Treatment strategy introducing immunosuppressive drugs with glucocorticoids ab initio or very early in giant cell arteritis: A multicenter retrospective controlled study

Quartuccio, Luca; Isola, Miriam; Bruno, Dario; Treppo, Elena; Gigante, Laura; Angelotti, Francesca; Capecchi, Riccardo; Vitiello, Gianfranco; Cavallaro, Elena; Tavoni, Antonio; Bosello, Silvia Laura; Cammelli, Daniele; Vita, Salvatore De; Gremese, Elisa

doi:10.1016/j.jtauto.2020.100072

Cited by 10 publications

(10 citation statements)

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“…REFERENCES: [1] Background: Glucocorticoids (GCs) are still the mainstay of treatment of Giant Cell Arteritis (GCA), while Tocilizumab (TCZ) has been licensed as the first biologic treatment for GCA. Although GCs are highly effective in GCA, it is well documented the high burden of toxicity of GCs as well as the disease relapse during GC tapering.…”

Section: Discussionmentioning

confidence: 99%

“…Although GCs are highly effective in GCA, it is well documented the high burden of toxicity of GCs as well as the disease relapse during GC tapering. Therefore, patients with GCA may benefit from GC-sparing treatments [1]. Objectives: The aim is to compare the efficacy as steroid-sparing agents of Tocilizumab (TCZ) or Methotrexate (MTX) in GCA.…”

Section: Discussionmentioning

confidence: 99%

“…Jayatilleke 1 , A. Anilkumar 1 , S. Janagan 1 , R. W. Marshall 1 , S. Skeoch 2 , C. Guly 3 , F. E. Sin 4 , K. Austin 2 , L. Al-Sweedan 5 , A. Bourn 5 , L. Clarke 4 , H. Gunawardena 4 , B. Boyce 6 , S. Knights 5 , J. D. Pauling 2 , E. Reilly 1 , T. D. Reynolds 1 , S. Villar 4 , J. C. Robson1,7 1. University HospitalsBristol and Weston NHS Foundation Trust, Rheumatology, Bristol, United Kingdom; …”

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confidence: 99%

“…NHS England requires all GCA patients to be discussed in a regional multidisciplinary team meeting (MDT) prior to commencing TCZ. TCZ has only been permitted for a maximum of one year; this time limitation was extended during the Covid-19 pandemic(1). The monthly virtual Bristol and Bath regional MDT started in November 2018.…”

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confidence: 99%

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Ab0589 tocilizumab for Giant Cell Arteritis: Baseline and Twelve Month Audit Data From the Uk Bristol and Bath Multidisciplinary Meeting.

et al. 2022

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BackgroundGiant Cell Arteritis (GCA) is a systemic vasculitis involving large and medium-sized blood vessels. Treatment is with high dose glucocorticoids. Steroid-sparing agents and Tocilizumab (TCZ) are used for refractory or relapsing cases. NHS England requires all GCA patients to be discussed in a regional multidisciplinary team meeting (MDT) prior to commencing TCZ. TCZ has only been permitted for a maximum of one year; this time limitation was extended during the Covid-19 pandemic (1). The monthly virtual Bristol and Bath regional MDT started in November 2018.ObjectivesWe aimed to review: 1) Baseline data on all patients referred to the Bristol and Bath TCZ for GCA MDT, including demographics, clinical presentation and previous steroid-sparing agents used and 2) 12 month follow up data including number of completions, adverse effects, and flares on treatment.MethodsThe TCZ MDT referral proforma, adapted from the NHS England Blueteq approval form, was reviewed for all patients referred. 12 month follow up data was obtained from clinic letters.ResultsBaseline dataThirty-eight cases were referred between November 2018 and September 2021. Of these, 31 were approved for TCZ usage; 100% fulfilled the criteria for either refractory (n=11) or relapsing (n=20) disease. Mean age was 74 years and 74.2% were female. Average disease duration was 161.5 days for the refractory and 827.3 days for the relapsing group.77.4% had cranial GCA, 48.4% had large vessel involvement, 45.2% had visual symptoms and 25.8% had ischaemic visual loss. The positive investigations were PET-CT (48.4%), temporal artery ultrasound (41.9%) and temporal artery biopsy (32.3%).64.5% had trialled a steroid-sparing agent at time of referral (61.3 % methotrexate, 9.7% azathioprine, 6.5% leflunomide), 35.5% had received intravenous methylprednisolone and 58% were receiving greater than 40mg prednisolone at the time of referral.Glucocorticoid adverse effects of osteoporosis, weight gain, cataracts and hypertension were each seen in 19.4%; whilst diabetes, neuropsychiatric symptoms and sleep disturbance were each reported in 16.1%.Those with ocular involvement tended to be referred earlier than those without (478.2 days vs 648.1 days), were referred on higher doses of glucocorticoids (71.4% vs 47.1% on ≥ 40mg) and had less steroid-sparing agents prior to referral.Follow up dataIn December 2021, a follow-up audit revealed 14/31 patients had completed at least 12 months of tocilizumab; 5 of these had had an extension under Covid-19 exceptional guidance (mean duration of 5.2 months). Of the remaining 17: 3 patients had stopped early (1 death, 1 moved away, 1 due to adverse effects of headache and gastro-intestinal side effects), 4 had not started tocilizumab and 10 had not completed 12 months of treatment at that point.Adverse events in the 14 patients at 12 months included: liver abnormalities (2/14; 14.3%), neutropenia (2/14; 14.3%), thrombocytopaenia (1/14; 7.1%), soft tissue infections (3/14; 21.4%), urinary tract infection (1/14; 7.1%) and lipid derangement (4/14 28.6%). One case of GCA relapse occurred on TCZ (mild headache and raised inflammatory markers settled on small increase in prednisolone). After 12 months, mean prednisolone dose was 3mg (range 0-15mg).ConclusionAll patients approved for Tocilizumab in the GCA MDT fulfilled NHS England criteria for either relapsing or refractory disease. The majority of cases had cranial disease, but almost half had either ocular or large vessel involvement, reflecting a severe spectrum of disease. Cases showed a high burden of glucocorticoid toxicity. Follow up data suggests that TCZ was effective in allowing glucocorticoid weaning and disease control, but with some adverse effects. Future work to follow up patients after stopping Tocilizumab would be informative, as the twelve month limitation on treatment is likely to be re-instated.References[1]https://www.england.nhs.uk/coronavirus/publication/tocilizumab-for-giant-cell-arteritis-gca-during-the-covid-19-pandemic-rps-2007/Disclosure of InterestsChandrin N. R. Jayatilleke: None declared, Aishwarya Anilkumar: None declared, Shalini Janagan: None declared, Robert W Marshall: None declared, Sarah Skeoch: None declared, Catherine Guly Grant/research support from: Eli Lilly and Company - paid consultant for a research trial, Fang En Sin: None declared, Keziah Austin: None declared, Laith Al-Sweedan: None declared, Alexandra Bourn: None declared, Lynsey Clarke: None declared, Harsha Gunawardena: None declared, Baashar Boyce: None declared, Sally Knights: None declared, John D Pauling: None declared, Elizabeth Reilly: None declared, Timothy D Reynolds: None declared, Sarah Villar: None declared, Joanna C Robson: None declared

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

mentioning

confidence: 99%

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Ab0589 tocilizumab for Giant Cell Arteritis: Baseline and Twelve Month Audit Data From the Uk Bristol and Bath Multidisciplinary Meeting.

et al. 2022

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“…It is noteworthy that in a recent multicentre retrospective study (n=165), the early (i.e. <3 months) introduction of immunosuppressive therapies (either MTX, TCZ, or cyclophosphamide) was associated with a lower incidence of steroid-induced diabetes compared to GCA patients who received GC only or an immunosuppressive therapy more than 3 months later (65).…”

Section: Guidelinesmentioning

confidence: 97%

The Italian Society of Rheumatology clinical practice guidelines for the management of large vessel vasculitis

et al. 2022

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Objective: Since of the last publication of last recommendations on primary large-vessel vasculitis (LVV) endorsed by the Italian Society of Rheumatology (SIR) in 2012, new evidence emerged regarding the diagnosis and the treatment with conventional and biologic immunosuppressive drugs. The associated potential change of clinical care supported the need to update the original recommendations. Methods: Using the grading of recommendations assessment, development and evaluation (GRADE)-ADOLOPMENT framework, a systematic literature review was performed to update the evidence supporting the European Alliance of Associations for Rheumatology (EULAR) guidelines on LVV as reference. A multidisciplinary panel of 12 expert clinicians, a trained nurse, and a patients’ representative discussed the recommendation in cooperation with an Evidence Review Team. Sixty-one stakeholders were consulted to externally review and rate the recommendations. Results: Twelve recommendations were formulated. A suspected diagnosis of LVV should be confirmed by imaging or histology. In active GCA or TAK, the prompt commencement of high dose of oral glucocorticoids (40-60 mg prednisone-equivalent per day) is strongly recommended to induce clinical remission. In selected patients with GCA (e.g., refractory or relapsing disease or patients at risk of glucocorticoid related adverse effects) the use of an adjunctive therapy (tocilizumab or methotrexate) is recommended. In all patients diagnosed with TAK, adjunctive therapies, such as conventional synthetic or biological immunosuppressants, should be given in combination with glucocorticoids. Conclusions: The new set of SIR recommendations was formulated in order to provide a guidance on both diagnosis and treatment of patients suspected of or with a definite diagnosis of LVV.

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Faster steroid-free remission with tocilizumab compared to methotrexate in giant cell arteritis: a real-life experience in two reference centres

Quartuccio,

Treppo,

De Martino

et al. 2024

Intern Emerg Med

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Glucocorticoids (GCs) are still the mainstay of treatment of giant cell arteritis (GCA). Although GCs are highly effective in GCA, the high burden of toxicity of GCs as well as the disease relapse during GC tapering is well documented. To compare the efficacy and rapidity of TCZ and MTX as steroid-sparing agents in a real-life cohort of GCA patients. A retrospective analysis was conducted including patients with newly diagnosed GCA from the Rheumatology Units of Udine and Rome. The inclusion criterion was the treatment with TCZ or MTX as first steroid-sparing drug. 112 GCA patients (81 females) with a median age of 70 (IQ 65–75) years were collected. Thirty-one out of 112 (27.7%) patients were treated with TCZ (162 mg/week), while 81/112 (72.3%) patients received MTX (up to 20 mg/week) as a GC-sparing agent. At month 6 after GCA onset, 5/31 (16.1%) patients in TCZ group and none in MTX group were in GC-free sustained remission (p value = 0.001). Similarly, at month 12, 64.5% (20/31) and 11.1% (9/81) of patients were in sustained GC-free remission in TCZ and MTX group, respectively (p value <0.001). At month 24 of follow-up, at least one relapse of the disease occurred in 7/31 (22.6%) in TCZ-treated and 28/81 (34.6%) in MTX-treated patients, respectively (p value = 0.22). TCZ allowed a faster discontinuation of steroid therapy than MTX in GCA patients, without increasing the risk of relapse.

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Treatment strategy introducing immunosuppressive drugs with glucocorticoids ab initio or very early in giant cell arteritis: A multicenter retrospective controlled study

Cited by 10 publications

References 32 publications

Ab0589 tocilizumab for Giant Cell Arteritis: Baseline and Twelve Month Audit Data From the Uk Bristol and Bath Multidisciplinary Meeting.

Ab0589 tocilizumab for Giant Cell Arteritis: Baseline and Twelve Month Audit Data From the Uk Bristol and Bath Multidisciplinary Meeting.

The Italian Society of Rheumatology clinical practice guidelines for the management of large vessel vasculitis

Faster steroid-free remission with tocilizumab compared to methotrexate in giant cell arteritis: a real-life experience in two reference centres

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