PsA Patient With Metabolic Syndrome
Meet Mahesh, a 58-year-old patient with PsA1 having metabolic syndrome.2-4
‘I am not sure how much more I can take. My life is dictated by my health’.
‘My family is my world. But with this new diagnosis, I do not have the energy to do anything. I already have weight issues, high blood pressure, high cholesterol and high blood sugar, and now PsO that has progressed to PsA1.’
‘Medications help to control a lot of it – but the first treatment prescribed for PsA was not successful’.
Patients with PsA are often affected by multiple comorbidities.2,3
2× higher odds of metabolic syndrome in patients with severe PsA.5,*
Note: This is a hypothetical case for representation purpose only.
PsA patients such as Mahesh benefit from treatment with Enbrel®1,6,7
- By Year 5.5, 77.6% of patients with PsA had zero joints with synovitis (P<0.001 for all time points vs. baseline)6,†
- From baseline to Week 24, patients with PsA achieved a 74% mean improvement in PASI score‡7
- Enbrel® is well tolerated across all its indications1,6,8-30
- PsA: Established safety profile for up to 5.5 years6,8-11
From PROVE, an observational, open-label study of 303 patients with PsA treated in a daily clinical setting.6,†
Long-term Effectiveness in Joints With Enbrel®6
P<0.01 for both groups versus baseline from Week 3 onwards.
Adapted from de Vlam K, et al. 2015.
From PRESTA, an outpatient RCT of 752 patients with PsA.7,‡
Effectiveness in Skin With Enbrel®7
P<0.01 for both groups versus baseline from Week 3 onwards.
Adapted from Sterry W, et al. 2010.
Please consult the LPD for contraindications, warnings, precautions and other important safety information.
Please note: The examples described here are not of actual patients, but fictitious representations of scenarios for which Enbrel® (etanercept) could be considered.
*In a cohort of 283 patients with PsA, a significant association of metabolic syndrome was noted with more severe PsA (OR=4.47, P<0.001). Severe PsA was defined as the presence of 1 or more PsA-related radiographic damage features (peripheral joint erosions, osteolysis, sacroiliitis), and PsA requiring TNFi therapy.5
†From PROVE, an observational open-label study of 303 patients with PsA treated in a daily clinical setting.6
Study design: de Vlam K, et al. 2015.
The PROVE study was a Phase IV, prospective, multicentre, open-label, observational study in patients with active PsA who had previously failed DMARDs. Enrolment started in October 2004 and was to last for 12 months but was extended to December 2006 with a study period of 5.5 years (66 months) to give a total duration of 6.5 years (78 months). The study’s objective was to describe the long-term adherence, efficacy and safety in patients with PsA treated with Enbrel® in a daily clinical setting in Belgium.6
Patients attended eight visits in total: Baseline and at Months 6, 12, 18, 30, 42, 54 and 66. Baseline (Visit 1) occurred within 4 weeks of starting Enbrel® treatment. Visits 2 through 8 were allowed to occur ±1 month of the required date. The proportions of patients who adhered to treatment were monitored throughout the study.6
Efficacy assessment included the number (%) of patients with 0 joints with synovitis, number of joints with active synovitis, the total HAQ score for patients with polyarticular-type PsA and the NRS patient and NRS physician scores for patients with oligoarticular-type PsA. AEs were documented throughout the study. The primary endpoint of the study was the percentage of patients suffering from at least 1 SAE per year.6
‡From PRESTA, an outpatient RCT of 752 patients with PsA.7
Study design: Sterry W, et al. 2010.
PRESTA was a randomised, double-blind, multicentre, outpatient study that compared: The efficacy of Enbrel® treatment of skin manifestations of psoriasis in 752 patients with PsA over 12 weeks (Enbrel® 50 mg QW or BiW); and the efficacy and safety of Enbrel® over an additional 12 weeks of open-label treatment (Enbrel® 50 mg QW).7
The study’s primary efficacy endpoint was the proportion of patients achieving ‘clear’ or ‘almost clear’ on the PGA of PsO at Week 12. Secondary analyses included PASI, ACR responses, PsA response criteria and improvement in joint and tendon disease manifestations.7
ACR, American College of Rheumatology; AE, adverse event; BIW, twice a week; DMARD, disease-modifying antirheumatic drug; HAQ, Health Assessment Questionnaire; NRS, numerical rating scale; OR, odds ratio; PASI, Psoriasis Area and Severity Index; PGA, physician global assessment; PsA, psoriatic arthritis; PsO, psoriasis; PRESTA, Psoriasis Randomized Etanercept STudy in Subjects with Psoriatic Arthritis; QW, once a week; RCT, randomised controlled trial; SAE, serious adverse event; SmPC, summary of product characteristics; TNFi, tumour necrosis factor inhibitor.
References:
Enbrel. Local product document. Version LPDENB062021.Haddad A, zisman D. Comorbidities in patients with psoriatic arthritis. Rambam maimonides med J. 2017;8(1):e0004.Radner H, Lesperance T, Accortt NA, Solomon DH. Incidence and prevalence of cardiovascular risk factors among patients with rheumatoid arthritis, psoriasis, or psoriatic arthritis. Arthritis Care Res (Hoboken). 2017;69(10):1510-1518.Cantini F, Niccoli L, Nannini C, et al. Tailored first-line biologic therapy in patients with rheumatoid arthritis, spondyloarthritis, and psoriatic arthritis. Semin Arthritis Rheum. 2016;45(5):519-532.Haroon M, Gallagher P, Heffernan E, FitzGerald O. High prevalence of metabolic syndrome and of insulin resistance in psoriatic arthritis is associated with the severity of underlying disease. J Rheumatol. 2014;41(7):1357-1365.de Vlam K, Boone C; The Prove Study Group A. Treatment adherence, efficacy, and safety of etanercept in patients with active psoriatic arthritis and peripheral involvement in Belgium for 66 months (PROVE study). Clin Exp Rheumatol. 2015;33(5):624-631.Sterry W, Ortonne JP, Kirkham B, et al. Comparison of two etanercept regimens for treatment of psoriasis and psoriatic arthritis: PRESTA randomised double blind multicentre trial. BMJ. 2010;340:c147.Girolomoni G, Altomare G, Ayala F, et al. Safety of anti-TNFα agents in the treatment of psoriasis and psoriatic arthritis. Immunopharmacol Immunotoxicol. 2012;34(4):548-560.Cantini F, Niccoli L, Nannini C, et al. Tailored first-line biologic therapy in patients with rheumatoid arthritis, spondyloarthritis, and psoriatic arthritis. Semin Arthritis Rheum. 2016;45(5):519-532.Puig L, López-Ferrer A, Laiz A. Etanercept in the treatment of psoriatic arthritis. Actas Dermosifiliogr. 2015;106(4):252-259.Mease PJ, Kivitz AJ, Burch FX, et al. Continued inhibition of radiographic progression in patients with psoriatic arthritis following 2 years of treatment with etanercept. J Rheumatol. 2006;33(4):712-721.Carmona L, Gómez-Reino JJ; BIOBADASER Group. Survival of TNF antagonists in spondylarthritis is better than in rheumatoid arthritis. Data from the Spanish registry BIOBADASER. Arthritis Res Ther. 2006;8(3):R72.Gottlieb AB, Gordon K, Giannini EH, et al. Clinical trial safety and mortality analyses in patients receiving etanercept across approved indications. J Drugs Dermatol. 2011;10(3):289-300.Hetland ML, Christensen IJ, Tarp U, et al. Direct comparison of treatment responses, remission rates, and drug adherence in patients with rheumatoid arthritis treated with adalimumab, etanercept, or infliximab: results from eight years of surveillance of clinical practice in the nationwide Danish DANBIO registry. Arthritis Rheum. 2010;62(1):22-32.Aaltonen KJ, Virkki LM, Malmivaara A, Konttinen YT, Nordström DC, Blom M. Systematic review and meta-analysis of the efficacy and safety of existing TNF blocking agents in treatment of rheumatoid arthritis. PLoS One. 2012;7(1):e30275.Gómez-Reino JJ, Rodríguez-Lozano C, Campos-Fernández C, et al. Change in the discontinuation pattern of tumour necrosis factor antagonists in rheumatoid arthritis over 10 years: data from the Spanish registry BIOBADASER 2.0. Ann Rheum Dis. 2012;71(3):382-385.Marchesoni A, Zaccara E, Gorla R, et al. TNF-alpha antagonist survival rate in a cohort of rheumatoid arthritis patients observed under conditions of standard clinical practice. Ann N Y Acad Sci. 2009;1173:837-846.Favalli EG, Pregnolato F, Biggioggero M, et al. Twelve-year retention rate of first-line tumor necrosis factor inhibitors in rheumatoid arthritis: real-life data from a local registry. Arthritis Care Res (Hoboken). 2016;68(4):432-439.Lovell DJ, Reiff A, Ilowite NT, et al. Safety and efficacy of up to eight years of continuous etanercept therapy in patients with juvenile rheumatoid arthritis. Arthritis Rheum. 2008;58(5):1496-1504.Assessment Report for Enbrel. European Medicines Agency. Procedure No. EMEA/H/C/000262/A46/145. January 11, 2013. Accessed May 5, 2022. https://www.ema.europa.eu/en/documents/variation-report/enbrel-h-c-262-p46-145-epar-assessment-report_en.pdfConstantin T, Foeldvari I, Vojinovic J, et al. Two-year efficacy and safety of etanercept in pediatric patients with extended oligoarthritis, enthesitis-related arthritis, or psoriatic arthritis. J Rheumatol. 2016;43(4):816-824.Foeldvari I, Constantin T, Vojinović J, et al. Etanercept treatment for extended oligoarticular juvenile idiopathic arthritis, enthesitis-related arthritis, or psoriatic arthritis: 6-year efficacy and safety data from an open-label trial. Arthritis Res Ther. 2019;21(1):125.Horneff G, Burgos-Vargas R, Constantin T, et al. Efficacy and safety of open-label etanercept on extended oligoarticular juvenile idiopathic arthritis, enthesitis-related arthritis and psoriatic arthritis: part 1 (week 12) of the CLIPPER study. Ann Rheum Dis. 2014;73(6):1114-1122.Lovell DJ, Reiff A, Jones OY, et al. Long-term safety and efficacy of etanercept in children with polyarticular-course juvenile rheumatoid arthritis. Arthritis Rheum. 2006;54(6):1987-1994.Minden K, Niewerth M, Zink A, et al. Long-term outcome of patients with JIA treated with etanercept, results of the biologic register JuMBO. Rheumatology (Oxford). 2012;51(8):1407-1415.Minden K, Klotsche J, Niewerth M, Horneff G, Zink A. Biologikaregister JuMBO. Langzeitsicherheit von biologikatherapie bei juveniler idiopathischer arthritis [Biologics register JuMBO. Long-term safety of biologic therapy of juvenile idiopathic arthritis]. Z Rheumatol. 2013;72(4):339-346.Southwood TR, Foster HE, Davidson JE, et al. Duration of etanercept treatment and reasons for discontinuation in a cohort of juvenile idiopathic arthritis patients. Rheumatology (Oxford). 2011;50(1):189-195.Windschall D, Müller T, Becker I, Horneff G. Safety and efficacy of etanercept in children with the JIA categories extended oligoarthritis, enthesitis-related arthritis and psoriasis arthritis. Clin Rheumatol. 2015;34(1):61-69.Kimball AB, Pariser D, Yamauchi PS, et al. OBSERVE-5 interim analysis: an observational postmarketing safety registry of etanercept for the treatment of psoriasis. J Am Acad Dermatol. 2013;68(5):756-764.Papp KA, Poulin Y, Bissonnette R, et al. Assessment of the long-term safety and effectiveness of etanercept for the treatment of psoriasis in an adult population. J Am Acad Dermatol. 2012;66(2):e33-e45.
Please click the Prescribing Information link to view the safety and adverse events information of Enbrel®.
For the use only of Registered Medical Practitioners or a Hospital or a Laboratory.
PP-ENB-IND-0814 August 2022