scholarly journals AB0555 IMPACT OF ADALIMUMAB VERSUS NON-BIOLOGIC THERAPY ON CLINICAL AND PATIENT-REPORTED OUTCOMES IN PSORIATIC ARTHRITIS OVER 24 MONTHS – RESULTS OF THE COMPLETE-PsA CANADIAN OBSERVATIONAL STUDY

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1312.2-1313
Author(s):  
M. Khraishi ◽  
S. Silverberg ◽  
Y. Setty ◽  
M. C. Laliberté ◽  
L. Bessette
Keyword(s):  
Psoriatic Arthritis ◽  
Observational Study ◽  
Disease Activity ◽  
Medical Research ◽  
Treatment Effect ◽  
Patient Reported Outcomes ◽  
Disease Burden ◽  
Morning Stiffness ◽  
Research Support ◽  
Patient Reported

Background:COMPLETE-PsA was a Canadian observational study of biologic-naïve adults with active psoriatic arthritis (PsA) treated with adalimumab (ADA) or conventional systemic disease-modifying anti-rheumatic drugs (csDMARDs) after switch from a previous conventional therapy.Objectives:To compare the impact of ADA vs csDMARDs on clinical and patient-reported outcomes due to PsA over 24 months.Methods:Eligible patients were biologic naïve adults with active PsA who required change in their treatment due to inadequate response or non-tolerance, as per treating physician judgement. Patients were enrolled between July/2011 and December/2017 and followed for a maximum 24 months. Treatment was as per routine care. Outcome measures included tender/swollen joint count (TJC/SJC), morning stiffness (min/day), patient’s global assessment of disease activity (PtGA) and pain (both 100 mm VAS), quality of life (DLQI), and functional disability (HAQ-DI). Outcome changes over time were evaluated using multivariable models adjusting for baseline measures. Achievement of modified minimal disease activity [mMDA, 5/7 of: TJC and SJC ≤1 each, psoriasis BSA ≤3%, pain ≤15 (VAS, mm), PtGA ≤20, HAQ-DI ≤0.5, and no enthesitis], and presence of enthesitis and dactylitis, were assessed descriptively. Analyses were conducted in the intent-to-treat population.Results:A total of 277 ADA and 148 csDMARD-treated patients were included in the analysis. At baseline, 61.7% of ADA and 81.1% of csDMARD patients reported concomitant methotrexate. Compared to the csDMARD group, ADA-treated patients demonstrated significantly (p<0.05) greater baseline disease severity with respect to mean (SD) joint count [TJC: 8.9 (6.2) vs. 7.4 (6.6); SJC: 7.4 (5.0) vs. 5.9 (4.6)], morning stiffness [83.5 (98.2) vs. 61.8 (77.4) min/day], PtGA [56.1 (24.1) vs. 45.1 (24.7) mm], pain [58.5 (24.3) vs. 50.1 (24.0) mm], DLQI scores [6.1 (6.9) vs. 4.3 (5.3)] and HAQ-DI [1.1 (0.6) vs. 0.8 (0.6)]. The rate of baseline mMDA was slightly lower for ADA patients (4.3% vs. 7.4%; p=0.178). Baseline prevalence of enthesitis was comparable (ADA: 28.4% vs. csDMARD: 23.4%; p=0.276), while dactylitis was significantly more prevalent for csDMARD patients (26.2% vs. 36.3%; p=0.031).Overall effect of treatment group, over 24 months, significantly (p<0.05) favored the ADA vs. csDMARD-treated patients for TJC [estimate (95%CI): -2.4 (-3.4, -1.4)] SJC [-1.8 (-2.5, -1.2)], PtGA [-3.7 (-9.3, 1.9)], DLQI [-1.5 (-2.5, -0.5)], and HAQ-DI [-0.1 (-0.2, 0.0)] (Figure 1). There was no significant difference for morning stiffness and pain.At month 24, statistically comparable (p>0.05) baseline-adjusted values (the least square means: LSM) were observed for ADA- vs. csDMARD-treated patients for TJC [LSM (95%CI): 1.8 (1.2, 2.4) vs. 3.0 (2.1, 3.8)], SJC [1.2 (0.8, 1.7) vs. 2.1 (1.5, 2.7)], morning stiffness [32.4 (19.1, 45.6) vs. 29.9 (11.1, 48.6) min/day], PtGA [31.6 (28.1, 35.2) vs. 36.9 (31.8, 41.9) mm], pain [35.3 (31.5, 39.0) vs. 38.4 (33.1, 43.7) mm], DLQI [2.9 (2.2, 3.6) vs. 2.9 (2.0, 3.8)], and HAQ-DI [0.7 (0.6, 0.8) vs. 0.9 (0.8, 1.0)].Achievement of mMDA at month 24 was reported by 34.1% and 34.9% of ADA- and csDMARD-treated patients, respectively (p=0.892). Rates of dactylitis (10.6% vs. 10.0%) and enthesitis (9.6% vs. 14.4%) were comparable in the ADA vs. csDMARDs groups respectively.Conclusion:The results of this real-world Canadian study indicate a physician selection bias for treatment with ADA for PsA patients with more severe disease burden, indicated by greater baseline disease activity and PROs. ADA-treated patients experienced a greater treatment effect over 24 months compared to csDMARD-treated patients. However, despite the greater treatment effect of ADA, residual disease burden in the two groups was comparable at 24 months.Acknowledgements:The authors wish to acknowledge JSS Medical Research for their contribution to the statistical analysis, medical writing, and editorial support during the preparation of this abstract. AbbVie provided funding to JSS Medical Research for this work.Disclosure of Interests:Majed Khraishi Speakers bureau: Speaker for AbbVie, Consultant of: Consultant for AbbVie, Grant/research support from: Principal Investigator for AbbVie, Samuel Silverberg Consultant of: Consultant for AbbVie, Janssen, and Pfizer, Yatish Setty Consultant of: Advisory Board meetings with AbbVie and Janssen, Marie-Claude Laliberté Employee of: Employee of AbbVie, Louis Bessette Speakers bureau: Speaker for Amgen, BMS, Janssen, UCB, AbbVie, Pfizer, Merck, Celgene, Lilly, Novartis, Gilead, Sandoz, Fresenius Kabi, Consultant of: Consultant for Amgen, BMS, Janssen, UCB, AbbVie, Pfizer, Celgene, Lilly, Novartis, Gilead, Sandoz, Samsung Bioepis, Fresenius Kabi, Grant/research support from: Investigator for Amgen, BMS, Janssen, UCB, AbbVie, Pfizer, Merck, Celgene, Sanofi, Lilly, Novartis, Gilead.

scholarly journals OP0143 IMPACT OF ADALIMUMAB VERSUS NON-BIOLOGIC THERAPY ON DISEASE ACTIVITY AND PATIENT-REPORTED OUTCOMES IN ANKYLOSING SPONDYLITIS OVER 24 MONTHS – RESULTS OF THE COMPLETE-AS CANADIAN OBSERVATIONAL STUDY

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 84.2-85
Author(s):  
L. Bessette ◽  
A. Chow ◽  
V. Pavlova ◽  
M. C. Laliberté ◽  
M. Khraishi
Keyword(s):  
Ankylosing Spondylitis ◽  
Observational Study ◽  
Disease Activity ◽  
Patient Reported Outcomes ◽  
Disease Burden ◽  
Therapeutic Response ◽  
Morning Stiffness ◽  
Research Support ◽  
Patient Reported ◽  
Response Thresholds

Background:COMPLETE-AS was an observational study among Canadian biologic-naïve adults with active ankylosing spondylitis (AS) treated with either adalimumab or subsequent non-biologic disease-modifying anti-rheumatic drugs and/or non-steroidal anti-inflammatory drugs (nbDMARD/NSAID) after having switched from initial treatment with a preceding nbDMARD and/or NSAID due to lack of response or intolerance, as per treating physician judgement.Objectives:To assess the impact of adalimumab on disease activity and patient-reported outcomes among adalimumab- vs. nbDMARD/NSAID-treated patients over 24 months.Methods:Patients were enrolled between July 2011 and December 2017 and followed for up to 24 months. Treatment was per routine care and all analyses were perfomed using the intent-to-treat (ITT) approach. Between-group differences for change in patient-reported disease activity (BASDAI), morning stiffness (minutes/day), functional limitation (BASFI), quality of life (QoL: SF-12), depression (BDI-II), and work productivity (WLQ) were assessed with repeated measures models for overall treatment effect; baseline-adjusted estimates (least square means [LSM]) for each visit were produced. Achievement of, and time to the following endpoints were assessed: 50% improvement from baseline in BASDAI (BASDAI50); minimum clinically important improvements (MCIIs) in BASDAI (Δ≥1.1); BASFI (Δ≥0.6); SF-12 physical component score (PCS; Δ≥4.4) and mental component score (MCS; Δ≥3.1); and low disease activity for BASDAI (<4) and BASFI (<3.8).Results:A total of 452 adalimumab-treated patients and 187 nbDMARD/NSAID-treated patients were enrolled in the study and included in the analyses. At baseline, mean (SD) BASDAI [6.4 (1.8) vs. 5.0 (1.8); p<0.001] and BASFI [5.5 (2.4) vs. 3.7 (2.4)] were however significantly (p<0.001) higher among adalimumab-treated patients compared to nbDMARD/NSAID-treated patients, respectively.Over 24 months, adalimumab-treated patients had significantly lower overall BASDAI scores compared to nbDMARD/NSAID-treated patients [estimate (95% CI): -0.7 (-1.2, -0.3); p=0.007]. BASFI scores were also significantly lower among adalimumab-treated patients over the course of the study [estimate (95% CI): -0.4 (-0.8, 0.0); p=0.013]. Both groups had statistically comparable outcomes for morning stiffness, BDI-II, WLQ, and SF-12.Adalimumab-treated patients were also at significantly higher odds of achieving therapeutic response thresholds, including BASDAI50 [OR (95% CI): 1.7 (1.2-2.3)], BASDAI<4 [1.8 (1.2-2.7)], MCII for BASDAI [1.9 (13.-2.9)], and MCII for BASFI [1.6 (1.1-1.2)]. Time to achievement of each threshold was significantly shorter among adalimumab-treated patients for BASDAI50 [HR (95% CI): 1.8 (1.1-2.8)], BASDAI<4 [1.7 (1.6-3.6)], and MCII for BASDAI [1.5 (1.0-2.3)]. Time to achievement of MCII for BASFI was not statistically different between groups; for BASFI<3.8 and MCII for both SF-12 PCS and MCS, both odds of, and time to achievement, were also statistically comparable.At month 24, baseline-adjusted BASDAI and BASFI was comparable (p>0.05): LSM (95%CI) 3.5 (3.3, 3.8) vs. 3.6 (3.2-4.0), and 2.9 (2.6-3.1) vs. 3.3 (2.9-3.7), respectively, for adalimumab-treated vs. nbDMARD/NSAID-treated patients.Conclusion:Among Canadian patients with active AS, adalimumab-treated patients reported a greater overall reduction in disease burden related to both self-reported disease activity and functional capacity compared to nbDMARD/NSAID-treated patients, along with higher odds and shorter time to achieving therapeutic response thresholds. Despite the overall beneficial effects observed with adalimumab, residual disease burden, however, is observed for Canadian AS patients even after 24 months of treatment.Acknowledgements:The authors wish to acknowledge JSS Medical Research for their contribution to the statistical analysis, medical writing, and editorial support during the preparation of this abstract. AbbVie provided funding to JSS Medical Research for this work.Disclosure of Interests:Louis Bessette Speakers bureau: Speaker for Amgen, BMS, Janssen, UCB, AbbVie, Pfizer, Merck, Celgene, Lilly, Novartis, Gilead, Sandoz, Fresenius Kabi, Consultant of: Consultant for Amgen, BMS, Janssen, UCB, AbbVie, Pfizer, Celgene, Lilly, Novartis, Gilead, Sandoz, Samsung Bioepis, Fresenius Kabi, Grant/research support from: Investigator for Amgen, BMS, Janssen, UCB, AbbVie, Pfizer, Merck, Celgene, Sanofi, Lilly, Novartis, Gilead, Andrew Chow Speakers bureau: Speaker for AbbVie, BMS, Janssen, Pfizer, Consultant of: Consultant for AbbVie, Amgen, BMS, Celgene, Janssen, Lilly, Merck, Novartis, Pfizer, Roche, Grant/research support from: Investigator for AbbVie, Amgen, BMS, Celgene, Janssen, Lilly, Merck, Novartis, Pfizer, Roche, Viktoria Pavlova Speakers bureau: Speaker for Amgen, Abbvie, BMS, Jenssen, Lilly, Merk, Novartis, Roche, UCB, and Pfizer, Consultant of: Consultant for Amgen, Abbvie, BMS, Jenssen, Lilly, Merk, Novartis, Roche, UCB, and Pfizer, Grant/research support from: Investigator for Janssen, UCB, Abbvie, and Pfizer; and received research grants from UCB, Marie-Claude Laliberté Employee of: Employee of AbbVie, Majed Khraishi Speakers bureau: Speaker for AbbVie, Consultant of: Consultant for AbbVie, Grant/research support from: Principal Investigator for AbbVie

scholarly journals POS0919 BIMEKIZUMAB SHOWS SUSTAINED LONG-TERM IMPROVEMENTS IN PATIENT-REPORTED OUTCOMES AND QUALITY OF LIFE IN ANKYLOSING SPONDYLITIS: 3-YEAR RESULTS FROM A PHASE 2B STUDY

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 720.2-721
Author(s):  
X. Baraliakos ◽  
M. Dougados ◽  
K. Gaffney ◽  
R. Sengupta ◽  
M. Magrey ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Ankylosing Spondylitis ◽  
Patient Reported Outcomes ◽  
Morning Stiffness ◽  
Spinal Pain ◽  
Research Support ◽  
Sf 36 ◽  
Patient Reported ◽  
Full Analysis

Background:Bimekizumab (BKZ), a monoclonal antibody that selectively inhibits interleukin (IL)-17A and IL-17F, has demonstrated clinical efficacy and safety in patients with ankylosing spondylitis (AS) treated over a period up to 96 weeks.1,2Objectives:To report 3-year interim patient-reported outcomes (PROs) in patients with active AS treated with BKZ in a phase 2b dose-ranging study (BE AGILE; NCT02963506) and its open-label extension (OLE; NCT03355573).Methods:BE AGILE study design has been described previously.1 Patients treated with BKZ 160 mg or 320 mg every 4 weeks (Q4W) at Week 48 in BE AGILE were eligible for OLE entry. All OLE patients received BKZ 160 mg Q4W. Outcome measures are reported for the OLE full analysis set (patients who entered the OLE and had ≥1 dose of BKZ and ≥1 valid efficacy variable measurement in the OLE), and include: BASDAI, BASDAI50 responder rate, BASFI, fatigue (BASDAI Q1), morning stiffness (mean of BASDAI Q5 + 6), total spinal pain (numeric rating scale [NRS]), SF-36 PCS and MCS, and ASQoL. Missing data were imputed using multiple imputation (MI; based on the missing at random assumption) for continuous variables and non-responder imputation (NRI) for dichotomous variables.Results:262/303 (86%) patients randomised at BE AGILE study baseline (BL) completed Week 48 on BKZ 160 mg or 320 mg, of whom 255/262 (97%) entered the OLE (full analysis set: 254). From baseline to Week 48 in BE AGILE, BKZ-treated patients showed clinically relevant improvements in disease activity (BASDAI, BASDAI50), physical function (BASFI), fatigue, morning stiffness, spinal pain, and quality of life (SF-36 PCS and MCS, ASQoL) (Figure 1). Group-level improvements in all reported continuous efficacy measures exceeded published minimally important difference (MID), minimum clinically important improvement (MCII), and/or minimum clinically important difference (MCID) thresholds (Figure 1).3,4 Efficacy in all reported outcome measures was maintained or continued to improve from Week 48 to Week 144 or 156 (Figure 1).Conclusion:BKZ treatment was associated with sustained and consistent efficacy in patients with active AS over 3 years, including patient-reported disease activity, physical function, fatigue, morning stiffness, spinal pain, and quality of life.References:[1]van der Heijde D. Ann Rheum Dis 2020;79:595–604.[2]Baraliakos X. Arthritis Rheumatol 2020;72 (suppl 10).[3]Ogdie A. Arthritis Care Res 2020;72 (S10):47–71.[4]Maruish ME. User’s manual for the SF-36v2 Health Survey (3rd ed). 2011; Lincoln, RI: QualityMetric Incorporated.Acknowledgements:This study was funded by UCB Pharma. Editorial services were provided by Costello Medical.Disclosure of Interests:Xenofon Baraliakos Speakers bureau: AbbVie, BMS, Chugai, Eli Lilly, Galapagos, Gilead, MSD, Novartis, Pfizer, UCB Pharma, Paid instructor for: AbbVie, BMS, Chugai, Eli Lilly, Galapagos, Gilead, MSD, Novartis, Pfizer, UCB Pharma, Consultant of: AbbVie, BMS, Chugai, Eli Lilly, Galapagos, Gilead, MSD, Novartis, Pfizer, UCB Pharma, Maxime Dougados Consultant of: AbbVie, Eli Lilly, Novartis, Pfizer and UCB Pharma, Grant/research support from: AbbVie, Eli Lilly, Novartis, Pfizer and UCB Pharma, Karl Gaffney Speakers bureau: AbbVie, Eli Lilly, Novartis, UCB Pharma, Consultant of: AbbVie, Eli Lilly, Novartis, UCB Pharma, Grant/research support from: AbbVie, Gilead, Eli Lilly, Novartis, UCB Pharma, Raj Sengupta Speakers bureau: AbbVie, Biogen, Celgene, MSD, Novartis, UCB Pharma, Consultant of: AbbVie, Biogen, Celgene, Eli Lilly, MSD, Novartis, UCB Pharma, Grant/research support from: AbbVie, Celgene, UCB Pharma, Marina Magrey Consultant of: AbbVie, Eli Lilly, Novartis, Pfizer, UCB Pharma, Grant/research support from: AbbVie, UCB Pharma, Natasha de Peyrecave Employee of: UCB Pharma, Marga Oortgiesen Employee of: UCB Pharma, Thomas Vaux Employee of: UCB Pharma, Carmen Fleurinck Employee of: UCB Pharma, Valerie Ciaravino Employee of: UCB Pharma, Atul Deodhar Speakers bureau: Janssen, Novartis, Pfizer, Consultant of: AbbVie, Amgen, BMS, Boehringer Ingelheim, Celgene, Eli Lilly, Gilead, GSK, Janssen, Novartis, Pfizer, UCB Pharma, Grant/research support from: AbbVie, Eli Lilly, GSK, Novartis, Pfizer, UCB Pharma

O24 Concomitant treatment with MTX does not increase the efficacy of ustekinumab or TFNi in PsA: results from the PsABio study

Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_2) ◽  
Author(s):  
Stefan Siebert ◽  
Elisa Gremese ◽  
Paul Bergmans ◽  
Kurt de Vlam ◽  
Beatriz Joven-Ibáñez ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Real World ◽  
Concomitant Treatment ◽  
Skin Involvement ◽  
Research Support ◽  
Real World Data ◽  
Low Disease Activity ◽  
Intention To Treat ◽  
Patient Reported

Abstract Background The additional benefit of methotrexate (MTX) as a concomitant treatment in PsA has not been fully elucidated for TNF inhibitors (TNFi) and no real-world data on this currently exist for ustekinumab (UST). We investigated the additive effect of MTX on the ability to reach composite treatment targets beyond monotherapy with UST or TNFi, and the ability to improve patient-reported outcomes in a real-world clinical setting in 8 European countries. Methods The PsABio study (NCT02627768) evaluates persistence, effectiveness and tolerability of 1st, 2nd or 3rd-line UST or TNFi in patients with PsA. Proportions of patients reaching minimal disease activity (MDA)/very low disease activity (VLDA) and clinical Disease Activity in Psoriatic Arthritis (cDAPSA) low disease activity (LDA) or remission, as well as the patient acceptable symptom state (PASS; score ≤4) of the 12-item Psoriatic Arthritis Impact of Disease questionnaire (PsAID-12) were evaluated. Here we present 6-month follow-up data using intention to treat (ITT) analysis; patients who stopped/switched initial treatment were imputed as non-responders. The effect of MTX co-therapy was investigated within UST and TNFi cohorts, as well as between the cohorts, using multivariate logistic regression including interaction terms, and propensity score (PS) analysis to adjust for imbalanced, potentially prognostic, baseline covariates. Results Of 930 patients, data was available for 868 ITT patients, including patients who switched/stopped before 6 months (UST: n = 28/426 [6.6%], TNFi: n = 44/442 [10.0%]). At baseline there were no relevant differences in demographics and disease activity, however there were significant differences in skin involvement as well as csDMARD and NSAID exposure. Co-therapy with MTX did not increase the likelihood of achieving any of the outcomes in either the UST or TNFi cohorts (Table 1). After PS adjustment, co-treatment with MTX did not influence treatment effects differently when added to UST compared with TNFi. concomitant use of csDMARDs other than MTX yielded very similar results. Conclusion In a real-world setting, concomitant treatment with MTX in addition to UST or TNFi was not associated with enhanced effects across a broad variety of disease outcomes, including disease activity, disease impact, and skin involvement within or between treatment cohorts, after PS adjustment for baseline confounders. Disclosures S. Siebert: Consultancies; AbbVie, UCB, Pfizer, Janssen, Boehringer Ingelheim, Celgene, Novartis. Grants/research support; Pfizer, Janssen, BMS, Celgene, UCB, Boehringer Ingelheim. E. Gremese: Consultancies; AbbVie, BMS, Celgene, Janssen, Lilly, MSD, Novartis, Sanofi, UCB, Roche, Pfizer. P. Bergmans: Shareholder/stock ownership; Johnson & Johnson. Other; Employee of Janssen. K. de Vlam: Consultancies; Johnson & Johnson. B. Joven-Ibáñez: Member of speakers’ bureau; Celgene, Novartis, MSD, Pfizer, AbbVie, Janssen. G. Katsifis: None. T.V. Korotaeva: Consultancies; Pfizer, MSD, Novartis, AbbVie, Celgene, Biocad, Janssen, UCB, Lilly, Novartis-Sandoz. W. Noël: Other; Employee of Janssen. C. Selmi: None. P.P. Sfikakis: None. P. Smirnov: Other; Employee of Janssen. E. Theander: Other; Employee of Janssen. M.T. Nurmohamed: Grants/research support; Pfizer, AbbVie, Roche, BMS, MSD, Mundipharma, UCB, Janssen, Menarini, Lilly, Sanofi, Celgene. L. Gossec: Honoraria; AbbVie, Celgene, Janssen, Lilly, Novartis-Sandoz, Pfizer, Sanofi, UCB. Grants/research support; Pfizer. J.S. Smolen: Consultancies; AbbVie, Amgen, AstraZeneca, Astro, Celgene, Celtrion, GlaxoSmithKline, ILTOO Pharma, Janssen, Lilly, Medimmune, MSD, Novartis-Sandoz, Pfizer, Roche, Samsung, Sanofi, UCB. Grants/research support; AbbVie, Janssen, Lilly, MSD, Pfizer, Roche.

Secukinumab improves patient-reported outcomes in subjects with active psoriatic arthritis: results from a randomised phase III trial (FUTURE 1)

2016 ◽  
Vol 76 (1) ◽  
pp. 203-207 ◽  
Author(s):  
Vibeke Strand ◽  
Philip Mease ◽  
Laure Gossec ◽  
Ori Elkayam ◽  
Filip van den Bosch ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Patient Reported Outcomes ◽  
Life Quality ◽  
Phase Iii ◽  
Patient Reported ◽  
Related Quality ◽  
Global Disease Activity

ObjectiveTo evaluate the effect of secukinumab on patient-reported outcomes (PROs) in subjects with active psoriatic arthritis (PsA) in the FUTURE 1 study.MethodsSubjects were randomised 1:1:1 to receive intravenous (i.v.) secukinumab 10 mg/kg at weeks 0, 2 and 4 followed by subcutaneous secukinumab 150 or 75 mg every 4 weeks or matching placebo until week 24.ResultsAt week 24, subjects receiving secukinumab i.v.→150 mg or i.v.→75 mg reported greater least squares mean changes from baseline than those receiving placebo in patient global assessment of disease activity (−20.6 and −20.0 vs −7.4, respectively), patient assessment of pain (−20.8 and −20.4 vs −6.7), psoriatic arthritis quality of life (−3.5 and −3.2 vs −0.4), Dermatology Life Quality Index (−8.8 and −7.9 vs 0.7); p<0.0001 vs placebo for both secukinumab groups for above PROs and Functional Assessment of Chronic Illness Therapy-Fatigue (6.74 (p<0.05 vs placebo) and 6.03 vs 4.00); all of which well exceeded minimum clinically important differences.ConclusionsIn subjects with PsA, secukinumab treatment resulted in clinically meaningful improvements in global disease activity, pain, generic and disease-specific measures of health-related quality of life and fatigue.Trial registration numberNCT01392326; Results.

scholarly journals AB0213 THE USE OF MUSCULOSKELETAL ULTRASOUND AND PATIENT REPORTED OUTCOMES TO IDENTIFY THE FACTOR TO GIVE RESIDUAL SYMPTOMS AMONG PATIENTS WITH RHEUMATOID ARTHRITIS IN SDAI-REMISSION OR LOW DISEASE ACTIVITY.

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1407.1-1407
Author(s):  
M. Nawata ◽  
M. Funada ◽  
Y. Fujita ◽  
A. Nagayasu ◽  
K. Someya ◽  
...  
Keyword(s):  
Disease Activity ◽  
Patient Reported Outcomes ◽  
Single Variable ◽  
Research Support ◽  
Low Disease Activity ◽  
Residual Symptoms ◽  
Significant Difference ◽  
Patient Reported ◽  
Stratified Analysis ◽  
Variable Analysis

Background:The goal of treatment in rheumatoid arthritis (RA) is to achieve remission. There is the patient with residual symptoms in the Japanese RA patient who achieved clinical remission. There are not many studies to examine the relation between everyday life, social activity and evaluation of disease activities using musculoskeletal ultrasound (MSKUS).Objectives:To identify the factor to give residual symptoms of RA patients in SDAI-remission (REM) or low disease activity (LDA), using MSKUS.Methods:300 patients were enrolled. The synovitis evaluated gray scale (GS) and power doppler (PD) with 22 both hands joints by MSKUS. We evaluated age, sex, the number of tender joint (TJ) and swelling joint (SJ), the serologic characteristics (CRP, ESR, CCP, RF, MMP-3), Patient Reported Outcomes (PROs) (morning stiffness (MS), pain-VAS, fatigue-VAS), HAQ and EQ5D-5L.Results:(1). Stratified analysis was performed between HAD/MDA group (N=106) and LDA/REM group (N=194). As a result of single variable analysis, many factors were extracted with significant difference. As a result of the multivariate analysis, MTX dose, number of TJ and SJ, MS, fatigue-VAS, HAQ, EQ5D-5L, and GS≧2 were extracted with a dominant difference. (2). For the stratified analysis in GS≧2, the ratio was low, and the disease duration was short significantly in the LDA/REM group. (3). Next, stratified analysis was performed between Low group (N=95) and REM group (N=99). As a result of single variable analysis, number of TJ and SJ, MTX dose, HAQ, EQ5D-5L, MS, pain-VAS, fatigue-VAS, EGA, GS≧1, GS≧2, GS total score, PD≧1 and PD total score were extracted with significant difference. As a result of the multivariate analysis, number of TJ and fatigue-VAS were extracted with a dominant difference.Conclusion:(1). It became clear that the factor which participated in the achievement with SDAI-remission or low disease activity was enough quantity of MTX dose, use of b/t DMARD, US-GS level, residual symptoms (lassitude · pain joint) to be caused by RA. Particularly, the ratio of GS≧2 was low, and the disease was short. (2). In the LDA patients (who do not achieve clinical remission), they had residual symptoms (fatigue and TJ). (3). In the REM patients, remaining inflammation was not seen in MSKUS. The conclusion is that the induction of remission is important from the viewpoint of not only the prevention of joint destruction but also improvement and maintenance of long-term QoL.Disclosure of Interests:MASAO NAWATA Grant/research support from: Eli Lilly Japan K.K., Masashi funada: None declared, YUYA FUJITA: None declared, Atsushi Nagayasu: None declared, Kazuki Someya: None declared, SAITO KAZUYOSHI: None declared, Yoshiya Tanaka Grant/research support from: Asahi-kasei, Astellas, Mitsubishi-Tanabe, Chugai, Takeda, Sanofi, Bristol-Myers, UCB, Daiichi-Sankyo, Eisai, Pfizer, and Ono, Consultant of: Abbvie, Astellas, Bristol-Myers Squibb, Eli Lilly, Pfizer, Speakers bureau: Daiichi-Sankyo, Astellas, Chugai, Eli Lilly, Pfizer, AbbVie, YL Biologics, Bristol-Myers, Takeda, Mitsubishi-Tanabe, Novartis, Eisai, Janssen, Sanofi, UCB, and Teijin

Clinical and Patient-reported Outcomes in Patients with Psoriatic Arthritis (PsA) by Body Surface Area Affected by Psoriasis: Results from the Corrona PsA/Spondyloarthritis Registry

2017 ◽  
Vol 44 (8) ◽  
pp. 1151-1158 ◽  
Author(s):  
Philip J. Mease ◽  
Chitra Karki ◽  
Jacqueline B. Palmer ◽  
Carol J. Etzel ◽  
Arthur Kavanaugh ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Surface Area ◽  
Body Surface Area ◽  
Body Surface ◽  
Patient Reported Outcomes ◽  
Skin Lesions ◽  
Skin Involvement ◽  
Activity Impairment ◽  
Patient Reported

Objective.Psoriatic arthritis (PsA) is commonly comorbid with psoriasis; the extent of skin lesions is a major contributor to psoriatic disease severity/burden. We evaluated whether extent of skin involvement with psoriasis [body surface area (BSA) > 3% vs ≤ 3%] affects overall clinical and patient-reported outcomes (PRO) in patients with PsA.Methods.Using the Corrona PsA/Spondyloarthritis Registry, patient characteristics, disease activity, and PRO at registry enrollment were assessed for patients with PsA aged ≥ 18 years with BSA > 3% versus ≤ 3%. Regression models were used to evaluate associations of BSA level with outcome [modified minimal disease activity (MDA), Health Assessment Questionnaire (HAQ) score, patient-reported pain and fatigue, and the Work Productivity and Activity Impairment questionnaire score]. Adjustments were made for age, sex, race, body mass index, disease duration, and history of biologics, disease-modifying antirheumatic drug, and prednisone use.Results.This analysis included 1240 patients with PsA with known BSA level (n = 451, BSA > 3%; n = 789, BSA ≤ 3%). After adjusting for potential confounding variables, patients with BSA > 3% versus ≤ 3% had greater patient-reported pain and fatigue and higher HAQ scores (p = 2.33 × 10−8, p = 0.002, and p = 1.21 × 10−7, respectively), were 1.7× more likely not to be in modified MDA (95% CI 1.21–2.41, p = 0.002), and were 2.1× more likely to have overall work impairment (1.37–3.21, p = 0.0001).Conclusion.These Corrona Registry data show that substantial skin involvement (BSA > 3%) is associated with greater PsA disease burden, underscoring the importance of assessing and effectively managing psoriasis in patients with PsA because this may be a contributing factor in PsA severity.

scholarly journals Canadian Adalimumab Post-Marketing Observational Epidemiological Study Effectiveness in Psoriatic Arthritis (COMPLETE-PsA): 12-Month Results of Comparative Effectiveness of Adalimumab and nbDMARDs

2022 ◽  
pp. jrheum.200609
Author(s):  
Majed Mustafa Khraishi ◽  
Valencia P. Remple ◽  
Samuel Silverberg ◽  
Jacqueline C. Stewart ◽  
Brandusa Florica ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Patient Reported Outcomes ◽  
Morning Stiffness ◽  
Routine Care ◽  
Inadequate Response ◽  
Lower Baseline ◽  
Patient Reported ◽  
Post Marketing ◽  
A Current ◽  
Disease Modifying Antirheumatic Drug

Objective COMPLETE-PsA was an observational study of biologic-naïve Canadian adults with active psoriatic arthritis (PsA) treated with adalimumab or a non-biologic disease-modifying antirheumatic drug (nbDMARDs) regimen, after inadequate response/intolerance to a current nbDMARD treatment regimen. The aim of this analysis was to assess 12-month effectiveness of adalimumab versus nbDMARDs. Methods Patients enrolled between March 2012 and November 2017 were included. The following clinical parameters and patient-reported outcomes were collected/calculated per routine care: DAPSA28, DAS28, ESR, CRP, MDGA, PtGA, pain, HAQ-DI, SF-12, enthesitis, dactylitis, BSA, and time to achieving ACR50, ACR70 and modified MDA (mMDA). Results Two hundred seventy-seven adalimumab-treated and 148 nbDMARD-treated patients were included. At baseline, adalimumab-treated patients were less likely to be employed; had longer morning stiffness; higher DAPSA28, DAS28, MDGA, PtGA, pain, and HAQ-DI; and lower prevalence of dactylitis (all p<0.05). Adalimumab-treated patients showed lower baseline-adjusted DAPSA28 (16.5 vs. 26.6), DAS28 (2.8 vs. 3.9), MDGA (25.3 vs. 37.1), and ESR (10.2 vs. 15.4 mm/hr) after 3 months compared to nbDMARD-treated patients, with observed improvements maintained to month 12. Time to achievement of ACR50, ACR70, and mMDA was significantly (p<0.01) shorter among adalimumab-treated patients, with the likelihood of having dactylitis [OR: 0.4 (0.2–0.6)] and BSA<3% [2.7 (1.5–5.0)] significantly lower and higher, respectively. Switching to another biologic was less likely in adalimumab-treated vs. nbDMARD -treated patients (HR [95% CI]: 0.3 [0.2-0.5]). Conclusion In a real-world Canadian PsA population, adalimumab was more effective than nbDMARDs at reducing disease activity and the severity of skin involvement and demonstrated higher retention.

AB1097 THE ASSOCIATION OF ULTRASOUND ASSESSMENT AND PATIENT REPORTED OUTCOMES IN RHEUMATOID ARTHRITIS: A SYSTEMATIC LITERATURE REVIEW

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1837.1-1838
Author(s):  
T. Gudu ◽  
M. A. D’agostino
Keyword(s):  
Literature Review ◽  
Disease Activity ◽  
Systematic Literature Review ◽  
Patient Reported Outcomes ◽  
Morning Stiffness ◽  
Self Assessment ◽  
Cross Sectional ◽  
Patient Reported ◽  
Longitudinal Association

Background:Patient reported outcomes (PROs) are recognized to be essential outcome measures in the assessment of patients with rheumatoid arthritis (RA), but they can be prone to being influenced by multiple variables. Thus, objective measures of disease activity, i.e. imaging techniques such as musculoskeletal ultrasound (US) are also of great interest.Objectives:The objective of this study was to determine if and to which extent the US assessment reflects patient perspective in patients with RA.Methods:A systematic literature review was conducted on PubMed and Embase, with the research question being formulated according to the PICO framework. The patient reported domains of health were selected from the ones included in the Core Set for RA [1] and from the ones frequently reported in RA clinical trials and observational studies [2], as well as patient self-assessment of pain or functionality at the joint level. We included articles that evaluated any kind of relationship between PROs and US assessment in RA patients.Results:Out of the 3757 abstracts identified through the systematic literature review, 53 articles were finally included in the qualitative analysis, of which 38 were cross-sectional and 15 were longitudinal studies (figure 1). The most frequently evaluated domains are depicted in table 1.DomainStudies reporting the domainN (%) out of 53 articlesFunction/ disability37 (69.8)Pain25 (47.2)Patient global assessment21 (39.6)Morning stiffness14 (26.4)Quality of life5 (9.4)Global or general health/ well-being5 (9.4)Fatigue4 (7.5)Disease activity1 (1.9)Mood disorders (anxiety/ depression)1 (1.9)Treatment adherence1 (1.9)Disease impact1 (1.9)Foot impact (impairment and participation restriction)1 (1.9)Pain catastrophizing1 (1.9)Table 1.Patient reported domains evaluated in the included studies.Figure 1.Flow chart of the systematic literature reviewCross-sectional studies: Overall, patient joint self-assessment of joint swelling or tenderness had a rather poor agreement with US evaluation but showed a stronger association with the clinical examination at the joint and/ or patient level. In studies evaluating RA patients in remission, disability and patient global assessment (PGA) were associated with Power Doppler (PD) synovitis (r= −0.395 to -0.460), while morning stiffness and patient assessment of flare with PD tenosynovitis (r= 0.29; odds ratio, OR 1.95 [95% CI, 1.17, 3.26]). In studies on RA disease activity, morning stiffness showed good associations with US inflammatory findings, especially PD tenosynovitis (r=0.280 – 0.561; OR 3.0 [95% CI, 1.2-7.5] or OR 10.9 [95% CI,1.2–39.13]) and disability with PD synovitis/ tenosynovitis (r=0.14 -0.55) and US damage/erosions (r=0.16-0.40). Pain, PGA and quality of life (QoL) mainly did not correlate with US assessment.Longitudinal studies: In total, there was no clear, consistent longitudinal association between PROs and US variables in RA studies on remission or treatment response. However, in studies on RA disease activity, there was a strong longitudinal association between disability and US inflammatory scores (r= 0.32 – 0.40; beta: -0.009 to -0.025), but not US damage scores. Additionally, US ankle synovitis and/or tenosynovitis were shown to predict ankle pain (beta: 16.8 [95% CI: 4.81, 28.8]), and to a lesser extent disability.Conclusion:Overall, we found contradictory results regarding the relationship between US evaluation and PROs in RA. While there were some consistent associations such as between disability and US inflammatory and structural findings or between MS and US inflammatory lesions, in particular tenosynovitis, there was no global strong correlation between US and PROs. Therefore, both assessments should be taken into consideration in RA evaluation and management.References:[1]Felson, AR 1993[2]Orbai, Curr Rheumatol Rep 2015Disclosure of Interests:None declared

scholarly journals SAT0434 MINIMAL CLINICALLY IMPORTANT DIFFERENCE IN OUTCOME MEASURES FOR USE IN CLINICAL CARE AND PRAGMATIC TRIALS IN PsA

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1173.1-1174
Author(s):  
A. Ogdie ◽  
M. E. Husni ◽  
J. Scher ◽  
E. Craig ◽  
S. Reddy ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Outcome Measures ◽  
Global Assessment ◽  
Outcome Measure ◽  
Pragmatic Trials ◽  
Research Support ◽  
Patient Reported ◽  
The Mean

Background:While several outcome measures have been studied for use in clinical studies of psoriatic arthritis, little is known about thresholds of meaning such as minimal clinically important improvement (MCII).Objectives:To investigate the distribution of scores for candidate outcome measures for pragmatic trials in PsA and to calculate the MCII for each outcome measure.Methods:We performed a longitudinal cohort study within the Psoriatic Arthritis Research Consortium (PARC), a multi-center study based in the US. Patients completed validated PROs (patient reported outcomes) and rheumatologists completed skin, joint, enthesis and dactylitis scores at therapy initiation and follow up 12-16 weeks later. In addition, patients completed a global assessment of response at the follow up visit, categorizing their status as improved, stayed the same, or worsened and then ratied the importance of the change on a scale from 0-7.1We then calculated and plotted the change in each of the following measures: Routine Assessment of Patient Index Data (RAPID3), clinical Disease Activity of Psoriatic Arthritis (cDAPSA), Patient Reported Outcome Measure Information System (PROMIS) Global Health short form (10a) physical health (PH) subscore, patient pain assessment, patient global assessment (0-10 NRS), and physician global assessments (0-10 NRS) of the joints and overall. We calculated the MCII as the mean change in score (with 95% confidence interval) among patients who reported improvement and rated the level of improvement as “almost none/hardly at all” or “a little important.” Additionally, we calculated Spearman’s correlation coefficients between the measures and the global assessment of response.Results:Among 148 unique patients, 233 therapy change visits were eligible for analysis. The average age was 52.5 years, 52% were female and mean BMI was 29.6. Baseline RAPID3 was 11.1 (SD 6), cDAPSA 17.9 (SD 13.9), PROMIS PH 42 (SD 8), patient global 4.2 (SD 2.5), TJC 5.9 (SD 7.5), and SJC 2.9 (SD 4.5). TNFi comprised 61% of drug initiations, 21% were IL17i and the remainder were other biologics and oral systemic therapies. At follow up, 63 (27%) patients rated themselves as improved whereas 103 (44%) stayed the same and 67 (29%) reported worsening. The mean change in each measure by patient-reported response (improved, stayed the same, or worsened) are shown in Figures 1A & B. In general, the mean score increased from ‘improved’ to ‘worsened’ as expected (with the exception of PROMIS PH which declines given a different direction of scoring). The MCII for each measure was as follows: RAPID3 -1.8 (-4.1 to 0.5), Patient Global -0.6 (-1.6 to 0.4), Physician Global -1 (-1.9 to -0.1), cDAPSA -5.7 (-9.8 to -1.7), and PROMIS PH 1.9 (-2.1 to 5.8). Correlation for each measure with the global assessment of response were: RAPID3 0.48, Patient Global 0.37, Physician Global 0.39, cDAPSA 0.51, and PROMIS PH 0.39.Figure 1A. Distribution of change (median, IQR) in RAPID3, Physician Global, Patient Global, PROMIS10a physical therapy by patient reported response.Conclusion:This is the first study to test thresholds of meaning for these particular measures in PsA. The MCII values are relatively low for all outcome measures. This may be related to the relatively low disease activity at baseline but is consistent with patients seen in clinical practice initiating therapy.2References:[1]Ward MM et al. J Clinical Epi 2014;2Ward MM et al. J Clinical Epi 2015Figure 2B. Distribution of change (median, IQR) in clinical DAPSA by patient reported response.Disclosure of Interests:Alexis Ogdie Grant/research support from: Pfizer, Novartis, Consultant of: Abbvie, Amgen, BMS, Celgene, Corrona, Janssen, Lilly, Pfizer, Novartis, M Elaine Husni Grant/research support from: Pfizer, Consultant of: AbbVie, Bristol-Myers Squibb, Eli Lilly, Janssen, Novartis, Regeneron, and UCB, Jose Scher Consultant of: Novartis, Janssen, UCB, Sanofi., Ethan Craig: None declared, Soumya Reddy Grant/research support from: AmgenCelgeneAbbvie, Consultant of: AmgenPfizerNovartisJaansenUCB, Jessica A. Walsh Grant/research support from: AbbVie, Pfizer, Janssen, Consultant of: AbbVie, Novartis, Eli Lilly and Company, UCB

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