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Biologics in allergic disease
Published in Richard F. Lockey, Dennis K. Ledford, Allergens and Allergen Immunotherapy, 2020
Tara V. Saco, Farnaz Tabatabaian
Auto-inflammatory syndromes such as Schnitzler syndrome and cryopyrin-associated periodic fever syndromes (CAPSs) are often associated with urticaria. These include Muckle-Wells syndrome, neonatal-onset multisystem inflammatory disease, and familial cold autoinflammatory syndrome. They are believed to be mediated by autosomal dominant mutations in the NLRP3 gene with the subsequent production of altered cryopyrin, which induces constitutive production of IL-1b. Anti-IL-1 monoclonal antibodies are utilized in these subjects to control the urticaria and other associated manifestations of these syndromes [39,40]. The FDA-approved monoclonal options for different types of urticaria include omalizumab, canakinumab, anakinra, and rilonacept.
Drug profiles: generic names A–Z
Published in Jerome Z. Litt, Neil H. Shear, Litt's Drug Eruption & Reaction Manual, 2017
Clinically important, potentially hazardous interactions with: abatacept, alefacept, azacitidine, azathioprine, betamethasone, cabazitaxel, certolizumab, cortocosteroids, cyclosporine, denileukin, docetaxel, fingolimod, gefitinib, leflunomide, lenalidomide, mercaptopurine, methotrexate, oxaliplatin, pazopanib, pemetrexed, rilonacept, temsirolimus, triamcinolone, vedolizumab
Drug profiles: generic names A-Z
Published in Jerome Z. Litt, Neil H. Shear, Litt's Drug Eruption & Reaction Manual, 2017
Clinically important, potentially hazardous interactions with: abatacept, alefacept, azacitidine, azathioprine, betamethasone, cabazitaxel, certolizumab, cortocosteroids, cyclosporine, denileukin, docetaxel, fingolimod, gefitinib, leflunomide, lenalidomide, mercaptopurine, methotrexate, oxaliplatin, pazopanib, pemetrexed, rilonacept, temsirolimus, triamcinolone, vedolizumab
Current treatment of recurrent pericarditis: safety considerations and future directions
Published in Expert Opinion on Drug Safety, 2022
A new anti-IL 1 agent, rilonacept (Arcalyst ®, Regeneron/Kiniksa, U.S.A.) was more recently tested in patients with recurrent pericarditis. Rilonacept is a soluble chimeric fusion protein, that functions as a decoy receptor, inhibiting the function of both IL-1α and IL-1β. In the RHAPSODY trial its efficacy has been reported for the first time in a double blind randomized trial [6]. This trial was a multicentre, double blind, event-driven, randomized-withdrawal trial of rilonacept in patients with acute symptoms of recurrent pericarditis (as assessed on a patient-reported scale) and systemic inflammation (as shown by elevated CRP levels). Patients presenting with a pericarditis recurrence while receiving standard therapy were enrolled in a 12-week run-in period, during which rilonacept (320 mg SC for the first day followed by 160 mg SC weekly) was initiated and background medications were discontinued. Patients who had a clinical response (i.e. met prespecified response criteria; all patients) were randomly assigned in a 1:1 ratio to receive continued rilonacept monotherapy (n = 30) or placebo (n = 31), administered subcutaneously once weekly. The primary efficacy end point was the time to the first pericarditis recurrence. The median time to the first adjudicated recurrence in the placebo group was 8.6 weeks (95% confidence interval [CI], 4.0 to 11.7; hazard ratio in a Cox proportional-hazards model, 0.04; 95% CI, 0.01 to 0.18; P < 0.001 by the log-rank test). During this period, 2 of 30 patients (7%) in the rilonacept group had a pericarditis recurrence, as compared with 23 of 31 patients (74%) in the placebo group. In the run-in period, 4 (13%) patients had adverse events leading to the discontinuation of rilonacept therapy. The most common adverse events with rilonacept were injection-site reactions and upper respiratory tract infections [6].
Drugs in phase I and phase II clinical trials for systemic sclerosis
Published in Expert Opinion on Investigational Drugs, 2020
Melody P. Chung, Lorinda Chung
Rilonacept, or IL-1 Trap, is a dimeric fusion protein consisting of portions of IL-1R and the IL-1R accessory protein linked to the Fc portion of immunoglobulin G1. Rilonacept functions as an IL-1 inhibitor and is used in the treatment of cryopyrin-associated periodic syndromes (CAPS). Several observations have implicated the inflammasome and IL-1 in fibrotic diseases including SSc [44–46].
Rilonacept for the treatment of recurrent pericarditis
Published in Expert Opinion on Biological Therapy, 2022
Agostina M Fava, Reza Reyaldeen, Saberio Lo Presti, Amit Goyal, Emmanuel Akintoye, Diarmaid Hughes, Allan L. Klein
With a better understanding of the physiopathology of RP, new targets along the IL‐1 pathway have permitted novel therapeutic options. Rilonacept represents a promising new class of medication for the treatment of patients with symptomatic RP. Patients with a clear inflammatory phenotype, not responsive to colchicine and corticosteroid dependence, are good candidates for this therapy. The Rhapsody study enrolled patients with idiopathic recurrent pericarditis or post-pericardiotomy syndromes. The trial has shown that the use of rilonacept not only induces a rapid normalization of CRP levels and resolution of symptoms, but also a reduction in recurrences. Rilonacept was recently approved by the FDA (18 March 2021) in the United States and commercially launched in April 2021, but still under evaluation in Europe. This anti-IL-1 agent has provided an additional treatment opportunity for patients who have either failed previous standard treatments with NSAIDs, colchicine, and glucocorticoids or suffered serious side effects due to glucocorticoids–dependence. At the present time, with a second recurrence, the management with this novel drug may alternatively be used before treatment with glucocorticoids in selective cases and potentially be used as monotherapy. Although the administration is by a subcutaneous injection, it offers a convenient weekly dosing and can administered by a caregiver or the patient themselves after proper instruction and training on the aseptic technique of injection. Decisions regarding treatment continuation or cessation involve many factors, including consideration of baseline characteristics as well as clinical status, inflammatory markers, and imaging (cardiac magnetic resonance) at periodic intervals that still require further elucidation with more clinical studies [43]. The median duration of therapy is 9 months, but it may varied according to the clinical response, and due to long half-life, tapering may not be needed. These are significant advantages compared with anakinra, another anti-IL 1 blocker, which has a daily administration and high short-term recurrences if there is an abrupt interruption.