Objective There are few real-world setting studies focused on apremilast effectiveness (i.e., retention rate) in psoriatic arthritis (PsA). The main aim of this retrospective observational study is the assessment of apremilast 3-year retention rate in real-world PsA patients. Moreover, the secondary objective is to report the reasons of apremilast discontinuation and the factors related to treatment persistence. Methods In fifteen Italian rheumatological referral centers, all PsA consecutive patients who received apremilast were enrolled. Anamnestic data, treatment history, and PsA disease activity (DAPSA) at baseline were recorded. The Kaplan-Meier curve and the Cox analysis computed the apremilast retention rate and treatment persistence-related risk factors. A p-value < 0.05 was considered statistically significant. ResultsThe 356 enrolled patients (median age 60 [interquartile range IQR 52-67] yrs; male prevalence 42.7%) median observation period was 17 [IQR 7-34] months (7218 patients-months). The apremilast retention rate at 12, 24, and 36 months was, respectively, 85.6%, 73.6%, and 61.8%. The main discontinuation reasons were secondary inefficacy (34% of interruptions), gastro-intestinal intolerance (24%), and primary inefficacy (19%). Age and oligo-articular phenotype were related to treatment persistence (respectively hazard ratio 0.98 IQR 0.96-0.99; p = 0.048 and 0.54 IQR 0.31-0.95; p = 0.03). Conclusion Almost three-fifths of PsA patients receiving apremilast were still in treatment after 3 years. This study confirmed its effectiveness and safety profile. Apremilast appears as a good treatment choice in all oligo-articular PsA patients and in those ones burdened by relevant comorbidities. Key Points• Apremilast retention rates in this real-life cohort and trials are comparable.• The oligo-articular phenotype is associated with long-lasting treatment (i.e., 3 years).• No different or more prevalent adverse events were observed.
Knee osteoarthritis (KOA) is a chronic progressive disease that can cause pain, functional impairment, and ultimately disability. A novel and promising therapeutic approach to KOA is the so-called regenerative medicine, a set of procedures designed to harness tissue regenerative capacity and optimize functional recovery. Increasing evidence points out that platelet-rich plasma (PRP) intra-articular injections can decrease pain and improve functional abilities in KOA patients. In the present case reports, we analyze two patients who were treated with PRP injections coupled with a posttreatment home-based rehabilitation program. The two patients were selected to represent two different populations: patient 1 was an 85-year-old with severe impairment of functional abilities, while patient 2 was a younger (59 years old) and more active patient. The protocol consisted in a series of exercise to be performed at home, during the five days following PRP injection for two consecutive weeks (10 days in total). The exercises were designed to reduce the inflammation after the injection, enhance the proprioceptive control of the treated lower limb, and strengthen hip and knee flexors and extensors, mainly by isometric work. Results were evaluated at two time points: before and 2 months after the first PRP injection. The outcomes considered were as follows: visual analog scale for pain, EuroQol 5 dimensions questionnaire, Tegner Activity Scale for functioning, and Knee Injury and Osteoarthritis Outcome Score (KOOS). Both patients did not report any side effects from the treatment. Improvement in patient 1 was drastic at the two months follow-up as far as pain and functional abilities are concerned. Patient 2’s improvement was less evident, probably due to the higher starting point in both pain and functionality. Overall, the developed program seemed safe and was tolerated by the patients analyzed in the study, who performed it with good compliance.
Background: To date, only a few real-world-setting studies evaluated apremilast effectiveness in psoriatic arthritis (PsA). The aims of this retrospective observational study are to report long-term Disease Activity Index for Psoriatic Arthritis (DAPSA) response of apremilast in PsA patients and to analyze the predictors of clinical response. Methods: All PsA consecutive patients treated with apremilast in fifteen Italian rheumatological referral centers were enrolled. Anamnestic data, treatment history, and PsA disease activity (DAPSA) at baseline, 6 months, and 12 months were recorded. The Mann–Whitney test and chi-squared tests assessed the differences between independent groups, whereas the Wilcoxon matched pairs signed-rank test assessed the differences between dependent samples. Logistic regressions verified if there were factors associated with achievement of DAPSA low disease activity or remission at 6 and 12 months. Results: DAPSA low disease activity or remission rates at 6 and 12 months were observed, respectively, in 42.7% (n = 125) and 54.9% (n = 161) patients. Baseline DAPSA was inversely associated with the odds of achieving low disease activity or remission at 6 months (odds ratio (OR) 0.841, 95% confidence interval (CI) 0.804–0.879; p < 0.01) and at 12 months (OR 0.911, 95% CI 0.883–0.939; p < 0.01). Conclusions: Almost half of the PsA patients receiving apremilast achieved DAPSA low disease activity or remission at 6 and 12 months. The only factor associated with achievement of low disease activity or remission at both 6 and 12 months was baseline DAPSA.
BackgroundJanus kinase (JAK) inhibitors have been approved for the treatment of Rheumatoid Arthitis (RA) and other systemic or organ-specific autoimmune diseases. Sustained remission or low disease activity are target treatments recomended by European League Against Rheumatism (EULAR) in RA patients [1]. Upadacitinib (UPA), a reversible, oral JAK inhibitor, has been engineered to have a greater selectivity for JAK1 vs JAK2, JAK3, and tyrosine kinase. In the Phase 3 SELECT clinical trial program, UPA has been shown to be effective and well tollerate in patients with RA [2]. However, data on the use of UPA in real-world clinical practice are limited.ObjectivesTo evaluate UPA effectiveness in RA patients and to report the main reasons of suspension and the most relevant factor related to treatment persistence.MethodsIn 25 Italian rheumatological referral centers, all RA consecutive patients who received UPA were enrolled. Anamnestic data, treatment history and RA disease activity at baseline were recorded.The 6 and 12 months UPA retention rate was assessed with the Kaplan-Meier curve methods. The Cox analysis investigated the effect of age, sex, smoke habit, ACPA/RF presence, disease duration, DAS28-CRP, line of treatment, concomitant csDMARD treatment on UPA retention rate. A p-value < 0.05 was considered statistically significant.ResultsThe one-hundred-eleven enrolled patients median age 57 (IQR 50-65 yrs); M:F 28:83; disease duration 78 (IQR 40-170 months). The median observation period was 6.1 (IQR 3.2-10.2) months. The observation lasted 812 patients-months. The majority of patients (54.0%) were in mono-therapy and received steroids (respectively 54.0% and 58.6%) (Table 1).The UPA retention rate at 6, 12 months was, respectively 90.4% and 74.7% (Figure 1). The main discontinuation reason was lack of efficacy (42% of interruptions), cancer onset and infections (both 11%). No thromboembolic events were reported.According to the Cox analysis, no one of the above mentioned parameters were associated to high risk of treatment interruption.Table 1.Baseline characteristics UPACharacteristicsValueM:F28:83Age, median [IQR] yrs58 [50-65]Smokers, n (%) (**)YesFormerNo16 (16,5)17 (17,5)64 (66,0)Body Mass Index, median [IQR] kg/m^2 (*)24,7 [22,4-27,7]Disease Duration, median [IQR], months78 [40-170]RF positivity, n (%)72 (64,9)ACPA positivity, n (%)68 (61,3)SJC, median [IQR]4 [3-8]TJC, median [IQR]8 [5-11]ESR, median [IQR], mm/h32 [20-53]CRP, median [IQR], mg/dl1,2 [0,5-3,3]VAS Patient (0-100), median [IQR]70 [50-80]DAS28, median [IQR]5,5 [4,9-5,9]Line of treatment, [IQR]3 [2-4]Concomitant csDMARDs use, n (%)MTXLFNSSZHCQ41 (36,9)3 (2,7)1 (0,9)5 (4,5)Concomitant steroids use, n (%)65 (58,6)Steroids dose (PDN-Eq), median, mg/die5 [5-6]Prior bDMARDs use, n (%)TNFiIL6iIL1iCD20iCD80i53 (47,7)13 (11,7)02 (1,8)11 (9,9)Prior tsDMARDs use, n (%)BaricitinibTofacitinib9 (8,1)2 (1,8)Concomitant relevant disease, n (%)DiabetesHypercholesterolemiaMACEArterial HypertensionCancer12 (10,8)23 (20,7)5 (4,5)34 (30,6)4 (3,6)Figure 1.ConclusionUPA effectiveness appears to be confirmed. The safety profile of UPA 15 mg in real-world practice is consistent with data from Phase 3 SELECT trials, with no new safety signals.References[1]Smolen JS, et al. Ann Rheum Diseases 2023;82:3-18.[2]Burmester GR et al.Lancet 2018; 23;391(10139):2503-2512Acknowledgements:NIL.Disclosure of InterestsNone Declared.
Introduction: Enthesitis and dactylitis are difficult-to-treat features of psoriatic arthritis (PsA), leading to disability and affecting quality of life. Objective: The aim of this study is to evaluate enthesitis (using the Leed enthesitis index (LEI)) and dactylitis at 6 and 12 months in patients treated with apremilast. Methods: Patients affected by PsA from fifteen Italian rheumatological referral centers were screened. The inclusion criteria were: (a) enthesitis or dactylitisphenotype; (b) treatment with apremilast 30 mg bid. Clinical and treatment history, including PsA disease activity, were recorded. Mann–Whitney and chi-squared tests were used to assess the differences between independent groups, and Wilcoxon matched pairs signed-rank test assessed the differences between dependent samples. A p-value of <0.05 was considered statistically significant. Results: The Eph cohort consisted of 118 patients (median LEI 3); the Dph cohort included 96 patients with a median dactylitis of 1 (IQR 1–2). According to an intention to treat analysis, 25% and 34% of patients with enthesitis achieved remission (i.e., LEI = 0) in T1 and T2. The remission of dactylitis was 47% in T1 and 44% in T2. The per protocol analysis (patients observed for at least 12 months) showed that both dactylitis and LEI significantly improved in T1 (median LEI 1 (IQR 1–3)) and T2 (median LEI 0 (IQR 1–2)). Conclusion: Eph and Dph PsA patients treated with apremilast experienced a significant improvement in enthesitis and dactylitis activity. After 1 year, enthesitis and dactylitis remission was achieved in more than one-third of patients.
BackgroundThe management of patients with immuno-rheumatological diseases has profoundly changed during the COVID 19 pandemic and telemedicine has played an important role in the disease follow-up.In addition to monitoring disease activity and any adverse events, especially infectious events, assessing the psychological situation of the patient can be fundamental in particular considering that COVID-19 has also a serious impact on mental health and it has been demonstrated a significantly higher incidence of anxiety disorders and depressive symptoms especially in younger peopleObjectivesThe aim of this study is to evaluate the incidence of depressive disorders, anxiety and fibromyalgia in our patients with rheumatoid arthritis and psoriatic arthritis during the lockdown period due to the COVID 19 pandemic and validate the use of telemedicine in the clinical management of these patients.MethodsPatients affected by rheumatoid and psoriatic arthritis treated with biological disease-modifying drugs were contacted to evaluate the state of health and the presence of any adverse events and a nurse administered the clinimetric questionnaires assessment to evaluate the disease activity, the impact of rheumatic disease on the health status and the presence of anxiety, depression and fibromyalgia. In particular the following scales have been used: The Rheumatoid Arthritis Impact of Disease (RAID), the Psoriatic arthritis impact of disease (PsAID), Beck Depression Inventory BDI-II, State-Trait Anxiety Inventory (STAI) and The Fibromyalgia Rapid Screening Tool questionnaire (FIRST), The VAS scale for the assessment of pain. Patients who reported disease flare-up or adverse events underwent an outpatient visit and during visit Disease Activity Score (DAS 28) and Disease Activity Index for Psoriatic Arthritis (DAPSA) were used.Results171 patients with rheumatoid arthritis (RA) and 129 patients with psoriatic arthritis were enrolled. The incidence of fibromyalgia was increased in the two groups during the lockdown compared to the previous evaluations and in particular in patients with psoriatic arthritis (AR p =0.013, AP p= 0.001).Our analysis did not report significant differences between the two groups for the presence of fibromyalgia and anxiety-related disorders during lockdown, but a prevalence of depressive disorders in patients with rheumatoid arthritis was observed.During lockdown in RA patients, (n=50), no correlation was found between DAS28 and RAID score (r=0.112, p=0.438) and in PsA patients (n=34), no correlation was found between DAPSA and PSAID score (r=0.131, p=0.459) while median value of RAID was higher in STAI I and II positive and median value of PSAID was higher in STAI I and II positive. Patients positive at BDI had higher RAID score (median 6.28 vs 1.14) and PSAID (median 4.95 vs 2.85) score (Mann Whitney p<0.001 and p=0.003)ConclusionIn conclusion, mental and physical stress during COVID-19 pandemic can greatly worsen FM symptoms and intensify the patients’ suffering without a clinical flare of the inflammatory disease for patients affected by rheumatoid arthritis.Telemedicine has allowed us to identify patients who needed a face-to-face approach for therapeutic reevaluation even if not related to a flare of the disease.References[1]Coletto LA DermatolTher. 2020 Apr 14:e13415. doi: 10.1111/dth.13415.[2]Lurie N JAMA Intern Med 2018;178:745–6[3]Matteo Piga Seminars in Arthritis and Rheumatism 47 (2017) 121–128123Disclosure of InterestsNone declared
BackgroundPsoriatic arthritis (PsA) is an inflammatory rheumatic disease characterized by different phenotypes in terms of joint involvement. Apremilast, PDE4 competitive inhibitor, has been introduced in the treatment of adult psoriatic arthritis (PsA) with moderate disease activity. Musculoskeletal ultrasound (MUS) is useful in the assessment of disease, treatment response and follow up in PsA patients. Choosing an effective and safe treatment over time is an increasingly urgent goal given the greater availability of indicated drugs.ObjectivesThe aim of this study is to evaluate if MUS assessment before apremilast treatment can improvement its retention rate.MethodsWe enrolled consecutive patients affected by PsA (according to the CASPAR Criteria) from 15 rheumatology centers. The following data were recorded for each patient: age, gender, duration of disease, DAPSA; smoke, comorbilities; concomitant treatment; duration of therapy with apremilast; reason of sospensione, PsA phenotype (poliarticular or oligoarticular) (Table 1). All patients were divided in two subset according to the presence of a MUS assessment before apremilast treatment. The differentes between two groups were calculated by means of the Mann-Whitney and Chi-quadro tests. The Kaplan Meier curve and Cox analysis assessed the retention rate and associated factors. P values < 0.05 were considered statistically significant.ResultsON Three hundred and fifty patients (m/f: 198/152; median age 60 years, IQR 52-67 years), 40% received MUS examination. In the MUS group there was a moderate disease (medium 22,9 IQR 18,2-29 vs 26,9 IQR 20,3-33,9; p=0,0006) and a prevalence of the oligoarticular pattern (73% vs 44%, p<0,0001). The retention rate was statistically higher in MUS group (Figure 1) (HR 0,57 IC95% 0,35-0,95; p=0,03).Table 1.No USYes USP-valueNumber216140-Age (years)61[54-69]58[50-65]0,0016Gender (M:F)85:13167:73NssSmoke (%)23,434,80,0198BMI (kg/m^2)25,7[23,4-29,8]26,1[23,7-29,0]nssDuration of disese PsA (months)44[13-95]37[12-78]nssDuration of disese PsO (months)13[0-83]30[0-93}nssComorbility (%)47,739,3nssSwollen joints8[4-12]4[3-7]<0,000001Tender joints3[2-5]2,5[2-4]0,0434PCR (mg/dl)2,9[0,8-5,2]1,0[0,7-3,0]0,0057DAPSA27,0[20,4-34,2]22,9[18,2-29,0]0,0004Concomitant treatment (%)13,427,10,0012Naive biologic (%)80,668,60,0100Oligoarticolar pattern (%)36,163,6<0,0001Figure 1.A: Psoriatic arthritis. Longitudinal volar scan of the interphalageal prossimal joint. Tenosinovitis of the flexor tendons()B: Psoriatic arthritis. Transversal volar scan of the interphalageal prossimal joint. Tenosinovitis of the flexor tendons ()ConclusionIn PSA patients treated with apremilast, MUS assessment at baseline was associated with an higher retetion rate. MUS could be useful in the PsA treatment algorithm in order to better identify those patients whose characteristics are favourable to apremilast response.References[1]\Ramona Lucchetti et al. IMAJ 2021 JULY;23(7): 412-415.[2]\Fulvia Ceccarelli et al. Clin Rheumatol. 2019 Nov;38(11):3145-3151Acknowledgements:NIL.Disclosure of InterestsNone Declared.
BackgroundTo date only few real-world setting studies evaluated apremilast efficacy in psoriatic arthritis (PsA). Enthesitis and dactylitis are difficult-to-treat features of PsA leading to disability and affecting quality of life.ObjectivesThe aims of this study is to evaluate the leed enthesitis index (LEI) and dactlitis index (DAI) at 6 and 12 month in patients on treatment with apremilast.MethodsAll PsA consecutive patients treated with apremilast in fifteen Italian rheumatological referral centers were enrolled. Anamnestic data, treatment history, and PsA disease activity (DAPSA), LEI, DAI at baseline (T0), 6 month (T1) and 12 months (T2) were recorded. The Mann-Whitney test and chi-squared tests assessed the differences between independent group, whereas the Wilcoxon matched pairs signed-rank test assessed the differences between dependent samples. A p-value<0.05 was considered statistically significant.Resultsthe total cohort consisted of 209 patients (M/F 94/105) of whom 72 (34.4%) (M/F 29:43) patients had an enthesitis with a median LEI of 3 and 65 patients (31.1%) had dactylitis with a median of DAI of 1; DAPSA at base line was 24.1 in the enthesitis group, and 27.2 in the dactylitis group(Table 1). Prior DMARDs use and concomitant DMARDs drugs were more common in LEI groups with respect to DAI group. Compared to base line, Apremilast 30 mg two times per day demonstrated at 6 and 12 months a significantly improvements in LEI(Figure 1a; p<0.001 for both T1 vs T0, T2 vs T1), DAI (Figure 1b;p<0.001 for both T1 vs T0, T2 vs T1) and DAPSA (Figure 1c; p<0.001 for both T1 vs T0, T2 vs T1). In the LEI group, 29 patients (28.7%) reached a remission with LEI=0 at six months and 40 (44%) patients had a sustained improvement with LEI=0 at 12 months. In the DAI group 45 patients (52.9%) had a remission of dactylitis at 6 months and 43 patients (56.6%) had no dactylitis at T1.ConclusionApremilast demonstrated significant and sustained efficacy in real-life Psa patients, including improvements in enthesitis and dactylitis for up to 12 months.References[1]Ariani A, Parisi S, Del Medico P et al. Apremilast retention rate in clinical practice: observations from an Italian multi-center study. Clin Rheumatol 2022 Oct;41(10):3219-3225.[2]de Vlam K, Toukap AN, Kaiser MJ. Real-World Efficacy and Safety of Apremilast in Belgian Patients with Psoriatic Arthritis: Results from the Prospective Observational APOLO Study Adv Ther. 2022 Feb;39(2):1055-1067.Table 1.Baseline CharacteristicTotal CohortDactylitis subgroupEnthesitic subgroupN2096572M:F94:10530:3529:43Age, median [IQR] yrs60[53-67]59[53-65]59[52-65]Smokers, n (%)YesFormerNoUnknown36 (17,2)27 (12,9)144 (68,9)2 (1,0)13 (20,0)10 (15,4)42 (64,6)011 (15,3)14 (19,4)47 (65,3)0Body Mass Index, median [IQR] kg/m^226,5[23,8-29,6] (*)27,1[23,7-29,9] (**)26,1[23,2-29,9] (***)PsA Duration, median [IQR], months50[19-97]42[15-85]51[15-85]PsO Duration, median [IQR], months72[28-140]84[21-141]67[17-142]SJC, median [IQR]3[2-4]3[2-4]3[2-4]TJC, median [IQR]5[3-8]5[3-7]6[4-12]LEI, median [IQR],--3[1-4]Dactylitis, median [IQR], fingers-1[1-2]-CRP, median [IQR], mg/dl1,8[0,7-4,8]2,3[1,0-5,0]3,6[0,9-6,7]PGA Patient (0-10), median [IQR]7[6-8]7[6-8]7[5-8]VAS pain (0-10), median [IQR]7[6-8]7[6-8]7[6-8]DAPSA, median [IQR]24,1[19,4-31,5]24,2[19,5-31,2]27,2[22,9-35,6]Concomitant csDMARDs use, n (%)49 (23,4)22 (33,8)19 (26,3)Prior bDMARDs use, n (%)69 (33,1)34 (52,3)20 (27,8)Concomitant relevant disease, n (%)94 (44,8)37 (56,9)31 (43,1)Figure 1.Acknowledgements:NIL.Disclosure of InterestsAlberto Lo Gullo Grant/research support from: BAYER, GALAPAGOS, NOVARTIS, Andrea Becciolini: None declared, Simone Parisi: None declared, Patrizia Del Medico: None declared, antonella farina: None declared, elisa visalli: None declared, Aldo Molica Colella: None declared, Federica Lumetti: None declared, rosalba caccavale: None declared, Palma Scolieri: None declared, Romina Andracco: None declared, Francesco Girelli: None declared, Elena Bravi: None declared, Matteo Colina: None declared, Alessandro Volpe: None declared, Aurora Ianniello: None declared, Maria Chiara Ditto: None declared, Valeria Nucera: None declared, Veronica Franchina: None declared, Ilaria Platé: None declared, eleonora Di Donato: None declared, Giorgio Amato: None declared, Carlo Salvarani: None declared, Lucia Gardelli: None declared, Gianluca Lucchini: None declared, Francesco De Lucia: None declared, Francesco Molica Colella: None declared, Daniele Santilli: None declared, Natalia Mansueto: None declared, Giulio Ferrero: None declared, Antonio Marchetta: None declared, eugenio arrigoni: None declared, Rosario Foti: None declared, Gilda Sandri: None declared, Vincenzo Bruzzese: None declared, Marino Paroli: None declared, Enrico Fusaro: None declared, ALARICO ARIANI: None declared.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.