scholarly journals AB0558 CLINICAL EFFECTIVENESS AND SAFETY OF ADALIMUMAB VERSUS NON-BIOLOGIC THERAPY IN PSORIATIC ARTHRITIS PATIENTS OVER 24 MONTHS – RESULTS OF THE COMPLETE-PsA CANADIAN OBSERVATIONAL STUDY

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1314-1315
Author(s):  
M. Khraishi ◽  
J. Stewart ◽  
Y. Setty ◽  
M. C. Laliberté ◽  
L. Bessette
Keyword(s):  
Disease Activity ◽  
Global Assessment ◽  
Therapeutic Response ◽  
Clinical Effectiveness ◽  
Advisory Board ◽  
Minimal Disease Activity ◽  
Research Support ◽  
Das 28 ◽  
Minimal Disease ◽  
Response Thresholds

Background:COMPLETE-PsA was an observational study of biologic-naïve Canadian adults with active psoriatic arthritis (PsA) treated with adalimumab or non-biologic disease-modifying anti-rheumatic drugs (nbDMARD) after switch from initial therapy.Objectives:The aim of this analysis was to assess the 24-month clinical effectiveness and safety of adalimumab vs. nbDMARD in the treatment of PsA in a real-life setting.Methods:Eligible patients were biologic naïve adults, with active PsA who required change in their treatment regimen due to inadequate response or intolerance, per the judgment of the treating physician. Patients were enrolled between July/2011 and December/2017 and followed for up to 24 months. Patients were treated as per routine care. The primary endpoint, change in DAS-28 to month 24, was assessed with baseline-adjusted multivariable models and the least square mean (LSM) estimates were generated; Physician’s Global Assessment of disease activity (PGA, 100mm VAS) was assessed using similar methodology. Probability of achieving the following therapeutic response thresholds was ascertained and odds ratios (ORs) were generated: 50%/70% improvement in the American College of Rheumatology criteria (ACR50/ACR70), DAS-28<3.2 (low disease activity or remission; LDA/remission), DAS-28<2.6 (remission), modified minimal disease activity (mMDA: achievement of 5/7 of: TJC and SJC ≤1 each, BSA ≤3%, pain ≤15 (VAS, mm), Patient Global Assessment [PtGA] ≤20, HAQ-DI ≤0.5, and no enthesitis), and psoriasis (PsO) BSA <3%.Results:A total of 277 adalimumab and 148 nbDMARD- treated patients were included as part of the intent-to-treat population. Baseline methotrexate was reported by 61.7% and 81.1% of adalimumab and nbDMARD-treated patients, respectively. PsO BSA at baseline was predominantly <3% for both adalimumab (60.2%) and nbDMARD (64.6%) patients. Adalimumab-treated patients reported significantly (p<0.05) higher mean (SD) disease activity for both DAS-28 [4.8 (1.2) vs. 4.3 (1.1)] and PGA [59.4 (19.5) vs. 51.0 (21.8) mm] at baseline.For the primary endpoint, baseline-adjusted month 24 DAS-28 levels were significantly lower for adalimumab vs. nbDMARD patients [LSM (95%CI): 2.4 (2.2-2.6) vs. 3.0 (2.7-3.3); p=0.037]. In addition, rapid and sustained reductions in DAS-28 were observed for adalimumab-treatment patients, with overall treatment effect significant (p<0.001) in favor of adalimumab [estimate (95%CI): -1.1 (-1.4, -0.7)]; similar results were observed for PGA [-12.9 (-1.7, -8.0)]. Adalimumab-treated patients were at significantly higher (p<0.001) odds of attaining therapeutic response thresholds compared to DMARD-treated patients, specifically: DAS-28 LDA/remission [OR (95%CI): 4.5 (2.8, 7.3)] or remission [OR (95% CI): 4.1 (2.7-6.3)], ACR50 [OR (95% CI): 3.0 (2.0-4.6)], ACR70 [OR (95% CI): 3.1 (2.0-4.9)], mMDA [OR (95% CI): 2.4 (1.6-3.6)], and PsO BSA <3% [OR (95% CI): 2.2 (1.2-3.7)].Overall, 32 (10.7%) of adalimumab-treated patients reported 86 AEs, the most common related to infections [16 events in 10 (3.3%) patients].Conclusion:Real-world treatment with adalimumab was more effective in improving disease activity and psoriasis severity, over 24 months when compared to nbDMARDs and was associated with significantly greater likelihood of achieving minimal disease activity. Observed AEs were consistent with the established safety profile of adalimumab.Disclosure of Interests:Majed Khraishi Speakers bureau: Speaker for AbbVie, Consultant of: Consultant for AbbVie, Grant/research support from: Principal Investigator for AbbVie, Jacqueline Stewart Speakers bureau: Speaker for Abbvie, Janssen, and Johnson & Johnson, Consultant of: Advisory Board Consultant for AbbVie, Amgen, Celgene, Merck, Novartis, Pfizer, and Sanofi-Genzyme;, Grant/research support from: Participated in research with AbbVie, Bristol Myers Squibb, Janssen, and Roche, 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, and Fresenius Kabi, Consultant of: Consultant for Amgen, BMS, Janssen, UCB, AbbVie, Pfizer, Celgene, Lilly, Novartis, Gilead, Sandoz, Samsung Bioepis, and Fresenius Kabi, Grant/research support from: Investigator for Amgen, BMS, Janssen, UCB, AbbVie, Pfizer, Merck, Celgene, Sanofi, Lilly, Novartis, and Gilead.

scholarly journals P261 Continuing versus withdrawing ixekizumab in patients with PsA who achieved sustained minimal disease activity: results from the SPIRIT-P3 study

Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_2) ◽  
Author(s):  
Laura C Coates ◽  
Sreekumar G Pillai ◽  
Lu Zhang ◽  
David Adams ◽  
Lisa Kerr ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Treatment Period ◽  
Median Time ◽  
Safety Data ◽  
Geographic Region ◽  
Minimal Disease Activity ◽  
Research Support ◽  
Minimal Disease ◽  
Time To Relapse

Abstract Background This study evaluated efficacy and safety of continuing vs. withdrawing ixekizumab (IXE), an IL-17A antagonist, in psoriatic arthritis (PsA) patients who achieved sustained minimal disease activity (MDA) on IXE and re-treating with IXE if required. Methods SPIRIT-P3 (NCT02584855) was a multicentre phase 3b study enrolling biologic-naïve patients with active PsA (diagnosis for ≥6 months, meeting classification criteria for psoriatic arthritis, ≥3/68 tender joints, ≥3/66 swollen joints) and previous inadequate response to conventional synthetic DMARDs (csDMARDs). Patients entered a 36-week, open-label (OL) treatment period with IXE every 2 weeks. Between Weeks 36-64, patients were randomised 1:1 to IXE or placebo (PBO) at the visit for which randomisation criteria were met (sustained MDA for at least 4 visits over 3 consecutive months) and evaluated up to Week 104. Patients not meeting randomisation criteria by Week 64 continued IXE up to Week 104. Maintenance of treatment response was measured by time to loss of sustained MDA (relapse) during randomised withdrawal (RW) period. The proportion of patients who relapsed during the first 40 weeks of RW period and time to regain MDA after re-treatment with IXE in relapsed patients were assessed. The Kaplan-Meier product limit method was used to estimate survival curves for time-to variables. Treatment comparisons were performed using a log-rank test adjusting for geographic region and csDMARD use as factors. Cumulative proportion of relapse was analysed using a logistic regression model with treatment, geographic region, and csDMARD use as factors. Safety data were summarised for the entire study period for patients who received ≥1 dose of IXE. Results In total, 394 patients entered the OL treatment period; 158 (40%) achieved sustained MDA criteria and were randomised to IXE (N = 79) or PBO (N = 79). Baseline characteristics were similar between groups. Time to relapse on PBO was significantly shorter than for IXE (p &lt; 0.001) during RW period, with a median time to relapse of 22.3 weeks in the PBO group. The cumulative relapse rate during the first 40 weeks of RW period was 73% for PBO vs. 34% for IXE (p &lt; 0.001). Of those who relapsed on PBO, 96% regained MDA following re-treatment with IXE. The median time to regain MDA was 4.1 weeks (95%CI 4.14-4.29) for PBO and 4.7 weeks (95%CI 4.14-8.29) for IXE. Safety data were consistent with previous IXE PsA studies with no unexpected safety signals. Conclusion Continued IXE therapy was superior to PBO in maintaining MDA in biologic-naïve PsA pts who achieved sustained MDA on initial IXE treatment. A vast majority of patients who lost MDA after IXE withdrawal regained MDA with IXE re-treatment. Continuous IXE treatment is optimal for maintaining MDA; however, patients can regain MDA after re-treatment with IXE in case of treatment interruption. Disclosures L.C. Coates: Corporate appointments; L. Coates is a consultant for: AbbVie, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly and Company, Janssen, MSD, Novartis, Pfizer, Prothena, Sun Pharma, and UCB. Consultancies: L. Coates is a consultant for: AbbVie, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly and Company, Janssen, MSD, Novartis, Pfizer, Prothena, Sun Pharma, and UCB. S.G. Pillai: Corporate appointments; S.G.P. is an employee and shareholder of Eli Lilly and Company. L. Zhang: Corporate appointments; Employee and shareholder of Eli Lilly and Company. D. Adams: Corporate appointments; Employee and shareholder of Eli Lilly and Company. L. Kerr: Corporate appointments; Employee and shareholder of Eli Lilly and Company. M. Hojnik: Corporate appointments; Employee and shareholder of Eli Lilly and Company. G. Gallo: Corporate appointments; Employee and shareholder of Eli Lilly and Company. I. Valter: None. H. Tahir: Grants/research support; H. Tahir has received grants/research support from: AbbVie, Celgene, Eli Lilly and Company, Janssen, and Novartis. V. Chandran: Grants/research support; V. Chandran has received grant/research support from AbbVie, is a consultant for: AbbVie, Amgen, Celgene, Eli Lilly and Company, Janssen, Novartis, Pfizer, and UCB. P. Mease: Consultancies; P. J. Mease is a consultant for and has received grant/research support from: AbbVie, Amgen, BMS, Celgene, Crescendo, Eli Lilly and Company, Genentech, Janssen, Merck, Novartis, Pfizer, UCB, is on the. A. Kavanaugh: Consultancies; A. Kavanaugh is a consultant for Eli Lilly and Company.

Patients with Psoriatic Arthritis Fulfilling the Minimal Disease Activity Criteria Do Not Have Swollen and Tender Joints, but Have Active Skin

2016 ◽  
Vol 43 (5) ◽  
pp. 907-910 ◽  
Author(s):  
Josefina Marin ◽  
María Laura Acosta Felquer ◽  
Leandro Ferreyra Garrot ◽  
Santiago Ruta ◽  
Javier Rosa ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Pain Score ◽  
Global Assessment ◽  
Severity Index ◽  
Minimal Disease Activity ◽  
Analog Scale ◽  
Scale Scores ◽  
Patient Pain ◽  
Minimal Disease

Objective.To evaluate components of the minimal disease activity (MDA) criteria in psoriatic arthritis (PsA).Methods.In patients achieving and not achieving MDA, fulfillment of each of the 7 criteria was evaluated.Results.Among 41 patients with MDA, 7.4% did not fulfill the tender/swollen joint count whereas 49% did not fulfill the skin criteria. Of the 42 patients not fulfilling MDA, 100%, 76.5%, and 65% did not fulfill the patient pain score, the patient’s global assessment, and the Psoriasis Area and Severity Index (PASI), respectively.Conclusion.A minority of patients with PsA fulfilling the MDA criteria presented active joints, but half had active skin. Visual analog scale scores and the PASI prevented patients from achieving MDA.

scholarly journals Application and Modifications of Minimal Disease Activity Measures for Patients with Psoriatic Arthritis Treated with Adalimumab: Subanalyses of ADEPT

2013 ◽  
Vol 40 (5) ◽  
pp. 647-652 ◽  
Author(s):  
Philip J. Mease ◽  
Michele Heckaman ◽  
Sonja Kary ◽  
Hartmut Kupper
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Global Assessment ◽  
Health Assessment ◽  
Severity Index ◽  
Tender Joint Count ◽  
Physician Global Assessment ◽  
Minimal Disease Activity ◽  
Tender Joint ◽  
Minimal Disease

Objective.This posthoc analysis evaluated the percentage of patients with psoriatic arthritis (PsA) who achieved minimal disease activity (MDA) and compared the results with a modified MDA substituting the physician global assessment (PGA) for the Psoriasis Activity and Severity Index (PASI) using data from the ADalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT; NCT00646386).Methods.Patients with active PsA were randomized to receive adalimumab 40 mg or placebo every other week for 24 weeks. MDA was defined as achieving ≥ 5 of the following criteria: tender joint count ≤ 1; swollen joint count ≤ 1; PASI ≤ 1 or body surface area ≤ 3%; patient pain score ≤ 15 [1–100 mm visual analog scale (VAS)]; patient global assessment (PGA) of disease activity ≤ 20 (1–100 mm VAS); Health Assessment Questionnaire ≤ 0.5; and tender entheseal points ≤ 1 (only heels assessed). For modification of the MDA, PASI ≤ 1 was substituted with PGA “Clear” as MDAPGA1 and PGA “Clear” or “Almost clear” as MDAPGA2.Results.Sixty-seven patients were treated with adalimumab and 69 with placebo. At Week 24, MDA, MDAPGA1, and MDAPGA2 were achieved by 39%, 37%, and 39%, respectively, of patients treated with adalimumab versus 7%, 5%, and 8% of patients on placebo (p < 0.001). Kappa coefficients indicated good agreement between PASI and PGA at Week 24.Conclusion.ADEPT results indicated that significantly more patients treated with adalimumab achieved MDA by Week 24 compared with placebo. Modification of the MDA by replacing PASI ≤ 1 with PGA assessments did not alter the results, which may improve feasibility of practical use of the index.

scholarly journals Minimal disease activity is a stable measure of therapeutic response in psoriatic arthritis patients receiving treatment with adalimumab

Rheumatology ◽  
2018 ◽  
Vol 57 (11) ◽  
pp. 1938-1946 ◽  
Author(s):  
Frank Behrens ◽  
Michaela Koehm ◽  
Eva C Schwaneck ◽  
Marc Schmalzing ◽  
Holger Gnann ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Therapeutic Response ◽  
Minimal Disease Activity ◽  
Stable Measure ◽  
Minimal Disease

scholarly journals Exploration of the Product of the 5-Point Investigator’s Global Assessment and Body Surface Area (IGA × BSA) as a Practical Minimal Disease Activity Goal in Patients with Moderate-to-Severe Psoriasis

Dermatology ◽  
2019 ◽  
Vol 235 (4) ◽  
pp. 348-354 ◽  
Author(s):  
Alice B. Gottlieb ◽  
Rebecca Germino ◽  
Vivian Herrera ◽  
Xiangyi Meng ◽  
Joseph F. Merola
Keyword(s):  
Disease Activity ◽  
Surface Area ◽  
Body Surface Area ◽  
Body Surface ◽  
Global Assessment ◽  
Severe Psoriasis ◽  
Minimal Disease Activity ◽  
Cutoff Values ◽  
Pasi Score ◽  
Minimal Disease

Background/Aims: In the treat-to-target era, psoriasis disease activity measures that can be easily performed in routine clinical practice are needed. This retrospective pooled analysis explored cutoff values of the product of the 5-point Investigator’s Global Assessment and percentage of affected body surface area (IGA × BSA) correlating with achievement of minimal disease activity (MDA). Methods: Post hoc analysis of the phase 3 clinical trials ERASURE, FIXTURE, FEATURE, and JUNCTURE was conducted to determine associations between IGA × BSA and 2 MDA definitions (Psoriasis Area and Severity Index [PASI] 90 and Dermatology Life Quality Index [DLQI] 0/1, or PASI score ≤1 or BSA <3%) in patients with moderate-to-severe psoriasis receiving secukinumab 300 mg. For each definition of MDA, a range of possible cutoff values of IGA × BSA was examined at each time point. The optimal cutoff value was determined using Youden index (YI), calculated as (sensitivity + specificity – 1). Results: For MDA defined as PASI 90 and DLQI 0/1, optimal IGA × BSA cutoffs were 2.10 at week 12 (YI, 0.60; sensitivity, 0.78; specificity, 0.82), 1.02 at week 24 (YI, 0.55; sensitivity, 0.73; specificity, 0.82), and 1.00 at week 52 (YI, 0.65; sensitivity, 0.79; specificity, 0.86). For MDA defined as PASI score ≤1 or BSA <3%, optimal IGA × BSA cutoffs were 2.98 at week 12 (YI, 0.91; sensitivity, 0.99; specificity, 0.92), 2.80 at week 24 (YI, 0.94; sensitivity, 0.99; specificity, 0.95), and 3.00 at week 52 (YI, 0.96; sensitivity, 1.00; specificity, 0.96). Conclusion: IGA × BSA could be a valid measure highly associated with achievement of MDA.

scholarly journals FRI0599 USEFUL II: DERIVATION OF THE LUPUS ARTHRITIS AND MUSCULOSKELETAL DISEASE ACTIVITY SCORE (LAMDA) USING DATA FROM A MULTICENTRE LONGITUDINAL STUDY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 905.2-906
Author(s):  
K. Mahmoud ◽  
A. Zayat ◽  
M. Y. MD Yusof ◽  
C. Ciurtin ◽  
C. S. Yee ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Disease Activity ◽  
Effect Size ◽  
Lasso Regression ◽  
Minimal Disease Activity ◽  
Research Support ◽  
Becton Dickinson ◽  
Tender Joint ◽  
Patient Reported ◽  
Minimal Disease

Background:Musculoskeletal (MSK) disease is the commonest manifestation of SLE. We showed that the MSK components of the BILAG index and SLEDAI have limited sensitivity, specificity and responsiveness compared to ultrasound (US) synovitis. The USEFUL study evaluated response to glucocorticoids in SLE patients with inflammatory pain.Objectives:To develop a disease activity tool for lupus MSK manifestations that is continuous, responsive, sensitive, and correlates with US-synovitisMethods:133 patients who received depomedrone 120mg IM were assessed at 0, 2 and 6 weeks for 66/68 swollen and tender joint counts, BILAG2004 index, SLEDAI-2K, physician global and MSK-VAS, inflammatory markers, patient pain and disease activity-VAS. Total US score (OMERACT-EULAR) in the hands and wrists was calculated blinded to patient and clinical assessor. Patients reported overall response using a Likert scale.The LAMDA was developed by modelling a core set of clinical variables against total US score using penalized (Lasso) regression. Responsiveness was compared between LAMDA and other variables at week 6 using effect sizes. Minimum clinically important difference (MCID) was explored using the SEM and minimal disease activity threshold using ROC.Results:The variables selected for the LAMDA score were swollen joint count, patient MSK pain VAS, physician MSK disease activity VAS and ESR. A continuous score was derived. This had a theoretical range from 0 to 26.5 based on maximum ESR of 100. The highest value observed in USEFUL was 15. LAMDA was significantly higher in patients with active US (mean (SD) 5.71 (2.67), n=78) compared to patients with normal US (3.27 (1.77), n=55; difference (95% CI) -2.45 (-3.26, -1.63), t=-5.93, p<0.001). This difference remained significant in patients with no swollen joints (difference (95% CI) -0.71 (-1.40, -0.02), t=-2.06, p=0.044).Effect size was greater for the LAMDA (0.37) than the BILAG-MSK (0.31), SLEDAI-MSK (0.27) and total US score (0.33). In patients with active US at baseline, LAMDA’s effect size was 0.42.The MCID was 0.71 and correlated with patient-reported change in pain. A threshold for minimal disease activity of 3.23 optimized sensitivity (0.77 (0.65, 0.89)) and specificity (0.80 (0.68, 0.92)) against US score >0.Conclusion:The LAMDA score is a novel continuous disease activity instrument for MSK manifestations of SLE derived from variables familiar to rheumatologists. The LAMDA score is sensitive to imaging detected synovitis without swelling and more responsive than other instruments. . LAMDA may improve the ability of clinicians to accurately determine therapeutic efficacy in clinical trials and practice. Future work will validate the LAMDA score in independent cohorts and randomized trials.Acknowledgements:This project was funded by Lupus UKDisclosure of Interests:Khaled Mahmoud: None declared, Ahmed Zayat: None declared, Md Yuzaiful Md Yusof: None declared, Coziana Ciurtin Grant/research support from: Pfizer, Consultant of: Roche, Modern Biosciences, Chee-Seng Yee: None declared, David Isenberg Consultant of: Study Investigator and Consultant to Genentech, Lee-Suan Teh: None declared, Katherine Dutton: None declared, David d’cruz Grant/research support from: GlaxoSmithKline, Nora Ng: None declared, Philip G Conaghan Consultant of: AbbVie, BMS, Eli Lilly, EMD Serono, Flexion Therapeutics, Galapagos, GSK, Novartis, Pfizer, Speakers bureau: AbbVie, Eli Lilly, Novartis, Pfizer, Paul Emery Grant/research support from: AbbVie, Bristol-Myers Squibb, Merck Sharp & Dohme, Pfizer, Roche (all paid to employer), Consultant of: AbbVie (consultant, clinical trials, advisor), Bristol-Myers Squibb (consultant, clinical trials, advisor), Lilly (clinical trials, advisor), Merck Sharp & Dohme (consultant, clinical trials, advisor), Novartis (consultant, clinical trials, advisor), Pfizer (consultant, clinical trials, advisor), Roche (consultant, clinical trials, advisor), Samsung (clinical trials, advisor), Sandoz (clinical trials, advisor), UCB (consultant, clinical trials, advisor), Christopher Edwards Grant/research support from: Abbvie, Biogen, Roche, Consultant of: Abbvie, Samsung, Speakers bureau: Abbvie, BMS, Biogen, Celgene, Fresenius, Gilead, Janssen, Lilly, Mundipharma, Pfizer, MSD, Novartis, Roche, Samsung, Sanofi, UCB, Elizabeth Hensor: None declared, Edward Vital Grant/research support from: AstraZeneca, Roche/Genentech, and Sandoz, Consultant of: AstraZeneca, GSK, Roche/Genentech, and Sandoz, Speakers bureau: Becton Dickinson and GSK

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

Sign in / Sign up

Export Citation Format

Share Document