Physician Global Assessment International Standardisation COnsensus in Systemic Lupus Erythematosus: the PISCOS study

Piga, Matteo; Chessa, Elisabetta; Morand, Eric F; Ugarte‐Gil, Manuel F.; Tektonidou, Maria G; Vollenhoven, Ronald van; Petri, Michelle; Arnaud, Laurent; Appenzeller, Simone; Aranow, Cynthia; Askanase, Anca; Avčin, Tadej; Bae, Sang‐Cheol; Βertsias, George; Bonfá, Eloísa; Cairoli, Ernesto; Cardiel, Mario H; Cervera, Ricard; Chasset, François; Chizzolini, Carlo; Clarke, Ann E.; Conti, Fabrizio; Costédoat-Chalumeau, Nathalie; Czirják, László; Doria, Andrea; Dörner, Thomas; Espinosa, Gerard; Fischer‐Betz, Rebecca; García, Mercedes; Gladman, Dafna D.; González, Luis Alonso; Gunnarsson, Iva; Hamijoyo, Laniyati; Hanly, John G.; Houssiau, Frédéric; İnanç, Murat; Inês, Luís; Isenberg, David; Jacobsen, Søren; Wu, Yeong‐Jian Jan; Kaneko, Yuko; Katsumata, Yasuhiro; Lau, Chak Sing; Legge, Alexandra C; Lerang, Karoline; Limper, Maarten; Louthrenoo, Worawit; Luo, Shue‐Fen; Marinho, António; Massardo, Loreto; Mathian, Alexis; Mosca, Marta; Nikpour, Mandana; Pego‐Reigosa, José María; Peschken, Christine A.; Pons-Éstel, Bernardo A; Pons‐Estel, Guillermo J.; Rahman, Anisur; Rednic, Simona; Ribi, Camillo; Ruíz-Irastorza, Guillermo; Sato, Emília Inoue; Saxena, Amit; Schneider, Matthias; Sebastiani, Gian Domenico; Strand, Vibeke; Svenungsson, Elisabet; Tanaka, Yoshiya; Mezalek, Z. Tazi; Tee, Michael L.; Tincani, Anǵela; Touma, Zahi; Troldborg, Anne; Vasconcelos, Carlos; Vinet, Évelyne; Vital, Edward M; Voskuyl, Alexandre E.; Voß, Anne; Wallace, Daniel J.; Ward, Michael M.; Zamora, Leonid

doi:10.1016/s2665-9913(22)00107-2

Cited by 23 publications

(16 citation statements)

References 74 publications

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“…We believe the PGA is relevant for the definition of remission and LLDAS; however, the PGA has not been consistently reported by different investigators, as reported in a recent systematic review (46) leading to some problems in its interpretation. However, the recent effort to standardize it (the PISCOS study) should solve this problem (47). Nevertheless, based on our results, definitions of remission and LDA without the PGA could be useful, particularly by physicians not properly trained in scoring it.…”

Section: Discussionmentioning

confidence: 88%

Remission and low disease activity (LDA) prevent damage accrual in patients with systemic lupus erythematosus: results from the Systemic Lupus International Collaborating Clinics (SLICC) inception cohort

et al. 2022

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ObjectiveTo determine the independent impact of different definitions of remission and low disease activity (LDA) on damage accrual.MethodsPatients with ≥2 annual assessments from a longitudinal multinational inception lupus cohort were studied. Five mutually exclusive disease activity states were defined: remission off-treatment: clinical Systemic Lupus Erythematosus Disease Activity Index (cSLEDAI)-2K=0, without prednisone or immunosuppressants; remission on-treatment: cSLEDAI-2K score=0, prednisone ≤5 mg/day and/or maintenance immunosuppressants; low disease activity Toronto cohort (LDA-TC): cSLEDAI-2K score of ≤2, without prednisone or immunosuppressants; modified lupus low disease activity (mLLDAS): Systemic Lupus Erythematosus Disease Activity Index-2K score of 4 with no activity in major organ/systems, no new disease activity, prednisone ≤7.5 mg/day and/or maintenance immunosuppressants; active: all remaining visits. Only the most stringent definition was used per visit. Antimalarials were allowed in all. The proportion of time that patients were in a specific state at each visit since cohort entry was determined. Damage accrual was ascertained with the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI). Univariable and multivariable generalised estimated equation negative binomial regression models were used. Time-dependent covariates were determined at the same annual visit as the disease activity state but the SDI at the subsequent visit.ResultsThere were 1652 patients, 1464 (88.6%) female, mean age at diagnosis 34.2 (SD 13.4) years and mean follow-up time of 7.7 (SD 4.8) years. Being in remission off-treatment, remission on-treatment, LDA-TC and mLLDAS (per 25% increase) were each associated with a lower probability of damage accrual (remission off-treatment: incidence rate ratio (IRR)=0.75, 95% CI 0.70 to 0.81; remission on-treatment: IRR=0.68, 95% CI 0.62 to 0.75; LDA: IRR=0.79, 95% CI 0.68 to 0.92; and mLLDAS: IRR=0.76, 95% CI 0.65 to 0.89)).ConclusionsRemission on-treatment and off-treatment, LDA-TC and mLLDAS were associated with less damage accrual, even adjusting for possible confounders and effect modifiers.

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Section: Discussionmentioning

confidence: 88%

Remission and low disease activity (LDA) prevent damage accrual in patients with systemic lupus erythematosus: results from the Systemic Lupus International Collaborating Clinics (SLICC) inception cohort

et al. 2022

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“…The detailed way to standardise the rating of the PGA in SLE has been recently described by our group in an international consensus paper. 17 …”

Section: Discussionmentioning

confidence: 99%

“…The detailed way to standardise the rating of the PGA in SLE has been recently described by our group in an international consensus paper. 17 Fatigue is reported by two-thirds of patients with SLE and currently remains one of the most challenging manifestations. 2 3 14 18 Fatigue can be related to general causes unrelated to SLE (eg, lifestyle, psychobehavioural causes including depression, 8 14 medications, sleep or metabolic disorders), but also associated with disease activity or organ damage.…”

Section: Discussionmentioning

confidence: 99%

Fatigue is independently associated with disease activity assessed using the Physician Global Assessment but not the SLEDAI in patients with systemic lupus erythematosus

et al. 2022

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ObjectivesTo analyse whether reported fatigue, one of the most challenging manifestations of systemic lupus erythematosus (SLE), may bias the assessment of disease activity in SLE according to the Physician Global Assessment (PGA).MethodsPatients from the Lupus BioBank of the upper Rhein database, a cross-sectional multicentre collection of detailed clinical and biological data from patients with SLE, were included. Patients had to fulfil the 1997 American College of Rheumatology criteria for SLE and the PGA (0–3 scale) at the time of inclusion had to be available. Fatigue was assessed according to the Fatigue Scale for Motor and Cognitive Functions. Univariate and multivariate regression models were built to determine which variables were associated with the PGA.ResultsA total of 350 patients (89% female; median age: 42 years, IQR: 34–52) were included. The median Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score was 4 (IQR: 2–6). Of these 350 patients, 257 (73%) reported significant fatigue. The PGA (p=0.004) but not the SELENA-SLEDAI (p=0.43) was significantly associated with fatigue. Both fatigue and SELENA-SLEDAI were independently associated with the PGA in two different multivariate models.ConclusionFatigue is independently associated with disease activity assessed using the PGA but not the SLEDAI. These findings highlight the fact that the PGA should capture only objectively active disease manifestations in order to improve its reliability.

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“…17 In addition, the PGA International Standardisation Consensus in SLE study has recently demonstrated a major need for both standardisation and training in the scoring of PGA, suggesting that only expert physicians can efficiently rate the PGA, and it should be preferably scored by the same rater at each visit, making its use particularly challenging in multicentre and longitudinal studies. 18 It has also to be pointed out that in a multicentre study evaluating different definitions of remission, the addition of PGA to clinical SLE Disease Activity Index 2000 (SLEDAI-2K) did not increase the performance of SLEDAI-2K in predicting damage accrual, 19 and no studies ever evaluated the correlation between PGA and damage accrual, according to a recent review. 17 Thus, since the choice of a target for treatment should be based on the interpretation of measures that are potential predictors of a bad outcome, PGA seems not essential in defining remission and LDA in SLE.…”

Section: Margherita Zen Mariele Gatto Andrea Doriamentioning

confidence: 99%

“…However, PGA has a substantial inter-rater variability partly related to variations among rheumatologists in weighing different organ manifestations and serological activity 17. In addition, the PGA International Standardisation Consensus in SLE study has recently demonstrated a major need for both standardisation and training in the scoring of PGA, suggesting that only expert physicians can efficiently rate the PGA, and it should be preferably scored by the same rater at each visit, making its use particularly challenging in multicentre and longitudinal studies 18. It has also to be pointed out that in a multicentre study evaluating different definitions of remission, the addition of PGA to clinical SLE Disease Activity Index 2000 (SLEDAI-2K) did not increase the performance of SLEDAI-2K in predicting damage accrual,19 and no studies ever evaluated the correlation between PGA and damage accrual, according to a recent review 17.…”

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confidence: 99%

Defining the targets in SLE management: insights and unmet gaps

2022

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Physician Global Assessment International Standardisation COnsensus in Systemic Lupus Erythematosus: the PISCOS study

Cited by 23 publications

References 74 publications

Remission and low disease activity (LDA) prevent damage accrual in patients with systemic lupus erythematosus: results from the Systemic Lupus International Collaborating Clinics (SLICC) inception cohort

Remission and low disease activity (LDA) prevent damage accrual in patients with systemic lupus erythematosus: results from the Systemic Lupus International Collaborating Clinics (SLICC) inception cohort

Fatigue is independently associated with disease activity assessed using the Physician Global Assessment but not the SLEDAI in patients with systemic lupus erythematosus

Defining the targets in SLE management: insights and unmet gaps

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