Factors associated with damage accrual in patients with systemic lupus erythematosus with no clinical or serological disease activity: a multicentre cohort study

Apostolopoulos, Diane; Kandane‐Rathnayake, Rangi; Louthrenoo, Worawit; Luo, Shue Fen; Wu, Yeong‐Jian Jan; Lateef, Aisha; Golder, Vera; Sockalingam, Sargunan; Navarra, Sandra V.; Zamora, Leonid; Hamijoyo, Laniyati; Katsumata, Yasuhiro; Harigai, Masayoshi; Chan, Madelynn; O’Neill, Sean; Goldblatt, Fiona; Lau, Chak Sing; Li, Zhan Guo; Hoi, Alberta; Nikpour, M; Morand, Eric F

doi:10.1016/s2665-9913(19)30105-5

Cited by 61 publications

(49 citation statements)

References 21 publications

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“…The risk of organ damage was increased by more than 3-fold when the mean daily dosage of prednisone was >20 mg. The multicenter Asia Pacific lupus collaboration group also reported that the time-adjusted mean prednisolone dose was independently associated with damage accrual in SLE patients (29). In a subset of patients with no disease activity over time, the mean prednisolone dose remained an independent risk factor for damage accrual.…”

Section: Discussionmentioning

confidence: 94%

Trend of Survival of a Cohort of Chinese Patients With Systemic Lupus Erythematosus Over 25 Years

Mok

Chan

et al. 2020

Front. Med.

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Objectives: To revisit the trend of survival of systemic lupus erythematosus in a cohort of Chinese patients over 25 years. Methods: Patients who fulfilled the 1997 ACR criteria for SLE and were followed in our hospital since 1995 were included. Patients were stratified into two groups according to the year of diagnosis: (1) 1995-2004 and (2) 2005-2018. Survival of patients was studied by Kaplan-Meier analysis. Organ damage as assessed by the Systemic Lupus International Collaborating Clinics (SLICC) damage index (SDI) and causes of death in the first 10 years of SLE onset was compared between the two groups. Cox regression was used to study factors associated with survival. Results: A total of 1,098 SLE patients were registered in our database. After excluding 157 patients diagnosed outside the time period of 1995-2018, 941 patients were studied (92% women). All were ethnic Chinese. The mean age of SLE onset was 35.1 ± 14.4 years, and the mean duration of observation was 13.1 ± 6.6 years. Seventy-seven (8.2%) patients were lost to follow-up. Groups 1 and 2 consisted of 364 and 577 patients, respectively. The mean SDI score at 10 years of disease onset was significantly higher in group 1 than group 2 patients (1.01 ± 1.43 vs. 0.57 ± 0.94; p < 0.01), particularly in the neuropsychiatric, musculoskeletal, and gonadal domains. Within 10 years of SLE onset, 32 (8.8%) patients in group 1 and 25 (4.3%) patients in group 2 died (p = 0.005). The 5-and 10-year cumulative survival rates were 93.6 and 91.0% in group 1 and 96.5 and 94.2% in group 2 patients, respectively (log-rank test p = 0.048). Infection accounted for more than half of the deaths in both groups. More group 1 than group 2 patients died of vascular events, but the difference was not statistically significant. Cox regression showed that the age of SLE onset and damage score accrued at 10 years, but not the time period in which SLE was diagnosed, were significantly associated with mortality. Conclusions: The improvement in survival of our SLE patients is probably related to the accrual of less organ damage in the past 15 years.

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Section: Discussionmentioning

confidence: 94%

Trend of Survival of a Cohort of Chinese Patients With Systemic Lupus Erythematosus Over 25 Years

Mok

Chan

et al. 2020

Front. Med.

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“…[4][5][6][7][8] Furthermore, treatments used to control flares, including glucocorticoids, also contribute to organ damage independent of disease activity. [9][10][11] Anifrolumab treatment was associated with flare reduction across multiple measures, including fewer cumulative flares and fewer patients with !1 flare among patients who were able to taper glucocorticoids. Preventing flares while maintaining the lowest possible glucocorticoid doses has long been a key therapeutic objective for the management of patients with SLE.…”

Section: Discussionmentioning

confidence: 99%

“…3 SLE flares contribute to organ damage, [4][5][6][7][8] and glucocorticoids, immunosuppressants, and other therapies used to control flares are also associated with adverse effects that incur organ damage. [9][10][11] It has been well documented that disease activity, steroid use, and organ damage increase mortality risk in patients with SLE. [12][13][14][15][16] Therefore, a major goal of long-term SLE management is to prevent flares while minimizing toxicity of treatments.…”

Section: Introductionmentioning

confidence: 99%

Anifrolumab reduces flare rates in patients with moderate to severe systemic lupus erythematosus

Furie

Morand

Askanase

et al. 2021

Lupus

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Background Systemic lupus erythematosus (SLE) management objectives include preventing disease flares while minimizing glucocorticoid exposure. Pooled data from the phase 3 TULIP-1 and TULIP-2 trials in patients with moderate to severe SLE were analyzed to determine anifrolumab’s effect on flares, including those arising with glucocorticoid taper. Methods TULIP-1 and TULIP-2 were randomized, placebo-controlled, 52-week trials of intravenous anifrolumab (300 mg every 4 weeks for 48 weeks). For patients receiving baseline glucocorticoid ≥10 mg/day, attempted taper to ≤7.5 mg/day prednisone or equivalent from Weeks 8–40 was required and defined as sustained reduction when maintained through Week 52. Flares were defined as ≥1 new BILAG-2004 A or ≥2 new BILAG-2004 B scores versus the previous visit. Flare assessments were compared for patients receiving anifrolumab versus placebo. Results Compared with placebo (n = 366), anifrolumab (n = 360) was associated with lower annualized flare rates (rate ratio 0.75, 95% confidence interval [CI] 0.60–0.95), prolonged time to first flare (hazard ratio 0.70, 95% CI 0.55–0.89), and fewer patients with ≥1 flare (difference −9.3%, 95% CI −16.3 to −2.3), as well as flares in organ domains commonly active at baseline (musculoskeletal, mucocutaneous). Fewer BILAG-based Composite Lupus Assessment responders had ≥1 flare with anifrolumab (21.1%, 36/171) versus placebo (30.4%, 34/112). Of patients who achieved sustained glucocorticoid reductions from ≥10 mg/day at baseline, more remained flare free with anifrolumab (40.0%, 76/190) versus placebo (17.3%, 32/185). Conclusions Analyses of pooled TULIP-1 and TULIP-2 data support that anifrolumab reduces flares while permitting glucocorticoid taper in patients with SLE. ClinicalTrials.gov identifiers TULIP-1 NCT02446912 (clinicaltrials.gov/ct2/show/NCT02446912); TULIP-2 NCT02446899 (clinicaltrials.gov/ct2/show/NCT02446899).

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“…Anifrolumab shows efficacy for the reduction of flares, and the onset of treatment effect for reducing disease activity occurs as early as 8-12 weeks after treatment initiation, when numerical separation of BICLA response rates by >10% were observed in favor of anifrolumab 300 mg and remained throughout 52 weeks of treatment. In addition, the steroid-sparing effect of anifrolumab potentially reduces the cumulative risk of long-term organ damage associated with SLE [42]. The improvements seen with anifrolumab treatment in skin manifestations (CLASI activity score) are also particularly important as they are common, and the face, head, and neck are frequently involved with lesions that are visible.…”

Section: Summary Of Evidence For Anifrolumab Clinical Efficacy In Slementioning

confidence: 99%

Anifrolumab, a monoclonal antibody to the type I interferon receptor subunit 1, for the treatment of systemic lupus erythematosus: an overview from clinical trials

Tanaka

Tummala

2020

Modern Rheumatology

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Chronic activation of the type I interferon (IFN) pathway plays a critical role in systemic lupus erythematosus (SLE) pathogenesis. Anifrolumab is a human monoclonal antibody to the type I IFN receptor subunit 1, which blocks the action of type I IFNs. Two phase 3 studies (TULIP-1 and TULIP-2) and a phase 2b study (MUSE) provide substantial evidence for the efficacy and safety of anifrolumab for moderately to severely active SLE. In all three studies, monthly intravenous anifrolumab 300 mg was associated with treatment differences >16% compared with placebo at Week 52 in British Isles Lupus Assessment Group-based Composite Lupus Assessment response rates. The combined data across a range of other clinically significant endpoints (e.g. oral corticosteroid reduction, improved skin disease, flare reduction) further support the efficacy of anifrolumab for SLE treatment. The safety profile of anifrolumab was generally similar across all studies; serious adverse events occurred in 8-16% and 16-19% of patients receiving anifrolumab and placebo, respectively. Herpes zoster incidence was greater with anifrolumab (7%) vs placebo (2%). Evidence from these clinical trials suggests that in patients with active SLE, anifrolumab is superior to placebo in achieving composite endpoints of disease activity response and oral corticosteroid reduction.

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Factors associated with damage accrual in patients with systemic lupus erythematosus with no clinical or serological disease activity: a multicentre cohort study

Cited by 61 publications

References 21 publications

Trend of Survival of a Cohort of Chinese Patients With Systemic Lupus Erythematosus Over 25 Years

Trend of Survival of a Cohort of Chinese Patients With Systemic Lupus Erythematosus Over 25 Years

Anifrolumab reduces flare rates in patients with moderate to severe systemic lupus erythematosus

Anifrolumab, a monoclonal antibody to the type I interferon receptor subunit 1, for the treatment of systemic lupus erythematosus: an overview from clinical trials

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