scholarly journals SAT0453 Efficacy of ustekinumab in psoriatic arthritis patients by prior treatment exposure and disease duration: data from psummit 1 and psummit 2

Author(s):  
I McInnes ◽  
SD Chakravarty ◽  
GJ Morgan ◽  
I Apaolaza ◽  
S Kafka ◽  
...  
RMD Open ◽  
2019 ◽  
Vol 5 (2) ◽  
pp. e000990 ◽  
Author(s):  
Iain B McInnes ◽  
Soumya D Chakravarty ◽  
Isabel Apaolaza ◽  
Shelly Kafka ◽  
Elizabeth C Hsia ◽  
...  

ObjectiveTo evaluate the efficacy of ustekinumab by prior treatment exposure and disease duration in tumour necrosis factor inhibitor (TNF)-naïve patients with psoriatic arthritis (PsA) in the PSUMMIT 1 and PSUMMIT 2 studies.MethodsIn the phase 3, randomised, placebo-controlled PSUMMIT 1 and PSUMMIT 2 studies, adults with active PsA for ≥6 months despite conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and/or non-steroidal anti-inflammatory drugs (NSAIDs) (PSUMMIT 1) or csDMARDs, NSAIDs and/or anti-TNF agents (PSUMMIT 2) were enrolled. Patients were randomised to subcutaneous injections of placebo, ustekinumab 45 mg or ustekinumab 90 mg at weeks 0 and 4 and every 12 weeks. Efficacy was assessed at week 24 using the American College of Rheumatology criteria and 28-joint count disease activity score using C reactive protein (DAS28-CRP); radiographical progression, enthesitis, and dactylitis were also assessed in this post hoc analysis.ResultsA total of 747 patients were included; all 747 were TNF-naïve, of which, 179 were methotrexate-naïve and TNF-naïve, and 146 were all csDMARD-naïve and TNF-naïve. At week 24, greater proportions of ustekinumab-treated patients had ≥20%/50%/70% improvement in American College of Rheumatology criteria (ACR20/ACR50/ACR70) responses, DAS28-CRP response and DAS28-CRP remission versus placebo in all three prior-treatment populations, with similar differences between treatment groups. Greater proportions of ustekinumab-treated patients also had complete resolution of enthesitis and dactylitis at week 24 across the three prior-treatment populations. Mean changes from baseline in total van der Heijde-Sharp Score at week 24 were generally smaller for ustekinumab-treated patients versus placebo but were statistically significant only in the full TNF-naïve population. Response rates for ACR20/ACR50/ACR70 were similar for TNF-naïve patients with PsA durations of <1 year, ≥1 to <3 years, and ≥3 years.ConclusionUstekinumab-treated patients demonstrated greater clinical response at week 24 compared with placebo regardless of prior treatment exposure and PsA disease duration.


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1188.2-1189
Author(s):  
A. Martins ◽  
D. Santos Oliveira ◽  
F. R. Martins ◽  
M. Rato ◽  
F. Oliveira Pinheiro ◽  
...  

Background:Induction of autoantibodies is frequently observed in patients treated with TNF-α antagonist and the possible development of drug-induced lupus erythematosus (DILE) remains a matter of concern. The prevalence of DILE secondary to anti-TNF-α therapy is estimated around 0.5-1% and clinical features include arthritis/arthralgia, rash, serositis, fever, myalgias, cytopenias, among others. According to the literature, DILE secondary to anti-TNF-α agents differs in several ways from the clinical and laboratory findings typically associated with classic DILE.Objectives:To estimate the incidence of induction of antinuclear antibodies (ANA) and DILE in a monocentric cohort of patients with spondyloarthritis and psoriatic arthritis treated with anti-TNF-α agents. To describe the clinical and laboratorial features and outcomes of patients with DILE.Methods:We performed a retrospective analysis of patients with spondyloarthritis and psoriatic arthritis treated with anti-TNF-α agents, from our University Hospital, who have been registered on the Portuguese Rheumatic Diseases Register (Reuma.pt) between July 2001 and December 2020. Patients with positive ANA (titer > 1/100) before the anti-TNF-α therapy were excluded. Because specific criteria for the diagnosis of DILE have not been established, we considered the diagnosis in case of a temporal relationship between clinical manifestations and anti-TNF-α treatment and fulfillment of ACR/EULAR 2019 classification criteria for SLE. In patients with DILE, clinical features, laboratory findings, systemic therapies and outcome after discontinuation of medication were collected from reuma.pt and medical records. For the clinical and demographic predictors, continuous variables were analyzed using a two-sided t-test and categorical variables using a Fisher’s exact test. P-value <0.05 was considered statistically significant.Results:In the spondyloarthritis group, 290 patients were included (44.8% females, mean age at diagnosis of 33.3 ± 11.5 years and mean disease duration of 15.1 ± 10.4 years) and in the psoriatic arthritis group, 116 patients were included (50.0% females, mean age at diagnosis of 40.1 ± 11.0 years and mean disease duration of 13.1 ± 6.8 years). In our study, we observed high serology conversion rates (positive ANA in 67.9% and 58.6% of patients with Spondyloarthritis and Psoriatic Arthritis, respectively), with similar conversion rates between different anti-TNF drugs. Three patients with spondyloarthritis (1.0%) and 1 patient with psoriatic arthritis (0.9%) developed DILE. Etanercept was the causative agent in 2 cases, infliximab and adalimumab in 1 case, each. Peripheral arthritis (new onset or abrupt worsening) occurred in 2 patients, serositis in 1 patient, constitutional symptoms in 2 patients, subnephrotic proteinuria in 1 patient, lymphopenia in 2 patients and hypocomplementemia in 1 patient. Specific treatment was prescribed to the 4 patients (oral corticosteroids) and they achieved complete recovery. After anti–TNF-α treatment interruption, no patient had recurrent disease. We observed that patients with DILE had a significantly longer disease duration (> 8.4 years; p=0.04) and a significantly longer duration of therapy with anti-TNF (> 4.0 years; p=0.04) when compared to patients without DILE.Conclusion:Despite the frequent induction of autoantibodies, the development of DILE secondary to anti–TNF-α agents is rare. Our study demonstrates an incidence rate similar to other studies reported before. The clinical and laboratorial characteristics of our patients with DILE attributable to anti–TNF-α agents differ significantly from DILE due to more traditional agents, as is described in literature. Overall, patients in this study had mild disease that improved after therapy discontinuation, without recurrence of the disease. It seems that a longer disease duration and a longer period under anti-TNF-α therapy may increase the risk of DILE development.Disclosure of Interests:None declared


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1926.2-1927
Author(s):  
K. Austin ◽  
R. Prasad

Background:Recent studies have demonstrated an increasing burden of musculoskeletal (MSK) diseases worldwide.1The importance of patient education (PE) is often overlooked in the management of long term inflammatory conditions. The European League Against Rheumatism recommends that PE should be integral to standard of care in inflammatory arthritis.2PE increases patients’ knowledge, skills and confidence in managing their condition and improves patient activation (PA). Evidence shows that improved PA results in better outcomes and improved experiences of care. We previously reported on improved knowledge and confidence amongst a small patient group with psoriatic arthritis (PsA) who had attended a pilot education session.3This education session was delivered to a wider group of patients with PsA over a 12 month period; we report on the evaluation received from this service.Objectives:To provide a PE programme to a wider group of patients with PsA, using a multi-disciplinary team (MDT) approach and to evaluate whether this improved patients’ knowledge, skills and confidence in managing their PsA.Methods:Adult patients with PsA attending their rheumatology clinic appointments were invited to a 2.5 hour MDT education session which covered: 1) a general overview of PsA; 2) medications used in PsA; 3) the role of physiotherapy and occupational therapy; 4) flares and self- management. These were interactive sessions, held in a small group setting to allow for informal discussion and questions to the MDT. Written materials including several booklets and online resources were also provided. Patients evaluated their knowledge or understanding before and after each topic covered, on the same day, using an evaluation tool with1-10 Likert scale items. Changes in ratings were analysed using student’s t-tests. Patients were also asked: which aspects they found particularly helpful; if there was anything they would like to have added/ have more of in the session; whether they found the session helpful; whether they would recommend it to other patients; whether they would be interested in developing a PsA patient support group.Results:Four sessions were held over a 12 month period. A total of 32 patients attended; 10 males and 22 females, across a range of age categories. Disease duration varied from less than1 year to over 10 years. There were statistically significant improvements in all topics covered: mean improvement of 91% in how well informed patients felt about PsA overall (p<0.0001); mean improvement of 74% in confidence in accessing help from the MDT (p<0.0001); mean improvement of 122% in how well informed patients were about medications used in PsA (p<0.0001); mean improvement of 99% in patients’ confidence in self-managing a flare (p<0.0001). Aspects that patients found particularly helpful included “The whole session”, “Asking questions to all different professionals”, “Meeting other sufferers”, “Management of flares”, “Fatigue information” and “Online resources”. Overall, 97% of patients (31 out of 32) found the session helpful and would recommend it to others. Over 40% of patients expressed interest in developing a local PsA support group.Conclusion:Following a 2.5 hour education session, improved knowledge, skills and confidence in managing their PsA was reported by 97% of patients, including patients with disease duration of > 10 years. This supports our previous finding that an interactive, group PsA education programme is a feasible and important adjunct to patient care.References:[1]Sebbag E, Felten R, Sagez F, et al. The world-wide burden of musculoskeletal diseases: a systematic analysis of the World Health Organization Burden of Diseases Database. Annals of the Rheumatic Diseases 2019;78:844-848.[2]Zangi HA, Ndosi M, Adams J, et al. EULAR recommendations for patient education for people with inflammatory arthritis. Ann Rheum Dis. 2015;74(6):954-62[3]Austin K, Jones N, Prasad R. Patient Education in psoriatic arthritis: addressing an unmet need. Ann Rheum Dis. 2019;78(suppl 2):A2134.Disclosure of Interests:Keziah Austin: None declared, Roopa Prasad Speakers bureau: Received speaker fees for Celgene, honorarium from Merck, advisory board fees from Bristol-Myers Squibb; all unrelated to the contents of this abstract.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1698.2-1699
Author(s):  
I. Mahmoud ◽  
S. Rahmouni ◽  
A. Ben Tekaya ◽  
S. Bouden ◽  
R. Tekaya ◽  
...  

Background:Entheseal involvement is a frequent and distinctive feature of psoriatic arthritis (PsA), often under diagnosed. It is especially associated with nail involvement. Because clinical examination is not sensitive enough for the detection of early signs of this involvement, US may be considered as an alternative imaging technique in the diagnosis of enthesopathy.Objectives:The aim of the present study is to evaluate US entheses abnormalities in PsA and their correlation with clinical characteristicsMethods:The study included patients diagnosed with PsA according to the CASPAR criteria. They underwent a thorough clinical examination with special regard to the presence of enthesitis using the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index.The US study bilaterally explored entheses at six sites: proximal plantar fascia, distal Achilles tendon, distal and proximal patellar tendon insertion, distal quadriceps tendon and distal brachial triceps tendon. We evaluated the following elemental lesions of enthesis at each site: thickness and structure of the tendon, calcifications, bursae, erosions, power Doppler signal in bursa or enthesis full tendon.Results:Of the 33 patients, 39.4 % were male. The mean age was 51.2±12.5 years. The mean disease duration was 13.5±10.2 years.The mean DAPSA was 22.8± 19.7 [0.1-84.5]: remission(n=9), low activity (n=5),moderate activity (n=11),high activity(n=8).At inclusion, 11 patients (33.4%) patients presented with psoriatic onychopathy (45 fingernails) with a mean mNAPSI of 14.1±16. Out of the 528 entheseal sites, 92 were tender at the palpation (17,4%) with a mean SPARCC at 2.87.A total of 396 entheseal sites were examined by US. In 140 of them (35.35%), US found at least 1 sign indicative of enthesopathy. The most affected tendon was the distal Achilles tendon (42/396), followed by proximal plantar fascia (32/396), distal patellar tendon (20/396), quadriceps tendon (20/396), distal brachial triceps tendon(14/396) and finally proximal patellar tendon (12/396).The most common elemental lesions were enthsophytes (176), erosions (114) and calcifications (50).We found a positive correlation between age and both calcification (r=0,4, p=0.021) and enthesophytes (r=0.479, p=0.005).We found a positive correlation between enthesophyte and the tender and swollen joints count (r= 0.352, p=0.045, r=0.378, p=0.03) and the SPARCC score (r=0.397, p=0.022).Patients with higher BASDAI had thicker tendons (r=0.355, p=0.05).Patients with nail dystrophy had more bursitis and erosions.US scores did not correlate with sexe, disease duration and disease activity measures (ASDAS, DAPSA, DAS28 and PASI). Patients with subclinical entheseal involvement didn’t have higher inflammatory biomarkers (ESR, CRP).Conclusion:US subclinical enthesopthy are not rare in psoriatic arthritis, in particular in patients with active disease.Clinical nail involvement was associated with bursitis and erosions. New studies including larger study groups are required to verify the findings of the present studyDisclosure of Interests:None declared


2012 ◽  
Vol 39 (4) ◽  
pp. 849-855 ◽  
Author(s):  
ANTONIO MARCHESONI ◽  
FABIOLA ATZENI ◽  
ANTONIO SPADARO ◽  
ENNIO LUBRANO ◽  
GIUSEPPE PROVENZANO ◽  
...  

Objective.To identify the clinical features that can help to distinguish between psoriatic arthritis (PsA) and fibromyalgia (FM).Methods.Our cross-sectional study was carried out in 10 Italian rheumatology centers between January and September 2009, and enrolled all consecutive patients with PsA and FM who agreed to participate. Standard clinical and laboratory data for PsA and FM were collected from all patients. Records were made of somatic symptoms, response to nonsteroidal antiinflammatory drugs (NSAID), self-evaluated pain, general health, disability, and responses to the Fibromyalgia Impact Questionnaire. Data were statistically analyzed by univariate and multivariate analyses, and receiver-operating characteristic curves. The analysis concentrated on the clinical features shared by the 2 conditions.Results.Two hundred sixty-six patients with PsA (mean age 51.7 yrs; disease duration 10.2 yrs) and 120 patients with FM (mean age 50.2 yrs; disease duration 5.6 yrs) were evaluated. Univariate analysis showed that patients with FM had higher mean tender point and enthesitis scores, more somatic symptoms, and responded less to NSAID. Multivariate analysis showed that the presence of ≥ 6 FM-associated symptoms and ≥ 8 tender points was the best predictor of FM.Conclusion.The shared clinical features of PsA and FM that had the greatest discriminating power for FM were the number of FM-associated symptoms and tender point count.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1670.2-1670
Author(s):  
K. Ben Abdelghani ◽  
H. Boussaa ◽  
S. Miladi ◽  
A. Fazaa ◽  
K. Ouenniche ◽  
...  

Background:Psoriatic arthritis (PsA) is a systemic inflammatory disease with articular and extra-articular features. In recent years, Ultrasonography (US) is playing an important role in the diagnosis and monitoring of this disease. Specific US features of PsA have been reported such as enthesitis, peritenon extensor tendon inflammation (PTI) and soft tissue edema.Objectives:The aims of this study were to evaluate the prevalence of these US signs in PsA patients and to determine their association with disease duration and activity.Methods:Patients with peripheral PsA responding to the Classification Criteria for Psoriatic Arthritis (CASPAR) were enrolled. Clinical and biological data were extracted, and then US examination was performed by an experimented rheumatologist blinded to clinical data using a machine type Esaote MyLAb 60 with a linear probe of 6-18 MHz. The following US features were evaluated: PTI at the dorsal aspect of metacarpo-phalangeal (MCP) joints, soft edema at the volar aspect of MCP joints and enthesitis of the digitorum extensor at the dorsal aspect of distal inter-phalangeal (DIP) joints.A p<0.05 was considered statistically significant.Results:We included twenty PsA patients, 8 men and 12 women, with a mean age of 55 ± 11 [33-77] years old. The mean disease duration was of 10±8 [1-34] years. A family history of PsA or psoriasis was reported in 53% of cases.Oral corticosteroids were used in 21% of patients, at a mean daily posology of 7 mg [5-10] of Prednisone equivalent, Methotrexate in 84% of cases at a mean posology of 15 mg [10-20] per week, Sulfasalazine in 10% of cases and a biological DMARD in 32% of cases (Etanercept=4, Infliximab=1, Adalimumab=1).The mean number of tender and swollen joints were respectively of 8 [0-16] and 2 [0-8]. The mean rate of patient global evaluation and visual analogue scale was of 5 [0-9].The mean DAPSA (Disease Activity in PSoriatic Arthritis) score was of 32±27 [4-112].US examination demonstrated that all patients had at least one of the three specific signs that we were looking for. At MCP level, PTI was noted in 11% of joints with Power Doppler (PD) signal in one case and soft tissue edema was noted in 3% of joints.At DIP level, enthesitis of digitorum extensor tendon was noted in 39% of joints. The elementary lesions reported were: enthesophyte in 25%, erosion in 8%, calcification in 5% and thickened or hypoecoic tendon in 4% of joints. However, no PD signal was detected at the enthesis.A positive association was found between DAPSA score and soft tissue edema (p=0.000), but not with PTI (0.668) and enthesitis (0.137). No relation was found between these three lesions and the disease duration.Conclusion:The presence of soft tissue edema, enthesitis and/or PTI on US can be an argument for the diagnosis of PsA. Soft tissue edema is shown to be associated with disease activity.Disclosure of Interests:None declared


2013 ◽  
Vol 71 (Suppl 3) ◽  
pp. 692.18-692
Author(s):  
S.O. Krasnenko ◽  
E.Y. Loginova ◽  
T.V. Korotaeva ◽  
D.V. Goryachev ◽  
A.V. Smirnov

Sign in / Sign up

Export Citation Format

Share Document