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

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.

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.

SAT0049 DIFFERENCES BETWEEN EARLY AND ESTABLISHED RHEUMATOID ARTHRITIS IN TIME TO ACHIEVING CDAI BUT NOT FATIGUE LOW DISEASE ACTIVITY AND REMISSION: DATA FROM THE OBRI REGISTRY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 955-956
Author(s):  
J. Pope ◽  
M. Movahedi ◽  
E. Rampakakis ◽  
A. Cesta ◽  
J. Sampalis ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Clinical Care ◽  
Disease State ◽  
Practice Research ◽  
Research Support ◽  
Low Disease Activity ◽  
Early Ra ◽  
Research Initiative ◽  
Patient Reported

Background:Previous studies have shown that early diagnosis and treatment of rheumatoid arthritis (RA) is important for achieving comprehensive disease control and have identified established disease as an independent predictor of worse clinical outcomes. However, it is not clear whether these differences are driven by patient-reported or objective outcome measures.Objectives:The aim of this analysis was to compare the time to achieving low disease activity (LDA) and remission based on both objective and patient-reported outcomes in people with early vs. established RA followed in routine clinical care.Methods:RA patients enrolled in the Ontario Best Practices Research Initiative (OBRI) registry that were not in a low disease state at baseline based on the CDAI, SJC28, PtGA, pain and fatigue criteria below, and had at least six months of follow-up, were included in the analysis. LDA was defined as CDAI≤10, SJC28≤2, TJC28≤2, PtGA≤2cm, pain≤2cm, fatigue≤2cm, and MDGA≤2cm; remission was defined as CDAI≤2.8, SJC28≤1, TJC28≤1, PtGA≤1cm, pain≤1cm, fatigue≤1cm, and MDGA≤1cm. Between group (early vs. established) differences in time to first LDA/remission were assessed with Kaplan-Meier survival analysis and the log-rank test.Results:A total of 986 patients were included, 347 (35%) with early RA and 639 (65%) with established RA. At baseline, patients with early RA were significantly younger (55.8 vs. 58.3 years) and were less likely to have a comorbidity (94.5% vs. 97.5%) or an erosion (26.7% vs. 62.6%), be RF-positive (65.6% vs. 74.2%), use bDMARDs (7.5% vs. 26.6%), and be non-smokers (38.9% vs. 47.3%).Time to achieving LDA based on CDAI (HR [95%CI]: (1.23 [1.07,1.43]), SJC28 (1.32 [1.15,1.51]), TJC28 (1.18 [1.02,1.36]), MDGA (1.28 [1.10,1.49]), PtGA (1.23 [1.05,1.44]), and pain (1.29 [1.09,1.52]) were significantly shorter in early RA compared to established RA. Similarly, time to achieving remission based on CDAI (HR [95%CI]: (1.50 [1.22,1.84]), SJC28 (1.35 [1.17,1.55]), MDGA (1.25 [1.06,1.47]), PtGA (1.22 [1.02,1.47]), and pain (1.37 [1.14,1.65]) were significantly shorter in early RA. However, no differences were observed in time to remission based on TJC28 (1.12 [0.96,1.31]) and either LDA or remission based on fatigue (LDA (1.10 [0.94,1.30]); remission (1.09 [0.92,1.31]).Adjustment for age, gender, presence of comorbidities, and baseline scores did not alter the results.Conclusion:Time to achieving low disease state or remission based on various objective and patient-reported measures is significantly shorter in early compared to established RA with the exception of fatigue.Disclosure of Interests:Janet Pope Grant/research support from: AbbVie, Bristol-Myers Squibb, Eli Lilly & Company, Merck, Roche, Seattle Genetics, UCB, Consultant of: AbbVie, Actelion, Amgen, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Eicos Sciences, Eli Lilly & Company, Emerald, Gilead Sciences, Inc., Janssen, Merck, Novartis, Pfizer, Roche, Sandoz, Sanofi, UCB, Speakers bureau: UCB, Mohammad Movahedi Consultant of: Allergan, Emmanouil Rampakakis: None declared, Angela Cesta: None declared, John Sampalis: None declared, Claire Bombardier Grant/research support from: Dr Bombardier reports sources of funding for Ontario Best Practice Research Initiative Research grants from Abbvie, Janssen, Amgen, Medexus, Merck, Pfizer, and Novartis outside of the submitted work. Consulting Agreements: Abbvie, Covance, Janssen, Merck, Pfizer, Sanofi and Novartis outside of the submitted work. Advisory Board Membership: Hospira, Sandoz, Merck, Pfizer and Novartis outside of the submitted work.

scholarly journals Treatment targets in SLE: remission and low disease activity state

Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_5) ◽  
pp. v19-v28
Author(s):  
Vera Golder ◽  
Michel W P Tsang-A-Sjoe
Keyword(s):  
Disease Activity ◽  
Patient Outcomes ◽  
Patient Reported Outcomes ◽  
Organ Damage ◽  
Treat To Target ◽  
Low Disease Activity ◽  
Patient Reported ◽  
Target States ◽  
Activity State ◽  
Development And Validation

Abstract Treat-to-target strategies have changed the approach to management of many chronic conditions, with improvements in patient outcomes. The key to success of treat to target is the availability of validated treatment endpoints, which have been difficult to derive for SLE, a condition notorious for its heterogeneity. This review will focus on the development and validation of the definitions of remission in SLE framework and the lupus low disease activity state. Lupus low disease activity state is more attainable than remission, with a stepwise concentric relationship between the target states indicating increasing stringency. Both lupus low disease activity state and definitions of remission in SLE remission have been proven to be associated with reduction in disease flares, reduced risk of accrual of irreversible end organ damage, and improvement in patient reported outcomes. These endpoints have therefore provided the key for the development of a treat-to-target approach in clinical practice in SLE and for the design of future clinical trials.

scholarly journals THU0498 PATIENT-REPORTED TREATMENT BURDEN AND ITS IMPACT ON QUALITY OF LIFE IN JUVENILE IDIOPATHIC ARTHRITIS: RESULTS FROM THE PHARMACHILD REGISTRY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 486-487
Author(s):  
A. Alongi ◽  
A. Consolaro ◽  
G. Vijatov-Djuric ◽  
G. Filocamo ◽  
O. Vougiouka ◽  
...  
Keyword(s):  
Medication Adherence ◽  
Disease Activity ◽  
Patient Reported Outcomes ◽  
Sleep Problems ◽  
Psychosocial Health ◽  
Research Support ◽  
School Problems ◽  
Patient Reported ◽  
The Impact

Background:Juvenile Idiopathic Arthritis (JIA) patients experience impaired health and wellbeing due to multiple causes of physical and psychosocial distress, including treatment burden. Despite emerging evidence of its relevance [1], the contribution of treatment adverse events to patient-reported outcomes (PROs) in JIA has been poorly explored.Objectives:To evaluate and rank the impact of patient-reported adverse events (AEs) on overall wellbeing, health-related quality of life (HRQoL), school problems and self-reported medication adherence using data from Pharmachild, a large international JIA pharmacovigilance registry.Methods:Registry entries on 5340 prospective visits of 2251 patients enrolled till December 2018 were analyzed; all included patients were treated with at least one DMARDS or Biologic agent at the time of visit. In the Juvenile Arthritis Multidimensional Assessment Report (JAMAR), patients and parents compiled a checklist of treatments, side effects, self-reported adherence, administration difficulties and disease-related school problems occurred in the previous 4 weeks. Evaluated outcomes included patient acceptable symptom state (PASS), VAS-measured patient assessment of overall wellbeing (PGA) and HRQoL, assessed through the physical health (PhH) and psychosocial health (PsH) subscales. The relationships between AEs and PROs were tested through generalized linear models, accounting for disease activity and symptoms levels. Bayesian Networks were used to explore the causal effects of specific AEs on outcomes to disentangle the confounding role of disease status.Results:AEs were reported in 22.9% of visits. For similar levels of physician global assessment (MD global), patient-assessed disease activity, pain and function, patients reporting AEs had worse PGA, PsH, and lower probability of reaching PASS (fig. 1, all p-values <0.001). The impact of AEs on PGA was small but not trivial (effect size η20.031) and appears to be mediated by effects on PsH and school problems (p <0.001). Non-linear regression modelling revealed a significant moderating effect of MD global levels < 2.5 on the relationship between AEs and PGA (p 0.003), indicating that the impact of AEs is higher for lower disease activity states. AEs predicted self-reported medication adherence (p<0.001), even when adjusted for the number of administered treatments. In the Bayesian network model, mood swing and sleep problems emerged as the most influential items affecting PsH, (respectively, total effect 2.62 and 1.25, both p< 0.001). Fig. 2 shows the total standardized effect of specific AEs on mean PsH levels. Nausea had the highest impact on treatment adherence (total effect -0.0541, p <0.001), being the only AE directly linked to drug refusal.Conclusion:AEs have a measurable effect on the wellbeing and psychosocial health of JIA patients, particularly when disease activity is low, and significantly affect school activity and medication adherence. Mood swings and sleep problems show the strongest influence on HRQoL. Addressing AEs appears important to reduce disease impact, improve patients’ satisfaction and therapeutic compliance.References: :[1]Weitzman, Elissa R., et al. Journal of patient-reported outcomes 2.1 (2018): 1.Acknowledgments:for the Paediatric Rheumatology International Trials Organisation (PRINTO)Disclosure of Interests: :Alessandra Alongi: None declared, Alessandro Consolaro Grant/research support from: Pfizer Inc., AlfaSigma, Speakers bureau: AbbVie, Gordana Vijatov-Djuric: None declared, Giovanni Filocamo: None declared, Olga Vougiouka: None declared, Alma Nunzia Olivieri: None declared, Cristina Herrera Mora: None declared, Wolfgang Emminger: None declared, Angelo Ravelli: None declared, Nicolino Ruperto Grant/research support from: Bristol-Myers Squibb, Eli Lily, F Hoffmann-La Roche, GlaxoSmithKline, Janssen, Novartis, Pfizer, Sobi (paid to institution), Consultant of: Ablynx, AbbVie, AstraZeneca-Medimmune, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lily, EMD Serono, GlaxoSmithKline, Hoffmann-La Roche, Janssen, Merck, Novartis, Pfizer, R-Pharma, Sanofi, Servier, Sinergie, Sobi, Takeda, Speakers bureau: Ablynx, AbbVie, AstraZeneca-Medimmune, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lily, EMD Serono, GlaxoSmithKline, Hoffmann-La Roche, Janssen, Merck, Novartis, Pfizer, R-Pharma, Sanofi, Servier, Sinergie, Sobi, Takeda

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

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