expert-based consensus standardisation of the Physician Global Assessment (PGA) scoring of disease activity in systemic lupus erythematosus (SLE). An international panel of 79 SLE experts participated in a three-round Delphi consensus process, in which 41 statements related to the PGA in SLE were rated, using a 0 (strongly disagree) to 10 (strongly agree) numerical rating scale. Statements with agreement of 75% or greater were selected and further validated by the expert panel. Consensus was reached on 27 statements, grouped in 14 recommendations, for the use of the PGA in SLE, design of the PGA scale, practical considerations for PGA scoring, and the relationship between PGA values and levels of disease activity. Among these recommendations, the expert panel agreed that the PGA should consist of a 0–3 visual analogue scale for measuring disease activity in patients with SLE in the preceding month. The PGA is intended to rate the overall disease activity, taking into account the severity of active manifestations and clinical laboratory results, but excluding organ damage, serology, and subjective findings unrelated to disease activity. The PGA scale ranges from “no disease activity” (0) to the “most severe disease activity” (3) and incorporates the values 1 and 2 as inner markers to categorise disease activity as mild (≥0·5 to 1), moderate (>1 and ≤2) and severe (>2 to 3). Only experienced physicians can rate the PGA, and it should be preferably scored by the same rater at each visit. The PISCOS results will allow for increased homogeneity and reliability of PGA ratings in routine clinical practice, definitions of remission and low disease activity, and future SLE trials.
Bibliographical noteFunding Information:
MPi reports consulting fees from GSK and Astra Zeneca, and participation on an Advisory Board for GSK and Astra Zeneca. EFM reports grants from Janssen, AstraZeneca, Bristol Myers Squibb, Eli Lilly, EMD Serono, Glaxo Smith Kline, Janssen, AbbVie, Amgen, Genentech, UCB, and Biogen; consultancy fees from AstraZeneca, Eli Lilly, Novartis, Biogen, EMD Serono, Bristol Myers Squibb, Capella, Glaxo Smith Kline, Genentech, Servier, and Wolf; honoraria from AstraZeneca, Eli Lilly, Novartis, Biogen, and EMD Serono; and is Board Director of the not-for-profit advocacy organisation Rare Voices Australia. MT reports grants for research or education activities from Pfizer, Genesis, UCB, GSK, and MSD, and consultancy fees from Genesis, GSK, and Novartis. MFU-G reports grants from Pfizer and Janssen and support for attending meetings and travel from Pfizer, Tecnofarma, and AbbVie. RvV reports research grants from BMS, GSK, Lilly, and mUCB; grants for educational programmes from Pfizer and Roche; consultancy fees from AbbVie, AstraZeneca, Biogen, Biotest, Celgene, Galapagos, Gilead, Janssen, Pfizer, Servier, and UCB; and honoraria from AbbVie, Galapagos, Janssen, Pfizer, and UCB. LA reports grants from GSK; consulting fees from Alexion, Amgen, Astra-Zeneca, Abbvie, Biogen, BMS, Boehringer-Ingelheim, GSK, Kezar, Janssen-Cilag, Medac, Lilly, Novartis, Pfizer, Roche-Chugai, and UCB; and honoraria from Alexion, Amgen, AstraZeneca, AbbVie, Biogen BMS, Boehringer-Ingelheim, GSK, Kezar, Janssen-Cilag Medac, Lilly, Novartis, Pfizer, Roche-Chugai, and UCB. MPe and EC declare no competing interests.
MPe leads the Hopkins Lupus Cohort, which was supported by National Institutes of Health grant R01-AR069572.
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