Smoking and pre-existing organ damage reduce the efficacy of belimumab in systemic lupus erythematosus

Parodis, Ioannis; Sjöwall, Christopher; Jönsen, Andreas; Ramsköld, Daniel; Zickert, Agneta; Frodlund, Martina; Sohrabian, Azita; Arnaud, Laurent; Rönnelid, Johan; Malmström, Vivianne; Bengtsson, Anders; Gunnarsson, Iva

doi:10.1016/j.autrev.2017.02.005

Cited by 90 publications

(99 citation statements)

References 378 publications

(561 reference statements)

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“…Second, the different pharmacokinetics of the 2 biologic agents reasonably accounts for a part of the observed differences. The gradual improvements in HRQoL in the belimumab group are in conformity with the gradual clinical and immunologic improvements observed and documented previously for this patient cohort (24). In this respect, evaluation of belimumab treatment earlier than 6-12 months after treatment initiation might underestimate improvements in HRQoL.…”

Section: Discussionsupporting

confidence: 87%

“…The gradual improvements in HRQoL in the belimumab group are in conformity with the gradual clinical and immunologic improvements observed and documented previously for this patient cohort (24). First, belimumab is mainly used to treat moderately active SLE despite standard of care background therapy, while rituximab is used in more refractory cases, including therapy-resistant lupus nephritis.…”

Section: Discussionsupporting

confidence: 86%

“…Recently, we demonstrated improvements in patient-reported outcomes, including fatigue, pain, and general health, in patients with SLE treated with belimumab from 3 Swedish tertiary referral centers (24). In the current study, we sought to demonstrate and compare the impact of belimumab and rituximab, the 2 most commonly used biologic agents in SLE, on HRQoL, fatigue, and functional ability in longitudinally followed patients with SLE.…”

Section: Introductionmentioning

confidence: 95%

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The Impact of Belimumab and Rituximab on Health‐Related Quality of Life in Patients With Systemic Lupus Erythematosus

Parodis

Benavides

Zickert

et al. 2019

Arthritis Care & Research

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Our findings corroborated considerable HRQoL impairments in SLE patients. Patients' perceptions of HRQoL showed discrepant patterns over time in the two treatment groups, and could provide additional information along with the clinical evaluation of biologic therapy in SLE. Survey on the effects of antimalarial agents on SLE patients' HRQoL in larger cohorts is merited. This article is protected by copyright. All rights reserved.

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Section: Discussionsupporting

confidence: 87%

Section: Discussionsupporting

confidence: 86%

Section: Introductionmentioning

confidence: 95%

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The Impact of Belimumab and Rituximab on Health‐Related Quality of Life in Patients With Systemic Lupus Erythematosus

Parodis

Benavides

Zickert

et al. 2019

Arthritis Care & Research

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“…The BLISS trials indicated that a damage index (SDI score) >1 reduced the efficacy of belimumab. 15 Whether the disease duration reflects the accrual damage over time, which in turn impacts the metformin response, deserves further investigation.…”

Section: Discussionmentioning

confidence: 99%

Effects of metformin on disease flares in patients with systemic lupus erythematosus: post hoc analyses from two randomised trials

et al. 2020

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ObjectiveTo confirm that metformin prevents flares in patients with SLE with low disease activity, we performed a post hoc analysis combining our previous two randomised trials.MethodsPost hoc analyses were performed on data from the open-labelled proof-of-concept trial (n=113, ChiCTR-TRC-12002419) and placebo-controlled ‘Met Lupus’ trial (n=140, NCT02741960) comparing the efficacy of metformin versus placebo/nil add-on to standard therapy in patients with SLE with low disease activity (SELENA-SLEDAI ≤4). The primary endpoint was defined by the SELENA-SLEDAI Flare Index at 12-month follow-up. A subgroup analysis was performed.ResultsOverall, 201 eligible patients were included, with 99 allocated to metformin group and 102 allocated to the placebo/nil group. By 12 months of follow-up, 21 patients (21.2%) flared in the metformin group, as compared with 36 (35.3%) in the placebo/nil group (p=0.027, risk ratio=0.68, 95% CI 0.46 to 0.96). Subgroup analysis showed that patients with negative anti-dsDNA antibody and normal complement at baseline, and a disease duration <5 years with concomitant use of hydroxychloroquine had a better response to metformin.ConclusionPost hoc pooled analyses suggested that metformin reduced subsequent disease flares in patients with SLE with low disease activity, especially for serologically quiescent patients.

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“…Although belimumab is not formally indicated for treating LN, post hoc analyses from RCTs and observational studies suggest that, when added to standard-of-care (including MMF), it may gradually reduce proteinuria and the risk for kidney flares. [79][80][81][82][83] Importantly, positive results from the phase III RCT of belimumab as an add-on therapy in LN have been released, 84 and the results of this study are awaited. The combination of RTX and belimumab has recently been used in refractory disease.…”

Section: Non-responding/refractory Diseasementioning

confidence: 99%

2019 Update of the Joint European League Against Rheumatism and European Renal Association–European Dialysis and Transplant Association (EULAR/ERA–EDTA) recommendations for the management of lupus nephritis

et al. 2020

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ObjectiveTo update the 2012 EULAR/ERA–EDTA recommendations for the management of lupus nephritis (LN).MethodsFollowing the EULAR standardised operating procedures, a systematic literature review was performed. Members of a multidisciplinary Task Force voted independently on their level of agreeement with the formed statements.ResultsThe changes include recommendations for treatment targets, use of glucocorticoids and calcineurin inhibitors (CNIs) and management of end-stage kidney disease (ESKD). The target of therapy is complete response (proteinuria <0.5–0.7 g/24 hours with (near-)normal glomerular filtration rate) by 12 months, but this can be extended in patients with baseline nephrotic-range proteinuria. Hydroxychloroquine is recommended with regular ophthalmological monitoring. In active proliferative LN, initial (induction) treatment with mycophenolate mofetil (MMF 2–3 g/day or mycophenolic acid (MPA) at equivalent dose) or low-dose intravenous cyclophosphamide (CY; 500 mg × 6 biweekly doses), both combined with glucocorticoids (pulses of intravenous methylprednisolone, then oral prednisone 0.3–0.5 mg/kg/day) is recommended. MMF/CNI (especially tacrolimus) combination and high-dose CY are alternatives, for patients with nephrotic-range proteinuria and adverse prognostic factors. Subsequent long-term maintenance treatment with MMF or azathioprine should follow, with no or low-dose (<7.5 mg/day) glucocorticoids. The choice of agent depends on the initial regimen and plans for pregnancy. In non-responding disease, switch of induction regimens or rituximab are recommended. In pure membranous LN with nephrotic-range proteinuria or proteinuria >1 g/24 hours despite renin–angiotensin–aldosterone blockade, MMF in combination with glucocorticoids is preferred. Assessment for kidney and extra-renal disease activity, and management of comorbidities is lifelong with repeat kidney biopsy in cases of incomplete response or nephritic flares. In ESKD, transplantation is the preferred kidney replacement option with immunosuppression guided by transplant protocols and/or extra-renal manifestations. Treatment of LN in children follows the same principles as adult disease.ConclusionsWe have updated the EULAR recommendations for the management of LN to facilitate homogenization of patient care.

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Smoking and pre-existing organ damage reduce the efficacy of belimumab in systemic lupus erythematosus

Cited by 90 publications

References 378 publications

The Impact of Belimumab and Rituximab on Health‐Related Quality of Life in Patients With Systemic Lupus Erythematosus

The Impact of Belimumab and Rituximab on Health‐Related Quality of Life in Patients With Systemic Lupus Erythematosus

Effects of metformin on disease flares in patients with systemic lupus erythematosus: post hoc analyses from two randomised trials

2019 Update of the Joint European League Against Rheumatism and European Renal Association–European Dialysis and Transplant Association (EULAR/ERA–EDTA) recommendations for the management of lupus nephritis

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