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dc.contributor.authorNash, P
dc.contributor.authorMease, PJ
dc.contributor.authorMcInnes, IB
dc.contributor.authorReich, K
dc.contributor.authorAndersson, M
dc.contributor.authorAbrams, K
dc.contributor.authorPricop, L
dc.contributor.authorFox, T
dc.date.accessioned2021-02-23T03:22:49Z
dc.date.available2021-02-23T03:22:49Z
dc.date.issued2018
dc.identifier.issn1444-0903en_US
dc.identifier.urihttp://hdl.handle.net/10072/402504
dc.description.abstractAims Pooled safety data from secukinumab psoriasis (PSO) and the psoriatic arthritis (PsA) clinical trial programs after about 1 year of exposure have been reported previously. Here, we report updated longer‐term safety data of secukinumab exposure from PSO and PsA studies. Methods The PSO data pool consisted of 9 Phase III studies in moderate‐to‐severe plaque PSO and PsA pool consisted of 3 Phase III studies in active PsA. Secukinumab doses differed in the studies and included intravenous (up to 10 mg/kg) or subcutaneous (s.c.) 75–300 mg loading, followed by s.c. maintenance dosing (300, 150 or 75 mg). Placebo patients were re‐randomized to secukinumab at 12‐24 weeks depending on study design. Exposure adjusted incident rates (EAIR) were used to adjust for differences in treatment exposure and analyses included all patients who received ≥1 dose of secukinumab. Results A total of 5181 and 1380 patients from PSO and PsA studies representing an exposure of 10416.9 and 3866.9 patient years, respectively, were included in this pooled safety analysis. In both PsO and PsA, the most frequently reported adverse events (AEs) with secukinumab were nasopharyngitis, headache, non‐serious infections of the upper respiratory tract and arthralgia. The EAIRs of AEs of special interest with secukinumab including serious infections, Candida infections, inflammatory bowel disease, and major adverse cardiac events were similar in both PSO and PsA indications, and comparable to those reported previously. No cases of tuberculosis were reported. Conclusion Secukinumab demonstrated a favorable safety profile during long term treatment (up to 14283.8 patient‐years of exposure) in patients with moderate‐to‐severe plaque PSO or PsA consistent with previous reports. Safety was comparable across psoriasis and PsA patients supporting long‐term use in these chronic conditions.en_US
dc.languageEnglishen_US
dc.publisherWileyen_US
dc.publisher.urihttps://onlinelibrary.wiley.com/doi/10.1111/imj.13772en_US
dc.relation.ispartofconferencenameAustralian Rheumatology Association Annual Scientific Meeting with the Rheumatology Health Professionals Associationen_US
dc.relation.ispartofconferencetitleInternal Medicine Journalen_US
dc.relation.ispartofdatefrom2018-05-05
dc.relation.ispartofdateto2018-05-08
dc.relation.ispartoflocationMelbourne, Australiaen_US
dc.relation.ispartofpagefrom15en_US
dc.relation.ispartofpageto15en_US
dc.relation.ispartofissueS4en_US
dc.relation.ispartofvolume48en_US
dc.subject.fieldofresearchCardiorespiratory Medicine and Haematologyen_US
dc.subject.fieldofresearchClinical Sciencesen_US
dc.subject.fieldofresearchPublic Health and Health Servicesen_US
dc.subject.fieldofresearchcode1102en_US
dc.subject.fieldofresearchcode1103en_US
dc.subject.fieldofresearchcode1117en_US
dc.subject.keywordsScience & Technologyen_US
dc.subject.keywordsLife Sciences & Biomedicineen_US
dc.subject.keywordsMedicine, General & Internalen_US
dc.subject.keywordsGeneral & Internal Medicineen_US
dc.titleSecukinumab demonstrates consistent safety over long-term exposure in patients with psoriatic arthritis and moderate to severe plaque psoriasis: updated pooled safety analysesen_US
dc.typeConference outputen_US
dc.type.descriptionE3 - Conferences (Extract Paper)en_US
dcterms.bibliographicCitationNash, P; Mease, PJ; McInnes, IB; Reich, K; Andersson, M; Abrams, K; Pricop, L; Fox, T, Secukinumab demonstrates consistent safety over long-term exposure in patients with psoriatic arthritis and moderate to severe plaque psoriasis: updated pooled safety analyses, Internal Medicine Journal, 2018, 48, pp. 15-15en_US
dc.date.updated2021-02-23T03:20:25Z
gro.hasfulltextNo Full Text
gro.griffith.authorNash, Peter


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