FDA Approves Ixekizumab (Taltz) for Nonradiographic axSpA FDA Approves Ixekizumab (Taltz) for Nonradiographic axSpA

The monoclonal interleukin-17A antagonist has three other indications: ankylosing spondylitis in adults, psoriatic arthritis in adults, and plaque psoriasis in adults and children age 6 and older.Medscape Medical News
Source: Medscape Dermatology Headlines - Category: Dermatology Tags: Rheumatology News Source Type: news

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CONCLUSIONS: The real impact of anti-TNF-α therapy on the development of AITD remains an open question. The available studies concern the adult population; there are no data regarding this problem in children. Due to the increasing use of anti-TNF-α therapy also in the paediatric population, it seems reasonable to evaluate this subject in this group of patients. PMID: 32462852 [PubMed - as supplied by publisher]
Source: Pediatric Endocrinology, Diabetes, and Metabolism - Category: Endocrinology Authors: Tags: Pediatr Endocrinol Diabetes Metab Source Type: research
Co-stimulatory T-cell inhibitors are used in the treatment of rheumatoid arthritis and to prevent rejection of renal transplants. Inhibitors of the intereukin (IL-17) cytokine are indicated for psoriasis, psoriatic arthritis and ankylosing spondylitis and anti- IL-23 drugs for psoriasis. Serious infections occur in 4.2% to 25.0% of co-stimulatory inhibitors and 1.0% to 2.0% with IL-17 or IL-23 inhibitors. Underlying disease, steroid dose greater than 7.5 to 10.0 mg, and comorbidities influence risk in individual patients. Opportunistic infections or reactivation of tuberculosis are rare.
Source: Infectious Diseases Clinics of North America - Category: Infectious Diseases Authors: Source Type: research
ConclusionBaseline demographics of the study population are consistent with existing literature. This large observational study across all secukinumab indications will provide valuable information on the long-term effectiveness and safety of secukinumab in the real-world setting.
Source: Advances in Therapy - Category: Drugs & Pharmacology Source Type: research
ConclusionThe CT-P13 safety profile appears consistent with previous studies for CT-P13 and reference infliximab, supporting the favourable risk/benefit balance for CT-P13 treatment.
Source: BioDrugs - Category: Drugs & Pharmacology Source Type: research
Authors: Fiorenza A, Bonitta G, Gerratana E, Marino F, Sarzi-Puttini P, Salaffi F, Atzeni F Abstract OBJECTIVES: The primary aim of this study was to compare the prevalence of clinical and particularly ultrasonographic signs of enthesitis in patients with psoriatic arthritis (PsA), fibromyalgia (FM), or both. The secondary aim was to assess the impact of FM on disease activity and clinimetric scores. METHODS: This single-centre, observational cross-sectional study involved 101 consenting patients: 39 with PsA (CASPAR criteria), 23 with FM (2016 criteria), and 39 with both. Standard PsA and FM clinical, laborato...
Source: Clinical and Experimental Rheumatology - Category: Rheumatology Tags: Clin Exp Rheumatol Source Type: research
AbstractPsoriatic arthritis (PsA) is an inflammatory arthritis with distinct phenotypic subtypes. Enthesitis is assigned as a hallmark of the disease, given its significant relations to disease activity and quality of life. Our objective is to evaluate the prevalence of enthesitis and its association with some clinical parameters, particularly quality of life, using data from a national registry. Patients with PsA meeting ClASsification criteria for Psoriatic Arthritis (CASPAR) were enrolled by means of a multi-centre Turkish League Against Rheumatism (TLAR) Network Project. The following information was recorded in web-ba...
Source: Rheumatology International - Category: Rheumatology Source Type: research
Authors: Puig L Abstract Introduction: Ixekizumab, a humanized IgG4 monoclonal antibody that selectively binds and neutralizes interleukin IL-17A, has been approved by the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of moderate to severe plaque psoriasis (2016), active psoriatic arthritis (FDA 2017, EMA 2018), and active ankylosing spondylitis (FDA 2019).Areas covered: This review evaluates the safety profile of ixekizumab for the treatment of moderate-to-severe psoriasis. A literature search was performed for articles published through November 2019.Ex...
Source: Expert Opinion on Drug Safety - Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research
Authors: Carli L, Calabresi E, Governato G, Braun J Abstract Spondyloarthritis (SpA) is the umbrella term for a broad spectrum of inflammatory rheumatic diseases with typical but also rather different clinical manifestations, limited laboratory abnormalities and characteristic imaging features. For classification purposes, a so-called non-radiographic form (nr-axSpA) is differentiated from a radiographic one (r-axSpA) which is almost identical to the classical ankylosing spondylitis (AS) that is genetically strongly associated with the major histocompatibility complex class 1 antigen HLA-B27. In axSpA, the axial sk...
Source: Clinical and Experimental Rheumatology - Category: Rheumatology Tags: Clin Exp Rheumatol Source Type: research
Pfizer Inc. (NYSE: PFE) announced the United States (U.S.) Food and Drug Administration (FDA) has approved ABRILADA™ (adalimumab-afzb), as a biosimilar to Humira® (adalimumab),(1) for the treatment of certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis.(2)
Source: World Pharma News - Category: Pharmaceuticals Tags: Featured Pfizer Business and Industry Source Type: news
ConclusionThe safety profile of adalimumab was consistent with previous findings and no new safety signals were observed.
Source: Advances in Therapy - Category: Drugs & Pharmacology Source Type: research
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