scholarly journals AB1111 PREDICTIVE VALUE OF FLUORESCENCE-OPTICAL IMAGING TECHNIQUE IN DETECTION OF PSORIATIC ARTHRITIS IN PSORIASIS PATIENTS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1845.1-1845
Author(s):  
M. Köhm ◽  
S. Ohrndorf ◽  
T. Rossmanith ◽  
M. Backhaus ◽  
G. R. Burmester ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Early Detection ◽  
Optical Imaging ◽  
Skin Diseases ◽  
Clinical Signs ◽  
Imaging Biomarkers ◽  
Clear Correlation ◽  
Research Support ◽  
Fluorescence Optical Imaging

Background:Psoriasis (Pso) is one of the most common chronic inflammatory skin diseases in Europe. Psoriatic arthritis (PsA) is closely associated to Pso whereas the skin manifestation appears usually years before PsA-related symptoms emerge. Up to 30% of Pso patients develop PsA, but there is no clear correlation between disease duration of Pso and PsA development. Therefore, biomarkers for its early detection are of major importance. In early PsA, changes in synovial vascularisation combined with increased expression of proangiogenic factors appear first. Therefore, imaging biomarkers for detection of changes in vascularisation might be useful for early detection of musculoskeletal disease. Fluorescence-optical imaging (FOI) is a new method to detect changes in microvascularisation of the hands.Objectives:To determine the number of positive PsA diagnosis within a 24 month follow-up period in PsO only patients with subclinical MSK-inflammation detected in FOI.Methods:Sensitivity of FOI for detection of subclinical signs of musculoskeletal inflammation as biomarker for early PsA was observed in a prospective, multicentre study (XCITING) including patients with dermatological confirmed skin psoriasis. 411 patients were included from dermatology care units across Germany without diagnosis of PsA but potential risk factors for its development (nail psoriasis and/or joint pain or swelling within the last 6 months). Clinical examination (CE; swollen (66) and tender (68) joint count, enthesitis, dactylitis assessment) and standardised ultrasound (US) assessment was performed by a qualified rheumatologist to assess musculoskeletal inflammation. FOI was performed additionally. Data was analysed in focus on increased vascularisation of musculoskeletal structures as inflammatory markers. In case of discrepant results (positive FOI and negative CE and US), MRI was performed to prove the findings. In case of MRI negativity, a follow-up period of 24-months was performed including FOI, CE, US and MRI assessment.Results:83 of the 411 patients of the cohort were negative in all assessments (Pso only), 136 of the 411 patients were classified as PsA by rheumatologic assessments. 119 patients showed subclinical signs of musculoskeletal inflammation in the central reading of FOI, whereas CE and US were negative. In 37,5% of those patients, subclinical inflammation was confirmed by MRI assessment. 22 patients of the cohort without MRI positivity were willing to be followed up until month 24. 5 (7.5%) patients developed a clinical PsA until month 24 whereas 7 (10.5%) patients converted to be FOI negative. In 5 patients an additional MRI examination was performed in which one patient showed positive signs for inflammation.Conclusion:FOI is an innovative method for measurement of changes in microvascularisation in the hands. 6/22 patients initial only positive in FOI (no clinical signs for PsA, negative US, negative MRI) developed either clinical evident PsA (n=5) or new inflammation in MRI (n=1) during follow-up of 24 months. Therefore, FOI positive signals in PsO patients increase the probability for PsA development.Figure 1.Flow Chart of the Follow-up period of the XCITING study.Disclosure of Interests:Michaela Köhm Grant/research support from: Pfizer, Janssen, BMS, LEO, Consultant of: BMS, Pfizer, Speakers bureau: Pfizer, BMS, Janssen, Novartis, Sarah Ohrndorf: None declared, Tanja Rossmanith Grant/research support from: Janssen, BMS, LEO, Pfizer, Marina Backhaus Grant/research support from: Pfizer, Gerd Rüdiger Burmester Consultant of: AbbVie Inc, Eli Lilly, Gilead, Janssen, Merck, Roche, Pfizer, and UCB Pharma, Speakers bureau: AbbVie Inc, Eli Lilly, Gilead, Janssen, Merck, Roche, Pfizer, and UCB Pharma, Siegfried Wassenberg: None declared, Benjamin Köhler Grant/research support from: Pfizer, Harald Burkhardt Grant/research support from: Pfizer, Roche, Abbvie, Consultant of: Sanofi, Pfizer, Roche, Abbvie, Boehringer Ingelheim, UCB, Eli Lilly, Chugai, Bristol Myer Scripps, Janssen, and Novartis, Speakers bureau: Sanofi, Pfizer, Roche, Abbvie, Boehringer Ingelheim, UCB, Eli Lilly, Chugai, Bristol Myer Scripps, Janssen, and Novartis, Frank Behrens Grant/research support from: Pfizer, Janssen, Chugai, Celgene, Lilly and Roche, Consultant of: Pfizer, AbbVie, Sanofi, Lilly, Novartis, Genzyme, Boehringer, Janssen, MSD, Celgene, Roche and Chugai

scholarly journals AB1138 ASSESSMENT OF FLUORESCENCE-OPTICAL IMAGING TECHNIQUE OF THE HANDS IN PSORIASIS AND PSORIATIC PATIENTS USING AN INNOVATIVE OBJECTIVE METHOD

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1859.2-1859
Author(s):  
L. Zerweck ◽  
U. Henkemeier ◽  
P. H. Nguyen ◽  
T. Rossmanith ◽  
A. Pippow ◽  
...  
Keyword(s):  
Time Series ◽  
Early Detection ◽  
Optical Imaging ◽  
Skin Diseases ◽  
Imaging Biomarkers ◽  
Research Support ◽  
Scoring Method ◽  
Inflammatory Skin Diseases ◽  
Data Set ◽  
Fluorescence Optical Imaging

Background:Psoriasis (Pso) is one of the most common chronic inflammatory skin diseases in Europe. Psoriatic arthritis (PsA) is closely associated to Pso whereas the skin manifestation appears usually years before PsA-related symptoms emerge. Up to 30% of Pso patients develop PsA, biomarkers for its early detection are of major importance. In early PsA, changes in synovial vascularisation appear first. Imaging biomarkers for detection of changes in vascularisation might be useful for early detection of musculoskeletal disease. Fluorescence-optical imaging (FOI) is a new method to detect changes in microvascularisation of the hands. Each collected data set of the FOI system contains 360 images representing a time progression of the indocyanine green (ICG) distribution.Objectives:To evaluate a reader-independent assessment method for evaluation of FOI in patients with PsO and PsA.Methods:A prospective study including patients with dermatological confirmed skin PsO was performed. 411 patients were included from German dermatology units without PsA diagnosis but potential risk for its development. Clinical examination (CE) was performed by a qualified rheumatologist. For a reader independent evaluation of the FOI images an objective joint-based scoring method was developed. For this method, the joint areas are defined by image segmentation and scored based on generated heatmaps. To calculate a heatmap indicating conspicuous joints from a data set containing 360 images, each pixel is converted to a time series containing 360 values. From this time series, three independent values (features) are extracted: amplitude, average value and maximal slope. Thus, each pixel is reduced to three different feature values. After the three features are determined for each pixel, k-means clustering is performed on each feature. The numbers of centroids (k) are set to 3, 5, 7 and 9. 12 heatmaps (3 features à 4 ks) are calculated, which results in 12 scores for each joint as well. The clusters are then sorted dependent on their centroid value and coloured accordingly to a predefined heatmap colour palette. To finally score each joint, the pixels in the segmented joint area and their assigned cluster are summed and normalized by the area’s amount of pixels and k.Results:271 of the patients were investigated by the newly developed method and compared with the CE scoring. 6426 joints were labeled as healthy whereas 1162 joints were either labeled as swollen, tender or both. The result over all investigated patients for k = 9 is summed in table 1. It is observable that every average and median healthy value is lower than the corresponding affected value.Table 1.Resulting scores for k = 9 for all 271 patients.Feature Statistic valueAmplitudeMeanSlopeHealthyAffectedHealthyAffectedHealthyAffectedAverage0.5030.5280.4860.5090.3950.414Median0.4960.5320.4820.5050.3890.415Conclusion:FOI is an innovative method that detects early changes in vascularization of the hands. So, this method can be useful in early detection of arthritis especially in risk populations such as PsO patients. The results of the objective scoring method show that a clear distinction between healthy and affected joints is possible with the average scores as well as the median values. However, if the range of the scores is considered, the overlap between healthy and affected is not neglectable. Thus, the current scoring system can be used as an indicator but not as a single classification marker. Nevertheless, the research at hand has shown the expected outcome and motivates further development on the heatmap approach.Disclosure of Interests:Lukas Zerweck: None declared, Ulf Henkemeier: None declared, Phuong-Ha Nguyen: None declared, Tanja Rossmanith Grant/research support from: Janssen, BMS, LEO, Pfizer, Andreas Pippow: None declared, Harald Burkhardt Grant/research support from: Pfizer, Roche, Abbvie, Consultant of: Sanofi, Pfizer, Roche, Abbvie, Boehringer Ingelheim, UCB, Eli Lilly, Chugai, Bristol Myer Scripps, Janssen, and Novartis, Speakers bureau: Sanofi, Pfizer, Roche, Abbvie, Boehringer Ingelheim, UCB, Eli Lilly, Chugai, Bristol Myer Scripps, Janssen, and Novartis, Frank Behrens Grant/research support from: Pfizer, Janssen, Chugai, Celgene, Lilly and Roche, Consultant of: Pfizer, AbbVie, Sanofi, Lilly, Novartis, Genzyme, Boehringer, Janssen, MSD, Celgene, Roche and Chugai, Michaela Köhm Grant/research support from: Pfizer, Janssen, BMS, LEO, Consultant of: BMS, Pfizer, Speakers bureau: Pfizer, BMS, Janssen, Novartis

scholarly journals AB1099 EVALUATION OF DIFFERENT FLUORESCENCE-OPTICAL IMAGING (FOI) ASSESSMENT METHODS TO DIFFERENTIATE CLINICAL PSORIATIC ARTHRITIS FROM PSORIASIS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1839.2-1839
Author(s):  
L. Haan ◽  
U. Henkemeier ◽  
A. C. Foldenauer ◽  
H. Burkhardt ◽  
F. Behrens ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Optical Imaging ◽  
Assessment Methods ◽  
Imaging Biomarkers ◽  
Stable Phase ◽  
Phase 2 ◽  
Research Support ◽  
Maximum Score ◽  
Fluorescence Optical Imaging ◽  
Significant Difference

Background:Psoriasis (Pso) is one of the most common chronic inflammatory skin diseases in Europe. Psoriatic arthritis (PsA) is closely associated to Pso whereas the skin manifestation appears usually years before PsA-related symptoms emerge. Up to 30% of Pso patients develop PsA, but there is no clear correlation between disease duration of Pso and PsA development. In early PsA, changes in synovial vascularisation combined with increased expression of proangiogenic factors appear first. Therefore, imaging biomarkers for detection of changes in vascularisation might be useful for early detection of musculoskeletal disease. Fluorescence-optical imaging (FOI) is an indocyanine green (ICG) tailored method to detect microvascular changes in the hands using ICG kinetics over 360 sec. Different methods for assessment of FOI are available. It has not yet been demonstrated to what extent these methods can be used to differentiate psoriasis from psoriasis arthritis.Objectives:To evaluate different reader dependent assessment methods to evaluate FOI in psoriasis and psoriatic arthritis.Methods:FOI data (clinical PsA n=137, PsO without PsA n=202) from an observational prospective multicentre trial in Germany was used for manual assessment of the films using two different published assessment methods:(1) FOI activity score (FOIAS) and (2) individual characteristics of ICG kinetics. For (1) FOIAS, the levels of signal enhancement were scored using a scoring system from 0 to 3 (0=no enhancement, 3=strong enhancement) per joint as well as an assessment of the summation picture. (2) Kinetics were determined by joint-related signal enhancements as well as by ICG related flow-on and flow-off behaviour. Time to the first appearance of the signal, the time to the maximum enhancement and the time to the end of the signal were determined.Results:By use of (1) FOIAS, the maximum score (overall signals of all joints assessed by FOIAS) showed a significant difference (p=0.0075) between PsA (mean 4.76) and PsO (mean 3.84). (2) Time to global maximum showed no significant difference (PsA mean 91.1 sec vs PsO 92.6 sec). Moreover, the mean time to maximum and clearance of ICG did not differ between the two diseases. The duration of the 3 phases of kinetic (phase 1: flow-in, phase 2: stable, phase 3: clearance) was 52.4 sec, 180.2 sec and 119.8 sec for PsA and 57.6 sec, 186.0 sec and 130.5 sec for PsO with an earlier phase 2 and 3 for PsA by trend. The most frequently affected joints in PsA (affected > 10%): PIP 3 right and PIP 5 right.Conclusion:FOI is a sensitive method to detect changes in microvascularisation in the hands. The use of the manual FOIAS is able to differentiate significantly between PsA and PsO patients by comparison of the sum of scores over all joints (maximum score). The assessment of ICG kinetics is limited to discriminate between musculoskeletal and joint disease, differentiation of diseases is only seen by trend. Both methods characterize disease states differently. A combination of both methods might be useful to increase the potential of manual assessment of FOI signals.Figure 1.Maximum sum score of FOIAS in PsO and PsA patients (p=0.0075 in two-sided t-test).Disclosure of Interests:Luis Haan: None declared, Ulf Henkemeier: None declared, Ann Christina Foldenauer: None declared, Harald Burkhardt Grant/research support from: Pfizer, Roche, Abbvie, Consultant of: Sanofi, Pfizer, Roche, Abbvie, Boehringer Ingelheim, UCB, Eli Lilly, Chugai, Bristol Myer Scripps, Janssen, and Novartis, Speakers bureau: Sanofi, Pfizer, Roche, Abbvie, Boehringer Ingelheim, UCB, Eli Lilly, Chugai, Bristol Myer Scripps, Janssen, and Novartis, Frank Behrens Grant/research support from: Pfizer, Janssen, Chugai, Celgene, Lilly and Roche, Consultant of: Pfizer, AbbVie, Sanofi, Lilly, Novartis, Genzyme, Boehringer, Janssen, MSD, Celgene, Roche and Chugai, Michaela Köhm Grant/research support from: Pfizer, Janssen, BMS, LEO, Consultant of: BMS, Pfizer, Speakers bureau: Pfizer, BMS, Janssen, Novartis

scholarly journals SAT0407 FOLLOW-UP EXAMINATION FOR THE DETECTION OF POTENTIAL PSORIATIC ARTHRITIS BY FLUORESCENCE OPTICAL IMAGING – IN COMPARISON TO MUSCULOSKELETAL ULTRASOUND

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1155.2-1156
Author(s):  
J. Büttner ◽  
A. M. Glimm ◽  
G. Kokolakis ◽  
M. Erdmann-Keding ◽  
G. R. Burmester ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Optical Imaging ◽  
Dropout Rate ◽  
Musculoskeletal Ultrasound ◽  
Group Iii ◽  
Fluorescence Optical Imaging ◽  
Group I ◽  
Group Ii ◽  
Inflammatory Changes

Background:Up to 30% of all plaque-type psoriasis patients develop psoriatic arthritis (PsA) (1). Early diagnosis of PsA can be difficult due to its heterogenous manifestation and the lack of disease- specific biomarkers, but it is crucial for disease outcome. Recently, our group has shown that fluorescence optical imaging (FOI) can be a helpful diagnostic tool for early PsA diagnosis since it can differentiate between patients with confirmed PsA and suspected PsA (2).Objectives:To follow-up patients by FOI with confirmed and suspected PsA with special focus on the group of patients in which PsA could be confirmed between baseline and follow-up – and to compare with the findings of musculoskeletal ultrasound (US).Methods:Patients included in our previous study (1) were re-evaluated by FOI of both hands in a standardized manner using the predefined phases 1-3 (p1-p3) and the PrimaVistaMode (PVM). US in greyscale (GS) and power Doppler (PD) were performed of the clinically dominant hand (for tenderness and/or swelling) in the dorsal and palmar view at wrist, MCP, PIP and DIP 2-5 joint levels for synovitis and tenosynovitis.Subsequently, a comparison of the findings in the affected joints was performed using US as the reference method. Furthermore, AUC was calculated to show the extent to which a new joint inflammation was associated with a change in diagnosis.Results:Of the 60 patients initially examined (1), 30 patients (dropout rate 50%) were followed-up approximately 3 years later. The patients were newly divided into 3 groups: Diagnosed PsA (n=14, Group I), still suspected PsA, (n=6, Group II) and in-between diagnosed PsA (n=10, Group III). Patients with a change in the diagnosis from suspected to diagnosed PsA (Group III) showed a significantly increased prevalence of joints with pathological findings in FOI (46% at baseline, 88% at follow-up; p=0.046), with an unchanged joint distribution pattern, i.e. with a dominant involvement of the DIP joints. Compared to baseline, patients of group III were three times more common to show enrichment in p3 in FOI at follow-up (1.7% vs. 7.0%; p=n.s.). Newly detected pathologic joints by FOI (PVM, p2) and US at follow-up were positively associated with the change of diagnosis from suspected PsA to confirmed PsA (FOI: AUC 0.78; GSUS: AUC 0.77).Using US in greyscale as reference, inflammatory changes in the joints were diagnosed in all 3 cohorts by means of FOI in P1 and P3 with high specificity (Group III: 90.6%, Group II: 97.5%, Group I: 94.2%) and low sensitivity (Group III: 24.4%, Group II: 20.3%, Group I: 19.8%).Conclusion:FOI appears to be helpful to differentiate between acute and chronic disease stages. Furthermore, it is specific for detecting inflammatory changes in the joints of the hands in PsA – in comparison to US. FOI could thereby become a helpful tool as a “dermatological-screening” method to select psoriasis patients with indication for further rheumatological evaluation.References:[1]Zachariae H. Prevalence of Joint Disease in Patients with Psoriasis: Implications for therapy. Am J Clin Dermatol. 2003;4(7):441–447. Review.[2]Erdmann-Keding M, Ohrndorf S, Werner SG, et al. Fluorescence optical imaging for the detection of potential psoriatic arthritis in comparison to musculoskeletal ultrasound. J Dtsch Dermatol Ges. 2019;17(9):913-921.Disclosure of Interests:Juliane Büttner: None declared, Anne-Marie Glimm: None declared, Georgios Kokolakis: None declared, Magdalena Erdmann-Keding: None declared, Gerd Rüdiger Burmester Consultant of: AbbVie Inc, Eli Lilly, Gilead, Janssen, Merck, Roche, Pfizer, and UCB Pharma, Speakers bureau: AbbVie Inc, Eli Lilly, Gilead, Janssen, Merck, Roche, Pfizer, and UCB Pharma, Jens Klotsche: None declared, Sarah Ohrndorf: None declared

scholarly journals POS1021 THE PsABio STUDY IN ITALY: A REAL-WORLD COMPARISON OF THE PERSISTENCE, EFFECTIVENESS AND SAFETY OF USTEKINUMAB AND TUMOUR NECROSIS FACTOR INHIBITORS IN PATIENTS WITH PSORIATIC ARTHRITIS

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 778-779
Author(s):  
E. Gremese ◽  
F. Ciccia ◽  
C. Selmi ◽  
G. Cuomo ◽  
R. Foti ◽  
...  
Keyword(s):  
Adverse Event ◽  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Tumour Necrosis Factor ◽  
Tumour Necrosis ◽  
Research Support ◽  
Treatment Persistence ◽  
Low Disease Activity ◽  
Necrosis Factor

Background:There are still unmet needs in the treatment of psoriatic arthritis (PsA), including in terms of treatment persistence, which is a function of effectiveness, safety and patient satisfaction. Ustekinumab (UST) was the first new biologic drug to be developed for the treatment of PsA after tumour necrosis factor inhibitors (TNFi).Objectives:To compare treatment persistence, effectiveness and safety of UST and TNFi in Italian patients within the PsABio cohort.Methods:PsABio (NCT02627768) is an observational study of 1st/2nd/3rd-line UST or TNFi treatment in PsA in 8 European countries. The current analysis set includes 222 eligible patients treated in 15 Italian centres, followed to Month 12 (±3 months). Treatment persistence/risk of stopping was analysed using Kaplan−Meier (KM) and Cox regression analysis. Proportions of patients reaching minimal disease activity (MDA)/very low disease activity (VLDA) and clinical Disease Activity Index for PsA (cDAPSA) low disease activity (LDA)/remission were analysed using logistic regression, including propensity score (PS) adjustment for imbalanced baseline covariates, and non-response imputation of effectiveness endpoints if treatment was stopped/switched before 1 year. Last observation carried forward data are reported.Results:Of patients starting UST and TNFi, 75/101 (74.3%) and 77/121 (63.6%), respectively, persisted with treatment at 1 year. The observed mean persistence was 410 days for UST and 363 days for TNFi. KM curves and PS-adjusted hazard ratios confirmed significantly higher persistence (hazard ratio [95% confidence interval (CI)]) for UST versus TNFi overall (0.46 [0.26; 0.82]; Figure 1). Persistence was also higher for UST than TNFi in patients receiving monotherapy without methotrexate (0.31 [0.15; 0.63]), in females (0.41 [0.20; 0.83]), and in patients with body mass index (BMI) <25 kg/m2 (0.34 [0.14; 0.87]) or >30 kg/m2 (0.19 [0.06; 0.54]). There was no significant difference in persistence between treatments in patients with BMI 25−30 kg/m2. While patients receiving 1st- and 3rd-line UST or TNFi showed similar risk of discontinuation (0.60 [0.27; 1.29] and 0.36 [0.10; 1.25], respectively), patients receiving 2nd-line UST showed better persistence than those receiving 2nd-line TNFi (0.33 [0.13; 0.87]). Other factors added to the PS-adjusted Cox model did not show significant effects. In patients with available follow-up data, the mean (standard deviation) baseline cDAPSA was 26.3 (15.4) for UST and 23.5 (12.3) for TNFi; at 1-year follow-up, 43.5% of UST- and 43.6% of TNFi-treated patients reached cDAPSA LDA/remission. MDA was reached in 24.2% of UST- and 28.0% of TNFi-treated patients, and VLDA in 12.5% of UST- and 10.2% of TNFi-treated patients. After PS adjustment (stoppers/switchers as non-responders), odds ratios (95% CI) at 1 year did not differ significantly between UST and TNFi groups for reaching cDAPSA LDA/remission (1.08 [0.54; 2.15]), MDA (0.96 [0.45; 2.05]) or VLDA (0.98 [0.35; 2.76]). In total, 23 (20.4%) patients reported ≥1 treatment emergent adverse event with UST and 30 (22.2%) with TNFi; 6 (5.3%) and 10 (7.4%) patients, respectively, discontinued treatment because of an adverse event.Conclusion:In the Italian PsABio cohort, UST had better overall persistence compared with TNFi, as well as in specific subgroups: females, patients on monotherapy without methotrexate, with BMI <25 or >30 kg/m2, and patients receiving UST as 2nd-line treatment. At 1 year, both treatments showed similar effectiveness, as measured by cDAPSA responses and MDA/VLDA achievement.Acknowledgements:This study was funded by Janssen. Contributing author: Prof. Piercarlo Sarzi-Puttini, ASST Fatebenefratelli-Sacco, University of Milan, ItalyDisclosure of Interests:Elisa Gremese: None declared, Francesco Ciccia Speakers bureau: AbbVie, Abiogen, Bristol-Myers Squibb, Celgene, Janssen, Lilly, Novartis, Pfizer, Roche, Consultant of: Celgene, Janssen, Lilly, Novartis, Pfizer, Roche, Grant/research support from: Celgene, Janssen, Novartis, Pfizer, Roche, Carlo Selmi Speakers bureau: AbbVie, Alfa-Wassermann, Amgen, Biogen, Celgene, Eli Lilly, Gilead, Janssen, MSD, Novartis, Pfizer, Sanofi-Genzyme, Consultant of: AbbVie, Alfa-Wassermann, Amgen, Biogen, Celgene, Eli Lilly, Gilead, Janssen, MSD, Novartis, Pfizer, Sanofi-Genzyme, Grant/research support from: AbbVie, Amgen, Janssen, Pfizer, Giovanna CUOMO: None declared, Rosario Foti Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Lilly, MSD, Janssen, Roche, Sanofi, Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Lilly, MSD, Janssen, Roche, Sanofi, Marco Matucci Cerinic Speakers bureau: Actelion, Biogen, Janssen, Lilly, Consultant of: Chemomab, Grant/research support from: MSD, Fabrizio Conti Consultant of: AbbVie, Bristol-Myers Squibb, Galapagos, Lilly, Pfizer, Enrico Fusaro Speakers bureau: AbbVie, Amgen, Lilly, Grant/research support from: AbbVie, Pfizer, Giuliana Guggino Speakers bureau: AbbVie, Celgene, Novartis, Pfizer, Sandoz, Grant/research support from: Celgene, Pfizer, Florenzo Iannone Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Lilly, MSD, Novartis, Pfizer, Sanofi, UCB, Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Lilly, MSD, Novartis, Pfizer, Sanofi, UCB, Andrea Delle Sedie: None declared, Roberto Perricone: None declared, Luca Idolazzi Speakers bureau: AbbVie, Eli Lilly, Janssen, MSD, Novartis, Sandoz, Paolo Moscato: None declared, Elke Theander Employee of: Janssen, Wim Noel Employee of: Janssen, Paul Bergmans Shareholder of: Johnson & Johnson, Employee of: Janssen, Silvia Marelli Employee of: Janssen, Laure Gossec Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Biogen, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, Samsung Bioepis, Sanofi-Aventis, UCB, Grant/research support from: Amgen, Galapagos, Janssen, Lilly, Pfizer, Sandoz, Sanofi, Josef S. Smolen Speakers bureau: AbbVie, Amgen, AstraZeneca, Astro, Bristol-Myers Squibb, Celgene, Celltrion, Chugai, Gilead, ILTOO, Janssen, Lilly, MSD, Novartis- Sandoz, Pfizer, Roche, Samsung, Sanofi, UCB, Grant/research support from: AbbVie, AstraZeneca, Lilly, Novartis, Roche.

FRI0362 COMPARATIVE EFFECTIVENESS OF USTEKINUMAB (UST) AND TNF INHIBITORS (TNFI) IN PATIENTS WITH PSORIATIC ARTHRITIS (PSA) IN THE REAL-WORLD, MULTINATIONAL PSABIO STUDY: 12-MONTH FOLLOW-UP

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 778-779
Author(s):  
J. S. Smolen ◽  
S. Siebert ◽  
T. Korotaeva ◽  
P. Bergmans ◽  
K. De Vlam ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Real World ◽  
Activity Index ◽  
Treatment Options ◽  
Disease Activity Index ◽  
Rapid Screening ◽  
Research Support ◽  
Real World Data

Background:Among treatment options for PsA, IL-12/23 inhibition with UST was the first new biologic mode of action after TNFi. Few real-world data comparing UST with TNFi are available.Objectives:Comparison of UST and TNFi treatment effectiveness within the prospectively followed PsABio cohort at 12-month (mo) follow-up.Methods:The PsABio study (NCT02627768) evaluates effectiveness, tolerability and persistence of 1st, 2nd or 3rd-line UST or TNFi in PsA. Proportions of patients (pts) reaching MDA/very low disease activity (VLDA) and clinical Disease Activity index for PSoriatic Arthritis (cDAPSA) LDA/remission are described. Comparison across UST and TNFi cohorts was done on last observation carried forward up to 12 (±3) mo, with non-response imputation for pts who had stopped/switched initial treatment. Logistic regression analysis was used, including propensity score (PS) analysis to adjust for imbalanced prognostic baseline (BL) covariates: country, age, sex, BMI, smoking (yes/no), comorbidities (cardiovascular/metabolic syndrome), PsA type (axial, polyarticular, oligoarticular), psoriasis body surface area (BSA), disease duration, cDAPSA, 12-item PsA Impact of Disease (PsAID-12), dactylitis, enthesitis, Fibromyalgia Rapid Screening Tool (FiRST) score, line of biologic (b)DMARD, synthetic DMARD use, and steroid or NSAID use.Results:Of 929 eligible pts, 893 had evaluable data at BL and at follow-up; 438 (95.6%) were treated with UST and 455 (96.6%) with TNFi (including stoppers/switchers). UST and TNFi groups had BL differences in mean age (51.0 vs 48.5 years, respectively), concurrent comorbidities (68.7% vs 60.9%), time since diagnosis (7.5 vs 6.2 years), line of treatment (1st-line 45.0% vs 55.2%; 3rd-line 20.5% vs 12.1%), NSAID use (54.8% vs 68.8%), concomitant MTX use (29.9% vs 42.0%) and psoriasis skin involvement (BSA >10% in 26.6% vs 14.8%).In 714 pts with available data, mean (standard deviation) BL cDAPSA was 30.6 (20.2; n=358) for UST and 29.3 (18.6; n=356) for TNFi. Observed data showed differences in proportion of pts achieving MDA/VLDA and cDAPSA LDA/remission in favour of TNFi, but after PS adjustment for BL differences (such as line of therapy, skin psoriasis, concomitant conventional DMARD, etc.), odds ratios for reaching targets at 12 mo did not significantly differ between UST and TNFi groups (Fig. 1).Comparison of 6- and 12-mo unadjusted data showed sustained MDA/VLDA responses with both UST (21.8%) and TNFi (29.5%), with comparable proportions of additional pts achieving these targets between 6 and 12 mo (17.0% and 20.3%, respectively). Sustained efficacy became lower with successive lines of treatment (data not shown).Conclusion:Various factors, including patient characteristics such as comorbidities, influence the physician’s selection of treatment modality for patients needing a bDMARD. Our real-world results demonstrate differences in observed clinical effectiveness between UST and TNFi. However, after PS adjustment for a number of BL differences, clinical results at 12 mo were comparable between UST and TNFi groups. Data at 12 mo also show sustained response with both UST and TNFi treatment, as well as a similar rate of pts achieving targets after 6 to 12 mo of treatment.Acknowledgments:This study was funded by Janssen.Disclosure of Interests:Josef S. Smolen Grant/research support from: AbbVie, AstraZeneca, Celgene, Celltrion, Chugai, Eli Lilly, Gilead, ILTOO, Janssen, Novartis-Sandoz, Pfizer Inc, Samsung, Sanofi, Consultant of: AbbVie, AstraZeneca, Celgene, Celltrion, Chugai, Eli Lilly, Gilead, ILTOO, Janssen, Novartis-Sandoz, Pfizer Inc, Samsung, Sanofi, Stefan Siebert Grant/research support from: BMS, Boehringer Ingelheim, Celgene, GlaxoSmithKline, Janssen, Novartis, Pfizer, UCB, Consultant of: AbbVie, Boehringer Ingelheim, Janssen, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, Celgene, Janssen, Novartis, Tatiana Korotaeva Grant/research support from: Pfizer, Consultant of: Abbvie, BIOCAD, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Novartis-Sandoz, Pfizer, UCB, Speakers bureau: Abbvie, BIOCAD, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Novartis-Sandoz, Pfizer, UCB, Paul Bergmans Shareholder of: Johnson & Johnson, Employee of: Janssen, Kurt de Vlam Consultant of: Celgene Corporation, Eli Lilly, Novartis, Pfizer, UCB – consultant, Speakers bureau: Celgene Corporation, Eli Lilly, Novartis, Pfizer, UCB – speakers bureau and honoraria, Elisa Gremese Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Sanofi, UCB, Roche, Pfizer, Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Sanofi, UCB, Roche, Pfizer, Beatriz Joven-Ibáñez Speakers bureau: Abbvie, Celgene, Janssen, Merck Sharp & Dohme, Novartis, Pfizer, Wim Noel Employee of: Janssen Pharmaceuticals NV, Michael T Nurmohamed Grant/research support from: Abbvie, Bristol-Myers Squibb, Celltrion, GlaxoSmithKline, Jansen, Eli Lilly, Menarini, Merck Sharp & Dohme, Mundipharma, Pfizer, Roche, Sanofi, USB, Consultant of: Abbvie, Bristol-Myers Squibb, Celltrion, GlaxoSmithKline, Jansen, Eli Lilly, Menarini, Merck Sharp & Dohme, Mundipharma, Pfizer, Roche, Sanofi, USB, Speakers bureau: Abbvie, Bristol-Myers Squibb, Celltrion, GlaxoSmithKline, Jansen, Eli Lilly, Menarini, Merck Sharp & Dohme, Mundipharma, Pfizer, Roche, Sanofi, USB, Petros Sfikakis Grant/research support from: Grant/research support from Abvie, Novartis, MSD, Actelion, Amgen, Pfizer, Janssen Pharmaceutical, UCB, Elke Theander Employee of: Janssen-Cilag Sweden AB, Laure Gossec Grant/research support from: Lilly, Mylan, Pfizer, Sandoz, Consultant of: AbbVie, Amgen, Biogen, Celgene, Janssen, Lilly, Novartis, Pfizer, Sandoz, Sanofi-Aventis, UCB

scholarly journals Detection of subclinical skin manifestation in patients with psoriasis and psoriatic arthritis by fluorescence optical imaging

2020 ◽  
Author(s):  
Angelique Schmidt ◽  
Anne-Marie Glimm ◽  
Ida Kristin Haugen ◽  
Paula Hoff ◽  
Gabriela Schmittat ◽  
...  
Keyword(s):  
Risk Factors ◽  
Body Weight ◽  
Psoriatic Arthritis ◽  
Optical Imaging ◽  
Correct Diagnosis ◽  
Skin Inflammation ◽  
The Body ◽  
Healthy Controls ◽  
Healthy Individuals ◽  
Fluorescence Optical Imaging

Abstract Objectives: To investigate the frequency of subclinical skin inflammation in both hands by fluorescence optical imaging (FOI) in patients with psoriasis/psoriatic arthritis (Pso/PsA) vs. rheumatoid arthritis (RA) and healthy individuals, and to correlate these findings with cardiovascular (CV) risk factors.Patients and Methods: The FOI scans were analyzed retrospectively to detect clinically invisible skin enhancement (0-3 scale) in both hands without relationship to underlying joints or blood vessels. We further characterized the FOI patterns and sorted the scans into groups based on the assumed diagnosis (Pso/PsA, RA and healthy controls), which was compared with the physician’s diagnosis. Furthermore, the associations between CV risk factors and imaging findings were investigated by regression analyses.Results: We included FOI scans of patients with Pso/PsA (n=80), RA (n=78) and healthy controls (n=25). Subclinical skin enhancement on the back of their hands was more common in Pso/PsA (72.5%) than in RA patients (20.5%) and healthy individuals (28.0%) (p<0.001). Based on the FOI pattern, the majority of patients with Pso/PsA (72.5%), RA (76.9%) and healthy controls (68.0%) were classified correctly using the physician-based diagnosis as reference (overall agreement of 74%, kappa=0.57). No CV risk factors except body weight (kg) was associated with subclinical skin enhancement (OR 1.04, 95% CI 1.02-1.06; p<0.001). Conclusion: Subclinical subdermal skin inflammation was common in Pso/PsA patients using FOI. Based on the FOI pattern, most patients with Pso/PsA and were classified with the correct diagnosis. We demonstrated an important influence of the body weight on our FOI results. FOI may be a helpful novel tool to study microcirculation in rheumatic diseases with skin involvement.

scholarly journals OP0224 FILGOTINIB TREATMENT LEADS TO RAPID AND SUSTAINED REDUCTIONS IN INFLAMMATORY BIOMARKERS IN PATIENTS WITH MODERATE TO SEVERE PSORIATIC ARTHRITIS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 140.1-140
Author(s):  
D. D. Gladman ◽  
W. Jiang ◽  
A. Hertz ◽  
V. Malkov ◽  
O. K. Yoon ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Proinflammatory Cytokines ◽  
Clinical Signs ◽  
Signs And Symptoms ◽  
Matrix Remodeling ◽  
Research Support ◽  
Serum Samples ◽  
Cytokines And Chemokines ◽  
Clinical Signs And Symptoms

Background:Psoriatic arthritis (PsA) is a chronic inflammatory musculoskeletal disease characterized by musculoskeletal and cutaneous inflammation. In the recent EQUATOR study (NCT03101670), patients (pts) with active PsA receiving the oral, selective Janus kinase 1 (JAK1) inhibitor filgotinib (FIL) had significant and sustained improvements versus placebo (PBO) in clinical signs and symptoms. We present here updated results of the EULAR 2019 presentation of EQUATOR on circulating biomarkers in PsA.Objectives:To evaluate the impact of FIL on the levels of circulating proinflammatory cytokines and chemokines, adhesion molecules, and markers of matrix remodeling in EQUATOR pts with active PsA.Methods:EQUATOR was a 16-week, double-blind, multicenter, Phase 2 study in pts with active PsA. Pts were randomized 1:1 to FIL 200 mg (n=65) or PBO (n=66) once daily. Serum samples (FIL n=60 and PBO n=61) were collected at baseline (BL) and at Weeks 1, 4, and 16. The association of BL biomarkers with PsA disease characteristics was analyzed by Spearman’s rank-order correlation. Biomarker changes from BL were assessed in time-paired serum samples using multiplex and high sensitivity ELISA-based assays. Analytes were grouped by hierarchical clustering; treatment effect on a biomarker was defined as a difference in change from BL between pts receiving FIL versus PBO. Improvements in PsA clinical signs and symptoms were determined by assessing changes from BL in a number of clinical disease activity scores including psoriatic arthritis disease activity score (PASDAS), psoriasis area and severity index (PASI) and disease activity index for psoriatic arthritis (DAPSA) scores.Results:BL levels of numerous biomarkers were associated (p<0.05) with clinical measures of PsA. Several clusters of biomarkers were identified based on the rate and magnitude of FIL treatment response. Cluster 1 included biomarkers with substantial reductions from BL with FIL by week 1, such as the acute phase proteins CRP and SAA (>50%), and the inflammatory mediators IL-6, CXCL10, and IL-23 (>25%). Cluster 2 included biomarkers of cell adhesion (ICAM-1, VCAM1) with a 5%–15% reduction from BL with FIL by week 1. Cluster 3 included biomarkers of matrix remodeling (MMP1, SC1M) with a delayed >25% reduction from BL with FIL that was significant by Week 4. Finally, Cluster 4 included biomarkers with a modest (5%–10%) increase from BL with FIL (Eotaxin, IL-15, and adiponectin). Spearman rank correlation analyses showed that at BL, many biomarkers were positively associated with disease scores, and tended to segregate between psoriasis weighted scores such as PASI and arthritis weighted scores such as DAPSA. The observed decrease in proinflammatory cytokines were associated with on-treatment improvements from BL in disease score for pts receiving FIL.Conclusion:Compared with PBO, FIL significantly decreased BL levels of circulating biomarkers associated with PsA disease activity, including proinflammatory cytokines and chemokines, adhesion molecules, and markers of matrix remodeling. The observed decreases in circulating proinflammatory cytokines and biomarkers of both bone pathobiology and psoriatic disease suggest that FIL improves PsA clinical signs and symptoms at a molecular level. These findings are consistent with reduced disease activity in pts with PsA and suggest that FIL treatment leads to a rapid and sustained reduction of inflammation in PsA.Acknowledgments:This study was funded by Gilead Sciences, Inc. Editorial support was provided by Fishawack Communications Inc and funded by Gilead Sciences, Inc.Disclosure of Interests:Dafna D Gladman Grant/research support from: AbbVie, Amgen Inc., BMS, Celgene Corporation, Janssen, Novartis, Pfizer, UCB – grant/research support, Consultant of: AbbVie, Amgen Inc., BMS, Celgene Corporation, Janssen, Novartis, Pfizer, UCB – consultant, Wendy Jiang Shareholder of: Gilead Sciences Inc., Employee of: Gilead Sciences Inc., Angie Hertz Shareholder of: Gilead Sciences Inc, Employee of: Gilead Sciences Inc, Vlad Malkov Shareholder of: Gilead Sciences Inc., Employee of: Gilead Sciences Inc., Oh Kyu Yoon Shareholder of: Gilead Sciences Inc., Employee of: Gilead Sciences Inc., Mona Trivedi Shareholder of: Amgen and Gilead Sciences, Employee of: Gilead Sciences, Muhsen Alani Employee of: Gilead Sciences, Lene Vestergaard Shareholder of: Gilead Sciences Inc., Employee of: Gilead Sciences Inc., Robin Besuyen Shareholder of: Galapagos, Employee of: Galapagos, René Galien Shareholder of: Galapagos, Employee of: Galapagos, Amer M. Mirza Shareholder of: Gilead Sciences Inc., Employee of: Gilead Sciences Inc., Vinod Chandran Grant/research support from: Abbvie, Celgene, Consultant of: Abbvie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lily, Janssen, Novartis, Pfizer, UCB, Employee of: Spouse employed by Eli Lily

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