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ciclosporin (Gengraf / ciclosporin, AbbVie)

✓ Approved

AbbVie, Inc. · PPIA · 小分子

什么是 ciclosporin？

ciclosporin 是一种小分子，由AbbVie, Inc.研发。该药已获批，用于治疗相关适应症，给药途径：Oral (PO)。

药物档案

商品名Gengraf, ciclosporin, AbbVie
公司AbbVie, Inc.
药物类别小分子
分子靶点PPIA
给药途径Oral (PO)
状态Approved
来源： ClinicalTrials.gov, AbbVie, Inc.

作用机制

分子靶点

ciclosporin 作用于 1 个分子靶点：

PPIApeptidylprolyl isomerase A (HEL-S-69p, CYPH)
需要更深入的分析？Noah AI 可解释复杂机制并与同类药物比较。

治疗适应症

ciclosporin 针对 3 个适应症，涉及 3 个治疗领域。

治疗领域疾病/病症分期
Skin and subcutaneous tissue disordersPsoriasis✓ Approved
Musculoskeletal and connective tissue disordersRheumatoid arthritis✓ Approved
Immune system disordersSolid organ transplant rejection✓ Approved

相关研究文献

PubMedFrontiers in allergy2026-10-25

From disease activity scores to precision medicine: biomarkers and composite models for risk stratification in chronic spontaneous urticaria.

Elkhalifa Shuayb S, Abuzakouk Mohamed M

Chronic spontaneous urticaria is a common, mast cell driven condition that presents with wheals, angioedema, or both, and a substantial proportion of patients remain inadequately controlled despite guideline-directed antihistamine therapy. The 2026 guideline has expanded the advanced-treatment options to include omalizumab, dupilumab and remibrutinib, while ciclosporin remains an alternative later-line immunosuppressive option, yet it is organised around treatment response rather than prognosis, so patients with difficult-to-control disease are often recognised only after months of sequential escalation. This narrative review examines the scoring systems and biomarkers available in urticaria and angioedema and considers whether they can support early risk stratification and help identify patients at increased risk of difficult-to-control disease. The validated instruments in routine use, namely the Urticaria Activity Score, the Urticaria Control Test, the Chronic Urticaria Quality of Life Questionnaire, and their angioedema counterparts, measure current disease activity, control, and quality of life rather than long term outcome. A separate body of work has described biomarkers associated with the autoimmune type IIb endotype and with response to omalizumab, including low total IgE, a high ratio of IgG anti-thyroid peroxidase to total IgE, basopenia, and raised inflammatory markers, although most of this evidence is associative rather than prospectively predictive. The distinction between markers of current burden, markers of prognosis, and markers of treatment response is emphasised. Composite models integrating clinical characteristics, patient-reported outcomes, and biomarkers represent a promising approach toward precision management of CSU, although no validated prognostic tool is currently available for routine clinical use.

PMID 42922821
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PubMedGlobal & regional health technology assessment2026-10-15

Determining value and the contribution of ciclosporin-based therapies in dry eye disease: a European expert MCDA pilot study.

Ahmad Sajjad S, Figueiredo Francisco F, Labetoulle Marc M, Messmer Elisabeth M EM et al.

Dry eye disease (DED) is a multifactorial, immune-mediated inflammatory condition affecting the ocular surface and lacrimal glands. Multiple ciclosporin-based therapies with different formulations are currently available in Europe, although clear guidance on their optimal use remains limited. The aim of this study was to determine the main unmet needs and the current management landscape of ciclosporin-based therapies, from the perspective of clinical experts using multi-criteria decision analysis (MCDA). A systematic literature review was conducted to gather evidence for each of the MCDA framework criteria. An international expert panel of seven clinical specialists in DED from four European countries independently weighted the criteria and scored the non-comparative criteria in the evidence matrix. Results were presented and discussed in a group online session. DED is a highly prevalent, chronic inflammatory disease associated with significant visual and functional burden. Its management is not uniform and often involves a stepwise approach. Recent ciclosporin-based treatment alternatives address some unmet needs; however, others-such as the need for greater standardization of diagnostic tools and improved objective markers of inflammation-remain to be addressed. Highest importance was assigned to Efficacy/effectiveness (4.7 ± 0.5), Quality of evidence (4.7 ± 0.5), and Safety/tolerability (4.6 ± 0.5) criteria, highlighting the relevance of treatment-related outcomes in clinical decision-making. The expert opinion, based on MCDA, enabled the identification of key value drivers and unmet needs in the current management of DED based on ciclosporin-based therapies. These early insights may contribute to promoting future work to support informed, evidence-based decision-making.

PMID 42876972
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PubMedAME case reports2026-10-14

Postpartum macrophage activation syndrome with temporal dissociation of cytopenias in a patient with Kikuchi-Fujimoto disease and undifferentiated connective tissue disease: a case report.

Zhou Xiying X, Li Jing J, Ma Yanhua Y, Liang Xuxia X

Macrophage activation syndrome (MAS) is a life-threatening hyperinflammatory disorder; postpartum MAS is extremely rare and often misdiagnosed due to overlap with sepsis and HELLP syndrome. Kikuchi-Fujimoto disease (KFD) and undifferentiated connective tissue disease (UCTD) may increase susceptibility, but reports are scarce. This case highlights the diagnostic challenges of postpartum MAS in the setting of overlapping inflammatory conditions. The patient was a 35-year-old primiparous woman with KFD and UCTD who underwent cesarean section for preeclampsia and cervical insufficiency. She developed septic shock postoperatively. Despite infection control, persistent fever and a distinct temporal dissociation emerged: platelets recovered from 12 to 198 ×109/L while neutrophils initially remained normal but subsequently declined to 0.04×109/L. Hyperferritinemia (>1,500 μg/L), hypertriglyceridemia (3.88 mmol/L), and hypofibrinogenemia (1.78 g/L) developed. The HScore was 176, exceeding the established cutoff of 169 associated with a high probability of reactive hemophagocytic syndrome. Natural killer (NK) cell activity was 2.76% (normal >15%), whereas serum sCD25 was unexpectedly low (<1.2 U/mL; reference range, 17.1-56.6 U/mL). Dexamethasone monotherapy failed, but adding ciclosporin led to rapid recovery. To our knowledge, postpartum MAS associated with KFD and UCTD has rarely been reported. This case demonstrates that a low or normal sCD25 level does not necessarily exclude the diagnosis of MAS. The temporal dissociation of platelet recovery preceding neutrophil decline may provide an early clue to distinguish evolving MAS from controlled infection. Prompt combination immunosuppressive therapy can be life-saving.

PMID 42871335
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PubMedJournal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics2026-10-13

The FAST Study: Examining Quality of Vision Outcomes in Dry Eye Disease Patients with Severe Keratitis Treated with the Ciclosporin A Cationic Emulsion.

Pisella Pierre-Jean PJ, Mourad Amrane A, Ismail Dahlia D, Garrigue Jean-Sebastien JS et al.

Examination of the relationship between improvements in dry eye disease (DED) signs and changes in functional visual acuity (FVA) parameters with ciclosporin A 0.1% cationic emulsion (CsA 0.1% CE) treatment. Adults with DED and severe keratitis were included in a Phase IV, prospective, open-label, multicenter, single-arm, proof-of-concept study. Patients instilled CsA 0.1% CE (one drop daily) and unpreserved artificial tears from baseline through month 3. Primary endpoints examined the change from baseline in corneal fluorescein staining (CFS) score (modified Oxford scale) and any correlation with changes in visual maintenance ratio (VMR) or objective scatter index (OSI) variance. Other endpoints included the change from baseline in CFS score, LogMAR FVA and reporting of adverse events (AEs). Seventeen DED patients were included. Spearman's correlation analyses showed CFS reductions from baseline were significantly correlated with VMR increases (ρ = -0.70; P = 0.0017) at month 3 but not with OSI variance changes (ρ = -0.04; P = 0.8837). Mean CFS score was reduced from 3.8 (baseline) to 1.8 (month 3). CFS reduction significantly correlated with LogMAR FVA changes at month 3 (ρ = 0.6005; P = 0.0139). Seven patients experienced mild/moderate ocular treatment-related AEs and one had severe eye burn. No discontinuations occurred due to treatment-related AEs and there were no serious or sight-threatening events. DED patients with severe keratitis treated with CsA 0.1% CE demonstrated reductions in CFS score that were strongly and significantly correlated with improvements in quality of vision indicators, including VMR and LogMAR FVA. CsA 0.1% CE was well tolerated throughout the study period.

PMID 42865223
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PubMedOphthalmology and therapy2026-10-08

Correction: Long-Term Evolution of Treatment Outcomes with Once-Daily Ciclosporin A 0.1% Cationic Emulsion in Patients with Dry Eye Disease and Severe Keratitis.

Leonardi Andrea A, Aragona Pasquale P, Sainz de la Maza Maite M, Seleznev Aleksei A et al.

PMID 42848189
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PubMedFrontiers in immunology2026-10-04

Short-course vunakizumab associated with rapid improvement of acute flares in paediatric generalised pustular psoriasis: a three-patient case series.

Huang Juan J, Li Yue Y, Peng Yiqian Y, Xia Ping P et al.

Paediatric generalised pustular psoriasis (GPP) is rare, frequently relapsing and associated with limited evidence for targeted therapy. Vunakizumab is an anti-interleukin-17A monoclonal antibody, but data in paediatric GPP are scarce. We retrospectively reviewed three boys with recurrent GPP who received short-course vunakizumab during acute flares. Clinical characteristics, diagnostic details, treatment timelines, follow-up outcomes and Generalized Pustular Psoriasis Area and Severity Index (GPPASI) scores were collected. A 13-year-old boy (87.5 kg) with ciclosporin-dependent recurrent GPP received vunakizumab 240 mg at weeks 0 and 2 with concomitant topical therapy; GPPASI decreased from 18 to 1, and no relapse was documented during approximately 6 months of follow-up. An 8-year-old boy (35 kg) received a single 120-mg administration; GPPASI decreased from 11 to 2, and no recurrent pustular eruption was reported during approximately 15 months of available follow-up, which was predominantly remote after the initial visit. Another 8-year-old boy (32 kg) with a febrile flare received two 120-mg administrations; GPPASI decreased from 14 to 2, and no relapse was documented during approximately 3 months of follow-up. No adverse events considered treatment-related were documented during the available observation periods. Short-course vunakizumab was temporally associated with rapid clinical improvement in three paediatric patients with acute GPP flares. Larger prospective studies with standardised follow-up are needed to evaluate efficacy, paediatric dosing, relapse prevention and long-term safety.

PMID 42827962
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