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Immune system modulators
Published in Gabriel Virella, Medical Immunology, 2019
Richard M. Silver, Stephen Elmore
TNF has been implicated as one of the primary cytokines responsible for inflammation in several diseases, including rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Several different medications have been developed to inhibit TNF in a number of ways. Etanercept exists as an artificial, plasma-based version of the TNF receptor that binds to TNF before it is able to interact with cell-bound receptors and initiate the inflammatory cascade. It is typically administered as a weekly subcutaneous injection. Infliximab is a monoclonal anti-TNF antibody that is a murine/human hybrid. It functions by binding and neutralizing TNF in the plasma and is given as an IV infusion every 6–8 weeks. Due to its chimeric nature, however, use of this medication can lead to development of antichimeric antibodies that can lower the functional level of the drug, making it less effective. Adalimumab differs in that it is a fully humanized monoclonal antibody to TNF. This theoretically lowers the immunogenicity of the molecule. Adalimumab is given as a subcutaneous injection every 7–14 days. Similar to adalimumab, golimumab also is a monoclonal antibody, and its longer half-life allows the medication to be given on a monthly basis subcutaneously or every 2 months intravenously. Finally, certolizumab is another TNF inhibitor, in this case a pegylated F(ab′)2 fragment of anti-TNF antibody. Its half-life is shorter (11 days) and thus it needs to be administered initially every 2 weeks and every 4 weeks for maintenance of its effects.
Reactive arthritis
Published in Biju Vasudevan, Rajesh Verma, Dermatological Emergencies, 2019
Anti-TNF agents: For patients who have ReA that is refractory to NSAIDs and glucocorticoids and who do not respond to or have a contraindication to the use of MTX or SSZ, an anti-tumor necrosis factor (TNF) agent (e.g., etanercept 50 mg/week administered by subcutaneous injection or infliximab 3–5 mg/kg administered intravenously on weeks 0, 2, 6 and then every eighth week) can be prescribed. In patients who do not respond initially to one agent after 3 months of therapy, another TNF inhibitor can be tried instead. Effort can be made to discontinue therapy in patients who have been in remission induced by TNF inhibitors for at least 3 months, but retreatment with the medication should be resumed if disease then recurs [57,58].
Comorbidities in Psoriatic Arthritis
Published in Siba P. Raychaudhuri, Smriti K. Raychaudhuri, Debasis Bagchi, Psoriasis and Psoriatic Arthritis, 2017
Maria J. Antonelli, Marina Magrey
General screening and management of osteoporosis should be done in PsA patients per guidelines for the general population (Ogdie et al. 2015). There are limited data on the effect of PsA treatments and bone quality. However, it has been noted that there is no evidence of an increased fracture risk in PsA patients in whom TNF inhibitor therapy was initiated (Kawai et al. 2013). In PsA patients who are on long-term glucocorticoids, physicians should be mindful of considering the American College of Rheumatology (ACR) recommendations for the prevention and treatment of glucocorticoid-induced osteoporosis (Grossman et al. 2010).
Approval of biosimilars: a review of unsuccessful regulatory filings
Published in Expert Opinion on Biological Therapy, 2021
Anurag S. Rathore, Hemlata Chhabra, Ankita Bhargava
EMA was the first regulatory agency to start reviewing applications for biosimilars approval. To date, EMA has approved 64 biosimilars within the product classes of 1) human growth hormone, 2) granulocyte colony-stimulating factor, 3) erythropoiesis-stimulating agent, 4) insulin, 5) follicle-stimulating hormone (FSH), 6) parathyroid hormone, 7) tumor necrosis factor (TNF) inhibitor, and 8) monoclonal antibodies for use in the EU [11]. Thus, far nine biosimilar approvals have been withdrawn after approval, one biosimilar has been withdrawn before approval, and two biosimilar applications have been refused by the agency (Table 1). This leaves a total of 55 biosimilars authorized for use in Europe [12]. In spite of the patent expiration in EU for Erbitux (cetuximab) and Aranesp (darbepoetin alfa) in 2014 and 2016, respectively, no biosimilars have been approved for the same. A number of biosimilar products for cetuximab including ABP-494 (Actavis/Amgen) and CT-P15 (Celltrion) are in development [13]. Two products, Retacrit (Hospira) and Silapo (Stada), are being approved by EMA for similar indications such as Aranesp including anemia, chronic kidney failure, cancer, and autologous blood transfusion. The reference medicine for both the products is Eprex/Erypo, which contains epoetin alpha as an active substance. [14]. Other blockbuster drugs that are set to lose their patents in the coming 2 years in Europe include Soliris (2020), Benlysta (2021), Lemtrada (2021), Avastin (2022), and Lucentis (2022) [15].
Pharmacotherapy for juvenile spondyloarthritis: an overview of the available therapies
Published in Expert Opinion on Pharmacotherapy, 2020
Achille Marino, Mirian De Souza, Teresa Giani, Rolando Cimaz
ACR also provided recommendations for the treatment of adult patients with SpA [53]. Although not intended for the pediatric population, these suggestions might be useful for adolescents and for young adults still followed by a pediatric rheumatologist. Once again TNF inhibition is the treatment of choice in case of disease refractory to NSAIDs. Interestingly, according to SpA recommendations, the choice of a particular TNF inhibitor is guided by the presence of concomitant involvement of certain organ systems. Indeed, in case of recurrent iritis or inflammatory bowel disease, anti-TNF-α monoclonal antibodies (adalimumab or infliximab) should be preferred over etanercept [53]. The emerging role of the interleukin-17 and interleukin 12/23 pathways in SpA has been recognized in the current ACR recommendations. Indeed, the use of anti-IL-17A antibodies (e.g. secukinumab or ixekizumab) is advocated for adults non-responder to TNF inhibitors or in the presence of contraindications (e.g. heart failure or demyelinating disease). Anti-IL-17A drugs are not recommended for patients with IBD or recurrent uveitis [53].
Pre-conception status, obstetric outcome and use of medications during pregnancy of systemic lupus erythematosus (SLE), rheumatoid arthritis (RA) and inflammatory bowel disease (IBD) in Japan: Multi-center retrospective descriptive study
Published in Modern Rheumatology, 2020
Sayaka Tsuda, Azusa Sameshima, Michikazu Sekine, Haruna Kawaguchi, Daisuke Fujita, Shintaro Makino, Akio Morinobu, Yohko Murakawa, Kiyoshi Matsui, Takao Sugiyama, Mamoru Watanabe, Yasuo Suzuki, Masakazu Nagahori, Atsuko Murashima, Tatsuya Atsumi, Kenji Oku, Nobuaki Mitsuda, Syuji Takei, Takako Miyamae, Naoto Takahashi, Ken Nakajima, Shigeru Saito
In conclusion, planned pregnancy rates were about 50% in SLE, RA, and IBD. Pre-conception counseling is recommended to increase planned pregnancy rates. Our findings showed an average of close to 10 years from disease onset to delivery. Additionally, ART pregnancy rates were high in RA, SLE, and UC. Intensive treatment aimed at rapid remission, and referring obstetrician to prescribe pregnancy compatible medications following remission may further reduce the time from disease onset to delivery. SLE-complicated pregnancies should be monitored closely because the risk for obstetric complications and disease flare-ups is highest during pregnancy. Insufficient weight gain during pregnancy was a risk for pregnancy complications in CD and UC and nutrition management is recommended in these cases. In RA pregnancies, risks for PTD and thromboembolisms increased. Gestational anti-TNF inhibitor exposure did not increase adverse obstetric events or birth defects. Anti-TNF inhibitor use during pregnancy might be acceptable if it is needed to control disease activity.