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  • 1
    In: The Open Rheumatology Journal, Bentham Science Publishers Ltd., Vol. 13, No. 1 ( 2019-04-30), p. 53-60
    Abstract: AQUILA is an ongoing, multicenter, prospective, Non-Interventional Study (NIS) with secukinumab, designed to evaluate real-world evidence for different aspects of treatment in patients with Ankylosing Spondylitis (AS) and psoriatic arthritis (PsA) in Germany. Here we report the study design and baseline characteristics including comorbidities and prior medication of patients as well as insights into medical care in Germany. Methods: Patients (age ≥18 years) with active AS or PsA, who were under secukinumab treatment or just about initiating secukinumab therapy based on medical therapeutic need, are enrolled. Each patient is observed for 52 weeks. Results: A total of 572 patients (AS, n = 187; PsA, n = 385) have been recruited in this ongoing study. Mean age, weight, and BMI were similar between the subgroups. About 66.4% of patients had previously received biologics other than secukinumab. Depression was the most common comorbidity (AS, 9.1%; PsA, 15.6%). Plaque psoriasis was also frequently reported (AS, 9.6%; PsA, 62.3%). Conclusion: The Non-Interventional Study (NIS) baseline characteristics indicate that the demographics were similar to populations of previous secukinumab trials of AS and PsA patients except to comorbidities and exposure to biologics. A majority of the patients who received secukinumab in this setting had previously received biologics. Comorbidities relating to obesity and cardiovascular disease were particularly evident in PsA patients whereas the elevated depression prevalence was equally distributed.
    Type of Medium: Online Resource
    ISSN: 1874-3129
    Language: English
    Publisher: Bentham Science Publishers Ltd.
    Publication Date: 2019
    detail.hit.zdb_id: 2395999-X
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  • 2
    In: Trials, Springer Science and Business Media LLC, Vol. 22, No. 1 ( 2021-12)
    Abstract: One key pathological finding in giant cell arteritis (GCA) is the presence of interferon-gamma and interleukin (IL)-17 producing T helper (Th) 1 and Th17 cells in affected arteries. There is anecdotal evidence of successful induction and maintenance of remission with the monoclonal anti-IL-17A antibody secukinumab. Inhibition of IL-17A could therefore represent a potential new therapeutic option for the treatment of GCA. Methods This is a randomized, parallel-group, double-blind, placebo-controlled, multi-center, phase II study in which patients, treating physicians, and the associated clinical staff as well as the sponsor clinical team are blinded. It is designed to evaluate efficacy and safety of secukinumab compared to placebo in combination with an open-label prednisolone taper regimen. Patients included are naïve to biological therapy and have newly diagnosed or relapsing GCA. Fifty patients are randomly assigned in a 1:1 ratio to receive either 300 mg secukinumab or placebo subcutaneously at baseline, weeks 1, 2 and 3, and every 4 weeks from week 4. Patients in both treatment arms receive a 26-week prednisolone taper regimen. The study consists of a maximum 6-week screening period, a 52-week treatment period (including the 26-week tapering), and an 8-week safety follow-up, with primary and secondary endpoint assessments at week 28. Patients who do not achieve remission by week 12 experience a flare after remission or cannot adhere to the prednisolone tapering will enter the escape arm and receive prednisolone at a dose determined by the investigator’s clinical judgment. The blinded treatment is continued. Two optional imaging sub-studies are included (ultrasound and contrast-media enhanced magnetic resonance angiography [MRA]) to assess vessel wall inflammation and occlusion before and after treatment. The primary endpoint is the proportion of patients in sustained remission until week 28 in the secukinumab group compared to the proportion of patients in the placebo group. A Bayesian approach is applied. Discussion The trial design allows the first placebo-controlled data collection on the efficacy and safety of secukinumab in patients with GCA. Trial registration ClinicalTrials.gov NCT03765788 . Registration on 5 December 2018, prospective registration, EudraCT number 2018-002610-12; clinical trial protocol number CAIN457ADE11C.
    Type of Medium: Online Resource
    ISSN: 1745-6215
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2021
    detail.hit.zdb_id: 2040523-6
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