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Introduction: Long-term safety data are critical for evaluating therapies for psoriasis. Ixekizumab has demonstrated efficacy and is well tolerated for the treatment of moderate-to-severe plaque psoriasis. We examined the safety and tolerability of up to 5 years of ixekizumab therapy in patients with psoriasis.
Methods: Integrated safety data were analyzed from 13 ixekizumab clinical studies. Rates of treatment-emergent adverse events (TEAEs), serious AEs (SAEs) and AEs of special interest were analyzed for the 12-week induction period in the combined pivotal studies, and for all pooled studies by year(s) of therapy and overall, reported as exposure-adjusted incidence rates (IRs) per 100 patient-years (p-y) and/or frequencies.
Results: Total ixekizumab exposure was 17,003.4 p-y (N = 5898); 2749 patients had ≥ 4 years of exposure. When compared across years of exposure, rates for AEs remained largely stable or declined, including TEAEs leading to discontinuation (3.8/100 p-y in year 1, declining to 2.0/100 p-y in year 5); SAEs (range 6.2-7.0/100 p-y); serious infections (range 1.3-1.7/100 p-y); nonmelanoma skin cancer (ranging from 0.5/100 p-y in year 1 to 0.2/100 p-y in years 4-5); other malignancies (range 0.4-0.6/100 p-y); inflammatory bowel disease including ulcerative colitis and Crohn's disease (IR 0.2/100 p-y); and major adverse cardiovascular events (MACE) (range 0.3-0.7/100 p-y). Candidiasis was reported in 327 patients (IR 1.9/100 p-y), with the majority identified as mucocutaneous. The rate of injection site reactions was 15.5/100 p-y during year 1 and 2.0-2.3/100 p-y by years 3-5.
Conclusions: The decrease in rates of TEAEs and the stable rates of SAEs, other malignancies and MACE during up to 5 years of ixekizumab dosing are consistent with previous reports describing a favorable safety profile of ixekizumab following shorter durations of exposure.
Funding: Eli Lilly and Company.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6994584 | PMC |
http://dx.doi.org/10.1007/s13555-019-00340-3 | DOI Listing |
Plant Dis
November 2024
Shaanxi Normal University, College of Life Sciences, No. 620, West Chang'an Avenue, Chang'an, Xi'an, [Select a State/Province], China, 710119;
Eur J Endocrinol
November 2024
Department of Rheumatology, Amsterdam University Medical Center, Amsterdam 1081HV, The Netherlands.
N Engl J Med
October 2024
From Columbia University Irving Medical Center, New York (R.T.H., M.B.L., S.K.K.); Cedars-Sinai Medical Center, Los Angeles (R.M., M.M.), and Stanford University, Stanford (R.P.S., C.H.) - both in California; Piedmont Heart Institute, Marcus Heart Valve Center, Atlanta (V.H.T., P.Y.); Northwestern University Feinberg School of Medicine, Chicago (C.J.D., A.N.); Henry Ford Hospital, Detroit (B.O., J.L.); Oregon Health and Science University, Portland (F.Z., S.C.); Mayo Clinic, Rochester, MN (M.E., S.P.); Baylor Scott and White Heart Hospital Plano (R.S., M.S., P.A.G., M.J.M.) and Baylor Scott and White Research Institute Cardiac Imaging Core Laboratory (P.A.G., A.S.) - both in Plano, TX; Intermountain Medical Center, Murray, UT (B.W., N.K.S.); Christ Hospital, Cincinnati (S.G., T.S.-D.), and the Cleveland Clinic Foundation, Cleveland (S.K., S.C.H.); Heart Center Leipzig at Leipzig University, Leipzig (H.T.), and University Medical Center Mainz, Mainz (P.L.) - both in Germany; Morristown Medical Center, Morristown, NJ (R.K., K.K.); and the University of Virginia, Charlottesville (D.S.L., D.F.).
Eur Respir J
November 2024
Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, Singapore
Background: Sensitisation to is linked to worse outcomes in patients with COPD; however, its prevalence and clinical implications in domestic (residential) settings remains unknown.
Methods: Individuals with COPD (n=43) recruited in Singapore had their residences prospectively sampled and assessed by shotgun metagenomic sequencing including indoor air, outdoor air and touch surfaces (a total of 126 specimens). The abundance of environmental and the occurrence of (Asp f) allergens in the environment were determined and immunological responses to allergens determined in association with clinical outcomes including exacerbation frequency.
Viruses
September 2024
Department of Tropical and Infectious Diseases, Policlinico Umberto I, 00161 Rome, Italy.
The prediction of liver-related events (LRE) after sustained virological response (SVR) in HCV-advanced chronic liver disease (ACLD) patients is crucial. We aimed to evaluate incidence and risk factors of LRE in HCV-cirrhotic patients after SVR and to assess dynamic changes of liver stiffness in participants without LRE at the end of follow-up. We enrolled 575 consecutive patients with HCV-ACLD treated with DAAs and followed up for 5 years after SVR12.
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