Efficacy and safety of leflunomide in the management of large vessel vasculitis: A systematic review and metaanalysis of cohort studies

Narváez, Javier; Estrada, Paula; LLop, Dídac; Vidal-Montal, Paola; Brugarolas, Emma; Maymó-Paituvi, Pol; Palacios-Olid, Judith; Nolla, Joan M.

doi:10.1016/j.semarthrit.2023.152166

Cited by 7 publications

(8 citation statements)

References 42 publications

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“…16 21 Recently, a systematic review with metaanalysis assessing LEF use in TAK showed angiographic stabilisation in 86% of patients (95% CI: 0.77 to 0.94) in three uncontrolled observational studies. 20 We acknowledge some limitations to this study due to its retrospective nature, the relatively low number of patients in the ADA group and the lack of randomisation. On the other hand, this study has the strengths of being a real-world study analysing a fair number of patients under ADA as an individual TNFi therapy, and it included patients with TAK who were refractory or intolerant to other csDMARD or bDMARD therapy.…”

Section: Discussionmentioning

confidence: 99%

“…13 Previous small case series and observational cohort studies have shown LEF, compared directly with MTX, cyclophosphamide and tofacitinib, as an effective therapy for inducing remission in patients with TAK presenting active disease. [14][15][16][17][18][19][20] LEF was shown to be more effective against MTX and cyclophosphamide, but its response rate was similar to that of tofacitinib. 16-18 21 Patients with TAK presenting severe disease manifestations are recommended to receive bDMARDs, such as tumour necrosis factor inhibitors (TNFi) or tocilizumab.…”

Section: How This Study Might Affect Research Practice or Policymentioning

confidence: 99%

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Effectiveness and safety of adalimumab compared with leflunomide in patients with Takayasu arteritis: a retrospective cohort study

Peron Filho,

Moreira,

Janes

et al. 2024

RMD Open

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ObjectiveThis study aims to evaluate the effectiveness and safety of adalimumab (ADA) compared with leflunomide (LEF) in patients with Takayasu arteritis (TAK).MethodA retrospective cohort study was performed with the following inclusion criteria: the fulfilment of the 2022 American College Classification/European Alliance of Associations for Rheumatology criteria for TAK, age ≥18 years, and written informed consent. Forty-four patients were treated with LEF (n=28) or ADA (n=16) therapy due to relapsing/refractory disease or toxicity from previous therapy. Patients were evaluated at baseline (T0), at a median of 7.0 months (T1) and at 15.0 months of follow-up (T2). Data regarding disease activity, daily dose of prednisone, side effects and angiographic progression were analysed.ResultsLEF and ADA groups had similar features on the baseline visit. However, intravenous methylprednisolone was more frequently prescribed for the ADA group (p=0.019). On T1 and T2 visits, complete response rates were similar for ADA and LEF groups (75.0% and 88.5%; p=0.397 and 62.5% vs 78.3%; p=0.307), respectively. The differences remained non-significant after adjusting for baseline variables by propensity score matching. Although the ADA group had a higher median daily prednisone on visit T1 (p=0.004), it was similar on visit T2 (p=0.595). Similar rates of angiographic progression were observed in ADA and LEF groups (40% vs 25%; p=0.467). Mild-to-moderate adverse events were observed only in the LEF group (17.9%).ConclusionLEF and ADA had comparable outcomes after a median of 15.0 months of follow-up. However, withdrawal from therapy and mild-to-moderate adverse events were only observed in the LEF group.

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Section: Discussionmentioning

confidence: 99%

Section: How This Study Might Affect Research Practice or Policymentioning

confidence: 99%

Effectiveness and safety of adalimumab compared with leflunomide in patients with Takayasu arteritis: a retrospective cohort study

Peron Filho,

Moreira,

Janes

et al. 2024

RMD Open

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“…In addition, glucocorticoids impair quality of life and are negatively regarded in the long-term by most patients with GCA [ 24 ]. Over the last several years, other drugs, such as methotrexate and TNF- inhibitors have been trialed with controversial or disappointing results [ 3 , 4 ]. More recently, phase 2 randomized controlled trials with abatacept, mavrilimumab, and secukinumab have shown encouraging preliminary findings that await confirmation [ 11 – 13 ].…”

Section: Discussionmentioning

confidence: 99%

“…Glucocorticoids have been the cornerstone of GCA treatment for decades at the expense of significant treatment-related toxicity and high relapse rates upon dose reduction or drug discontinuation. Other therapies, such as methotrexate, leflunomide, azathioprine, hydroxychloroquine, cyclophosphamide or tumor necrosis factor (TNF)- inhibitors have proven to be ineffective or shown mixed results [ 3 , 4 ]. To date, tocilizumab, a monoclonal antibody against the IL-6 receptor (IL-6R), is the only medication with demonstrated efficacy in terms of remission maintenance and glucocorticoid-sparing [ 5 , 6 ].…”

Section: Introductionmentioning

confidence: 99%

Effectiveness of janus kinase inhibitors in relapsing giant cell arteritis in real-world clinical practice and review of the literature

Loricera,

Tofade,

Prieto-Peña

et al. 2024

Arthritis Res Ther

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Background A substantial proportion of patients with giant cell arteritis (GCA) relapse despite standard therapy with glucocorticoids, methotrexate and tocilizumab. The Janus kinase/signal transducer and activator of transcription (JAK/STAT) signalling pathway is involved in the pathogenesis of GCA and JAK inhibitors (JAKi) could be a therapeutic alternative. We evaluated the effectiveness of JAKi in relapsing GCA patients in a real-world setting and reviewed available literature. Methods Retrospective analysis of GCA patients treated with JAKi for relapsing disease at thirteen centers in Spain and one center in United States (01/2017-12/2022). Outcomes assessed included clinical remission, complete remission and safety. Clinical remission was defined as the absence of GCA signs and symptoms regardless of the erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) values. Complete remission was defined as the absence of GCA signs and symptoms along with normal ESR and CRP values. A systematic literature search for other JAKi-treated GCA cases was conducted. Results Thirty-five patients (86% females, mean age 72.3) with relapsing GCA received JAKi therapy (baricitinib, n = 15; tofacitinib, n = 10; upadacitinib, n = 10). Before JAKi therapy, 22 (63%) patients had received conventional synthetic immunosuppressants (e.g., methotrexate), and 30 (86%) biologics (e.g., tocilizumab). After a median (IQR) follow-up of 11 (6-15.5) months, 20 (57%) patients achieved and maintained clinical remission, 16 (46%) patients achieved and maintained complete remission, and 15 (43%) patients discontinued the initial JAKi due to relapse (n = 11 [31%]) or serious adverse events (n = 4 [11%]). A literature search identified another 36 JAKi-treated GCA cases with clinical improvement reported for the majority of them. Conclusions This real-world analysis and literature review suggest that JAKi could be effective in GCA, including in patients failing established glucocorticoid-sparing therapies such as tocilizumab and methotrexate. A phase III randomized controlled trial of upadacitinib is currently ongoing (ClinicalTrials.gov ID NCT03725202).

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“…Another study showed that the efficacy of LEF was comparable to tocilizumab. [ 75 ] Since the studies on csDMARDs for the treatment of TAK are observational studies and lack of high-quality evidence, the expert panel recommend that csDMARDs should be selected based on comprehensive evaluation of the patient’s disease activity, severity, complications or comorbidities, fertility requirements, costs and safety.…”

Section: Recommendationsmentioning

confidence: 99%

Chinese guideline for the diagnosis and treatment of Takayasu’s arteritis (2023)

Tian,

Zeng

2024

Rheumatology and Immunology Research

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Takayasu’s arteritis (TAK) is a chronic granulomatous inflammatory disease that involves aorta and its primary branches. It is characterized by wall thickening, stenosis/obliteration or aneurysm formation of the involved arteries. In order to standardize the diagnosis and treatment of TAK in China, a clinical practice guideline with an evidence-based approach is developed under the leadership of National Clinical Medical Research Center for Dermatologic and Immunologic Diseases (NCRC-DID). Eleven recommendations for 11 clinical questions that are important to the diagnosis and treatment of TAK are developed based on the latest evidence and expert opinions combined with real clinical practice in China.

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Efficacy and safety of leflunomide in the management of large vessel vasculitis: A systematic review and metaanalysis of cohort studies

Cited by 7 publications

References 42 publications

Effectiveness and safety of adalimumab compared with leflunomide in patients with Takayasu arteritis: a retrospective cohort study

Effectiveness and safety of adalimumab compared with leflunomide in patients with Takayasu arteritis: a retrospective cohort study

Effectiveness of janus kinase inhibitors in relapsing giant cell arteritis in real-world clinical practice and review of the literature

Chinese guideline for the diagnosis and treatment of Takayasu’s arteritis (2023)

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