scholarly journals Association of Nail Psoriasis With Disease Activity Measures and Impact in Psoriatic Arthritis: Data From the Corrona Psoriatic Arthritis/Spondyloarthritis Registry

2020 ◽  
pp. jrheum.190923
Author(s):  
Philip J. Mease ◽  
Mei Liu ◽  
Sabrina Rebello ◽  
Robert R. McLean ◽  
Blessing Dube ◽  
...  

Objective To examine the association of nail psoriasis with disease activity, quality of life, and work productivity in patients with psoriatic arthritis (PsA). Methods All patients with PsA who enrolled in the Corrona PsA/Spondyloarthritis Registry between March 2013 and October 2018 and had data on physician-reported nail psoriasis were included and stratified by presence vs absence of nail psoriasis at enrollment. Patient demographics, disease activity, quality of life, and work productivity at enrollment were compared between patients with vs without nail psoriasis using t-tests or Wilcoxon rank-sum tests for continuous variables and χ2 or Fisher exact tests for categorical variables. Results Of the 2841 patients with PsA included, 1152 (40.5%) had nail psoriasis and 1689 (59.5%) did not. Higher proportions of patients with nail psoriasis were male (51.9% vs 44.1%) and disabled from working (12.3% vs 7.8%) compared with patients without nail psoriasis (all P < 0.05). Patients with nail psoriasis had higher disease activity than those without nail psoriasis, including higher tender and swollen joint counts, worse Disease Activity in Psoriatic Arthritis and Psoriatic Arthritis Disease Activity Score values, and increased likelihood of having enthesitis and dactylitis (all P< 0.05). Patients with nail psoriasis had worse pain, fatigue, and work and activity impairment than those without nail psoriasis (all P < 0.05). Conclusion Patients with PsA who have nail psoriasis had worse disease activity, quality of life, and work productivity than those without nail involvement, emphasizing the importance of identification and management of nail disease in patients with PsA.

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 815.2-815
Author(s):  
E. Gubar ◽  
Y. Korsakova ◽  
E. Loginova ◽  
S. Glukhova ◽  
T. Korotaeva ◽  
...  

Background:Limited data are available regarding the burden of nail disease in psoriatic arthritis (PsA). The latest data show that nail involvement in PsA patients (pts) is associated with significantly more severe disease status (1).Objectives:To analyze, in clinical practice, the association of nail psoriasis with disease activity, quality of life, and work productivity in PsA pts.Methods:588 pts (M/F–277 /311) with PsA according to CASPAR criteria were included in the study. Data were collected from 43 rheumatology clinics from different regions of the Russian Federation. Pts’ age 48.6±0.5 years (yrs), disease duration 7.0±0.3 yrs. Pts underwent standard clinical examination of PsA activity. Pts were split into two groups (gr.): those with nail psoriasis – gr.1, and those without it – gr.2. Demographics, disease activity, quality of life, and work productivity were compared between pts with and without nail psoriasis using Pearson’s chi-square test and Mann–Whitney U test.Results:Gr.1 includes 312 (53.1%) cases, gr.2 – 276 (46.9%) cases. More pts in gr.1 were males (51.9% vs 44.1%, р=0.013), disabled at work (37.20% vs 26.40%, р=0.000), chronic smokers (18.9% vs 8.7%, р=0.000) and with axial PsA disease signs according to physician (35.0% vs 26.4%, р=0.025) compared to pts in gr.2. Pts in gr.1 had higher tender and swollen joint counts: 8 [4-15] vs 5 [2-12] (р=0.002) and 5 [1-9] vs 2 [0-7] (р=0.003) respectively. Gr.1 pts had higher disease activity measured by DAPSA 25 [15-39] vs 20 [12-33] (p= 0.001), higher frequency of dactylitis (24.4% vs 16.7% р=0.022) and heel enthesitis (17.0% vs 10.1% р=0.016) respectively, higher frequency of erosive radiographic arthritis of feet (45.0% vs 31.2% р=0.003) compared to gr.2 pts. Pts in gr.1 had worse skin psoriasis measured by Psoriasis Area Severity Index – 6 [2-14] vs 3 [1-6] (р=0.000). Less pts in gr.1 than in gr.2 (27.0% vs 52.0% р=0.004) achieved minimal disease activity (MDA). Pts’ reported outcomes (PRO’s) in gr.1 were worse than in gr.2 in regard to reduced health-related quality of life according to PsAID (4.9±2.3 vs 4.0±2.3, р=0.040) and to EQ-5D (0.56±0.19 vs 0.64 ±0.21, р=0.024) questionnaires, overall work impairment (0.0 [0.0-0.3] vs 0.0 [0.0-0.2], р=0.034) and overall activity impairment (0.4 [0.1-0.7] vs 0.3 [0.0-0.5], р=0.006) according to WPAI.Conclusion:Nail involvement in PsA pts is associated with male gender and axial disease. PsA pts with nail involvement are more often disabled, more often are chronic smokers, have significantly worse disease status as measured by disease activity; they are more likely to have more severe (erosive) peripheral arthritis of feet, higher frequency of heel enthesitis and dactylitis, higher psoriasis disease severity, lower frequency of MDA achievement, and worse quality of life and work productivity according to PRO’s. Detection of nail involvement is critical for choice of treatment approach and better outcomes.References:[1]Mease PJ et al.J Rheumatol, 2020Disclosure of Interests:None declared.


2019 ◽  
Vol 82 (6) ◽  
pp. 376-382 ◽  
Author(s):  
Nuh Atas ◽  
Ozkan Varan ◽  
Hakan Babaoglu ◽  
Hasan Satis ◽  
Reyhan Bilici Salman ◽  
...  

Introduction Behçet disease is a chronic vasculitis that generally affects young adults in the most productive period of their life. The purpose of this study is to evaluate patients’ work productivity and daily activity impairment, and their relationship with disease activity and quality of life. Method In this study, 55 patients with Behçet disease who are currently working and 50 healthy controls were included. To evaluate quality of life, a 36-item short form health survey was used. For the evaluation of Behçet disease activity and work productivity, the Behçet Disease Current Activity Form and Work Productivity and Activity Impairment questionnaire were used, respectively. Quality of life and work productivity between patients and healthy controls were compared. Results Scores of all domains of the health survey were significantly worse in patients with Behçet disease (range, p = 0.006 to p < 0.001). The mean Work Productivity and Activity Impairment absenteeism, presenteeism and activity impairment scores were higher in patients with Behçet disease ( p = 0.005, p < 0.001 and p < 0.001, respectively). There was a significant correlation between Behçet Disease Current Activity Form score and absenteeism ( r = 0.32, p = 0.016). Moreover, there was significant correlation between Work Productivity and Activity Impairment and most domains of the health survey (range, r = −0.27 to –0.64, range, p = 0.047 to p < 0.001). Conclusion Our results showed remarkable impairment in work productivity and health-related quality of life in Behçet disease. There is a strong correlation between work productivity and quality of life. To improve work productivity, more effective therapeutic approaches and improvements in working conditions should be provided.


2021 ◽  
Vol 17 (1) ◽  
Author(s):  
Julia Hews-Girard ◽  
Marilyn Dawn Goodyear

Abstract Background Hereditary angioedema (HAE) is a rare but serious disorder associated with a multifaceted burden of illness including a high prevalence of psychiatric symptoms and impaired health-related quality of life (HRQoL). Despite recent efforts to clarify the psychosocial implications of HAE, important gaps still remain. The aim of this study was to characterize the psychosocial burden associated with HAE types 1 and 2. Methods Type 1 or 2 HAE patients (n  =  17), aged 19 years or older, completed the Depression, Anxiety, Stress Scale (DASS-21) and the DSM-5 cross cutting measures to identify psychiatric symptomatology, Angioedema Quality of Life Questionnaire (AE-QoL) and the Short-Form 36-Item Health Survey version 2 (SF-36v2) to assess disease-related and generic HRQoL respectively, and the Work Productivity and Activity Impairment Questionnaire (WPAI) to measure impact on work productivity and daily activities. Data analyses were conducted using SPSS statistical software (Version 25.0; IBM, Armonk, NY). Descriptive statistics were used to summarize continuous demographics and clinical characteristics and outcomes of interest while frequency distributions were used for categorical variables. T tests were used to compare SF-36v2 domain scores to Canadian norms and sex differences in scale scores. Results Depression [DASS-21 score  =  6.8  ±  10.2; n  =  12 (71%)] anxiety [DASS-21 score  =  6.2  ±  8.2; n  =  13 (76%)] and stress [DASS-21 score  =  10  ±  10.2; n  =  13 (76%)] were prevalent. Other psychiatric symptoms warranting inquiry included mania (n  =  14, 82.4%), anger (n  =  14, 82.4%), sleep disturbances (n  =  13, 76.5%), somatic symptoms (n  =  11, 64.7%) and impaired personality functioning (n  =  9, 52.9%). Mean AE-QoL score was 39  ±  18.2. Mean SF-36v2 domain scores were significantly lower than Canadian normative data for the entire sample (p  <  0.05). Impairment in work productivity was minimal; mean activity impairment was 20.6%  ±  21.1% [n  =  11 (64.7%)]. Female participants reported significantly greater HAE-related stress [DASS; t(15)  =   − 2.2, p  =  0.04], greater HAE-related fears [AEQoL; t(5.6)  =   − 2.7, p  =  0.04), and lower SF-36v2 domain scores than male patients. Conclusions Study findings offer specific, valuable insight into the psychosocial burden of HAE with the potential to improve clinical management of HAE. Best practices for effective management of HAE should include providing holistic care to address the psychosocial and mental health of HAE patients.


2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S430-S431
Author(s):  
G J Correa ◽  
M Yantorno ◽  
P Olivera Sendra ◽  
J S Lasa ◽  
P Lubrano ◽  
...  

Abstract Background Patient-reported outcomes (PROs) are increasingly recognized as complementary to objective markers of disease activity, yet evidence on PROs in inflammatory bowel disease (IBD) in the real-world setting in Latin America is limited. Herein, we describe health-related quality of life (HRQoL) and work productivity and activity impairment (WPAI) of IBD patients (pts) in Argentina. Methods RISE-AR (NCT03488030) was a non-interventional study with a cross-sectional evaluation and a 3-year retrospective chart review conducted in 7 centres in Argentina (12/2018-05/2019) to assess healthcare resource utilisation, HRQoL and WPAI. Adult pts (≥18 yr old) with a previous diagnosis of moderate-to-severe (Mod/Sev) ulcerative colitis (UC) or Crohn′s disease (CD) based on clinical, endoscopic or imaging criteria ≥6 months prior to enrolment, were included. HRQoL (IBD Questionnaire [IBDQ], 5-dimensional EuroQoL measure [EQ5D]) and WPAI instruments were administered at screening. Disease activity at enrolment was classified as Mod/Sev (Harvey Bradshaw Index ≥8 or partial Mayo Score ≥5) vs. “no-or-mild” (No/Mild). A p-value ≤0.05 was considered statistically significant (Mann-Whitney U test). Results Overall, 246 pts were included (41.1% CD; 58.9% UC). At enrolment, median (range) age (years) was 39.5 (18.2-74.0) for CD (51.2% female) and 41.9 (18.0-80.4) for UC (55.2% female) pts; 20 pts (9.3% CD; 7.7% UC; excluding 4 ostomized pts) had Mod/Sev disease activity. During the previous 3 years, 17.8% (CD) and 1.4% (UC) of pts required ≥1 surgery, and 33.7% (CD) and 21.4% (UC) were hospitalized. No/Mild pts showed significantly higher overall HRQoL scores (mean±SD) vs. Mod/Sev pts in CD (IBDQ: 178.1±35.4 vs. 140.0±43.5, p&lt;0.05; EQ5D [visual analogue scale]: 75.7±1.8 vs. 64.4±5.5, p&lt;0.05) and UC (180.2±32.9 vs. 132.9±43.8, p&lt;0.001; 77.1±1.3 vs. 57.7±5.3, p&lt;0.001), respectively. Activity impairment was reported by 55.4% and 58.6% of CD and UC pts, respectively, while 37.9% and 43.9% of CD and UC employed pts (67 CD, 92 UC; Mod/Sev: 5 CD, 6 UC) reported work impairment. Mod/Sev IBD pts had higher absenteeism (30.8% vs. 6.3%, p&lt;0.05) and presenteeism (20.0% vs. 7.5%, p=0.149) vs. No/Mild pts. Female gender, surgeries and hospitalizations were associated with lower QoL in the overall IBD population. Conclusion This is the first study to evaluate QoL and WPAI in IBD pts in Argentina. Pts with Mod/Sev activity showed impaired QoL and WPAI compared to No/Mild pts. Whilst, less than 10% of IBD pts had Mod/Sev disease activity at enrolment, nearly 60% of the overall IBD population reported either work or activity impairment. Thus, disease activity scores alone may fail to assess the real burden of IBD, suggesting a relevant role for PROs in disease management.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 166.2-167
Author(s):  
C. Airoldi ◽  
P. Girard Bosch ◽  
M. Benegas ◽  
V. Duarte ◽  
V. Cosentino ◽  
...  

Background:Work disability is an important outcome in the treatment of Spondyloarthritis (SpA) since this disease affects people in the most productive stage of life.Objectives:The aim of this study is to investigate the working status and the factors associated with work productivity loss (WPL) in patients with axial (axSpA) and peripheral SpA (pSpA).Methods:Patients with SpA according to ASAS criteria were included consecutively in this multicentric cross-sectional study. Evaluation of activity through a visual analogue scale (0-100), enthesitis (LEI), functional capacity (HAQ and BASFI), disease activity (DAS28 and BASDAI), health status (ASAS Health Index) and quality of life (ASQoL) were calculated. The Ankylosing Spondylitis Disease Activity Score (ASDAS) was recorded. The Work Productivity and Activity Impairment Spondyloarthritis (WPAI SpA) questionnaire was used to assess work productivity.Spearman’s correlation coefficient (ρ) was used to assess the correlation with the percentage of WPL.Results:274 patients with SpA were recruited, 129 (47.1%) with axSpA and 145 (52.9%) with pSpA. 56.6% were women and 33.2% stopped working due to the underlying disease.Among axSpA patients, 70% were radiographic and 30% non radiographic, mean age 45.5 (SD14) yrs, median disease duration 72 (IQR 36-144) months and diagnosis delay 20 (IQR 11-70) months. 45.7% were employed, median hours worked in the last week was 40 (IQR 25-45), median scores for absenteeism was 0% (IQR 0-2), presenteeism 30% (IQR 5-40), WPL 30% (IQR 10-52.5) and activity impairment 30% (IQR 10-50). A positive correlation was found between WPL and the following variables: HAQ (ρ:0.40, p<0.001), BASDAI (ρ:0.48, p<0.001), ASDAS (ρ:0.46, p<0.001), BASFI (ρ:0.59, p<0.001), ASQoL (ρ:0.60, p<0.0001), LEI (ρ:0.31, p:0.02) and ASAS health index (ρ:0.54, p<0.001).Among pSpA patients, mean age was 52.3 (SD13) yrs, median disease duration 60 (IQR 14-120) months and diagnosis delay 12 (IQR 3-24) months. 46.9% were employed, median hrs worked in the last week was 30 (IQR 14-40), absenteeism 0% (IQR 0-7), presenteeism 30% (IQR 2.5-58), WPL 30% (IQR 5-52) and activity impairment 20% (IQR 0-40). A positive correlation was found between WPL and: HAQ (ρ:0.49, p<0.001), ASDAS (ρ:0.58, p<0.001), ASQoL (ρ:0.57, p<0.0001), DAS28 (ρ:0.50, p<0.001), LEI (ρ:0.36, p:0.04) and ASAS health index (ρ:0.52, p<0.001). No statistically significant differences were found in absenteeism, presenteeism, WPL and activity impairment between axSpA and pSpA.Conclusion:Our study showed that WPL in this national cohort was 30% in both groups of patients and is associated with disease activity, enthesitis, health status, quality of life and functional ability.Disclosure of Interests:None declared


Rheumatology ◽  
2021 ◽  
Vol 60 (Supplement_1) ◽  
Author(s):  
Sinead Maguire ◽  
Finbar O'Shea

Abstract Background/Aims  Previous research in axial spondyloarthropathy (axSpA) has shown this population to have a high prevalence of depression. This co-morbidity has been previously shown to impact disease activity in patients with rheumatic disease. The purpose of this study was to screen for signs of depression using two validated tools, the Patient Health Questionaire-9 (PHQ-9) and the Hospital Anxiety and Depression Scale for depression (HADs-D) in axSpA patients. Methods  AxSpA patients attending the rheumatology department in St James’ Hospital between February and October 2020 were invited to take a self-administered survey which included the PHQ-9 and the HADs-D. Scores from the HADs-D yielded a numerical result which was then categorised as normal, borderline or abnormal. PHQ-9 numerical results were categorised as normal, mild, moderate, moderate/severe or severe. Patients with a known diagnosis of depression were excluded. In addition to baseline demographics, patient reported outcomes were also recorded. Data analysis was performed using IBM SPSS version 26. Continuous variables were recorded as means, categorical variables as frequencies with percentages. A one-way analysis of variance analysis (ANOVA) determined significance of variation in outcomes between patient outcomes as determined by the HADs-D and PHQ-9. A p-value of &lt; 0.05 was deemed significant. Consent was obtained prior to participation. Approval was received from the St James’/Tallaght Hospital Joint Ethics Committee. Results  In total 71 axSpA patients took part in the survey. The population was 70.4% (50) males and 29.5% (21) female, with an average age 47.9 years and mean disease duration 19.7 years (mean outcomes: BASDAI 4.08, BASFI 3.62, BASMI 3.54, ASQoL 6.79). Overall, 7 (9.9%) participants recorded abnormal HADs D scores, while 17 (23.9%) recorded moderate to severe PHQ-9 scores indicative of underlying depression. AxSpA females had higher mean HADs-D scores (7.5 vs 4.8, p = 0.01) than males, with abnormal scores in 19% (4) of females and 6% (3) of males. No significant differences were found in PHQ-9 scores between genders. Analysis revealed significantly worse BASDAI (6.27 vs 3.42, p &lt; 0.01) and AQoL scores (12.57 vs 5.26, p &lt; 0.01) in axSpA patients with abnormal compared to normal HADs D scores. No significant differences were noted in BASFI, BASMI or baseline demographics. A similar pattern was noted on analysis of PHQ-9 scores, with significantly worse BASDAI (7.9 vs 2.55, p &lt; 0.01), BASFI (8.05 vs 2.33, p &lt; 0.01) and ASQoL (19.5 vs 2.62, p &lt; 0.01) noted in those scoring as severe compared to normal. No significant differences were detected in BASMI scores or baseline demographics. Conclusion  A high percentage of axSpA patients recorded high HADs D and PHQ-9 scores for undiagnosed depression. These patients had significantly worse disease activity and quality of life as compared to patients with normal scores. Clinicians treating axSpA should consider screening for depression in this population. Disclosure  S. Maguire: None. F. O'Shea: None.


Author(s):  
Alexis Ogdie ◽  
Jessica A. Walsh ◽  
Soumya D. Chakravarty ◽  
Steven Peterson ◽  
Kim Hung Lo ◽  
...  

Abstract Introduction/objectives To evaluate changes in health-related quality of life (HRQoL) and productivity following treatment with intravenous (IV) golimumab in patients with psoriatic arthritis (PsA). Methods Patients were randomized to IV golimumab 2 mg/kg (n=241) at Weeks 0, 4, then every 8 weeks (q8w) through Week 52 or placebo (n=239) at Weeks 0, 4, then q8w, with crossover to IV golimumab 2 mg/kg at Weeks 24, 28, then q8w through Week 52. Change from baseline in EuroQol-5 dimension-5 level (EQ-5D-5L) index and visual analog scale (EQ-VAS), daily productivity VAS, and the Work Limitations Questionnaire (WLQ) was assessed. Relationships between these outcomes and disease activity and patient functional capability were evaluated post hoc. Results At Week 8, change from baseline in EQ-5D-5L index (0.14 vs 0.04), EQ-VAS (17.16 vs 3.69), daily productivity VAS (−2.91 vs −0.71), and WLQ productivity loss score (−2.92 vs −0.78) was greater in the golimumab group versus the placebo group, respectively. At Week 52, change from baseline was similar in the golimumab and placebo-crossover groups (EQ-5D-5L index: 0.17 and 0.15; EQ-VAS: 21.61 and 20.84; daily productivity VAS: −2.89 and −3.31; WLQ productivity loss: −4.49 and −3.28, respectively). HRQoL and productivity were generally associated with disease activity and functional capability, with continued association from Week 8 through Week 52. Conclusion IV golimumab resulted in early and sustained improvements in HRQoL and productivity from Week 8 through 1 year in patients with PsA. HRQoL and productivity improvements were associated with improvements in disease activity and patient functional capability. Key Points• In patients with active psoriatic arthritis (PsA), intravenous (IV) golimumab improved health-related quality of life (HRQoL) and productivity as early as 8 weeks and maintained improvement through 1 year• Improvements in HRQoL and productivity outcomes in patients with PsA treated with IV golimumab were associated with improvements in disease activity and patient functional capability outcomes• IV golimumab is an effective treatment option for PsA that can mitigate the negative effects of the disease on HRQoL and productivity


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1658.1-1658
Author(s):  
L. Tu ◽  
Y. Xie ◽  
Q. Lv ◽  
M. Yang ◽  
Z. Liao ◽  
...  

Background:Poorer work productivity due to pain and functional impairment is commonly seen in ankylosing spondylitis (AS) patients, which may contribute to huge social economic burden. However, data about work outcomes and associated factors in Chinese AS patients were barely reported.Objectives:To assess work outcomes and identify factors associated with poor work productivity in patients with AS in China.Methods:A cross-sectional study was conducted in China. Adult patients (aged ≥ 18 years) fulfilled the 1984 New York modified criteria of AS were enrolled from rheumatology center from Jan 2017 to Aug 2017. All participants completed questionnaires about socio-demographic characteristics, disease characteristics, quality of life and the Work productivity and activity impairment questionnaire in AS (WPAI:SpA) to accesses the impact of chronic health conditions on job performance and productivity. Factors associated with work outcomes were evaluated.Results:A total of 91 patients with AS were included: 87.8% males, 78.02% employed, mean age and disease duration of 30 and 10 years respectively. The mean (SD) activity impairment of all patients was 48.57% (22.02%). For patients with employed work, mean (SD) absenteeism, presenteeism and work productivity loss were 10.22% (19.44%), 43.86% (22.48%) and 47.92% (25.81%) respectively. In multivariable analysis, activity impairment was associated with Bath Ankylosing Spondylitis Functional Index (BASFI) (P<0.01) and Ankylosing Spondylitis Quality of Life (ASQoL) (P<0.01). Absenteeism was associated with disease duration (P=0.03). Presenteeism was associated with disease duration (P=0.04), BASFI (P<0.01) and ASQoL (P<0.01). Work productivity loss was associated with BASFI (P<0.01) and ASQoL (P<0.01).Conclusion:Longer disease duration, reduced physical function and poorer quality of life are associated with reduced work productivity in Chinese AS patients.References:[1]Boonen A, van der Heijde D, Landewe R, Spoorenberg A, Schouten H, Rutten-van Molken M, et al. Work status and productivity costs due to ankylosing spondylitis: comparison of three European countries. Annals of the rheumatic diseases. 2002;61(5):429-37.[2]Martindale J, Shukla R, Goodacre J. The impact of ankylosing spondylitis/axial spondyloarthritis on work productivity. Best Pract Res Clin Rheumatol. 2015;29(3):512-23.[3]Castillo-Ortiz JD, Ramiro S, Landewe R, van der Heijde D, Dougados M, van den Bosch F, et al. Work Outcome in Patients With Ankylosing Spondylitis: Results From a 12-Year Followup of an International Study. Arthritis Care Res (Hoboken). 2016;68(4):544-52.[4]Sag S, Nas K, Sag MS, Tekeoglu I, Kamanli A. Relationship of work disability between the disease activity, depression and quality of life in patients with ankylosing spondylitis. J Back Musculoskelet Rehabil. 2018;31(3):499-505.[5]Goh Y, Kwan YH, Leung YY, Fong W, Cheung PP. A cross-sectional study on factors associated with poor work outcomes in patients with axial spondyloarthritis in Singapore. Int J Rheum Dis. 2019;22(11):2001-8.Disclosure of Interests:None declared


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1709-1710
Author(s):  
A. M. Orbai ◽  
J. Gratacos-Masmitja ◽  
E. Dokoupilova ◽  
B. Combe ◽  
A. Constantin ◽  
...  

Background:Ixekizumab (IXE), a high-affinity monoclonal antibody that selectively targets IL-17A, has shown improvements compared to placebo (PBO) not only in disease activity but also in various patient-reported outcomes (PROs) assessing physical function, quality of life (QoL), and work productivity in PsA patients treated for 24 weeks and sustained up to 52 weeks.1, 2Objectives:To report the effects of treatment with IXE on these PROs after up to 3 years of treatment.Methods:In SPIRIT-P2 (NCT02349295), a Phase 3 trial, 363 adult patients with active PsA and prior inadequate response or intolerance to 1 or 2 TNF inhibitors (TNFis) were randomized 1:1:1 to IXE 80 mg every 4 weeks (IXEQ4W; N=122) or every 2 weeks (IXEQ2W; N=123), or PBO (N=118) in the double-blind treatment period (Weeks 0-24). Both IXE regimens had a starting dose of 160 mg. Results are reported from a subset of the intent-to-treat population who were randomized to IXE at baseline (Week 0). The following PROs were assessed during Weeks 0-156: HAQ-DI (minimally clinically important difference [MCID] an improvement ≥0.35), medical outcomes survey Short Form-36 (SF-36) Physical and Mental Component Summary (PCS and MCS), European Quality of Life 5 Dimensions Visual Analog Scale (EQ-5D VAS), and Work Productivity and Activity Impairment Questionnaire-Specific Health Problem (WPAI-SHP; absenteeism, presenteeism, work productivity, and activity impairment). Missing values were imputed by observed analysis and modified baseline observation carried forward (mBOCF) for continuous data or by modified non-responder imputation (mNRI) for categorical data.Results:Mean baseline scores for SF-36 (PCS and MCS), EQ-5D VAS, and WPAI-SHP (Figure 1) and HAQ-DI (mean [SD]: IXEQ4W=1.2 [0.6]; IXEQ2W=1.2 [0.6]), indicated impaired physical function and QoL. The percentage of patients of who completed 156 weeks of the study in IXEQ4W and IXEQ2W arms were 57.4% (n=70) and 44.7% (n=55), respectively. Patients receiving IXE treatment up to 3 years reported sustained improvements in SF-36 (PCS and MCS), EQ-5D VAS, and WPAI-SHP (presenteeism, work productivity, and activity impairment) (Figure 1). Observed HAQ-DI mean change from baseline in IXEQ4W: -0.46 (0.62) and IXEQ2W: -0.48 (0.55). The percentage of IXE treated patients achieving MCID for HAQ-DI (improvement ≥0.35) was sustained at 3 years (Figure 2).Figure 1.Summary of Patient-Reported Outcomes presented as change from baseline at Week 156 (Observed and mBOCF): Intent-to-Treat Population (Patients Randomized to IXE at Baseline)Figure 2.Patients achieving HAQ-DI MCID Response up to Week 156 (Observed) and at Week 156 (mNRI) among patients with HAQ-DI≥0.35 at baseline: Intent-to-Treat Population (Patients Randomized to IXE at Baseline)Conclusion:Improvements in PROs, measuring physical and mental function, quality of life, and work productivity are maintained up to 3 years with IXE treatment in patients with active PsA who have had an inadequate response or intolerance to 1 or 2 TNFis.References:[1]Nash P, et al. Lancet. 2017;389(10086):2317-2327.[2]Genovese MC, et al. Rheumatology (Oxford). 2018;57(11):2001-2011.Disclosure of Interests:Ana-Maria Orbai Grant/research support from: Abbvie, Eli Lilly and Company, Celgene, Novartis, Janssen, Horizon, Consultant of: Eli Lilly; Janssen; Novartis; Pfizer; UCB. Ana-Maria Orbai was a private consultant or advisor for Sun Pharmaceutical Industries, Inc, not in her capacity as a Johns Hopkins faculty member and was not compensated for this service., Jordi Gratacos-Masmitja Grant/research support from: a grant from Pfizzer to study implementation of multidisciplinary units to manage PSA in SPAIN, Consultant of: Pfizzer, MSD, ABBVIE, Janssen, Amgen, BMS, Novartis, Lilly, Speakers bureau: Pfizzer, MSD, ABBVIE, Janssen, Amgen, BMS, Novartis, Lilly, Eva Dokoupilova Grant/research support from: Eli Lilly and Abbvie, Bernard Combe Grant/research support from: Novartis, Pfizer, Roche-Chugai, Consultant of: AbbVie; Gilead Sciences, Inc.; Janssen; Eli Lilly and Company; Pfizer; Roche-Chugai; Sanofi, Speakers bureau: Bristol-Myers Squibb; Gilead Sciences, Inc.; Eli Lilly and Company; Merck Sharp & Dohme; Pfizer; Roche-Chugai; UCB, Arnaud Constantin Grant/research support from: Study was sponsored by Sanofi Genzyme, Consultant of: Consulting fees from Abbvie, BMS, Celgene, Gilead, Janssen, Lilly, Novartis, Pfizer, Roche, Sanofi, UCB, Amanda M. Gellett Shareholder of: Eli Lilly and company, Employee of: Eli Lilly and company, Aubrey Trevelin Sprabery Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Julie Birt Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Vladimir Geneus Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Peter Nash Grant/research support from: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly and Company, Gilead, Janssen, MSD, Novartis, Pfizer Inc, Roche, Sanofi, UCB, Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Gilead, Janssen, MSD, Novartis, Pfizer Inc, Roche, Sanofi, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Gilead, Janssen, MSD, Novartis, Pfizer Inc, Roche, Sanofi, UCB


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