scholarly journals Remission, low disease activity and improvement of pain and function in psoriatic arthritis patients treated with IL-12/23 and IL-17 inhibitors. A multicenter prospective study

Reumatismo ◽  
2020 ◽  
Vol 72 (1) ◽  
pp. 52-59 ◽  
Author(s):  
F.M. Perrotta ◽  
A. Delle Sedie ◽  
S. Scriffignano ◽  
P. Volpe ◽  
E. Cordisco ◽  
...  

The development of new biologic and targeted synthetic DMARDs can lead to good disease control. The aim of the present study was to assess the rate of remission and low disease activity, and the improvement of pain and function, in psoriatic arthritis (PsA) patients treated with new anti-IL-12/23 and anti-IL-17 biologic agents. A prospective 6-month study was performed. Patients fulfilling the CASPAR criteria for PsA that started ustekinumab, secukinumab and ixekizumab were enrolled and prospectively followed in a setting of clinical practice. Patients were considered in minimal disease activity (MDA), when they met at least 5/7 of the criteria previously defined. DAPSA score ≤4 was also evaluated as a remission criterion. Pain on VAS, PtGA and HAQ were also assessed in all patients. Patients achieving MDA were compared to non-MDA to identify outcome predictive factors. Of the 70 patients treated with ustekinumab, secukinumab and ixekizumab, at baseline, no patients were in MDA or had a DAPSA score ≤4. Ten patients (14.2%) were lost during the follow-up. After 6 months, MDA was achieved in 22 (31.4%) patients. DAPSA≤4 was achieved in 17 (24.2%) patients. Significant improvement in pain, PtGA and HAQ was also found. Patients naïve to anti-TNF treatment achieved more frequently MDA compared to anti-TNF-experienced patients. Male sex, high levels of CRP and absence of comorbidities were found to be predictors of MDA. In our prospective observational study, MDA was achieved in 31.4% and DAPSA remission in 24.2% of patients treated with inhibitors of IL-12/23 and IL-17, thus making this target achievable in PsA patients treated with these drugs.

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 778-779
Author(s):  
E. Gremese ◽  
F. Ciccia ◽  
C. Selmi ◽  
G. Cuomo ◽  
R. Foti ◽  
...  

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.


Rheumatology ◽  
2018 ◽  
Vol 58 (5) ◽  
pp. 869-873 ◽  
Author(s):  
Sravan Kumar Appani ◽  
Phani Kumar Devarasetti ◽  
Rajendra Vara Prasad Irlapati ◽  
Liza Rajasekhar

Abstract Objective Despite the widespread clinical use of MTX in PsA, data from published randomized controlled studies suggest limited efficacy. The objective of the present study was to document the efficacy of MTX. Methods This was an open-label, prospective study of patients satisfying the ClASsification criteria for Psoriatic ARthritis study (CASPAR) criteria for PsA who received MTX in doses of ⩾15 mg/week throughout the follow-up period of 9 months. Disease activity was assessed across various domains by tender and swollen joint count, physician and patient global assessment, DAS-28 ESR, Clinical Disease Activity Index for PsA (cDAPSA), Leeds Dactylitis Instrument basic, Leeds Enthesitis Index (LEI), Psoriasis Area and Severity Index (PASI), Minimal Disease Activity and HAQ (CRD Pune version) at baseline and at 3, 6 and 9 months of follow-up. Response to therapy was assessed by EULAR DAS28 ESR, Disease Activity Index for PsA (cDAPSA) response, HAQ response and PASI75. MTX dose escalation and the use of combination DMARDS were dictated by disease activity. Results A total of 73 patients were included, with mean (s.d.) age 44 (9.7) years. The mean (s.d.) dose of MTX used was 17.5 (3.8) mg/week. Seven patients received additional DMARDS (LEF/SSZ). At the end of 9 months, significant improvement (P < 0.05) was noted in the tender joint count, swollen joint count, global activity, DAS-28ESR, cDAPSA, Leeds Dactylitis Index basic, LEI, PASI and HAQ. Major cDAPSA response was achieved in 58.9% of patients. EULAR DAS28 moderate and good response was achieved in 74% and 6.8% of patients, respectively. Minimal Disease Activity was achieved in 63% of patients. A PASI75 response and HAQ response was achieved in 67.9% and 65.8% of patients, respectively. Conclusion MTX initiated at ⩾15 mg/week with targeted escalation resulted in significant improvement in the skin, joint, dactylitis, enthesitis and functional domains of PsA.


2015 ◽  
Vol 43 (2) ◽  
pp. 371-375 ◽  
Author(s):  
Laura C. Coates ◽  
Philip S. Helliwell

Objective.To explore the relationship between minimal disease activity (MDA) and the low disease activity cutoffs of the Psoriatic ArthritiS Disease Activity Score (PASDAS) and the Composite Psoriatic Disease Activity Index (CPDAI).Methods.Data from the GRAPPA (Group for Research and Assessment of Psoriasis and Psoriatic Arthritis) composite exercise (GRACE) study were used for these analyses. Alternative definitions of low disease activity were used with 6/7 and 7/7 of MDA items, and a criteria set mandating the 2 articular items and 3/5 alternate items (MDA-joints). Two reference questions were used as anchors: physician’s global opinion of MDA, and patient’s opinion on their disease control.Results.Substantial agreement was found between MDA, MDA-joints, PASDAS, and CPDAI. Compared to the 2 reference questions, the various definitions of low disease activity gave sensitivities that were generally worse than specificities, the latter being high (> 0.9) in most cases. Both PASDAS and CPDAI demonstrated good discrimination between the “low” and “high” disease activity states by all the MDA definitions. Using these data, with an MDA of 7/7 to define a very low disease cutoff, the corresponding values for PASDAS and CPDAI were 1.9 and 2, respectively.Conclusion.An MDA score of 7/7 is proposed as very low disease activity in psoriatic arthritis. Using this definition, the equivalent cutoffs for PASDAS and CPDAI are 1.9 and 2, respectively.


Rheumatology ◽  
2019 ◽  
Vol 58 (12) ◽  
pp. 2212-2220 ◽  
Author(s):  
Philipp Bosch ◽  
Rusmir Husic ◽  
Anja Ficjan ◽  
Judith Gretler ◽  
Angelika Lackner ◽  
...  

Abstract Objective To evaluate low disease activity (LDA) cut-offs in psoriatic arthritis (PsA) using ultrasound. Methods Eighty-three PsA patients underwent clinical and ultrasound examinations at two visits. LDA was assessed using the Disease Activity index for Psoriatic Arthritis (DAPSA ⩽ 14), the Psoriatic ArthritiS Disease Activity Score (PASDAS ⩽ 3.2), the Composite Psoriatic Disease Activity Index ⩽ 4, the DAS28-CRP ⩽ 2.8 and the minimal disease activity criteria. Ultrasound was performed at 68 joints and 14 entheses. Minimal ultrasound disease activity (MUDA-j/e) was defined as a Power Doppler score ⩽ 1, respectively at joints, paratendinous tissue, tendons and entheses. A global ultrasound score was calculated by summing Grey Scale and Power Doppler information (GUIS-j/e). Results LDA was present in 33.7–65.0% at baseline and in 44.3–80.6% at follow-up, depending on the criteria used. MUDA-j/e was observed in 16.9% at baseline and in 30% at follow-up. GUIS-j/e was significantly higher in patients with moderate/high disease activity vs LDA according to DAPSA and PASDAS at baseline and DAPSA, PASDAS, Composite Psoriatic Disease Activity Index and minimal disease activity at follow-up. Patients in moderate/high disease activity had MUDA-j/e in 8.1–21.4% at baseline and in 8.3–20.0% at follow-up, depending on the applied clinical composite. MUDA-j/e patients with moderate/high disease activity had higher levels of pain and pain-related items than those with LDA. Conclusion The LDA cut-offs of DAPSA, PASDAS, Composite Psoriatic Disease Activity Index, minimal disease activity, but not DAS28-CRP are capable of distinguishing between high and low ultrasound activity. Pain and pain-related items are the main reason why PsA patients without signs of ultrasound inflammation are classified with higher disease activity.


2019 ◽  
Vol 46 (7) ◽  
pp. 710-715 ◽  
Author(s):  
Ruben Queiro ◽  
Juan D. Cañete ◽  
Carlos Montilla ◽  
Miguel Angel Abad ◽  
María Montoro ◽  
...  

Objective.To examine the grade of agreement between very low disease activity (VLDA) and Disease Activity Index for Psoriatic Arthritis (DAPSA) remission, as well as their association with the effect of the disease as assessed by the Psoriatic Arthritis Impact of Disease (PsAID) questionnaire in patients with psoriatic arthritis in routine clinical practice.Methods.Posthoc analysis of data from a cross-sectional multicenter study. Patients were included who fulfilled the Classification for Psoriatic Arthritis (CASPAR) criteria with at least 1 year of disease duration and were treated with biological and/or conventional synthetic disease-modifying antirheumatic drugs according to routine clinical practice in Spain. Patients were considered in VLDA if they met 7/7 of the minimal disease activity criteria. DAPSA and clinical (c)DAPSA score ≤ 4 identified remissions.Results.Of the 227 patients included in the original study, 26 (11.5%), 52 (22.9%), and 65 (28.6%) were in VLDA, DAPSA remission, and cDAPSA remission, respectively. There was a moderate agreement between VLDA and DAPSA remission (κ = 0.52) or cDAPSA remission (κ = 0.42). Patients with VLDA had less effect of the disease as measured by PsAID [mean total score (SD): VLDA 1.1 (1.2); DAPSA remission 1.3 (1.5); cDAPSA remission 1.7 (1.6)]. There was a moderate agreement between DAPSA remission or cDAPSA remission and PsAID < 4 (κ = 0.46 and κ = 0.58 respectively), while poor agreement (κ = 0.18) was found between VLDA and PsAID < 4.Conclusion.VLDA criteria seem to be more stringent for assessing a status of remission; however, DAPSA remission shows better correlation with a patient-acceptable symptoms state than VLDA does.


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1134.2-1134
Author(s):  
V. Rybakova ◽  
A. Avdeeva ◽  
Y. Olyunin ◽  
E. Nasonov

Background:Current guidelines for the treatment of rheumatoid arthritis (RA) recommend early administration of methotrexate (MTX) and addition of a biologic if MTX monotherapy does not provide remission or low activity of the disease. Efficacy of this strategy in real clinical practice was assessed using data from the Russian RA registry OREL.Objectives:To analyze long-term results of intensive treatment initiated at RA onset in real clinical practice.Methods:141 RA patients with disease duration less than 3 years (29 men, 112 women) were included. 112 were positive for rheumatoid factor and 119 – for anti-cyclic citrullinated peptide antibody. Subcutaneous MTX was initiated at 10-15 mg per week with further dose escalation up to 20-30 mg per week. Therapy was adjusted every 3 months. If MTX monotherapy did not allow to achieve treatment target of remission or low disease activity, biologics were added.Results:Median DAS 28 at baseline was 5,31 [4,79; 6,14]. Initiation of treatment resulted in steady decrease of disease activity (p<0.05, table1). After 1 year of follow-up 33.8% of patients received MTX monotherapy, 33.8% – MTX in combination with tumor necrosis factor alpha inhibitors, 22.0% – MTX +abatacept, 0.55% – MTX+ tocilizumab, 0.47% – MTX + rituximab. Low disease activity was achieved in 16.3% patients, and remission - in 45.8%. After 6 years median age of patients was 58 [49; 66] years, disease duration – 84 [79; 89] months, low disease activity was documented in 21.3%, and remission – in 7.8% of cases (fig. 1). 7% of patients were able to maintain remission without any treatment. Biologics were discontinued in 15 patients after achieving remission or low disease activity, and synthetic DMARDs – in 5 patients having remission.Conclusion:Intensive therapy initiated at RA onset demonstrates high effectiveness, allowing 61.5% of patients to achieve low disease activity or remission within 12 months, and to maintain these results after 6 years of treatment in 29.2%. Adherence to this strategy allowed to discontinue biologics in 15 patients and synthetic DMARDs in 5 patients after achieving treatment target.Figure 1.Changes of the disease activity during follow-upTable 1.Changes of the main inflammatory activity measures, Me [25th; 75th percentile]Parametres012 months6 yearsDAS285,31 [4,79; 6,14]2,85 [2; 3,90] *4,008 [3,4; 4,59] *SDAI28,27 [18,79; 40,73]5,67 [2; 11,98] *15,06 [9,32; 21] *CDAI25 [17; 36]5 [1,7; 11] *15 [9; 21] *ESR (mm/hr)32 [19; 50]16 [8; 30] *16 [10; 25] *CRP (mg/l)26,55 [6,4; 45,30]3,85 [1,5; 11,3]*2,2 [0,9; 4,9] ** p<0.05 in all cases.Disclosure of Interests:None declared


2018 ◽  
Vol 78 (2) ◽  
pp. 201-208 ◽  
Author(s):  
Clémence Gorlier ◽  
Ana-Maria Orbai ◽  
Déborah Puyraimond-Zemmour ◽  
Laura C Coates ◽  
Uta Kiltz ◽  
...  

BackgroundThe objective was to compare different definitions of remission and low disease activity (LDA) in patients with psoriatic arthritis (PsA), based on both patients’ and physicians’ perspectives.MethodsIn ReFlap (Remission/Flare in PsA; NCT03119805), adults with physician-confirmed PsA and >2 years of disease duration in 14 countries were included. Remission was defined as very low disease activity (VLDA), Disease Activity index for PSoriatic Arthritis (DAPSA) ≤4, and physician-perceived and patient-perceived remission (specific question yes/no), and LDA as minimal disease activity (MDA), DAPSA <14, and physician-perceived and patient-perceived LDA. Frequencies of these definitions, their agreement (prevalence-adjusted kappa), and sensitivity and specificity versus patient-defined status were assessed cross-sectionally.ResultsOf 410 patients, the mean age (SD) was 53.9 (12.5) years, 50.7% were male, disease duration was 11.2 (8.2) years, 56.8% were on biologics, and remission/LDA was frequently attained: respectively, for remission from 12.4% (VLDA) to 36.1% (physician-perceived remission), and for LDA from 25.4% (MDA) to 43.9% (patient-perceived LDA). Thus, patient-perceived remission/LDA was frequent (65.4%). Agreement between patient-perceived remission/LDA and composite scores was moderate to good (kappa range, 0.12–0.65). When patient-perceived remission or LDA status is used as reference, DAPSA-defined remission/LDA and VLDA/MDA had a sensitivity of 73.1% and 51.5%, respectively, and a specificity of 76.8% and 88.0%, respectively. Physician-perceived remission/LDA using a single question was frequent (67.6%) but performed poorly against other definitions.ConclusionIn this unselected population, remission/LDA was frequently attained. VLDA/MDA was a more stringent definition than DAPSA-based remission/LDA. DAPSA-based remission/LDA performed better than VLDA/MDA to detect patient-defined remission or remission/LDA. Further studies of long-term outcomes are needed.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 508-508
Author(s):  
M. Moly ◽  
C. Lukas ◽  
J. Morel ◽  
B. Combe ◽  
G. Mouterde

Background:Psoriatic arthritis (PsA) is a heterogeneous disease and its assessment is sometimes difficult. Perception of disease activity by patient and physician is frequently discordant in patients in clinical remission. Ultrasound (US) is an imaging technique, which can detect inflammation in PsA.Objectives:The aim of our study was to assess whether persistence of disease activity evaluated by the patient, considered in remission by his rheumatologist, was associated with inflammation measured by US.Methods:We performed a transversal monocentric study. PsA patients were included if they met the CASPAR criteria and were considered in remission by their rheumatologist. Demographic data, characteristics of the disease and treatments were collected. Discordance was defined by a difference between patient’s and rheumatologist’s global assessment ≥30/100 on a Visual Analogic Scale. An US examination was performed on 50 joints, 28 tendons and 14 entheses by an independent investigator. Synovial or tendon sheath hypertrophy and PD signal were evaluated on a semi-quantitative scale, B Mode and PD signal abnormalities on entheses were searched, according to the EULAR-OMERACT scoring system. US remission was defined by no power Doppler (PD) signal on joints, tendons and entheses and minimal US activity by maximum one PD signal on the same sites. Univariate and multivariate analyses were performed to evaluate factors associated with US abnormalities.Results:Sixty-two PsA patients were included. 40.3% were women, the mean (SD) age was 55 (14) years, 42% were in US remission and 71% in minimal US activity (Table 1), 19.4% had ≥1 PD synovitis and 88.7% had a B mode synovitis, 95.2% had a B mode abnormality on entheses and 51.6% had ≥1 PD signal on entheses. Thirty nine percent had a discordant disease activity assessment with their rheumatologist. In univariate analysis, discordance was not associated with US remission (OR=1.71 (95%CI 0.61-4.83), p=0.224) or US minimal disease activity (OR=0.99 (95%CI 0.32-3.05), p=0.602). In multivariate analysis, US remission was independently associated with female gender (OR=3.94 (95%CI 1.20-12.9), p=0.024) and younger age (OR=0.95 (95%CI 0.91-0.99), p=0.027). Minimal US activity was associated with history of enthesis lesion (OR=11.26 (95%CI 1.34-94.93), p=0.026) and age (OR=0.95 (95%CI 0.90-1), p=0.044).Table 1.Ultrasound characteristics of the 62 PsA patients.N (%)Ultrasound remission26 (41.9)Ultrasound minimal disease activity44 (71)Patients with ≥1 grey scale synovitis55 (88.7)Patients with ≥1 Power Doppler synovitis12 (19.4)Patients with ≥1 grey scale tenosynovitis15 (24.2)Patients with ≥1 Power Doppler tenosynovitis1 (1.6)Patients with ≥1 grey scale enthesitis lesion (thickness, hypo echogenicity, calcification, enthesophyte, erosion, bursitis)59 (95.2)Patients with ≥1 Power Doppler enthesitis32 (51.6)Conclusion:Our study showed persistent inflammation evaluated by US in PsA patients considered in remission by their rheumatologist. However, prevalence of residual inflammation evaluated by US was not higher in patients with self-assessment of their disease discordant from their rheumatologist.Disclosure of Interests:Marie Moly: None declared, Cédric Lukas: None declared, Jacques Morel: None declared, Bernard Combe Grant/research support from: Novartis, Pfizer, Roche-Chugai, Consultant of: AbbVie; Gilead Sciences, Inc.; Janssen; Eli Lilly and Company; Pfizer; Roche-Chugai; Sanofi, Speakers bureau: Bristol-Myers Squibb; Gilead Sciences, Inc.; Eli Lilly and Company; Merck Sharp & Dohme; Pfizer; Roche-Chugai; UCB, Gael Mouterde: None declared


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 320.1-321
Author(s):  
E. Loibner ◽  
V. Ritschl ◽  
B. Leeb ◽  
P. Spellitz ◽  
G. Eichbauer-Sturm ◽  
...  

Background:Gender differences in prevalence and disease course are known in various rheumatic diseases; however, investigations of gender difference concerning therapeutical response have yielded variable results.Objectives:The aim of this retrospective study was to investigate, whether a gender difference in response rate to biological disease-modifying antirheumatic drugs (bDMARDs) and apremilast in bDMARD-naïve patients could be observed across the three most prevalent inflammatory arthritis diseases: rheumatoid arthritis (RA), spondylarthritis (SpA) and psoriatic arthritis (PsA). Additionally, a response to individual TNF blockers was investigated in this respect.Methods:Data from bDMARD-naïve RA-, SpA- and PsA-patients from Bioreg, the Austrian registry for biological DMARDs in rheumatic diseases, were used. Patients with a baseline (Visit 1=V1) and follow-up visits at 6 months (Visit 2=V2) and 12 months (Visit 3=V3) were included and response to therapy with TNF-inhibitors (TNFi), furthermore to therapy with rituximab, tocilizumab and apremilast was analyzed according to gender. The remaining bDMARDs were not analyzed due to small numbers. Key response-parameter for RA was disease activity score (DAS28), whereas for PsoA the Stockerau Activity Score for Psoriatic Arthritis (SASPA) and for SpA the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) were employed; in addition, the Health assessment Questionnaire (HAQ) was used. Data were analyzed in R Statistic stratified by gender using Kruskal-Wallis and Wilcoxon tests.Results:354 women and 123 men with RA (n=477), 81 women and 69 men with PsA (n=150), 121 women and 191 men with SpA (n=312) were included. No significant differences in biometrics was seen between female and male patients at baseline in all diseases.In RA patients overall DAS28 decreased from baseline (V1) to V2 and V3 (DAS28: V1: male: 4.38 [3.66, 5.11], female: 4.30 [3.68, 5.03], p(m/f) = 0.905; V2: male: 2.66 [1.73, 3.63], female: 3.10 [2.17, 3.98], p(m/f) = 0.015; V3: male: 2.25 [1.39, 3.36], female: 3.01 [1.87, 3.87], p(m/f) = 0.002). For TNF inhibitors (n=311), there was a significant difference between genders at V2 (Fig.1a). Patients receiving Rituximab (n=41) displayed a significantly higher DAS28 at baseline in females, which diminished in the follow up: V1: (p(m/f) p=0.002; V2: p=0.019; V3: p=0.13); response to tocilizumab (n=63) did not show any gender differences.In PsA patients overall SASPA decreased from baseline (V1) to V2 and V3 (SASPA: V1: male: 4.00 [2.80, 5.20], female: 4.40 [2.80, 5.80], p(m/f) = 0.399; V2: male: 2.20 [1.20, 3.50], female: 3.40 [2.00, 5.00], p(m/f) = 0.071; V3: male: 1.80 [0.80, 2.70], female: 3.01 [2.35, 4.80], p(m/f) = 0.001). For TNF inhibitors (n=79), there was a significant difference between genders at V3 (Fig 1a). For Apremilast (n=39), there was a significant difference between genders at V2 (Fig.1c).In SpA patients overall BASDAI decreased from baseline (V1) to V2 and V3 (BASDAI: V1: male: 4.70 [2.88, 6.18], female: 4.80 [3.30, 6.20], p(m/f) = 0.463; V2: male: 3.05 [2.00, 4.60], female: 3.64 [2.62, 5.41], p(m/f) = 0.039; V3: male: 3.02 [1.67, 4.20], female: 3.65 [2.18, 5.47], p(m/f) = 0.016). In V3 a differential BASDAI in response to TNFi (n=299) was observed (Fig.1a).Possible differences of response to individual TNFi (etanercept, infliximab, other TNFi) measured by HAQ were investigated in all diseases together. The difference between male and females was significant at baseline for all 3 TNFi; whereas with the use of ETA the significant difference was carried through to V2 and V3, it was lost with the use of IFX and was variable with the other TNFi (Fig.1b)Figure 1.Conclusion:Female patients showed a statistically lower response to TNFi in all three disease entities (RA, SpA and PsoA) to a variable degree in our homogenous central european population. Interestingly, the difference was not uniform across individual TNFi when measured by HAQ. Gender differences were also seen in response to Apremilast.Disclosure of Interests:Elisabeth Loibner: None declared, Valentin Ritschl: None declared, Burkhard Leeb Speakers bureau: AbbVie, Roche, MSD, Pfizer, Actiopharm, Boehringer-Ingelheim, Kwizda, Celgene, Sandoz, Grünenthal, Eli-Lilly, Grant/research support from: TRB, Roche, Consultancies: AbbVie, Amgen, Roche, MSD, Pfizer, Celgene, Grünenthal, Kwizda, Eli-Lilly, Novartis, Sandoz;, Peter Spellitz: None declared, Gabriela Eichbauer-Sturm: None declared, Jochen Zwerina: None declared, Manfred Herold: None declared, Miriam Stetter: None declared, Rudolf Puchner Speakers bureau: AbbVie, BMS, Janssen, Kwizda, MSD, Pfizer, Celgene, Grünenthal, Eli-Lilly, Consultant of: AbbVie, Amgen, Pfizer, Celgene, Grünenthal, Eli-Lilly, Franz Singer: None declared, Ruth Fritsch-Stork: None declared


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