scholarly journals Sustained Improvements in Workplace and Household Productivity and Social Participation With Certolizumab Pegol Over 96 Weeks in Patients With Psoriatic Arthritis

2014 ◽  
Vol 17 (7) ◽  
pp. A387-A388 ◽  
Author(s):  
A. Kavanaugh ◽  
D. Gladman ◽  
der Heijde D. van ◽  
O. Purcaru ◽  
P.J. Mease
Keyword(s):  
Psoriatic Arthritis ◽  
Social Participation ◽  
Certolizumab Pegol ◽  
Household Productivity

scholarly journals P242 CZP improves work and household productivity and social participation over 1 year of treatment in patients with non-radiographic axSpA

Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_2) ◽  
Author(s):  
Karl Gaffney ◽  
Atul Deodhar ◽  
Lianne Gensler ◽  
Jonathan Kay ◽  
Walter Maksymowych ◽  
...  
Keyword(s):  
Social Participation ◽  
Certolizumab Pegol ◽  
Specific Work ◽  
Inadequate Response ◽  
Research Support ◽  
Open Label ◽  
Double Blind ◽  
Research Grants ◽  
Household Productivity ◽  
The Impact

Abstract Background Certolizumab pegol (CZP) treatment has been shown to significantly improve work and household productivity and social participation compared to placebo in active non-radiographic axial spondyloarthritis (nr-axSpA) patients up to 24 weeks. Here, we report the impact of CZP in combination with non-biologic background medication (NBBM) on signs and symptoms of nr-axSpA compared to placebo+NBBM. Methods C-axSpAnd (NCT02552212) is a 3-year, phase 3, multicentre study including a 52-week double-blind, placebo-controlled period (completed). Patients had active nr-axSpA, objective signs of inflammation (OSI; elevated CRP and/or positive MRI of the sacroiliac joint), previous inadequate response to ≥ 2 NSAIDs and were randomised 1:1 to CZP (400 mg at Weeks 0/2/4, then 200 mg every 2 weeks) or placebo. The validated arthritis-specific Work Productivity Survey (WPS) assessed the impact of nr-axSpA on work and household productivity and social participation. Missing data were imputed using last observation carried forward (LOCF) post hoc in the Full Analysis Set (randomised patients who received ≥1 dose of CZP). Results 317 patients were randomised (CZP: 159; placebo: 158). Mean age at baseline was 37.3 years and 51.4% of patients were female. At baseline, most patients were employed (CZP: 124 [77.8%]; placebo: 123 [78.0%]) and reported a mean 3.7 (CZP) and 3.5 (placebo) workdays missed per month due to disease (Table 1). By Week 12, work absenteeism substantially improved in the CZP group compared with placebo (0.9 vs 2.1 days missed per month, LOCF), with further improvements at Week 52 (0.3 vs 2.0 days missed per month, LOCF). Between Week 12 and Week 52, most placebo patients (104, 65.8%) switched to open-label CZP, impacting Week 52 imputed outcomes. Despite this, similar patterns of improvement following CZP treatment were seen for absenteeism, workdays with impaired productivity, household days with missed/reduced productivity and social participation between imputed and observed case data (Table 1). Improvements were similar between male and female patients (data not shown). Conclusion CZP treatment resulted in improvements in work and household productivity and social participation for nr-axSpA patients as early as Week 12 compared to background medication only, with benefits maintained to Week 52. Disclosures K. Gaffney: Other; Research Grants/Consultancy Fees from Abbvie, Biogen, Celgene, Gilead, Izana, Janssen, Lilly, Novartis, Pfizer, UCB Pharma. A. Deodhar: Consultancies; AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Glaxo Smith and Klein, Janssen, Novartis, Pfizer and UCB. Grants/research support; BMS, Eli Lilly, Glaxo Smith & Kline, Janssen, Novartis, Pfizer and UCB. L. Gensler: Consultancies; Galapagos, Eli Lilly and Janssen. Grants/research support; AbbVie, Amgen, Novartis, UCB Pharma. J. Kay: Consultancies; AbbVie, Boehringer Ingelheim, Celltrion Healthcare, Horizon Therapeutics, Merck Sharp & Dohme, MorphoSys, Novartis, Pfizer, Samsung Bioepis, Sandoz and UCB Pharma. Grants/research support; Gilead Sciences, Novartis AG, Pfizer and UCB Pharma. W. Maksymowych: Other; Consultant and/or speaker fees and/or grants from AbbVie, Amgen, Eli Lilly, Janssen, Merck, Pfizer, Synarc, Sanofi and UCB Pharma. N. Haroon: Consultancies; Abbvie, Amgen, Eli Lilly, Janssen, Novartis and UCB Pharma. R. Landewé: Consultancies; Abbott, Ablynx, Amgen, Astra-Zeneca, Bristol Myers Squibb, Centocor, GlaxoSmithKline, Novartis, Merck, Pfizer, Roche, Schering-Plough, UCB Pharma, Wyeth. Member of speakers’ bureau; Abbott, Amgen, Bristol Myers Squibb, Centocor, Merck, Pfizer, Roche, Schering-Plough, UCB Pharma, Wyeth. Grants/research support; Abbott, Amgen, Centocor, Novartis, Pfizer, Roche, Schering-Plough, UCB Pharma, Wyeth. M. Rudwaleit: Consultancies; Abbott, Bristol-Myers Squibb, Janssen, MSD, Pfizer, Roche, UCB Pharma. S. Hall: Other; Consulting fees/ research grants from AbbVie, Eli Lilly, Novartis, and UCB Pharma. L. Bauer: Other; Employee of UCB Pharma. B. Hoepken: Other; Employee of UCB Pharma. N. de Peyrecave: Other; Employee of UCB Pharma. T. Kumke: Other; Employee of UCB Pharma. D. van der Heijde: Consultancies; AbbVie, Amgen, Astellas, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Daiichi, Eli Lilly, Galapagos, Gilead, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, and UCB. Other; Director of Imaging Rheumatology BV.

scholarly journals Improvements in productivity at paid work and within the household, and increased participation in daily activities after 24 weeks of certolizumab pegol treatment of patients with psoriatic arthritis: results of a phase 3 double-blind randomised placebo-controlled study

2014 ◽  
Vol 74 (1) ◽  
pp. 44-51 ◽  
Author(s):  
A Kavanaugh ◽  
D Gladman ◽  
D van der Heijde ◽  
O Purcaru ◽  
P Mease
Keyword(s):  
Psoriatic Arthritis ◽  
Certolizumab Pegol ◽  
Leisure Activities ◽  
Controlled Study ◽  
Social Activities ◽  
Paid Work ◽  
Phase 3 ◽  
Double Blind ◽  
Household Productivity ◽  
The Impact

ObjectivesTo evaluate the effect of certolizumab pegol (CZP) on productivity outside and within the home, and on participation in family, social and leisure activities in adult patients with psoriatic arthritis (PsA).MethodsRAPID-PsA (NCT01087788) is a phase 3, double-blind, placebo-controlled trial. 409 patients with active PsA were randomised 1:1:1 to placebo, CZP 200 mg every 2 weeks (Q2W) or CZP 400 mg every 4 weeks (Q4W). The arthritis-specific Work Productivity Survey (WPS) assessed the impact of PsA on paid work and household productivity, and participation in social activities during the preceding month. WPS responses were compared between treatment arms using a non-parametric bootstrap-t method.ResultsAt baseline, 56.6%, 60.1% and 61.5% of placebo, CZP 200 mg Q2W and CZP 400 mg Q4W patients were employed. By week 24, employed CZP patients reported an average of 1.0–1.8 and 3.0–3.9 fewer days of absenteeism and presenteeism, respectively, per month compared with 1.0 and 0.3 fewer days for placebo patients (p<0.05). Within the home, by week 24, CZP patients reported an average of 3.0–3.5 household work days gained per month versus 1.0 day for placebo (p<0.05). CZP patients also reported fewer days with reduced household productivity or days lost for participation in family, social and leisure activities. Improvements with CZP were seen as early as week 4 and continued to week 24.ConclusionsCZP treatment significantly improved productivity at paid work and within the home, and resulted in greater participation in social activities for PsA patients.Trial registration numberNCT01087788.

scholarly journals AB0649 REAL WORLD EFFICACY OF SECUKINUMAB: A SINGLE CENTRE EXPERIENCE

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1619-1620
Author(s):  
G. Kasavkar ◽  
T. Blake ◽  
N. Gullick
Keyword(s):  
Clinical Trial ◽  
Psoriatic Arthritis ◽  
Ankylosing Spondylitis ◽  
Adverse Events ◽  
Real World ◽  
Certolizumab Pegol ◽  
Tender Joint Count ◽  
Inadequate Response ◽  
Technology Appraisal ◽  
New Onset

Background:Secukinumab was approved by NICE for patients with active Ankylosing Spondylitis and Psoriatic Arthritis in 2017. Clinical trial data suggests secukinumab is a useful treatment option in both conditions, but often real world experience differs greatly from clinical trial results. In addition, patients with more refractory disease are often excluded from clinical trials.Objectives:To assess the response to secukinumab in patients with seronegative spondyloarthropathy receiving treatment at University Hospital Coventry and WarwickshireMethods:Patients starting secukinumab at UHCW were identified from the Blueteq funding database. Medical notes were reviewed retrospectively to assess response rates using BASDAI responses in Ankylosing spondylitis and PsARC responses in PsA. Patients who had previously had inadequate response to TNF inhibitors (PsA only) and severe psoriasis received 300mg secukinumab monthly; the remainder were prescribed 150mg monthly.Results:146 patients commenced secukinumab between June 2017 and January 2020 and had outcome data recorded. 73 patients (50%) had received previous biologic agents prior to secukinumab exposure. Patients with Ankylosing spondylitis had high BASDAI (6.8±1.4) and spinal pain (7.5±1.4). 48 patients had an initial response to treatment as per outcome measures done before and after Secukinumab inception. Secukinumab was effective in 89 patients (94%), and 87 (91%) continued treatment.In psoriatic arthritis, despite high levels of activity at baseline (mean tender joint count 10±8; swollen joint count 6±3) and 65% prior biologic exposure; high rates of response were seen. The majority of patients have continued treatment. Secukinumab was well tolerated in both patient groups with low rates of discontinuation due to adverse events (8 patients, 5%). Adverse events included recurrent infection (3), rash (1), mouth ulcers (1), vertigo (1), new onset cancer (1) and new onset Crohn’s (1) although rates were low overall. Patients with pre-existing uveitis did not develop exacerbations but low numbers of patients with prior uveitis were treated.PsA (n=51)AS (n=95)Age in years, mean (SD)53 (13)49(12)Male sex, n (%)21 (41)62 (65)Disease duration in years, mean (SD)8 (8)10.9 (9.2)Previous biologic exposure, n (%)30 (65)43 (48)Number of prior biologics, median (range)1 (1-4)1 (1-4)Responder, n (%)37 (72)*89 (93)Discontinuation, n(%)12 (24)8 (8.5)Adverse events62Lack of efficacy64Other02*Response could not be assessed in 3/51 PsA patients due to insufficient clinical data; these patients have been recorded as non respondersConclusion:Secukinumab demonstrates high levels of efficacy even in a cohort of patients with longstanding PSA and AS with high rates of inadequate responses to other biologics.Secukinumab is well tolerated with low rates of discontinuation due to adverse events.References:Certolizumab pegol and secukinumab for treating active psoriatic arthritis after inadequate response to DMARDs Technology appraisal guidance [TA445]Secukinumab for active ankylosing spondylitis after treatment with non-steroidal anti-inflammatory drugs or TNF-alpha inhibitors Technology appraisal guidance [TA407]Disclosure of Interests:None declared

Sign in / Sign up

Export Citation Format

Share Document