Drug Database
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anakinra (PerkinRA)

✓ Approved

PersisGen Par · IL1R1 · Recombinant Proteins

What is anakinra?

anakinra is a recombinant proteins developed by PersisGen Par. It is approved for therapeutic indications via injectable (others) or intravenous (iv) or subcutaneous injection.

Drug Profile

Brand NamesPerkinRA
CompanyPersisGen Par
Drug ClassRecombinant Proteins
Molecular TargetIL1R1
RouteInjectable (Others), Intravenous (IV), Subcutaneous Injection
StatusApproved
Sources: ClinicalTrials.gov, PersisGen Par

Mechanism of Action

Molecular Targets

anakinra acts on 1 molecular target:

IL1R1interleukin 1 receptor type 1 (P80, CD121A)
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Therapeutic Indications

anakinra is developed for 11 unique indications across 5 therapeutic areas.

Therapeutic AreaConditionPhase
Musculoskeletal and connective tissue disordersRheumatoid arthritis✓ Approved
Musculoskeletal and connective tissue disordersStill's disease✓ Approved
Musculoskeletal and connective tissue disordersJuvenile idiopathic arthritis✓ Approved
Congenital, familial and genetic disordersChronic infantile neurological cutaneous and articular syndrome✓ Approved
Congenital, familial and genetic disordersMuckle-Wells syndrome✓ Approved

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Related Research Articles

PubMedFrontiers in immunology2026-06-08

Dynamic hyperinflammatory response assessment using HIC scores in COVID-19: application to a large series of patients receiving anakinra.

Amikishiyev Shirkhan S, Deniz Rabia R, Gunver Mehmet Guven MG, Aghamuradov Sarvan S et al.

Hyperinflammatory responses substantially contribute to morbidity and mortality in severe COVID-19 and share features with secondary hemophagocytic lymphohistiocytosis and macrophage activation syndrome. The Hyperinflammation in COVID-19 (HIC) criteria allow early diagnosis and may provide a framework for dynamic treatment monitoring. We retrospectively analyzed 218 hospitalized patients with hyperinflammation (HIC ≥35) who received anakinra at a tertiary referral center. The daily anakinra dose (100-800 mg/day, administered intravenously or subcutaneously) was adjusted according to clinical and laboratory parameters. The primary outcome was in-hospital mortality. Secondary outcomes included time to ≥50% CRP reduction, ICU admission, mechanical ventilation, and dynamic changes in ΔHIC and inflammatory biomarkers. Overall mortality was 12.8%. Survivors achieved earlier CRP reduction than non-survivors (3.1 vs. 4.7 days) and showed a progressive decline in HIC, whereas non-survivors had persistently elevated or rising scores. Divergence in ΔHIC and other parameters, including neutrophil count, D-dimer, LDH, procalcitonin, and creatine kinase, emerged within 3-4 days. ROC analysis demonstrated that HIC on the day of anakinra initiation and at the final assessment discriminated survivors from non-survivors (AUC 0.75, p < 0.001; cut-offs 70.8 and 66.5, with high sensitivity but moderate specificity), whereas baseline and first-response-day HIC had limited predictive value (AUC approximately 0.50-0.55) . These findings support the HIC score as both a diagnostic and dynamic monitoring tool during IL-1 blockade. Initiating anakinra when HIC is ≥35 but <70, and reassessing treatment response after 3-4 days using ΔHIC together with CRP kinetics, may help optimize outcomes.

PMID 42253999
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PubMedPediatric rheumatology online journal2026-06-05

Breaking the storm: canakinumab as salvage therapy for refractory macrophage activation syndrome in pediatric systemic lupus erythematosus-a case report.

Selvarajan Tarun T, Kannekanti Lavanya L, Green Ashlyn A, Smith Alexandra Zamora AZ et al.

Macrophage activation syndrome (MAS) complicating pediatric systemic lupus erythematosus (cSLE) is a life-threatening hyperinflammatory state driven by dysregulated cytokine release. A recent systematic literature review identified only a limited number of cSLE-MAS cases treated with IL-1 inhibitors, with variable efficacy, underscoring the need for evidence-based salvage strategies when first-line biologic therapy fails. We report a 17-year-old female with cSLE who developed secondary hemophagocytic lymphohistiocytosis/MAS fulfilling HLH-2004 criteria approximately 17 months after initial diagnosis, in the setting of medication nonadherence and nutritional failure. The MAS course was refractory to intravenous immunoglobulin, pulse methylprednisolone, dexamethasone, cyclosporine, and intravenous anakinra, and was further complicated by a secondary Clostridioides difficile superinfection precipitating a MAS flare with ferritin peaking at > 10,000 ng/mL. Following transfer to our institution, subcutaneous canakinumab at standard weight-based dosing produced prompt defervescence, sustained ferritin normalization, and clinical stabilization permitting transition to outpatient immunomodulation. This case highlights canakinumab as a viable salvage therapeutic option for patients with biologic-refractory cSLE-MAS. Emerging evidence supports an expanding role for selective IL-1β blockade in pediatric lupus-associated hyperinflammatory syndromes; prospective studies are needed to define optimal dosing, sequencing, and treatment duration.

PMID 42243916
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PubMedExpert review of hematology2026-06-03

Managing cytokine release syndrome in hematological malignancies being treated with CAR-T therapy.

Alarcon Tomas Ana A, Segura Alicia A, Chavez Julio J

Cytokine release syndrome (CRS) is a potentially life-threatening toxicity associated with chimeric antigen receptor (CAR)-T cell therapy, particularly in hematological malignancies. As CAR-T therapies are increasingly integrated into clinical practice, managing CRS effectively is critical to maximizing therapeutic benefit while minimizing harm. This review provides a comprehensive overview of CRS in the context of CAR-T therapy for hematologic cancers. It outlines the current definitions and grading systems, highlights key aspects of CRS pathophysiology, and analyzes the incidence and severity of CRS across pivotal clinical trials in large B-cell lymphoma, acute lymphoblastic leukemia, and multiple myeloma. Standard management approaches, including anti-cytokine therapies and corticosteroids, are discussed alongside emerging strategies such as early intervention and prophylaxis using anakinra and corticosteroids. The review is informed by a structured evaluation of clinical studies and real-world data, reflecting evolving treatment paradigms. CRS remains a major challenge, therefore early recognition, standardized grading, and targeted intervention will improve outcomes. Future efforts should focus on predictive biomarkers, personalized prophylaxis, and next-generation CAR constructs to reduce toxicity. The real-world experience mirrors trial data, reinforcing the reproducibility and scalability of these evolving management strategies.

PMID 42233607
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PubMedScience China. Life sciences2026-06-02

Immune interventions in stroke: current progress and perspectives.

Guo Cunle C, Guan Di D, Liu Qiang Q, Han Zhaoli Z

Acute ischemic stroke (AIS) is a devastating cerebrovascular disorder associated with high morbidity, mortality, and long-term disability, where neuroinflammation serves as a central pathogenic driver mediating secondary brain injury and functional impairment. This comprehensive review synthesizes the latest advances in neuroimmune interventions for AIS over the past decade, drawing on systematic literature retrieval from PubMed, Web of Science, Embase, and Ovid Medicine. We first delineate the dual pro-inflammatory and anti-inflammatory mechanisms of key immune cells-including microglia, astrocytes, T cells, B cells, natural killer (NK) cells, monocytes, and neutrophils-in the ischemic brain. Specifically, we highlight their dynamic phenotypic polarization, intercellular crosstalk, and regulatory roles in shaping the post-ischemic immune microenvironment, which provides a theoretical basis for targeted immune interventions. Subsequently, we systematically summarize the clinical research progress on promising therapeutic strategies, encompassing traditional and novel agents such as tirofiban, methylprednisolone, natalizumab, fingolimod combined with alteplase, edaravone dexborneol, butylphthalide, JAK/STAT pathway inhibitors, ApTOLL, anakinra, and tocilizumab, as well as cell transplantation therapies. For each intervention, we analyze its efficacy, safety, underlying immune-modulatory mechanisms, and current clinical trial status. Finally, we discuss the existing challenges in clinical translation-such as suboptimal targeting efficiency, individual variability in treatment response, and unresolved safety concerns-and prospect future directions for precision immune therapy in AIS. This review offers a comprehensive and up-to-date overview of the neuroimmune landscape in AIS, providing valuable insights for researchers and clinicians engaged in stroke treatment and drug development.

PMID 42228253
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PubMedFrontiers in pediatrics2026-06-01

Respiratory effects of off label anakinra in critically ill neonates: a 15-patient observational cohort study.

De Rose Domenico Umberto DU, Cesaroni Gaia Maria GM, Campi Francesca F, Maddaloni Chiara C et al.

Interleukin-1 (IL-1)-mediated inflammation can contribute to lung injury, impaired alveolar development, and pulmonary vascular dysfunction in critically ill neonates. Anakinra, a recombinant IL-1 receptor antagonist, has emerged as a potential adjunct therapy in severe neonatal hyperinflammatory and respiratory conditions, but evidence in this population remains limited. We conducted a retrospective observational study of 15 neonates treated off label with anakinra (10 mg/kg/day in two doses) at a tertiary neonatal intensive care unit between 2021 and 2025. Clinical indications included severe or evolving bronchopulmonary dysplasia (BPD), secondary hemophagocytic lymphohistiocytosis (HLH), pulmonary hypertension, interstitial lung disease and complex congenital anomalies. Respiratory support was evaluated at treatment initiation and at predefined follow-up timepoints up to 60 days. At baseline, 73% of infants required mechanical ventilation and 27% non-invasive ventilation. By the end of treatment (data available for 14/15 infants), mechanical ventilation decreased to 21% (absolute reduction 52%, relative reduction 71%), while spontaneous breathing with or without supplemental oxygen increased to 64%. All infants survived. Anakinra was generally well tolerated: transient transaminase elevations occurred in 40%, γGT increases in 20%, and transient neutropenia in 13%, with no clinically significant hepatotoxicity, allergic reactions, or seizures. In this largest neonatal cohort to date, Anakinra administration was associated with improvements in respiratory status, although a direct causal relationship cannot be established, and a favorable safety profile. Multicenter randomized controlled trials are warranted to confirm these findings, especially in preterm infants at risk of developing bronchopulmonary dysplasia.

PMID 42220990
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PubMedCureus2026-06-01

Secondary Hemophagocytic Lymphohistiocytosis Presenting As the Initial Manifestation of Diffuse Gastric Signet Ring Cell Adenocarcinoma: A Case Report.

Santos Joana N JN, Batista Francisca S FS, Castanheira Beatriz B, Gonçalves-Nobre J Guilherme JG et al.

Hemophagocytic lymphohistiocytosis (HLH) is a life-threatening hyperinflammatory syndrome driven by uncontrolled immune activation, most commonly associated with hematologic malignancies. Its occurrence as the presenting manifestation of a solid tumor is rare and frequently underrecognized due to significant clinical overlap with severe infectious syndromes. We report the case of a 38-year-old male with no prior medical history who presented with persistent fever, severe lower back pain, and night sweats. These nonspecific constitutional symptoms, including fever, weight loss, and night sweats, initially raised suspicion for an infectious or inflammatory etiology. Laboratory evaluation revealed severe anemia, thrombocytopenia, marked hyperferritinemia, elevated lactate dehydrogenase, hepatic cytolysis, and hypertriglyceridemia. Peripheral blood smear demonstrated a leukoerythroblastic pattern with schistocytes and circulating erythroblasts, suggestive of bone marrow infiltration. An HScore indicated an 80-88% probability of HLH, supporting a high likelihood of reactive HLH in the adult setting. Extensive infectious workup was negative, including blood and urine cultures, which remained sterile throughout hospitalization. Imaging identified a left supraclavicular lymph node conglomerate consistent with Virchow's node and diffuse bone marrow infiltration throughout the spine, with anterior epidural extension at the D6 level. Initial computed tomography of the chest, abdomen, and pelvis did not reveal a clear primary intra-abdominal lesion but demonstrated hepatomegaly and lymphadenopathy, prompting further investigation. Upper gastrointestinal endoscopy revealed multiple large gastric ulcers, and histopathological analysis confirmed diffuse gastric adenocarcinoma with signet ring cell features. The tumor demonstrated proficient mismatch repair (pMMR), PD-L1 combined positive score (CPS) 5, HER2-negative status, and claudin 18 (CLDN18) positivity. A bone marrow biopsy was non-diagnostic due to extensive necrosis but showed immunohistochemical evidence suggestive of metastatic epithelial infiltration. Immunomodulatory therapy with anakinra was initiated; however, persistent severe thrombocytopenia precluded systemic oncologic therapy. The patient died 28 days after admission from multiorgan failure, highlighting the fulminant course and high mortality associated with malignancy-triggered HLH. This case highlights the importance of early consideration of malignancy in unexplained HLH and illustrates how hematologic compromise may preclude disease-modifying treatment.

PMID 42220735
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