Long-term Safety of Secukinumab Over Five Years in Patients with Moderate-to-severe Plaque Psoriasis, Psoriatic Arthritis and Ankylosing Spondylitis: Update on Integrated Pooled Clinical Trial and Post-marketing Surveillance Data

Gottlieb, Alice B.; Deodhar, Atul; McInnes, Iain B.; Baraliakos, Xenofon; Reich, Kristian; Schreiber, Stefan; Bao, Weibin; Marfo, Kwaku; Richards, Hanno B.; Pricop, Luminita; Shete, Abhijit; Trivedi, Vivek; Keefe, Deborah L.; Papavassilis, Charis; Jagiello, Piotr; Papanastasiou, P.; Mease, Philip J.; Lebwohl, Mark

doi:10.2340/actadv.v102.563

Cited by 44 publications

(34 citation statements)

References 37 publications

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“…Finally, we recorded good adherence to secukinumab, which settled on average at 75%, in line with other realworld observations [29,30]. In agreement with RCTs [48], we were able to confirm an excellent tolerability and safety profile of the drug. None of the patients discontinued secukinumab due to adverse events, while the rate of local reactions stood at 5%, similar to that observed in the EXCEED trial [23].…”

Section: Discussionsupporting

confidence: 89%

Effectiveness and safety of secukinumab in ankylosing spondylitis and psoriatic arthritis: a 52-week real-life study in an Italian cohort

et al. 2023

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Background Secukinumab has shown high efficacy in randomized controlled trials in both ankylosing spondylitis (AS) and psoriatic arthritis (PsA). Here, we investigated its real-life effectiveness and tolerability in a cohort of AS and PsA patients. Methods We retrospectively analyzed medical records of outpatients with AS or PsA treated with secukinumab between December 2017 and December 2019. ASDAS-CRP and DAS28-CRP scores were used to measure axial and peripheral disease activity in AS and PsA, respectively. Data were collected at baseline and after 8, 24, and 52 weeks of treatment. Results Eighty-five adult patients with active disease (29 with AS and 56 with PsA; 23 males and 62 females) were treated. Overall, mean disease duration was 6.7 years and biologic-naïve patients were 85%. Significant reductions in ASDAS-CRP and DAS28-CRP were observed at all time-points. Body weight (in AS) and disease activity status at baseline (particularly in PsA) significantly affected disease activity changes. ASDAS-defined inactive disease and DAS28-defined remission were achieved in comparable proportions between AS and PsA patients, at both 24 weeks (45% and 46%) and 52 weeks (65.5% and 68%, respectively); male sex was found an independent predictor of positive response (OR 5.16, P = 0.027). After 52 weeks, achievement of at least low disease activity and drug retention were observed in 75% of patients. Secukinumab was well-tolerated and only mild injection-site reactions were recorded in 4 patients. Conclusion In a real-world setting, secukinumab confirmed great effectiveness and safety in both AS and PsA patients. The influence of gender on treatment response deserves further attention.

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Section: Discussionsupporting

confidence: 89%

Effectiveness and safety of secukinumab in ankylosing spondylitis and psoriatic arthritis: a 52-week real-life study in an Italian cohort

et al. 2023

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“…The overall IRs for malignancies in the PsA and PsO cohorts were 0.71 and 0.65 per 100 PY, respectively, and were in line with those observed with tofacitinib in other clinical trials. 33 They were also similar to those seen in the literature for adalimumab (0.2/100 PY in PsA, 0.5/100 PY in PsO), 43 secukinumab (1.0/100 PY in PsA and 0.9/100 PY in PsO), 35 ixekizumab (⩽0.5/100 PY in both PsA and PsO), 36 and upadacitinib (15 mg QD; 0.7/100 PY in PsA). 37 …”

Section: Discussionsupporting

confidence: 86%

Association between baseline cardiovascular risk and incidence rates of major adverse cardiovascular events and malignancies in patients with psoriatic arthritis and psoriasis receiving tofacitinib

Kristensen

Strober

Poddubnyy

et al. 2023

Therapeutic Advances in Musculoskeletal

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Background: Tofacitinib is a Janus kinase inhibitor for the treatment of psoriatic arthritis (PsA) and has been investigated for psoriasis (PsO). Objectives: This post hoc analysis examined baseline cardiovascular (CV) disease risk and its association with the occurrence of major adverse cardiovascular events (MACE) and malignancies in tofacitinib-treated patients with PsA and PsO. Design: Included three phase III/long-term extension (LTE) PsA trials and seven phase II/phase III/LTE PsO trials of patients receiving ⩾ 1 dose of tofacitinib. Methods: Incidence rates (IRs: patients with events/100 patient-years) for MACE and malignancies (excluding non-melanoma skin cancer) were determined in subgroups according to history of atherosclerotic CV disease (ASCVD), baseline 10-year risk of ASCVD (in patients without history of ASCVD), and baseline metabolic syndrome (MetS). Results: For patients with PsA ( N = 783) and PsO ( N = 3663), respectively, tofacitinib exposure was 2038 and 8950 patient-years (median duration: 3.0 and 2.4 years), and 40.9% and 32.7% had MetS. Excluding missing CV risk profile data, 51/773 (6.6%) and 144/3629 (4.0%) patients had history of ASCVD, and in patients without history of ASCVD, around 20.0% had intermediate/high baseline 10-year ASCVD risk. For PsA and PsO, IRs of MACE were greatest in those with history of ASCVD or high baseline 10-year ASCVD risk. For PsA, five of six patients with MACE had baseline MetS. Malignancy IRs in patients with PsA were greatest in those with intermediate/high baseline 10-year ASCVD risk. Of these, eight of nine patients with malignancies had baseline MetS. In the PsO cohort, IR of malignancies was notably greater with high versus low/borderline/intermediate baseline 10-year ASCVD risk. Conclusion: In tofacitinib-treated patients with PsA/PsO, increased ASCVD risk and baseline MetS were associated with higher IRs for MACE and malignancies. Our results support assessing CV risk in patients with PsA/PsO and suggest enhanced cancer monitoring in those with increased ASCVD risk. Registration (ClinicalTrials.gov): NCT01877668/NCT01882439/NCT01976364/NCT00678210/NCT01710046/NCT01241591/NCT01186744/NCT01276639/NCT01309737/NCT01163253 Plain Language Summary People who have psoriatic arthritis or psoriasis may have more heart-related problems and cancer if they have a higher risk of cardiovascular disease: A study in people with psoriatic arthritis or psoriasis receiving tofacitinib Why was this study done? • People with psoriatic arthritis (PsA) and psoriasis (PsO) are more likely than the general population to have a disease affecting the heart and blood vessels [cardiovascular (CV) disease]. • People who are more likely to have CV disease may also be more likely to have certain types of cancer. • Tofacitinib is a medicine to treat people with PsA and has been tested in people with PsO. • We wanted to know if the risk of CV disease affects the number of heart-related problems (including heart attack, stroke, or death) and cancer in people with PsA and PsO. What did the researchers do? • We used results from 10 clinical trials. • In these trials, people with PsA and PsO were taking tofacitinib 5 or 10 mg twice a day. • After the trials had ended, we measured people’s risk of CV disease using a risk calculator. This risk calculator showed if they had a low, borderline, intermediate, or high risk of CV disease over the next 10 years. We also checked if they had had CV disease before treatment. • We checked if people had a group of conditions linked to CV disease: diabetes, high blood pressure, and obesity. • We counted the cases of heart-related problems and cancer in people once they started taking tofacitinib. What did the researchers find? In people with PsA and PsO taking tofacitinib: • There were more cases of heart-related problems and cancer in people who had intermediate or high risk of CV disease. • There were more cases of heart-related problems in people who had had CV disease before. • More people with diabetes, high blood pressure, and obesity had heart-related problems and cancer than people without those conditions. What do the findings mean? • It is important to measure risk and assess history of CV disease in people with PsA and PsO, including those taking tofacitinib. • We should test for cancer in people with high risk of CV disease.

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“…The long‐term safety data from this study reinforce the established safety profile of secukinumab in adult patients with moderate to severe chronic plaque psoriasis, psoriatic arthritis and ankylosing spondylitis 15,16,19,20 and in paediatric patients with moderate to severe plaque psoriasis 13,21,22 and juvenile idiopathic arthritis 23 . No new or unexpected safety signals were identified during this study.…”

Section: Discussionsupporting

confidence: 72%

Long‐term efficacy, safety and tolerability of secukinumab in children and adolescents with severe chronic plaque psoriasis: Two‐year results from a Phase III double‐blind, randomized controlled trial

Krasowska

Gambichler

Gutiérrez‐Cortés

et al. 2023

Acad Dermatol Venereol

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Background Secukinumab has previously demonstrated sustained efficacy and favourable safety for up to 52 weeks in paediatric patients (children and adolescents aged 6 to <18 years) with severe chronic plaque psoriasis (NCT02471144). Objective To investigate the long‐term (104 weeks) efficacy and safety of secukinumab. Methods After 52 weeks, patients continued to receive secukinumab low dose (LD [75/150 mg]) or high dose (HD [75/150/300 mg]). Patients on etanercept (0.8 mg/kg) until Week 52 entered follow‐up. Data for patients receiving secukinumab LD from the beginning and those switching to secukinumab LD from placebo (‘Any secukinumab’ LD) and patients receiving secukinumab HD from the beginning and those switching to secukinumab HD from placebo (‘Any secukinumab’ HD) are presented. Assessments: Psoriasis Area and Severity Index (PASI) score, PASI (75/90/100) responses, Investigator's Global Assessment modified 2011 (IGA mod 2011) 0/1 response, Children's Dermatology Life Quality Index (CDLQI) score and CDLQI 0/1 response up to Week 104, and, safety up to Week 104 for all patients and up to 4 years for some patients (~320 patient‐years [PY] of treatment). Results Secukinumab‐treated patients showed sustained PASI 75/90/100 and IGA mod 2011 0/1 responses up to Week 104. Throughout the second year of treatment, efficacy was similar for the ‘Any secukinumab’ LD and HD groups for PASI 75 and IGA mod 2011 0/1 responses. PASI 90/100 responses were mostly comparable between the dose groups up to Week 88, but higher in the ‘Any secukinumab’ HD than the ‘Any secukinumab’ LD group at Week 104. Patients achieved a sustained CDLQI 0/1 response that was similar between the ‘Any secukinumab’ LD (61.1%) and HD (65.0%) groups. Safety data were consistent with the established safety profile of secukinumab. Conclusion Secukinumab demonstrated sustained long‐term efficacy (up to 2 years) and a favourable safety profile (~320 PY of treatment) in paediatric patients with severe chronic plaque psoriasis.

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Long-term Safety of Secukinumab Over Five Years in Patients with Moderate-to-severe Plaque Psoriasis, Psoriatic Arthritis and Ankylosing Spondylitis: Update on Integrated Pooled Clinical Trial and Post-marketing Surveillance Data

Cited by 44 publications

References 37 publications

Effectiveness and safety of secukinumab in ankylosing spondylitis and psoriatic arthritis: a 52-week real-life study in an Italian cohort

Effectiveness and safety of secukinumab in ankylosing spondylitis and psoriatic arthritis: a 52-week real-life study in an Italian cohort

Association between baseline cardiovascular risk and incidence rates of major adverse cardiovascular events and malignancies in patients with psoriatic arthritis and psoriasis receiving tofacitinib

Long‐term efficacy, safety and tolerability of secukinumab in children and adolescents with severe chronic plaque psoriasis: Two‐year results from a Phase III double‐blind, randomized controlled trial

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