Years Of Etanercept Research Articles

Clinical Outcomes in Iraqi Patients with Rheumatoid Arthritis Following Earlier or Later Treatment with Etanercept.

PurposeThe development of evidence-based guidelines on early pharmacotherapeutic treatment of rheumatoid arthritis (RA) could be useful in Middle Eastern nations striving to improve outcomes in patients with this chronic, debilitating disease. Evidence obtained from local populations should inform such guidelines and therefore our aim was to use real-world data to evaluate the clinical responses of Iraqi patients with RA who received earlier or later treatment with the TNF inhibitor etanercept.Patients and MethodsData from patients registered in the Iraq National Center of Rheumatology database from May 2012 to December 2018, inclusive, were analyzed retrospectively. Inclusion criteria were age ≥18 years, meeting the ACR/EULAR 2010 criteria for RA, referral for etanercept treatment, and ≥1 year of follow-up after etanercept initiation. Patients were excluded if they had received another biologic for RA. Included patients were categorized according to two separate stratifications: whether duration of RA symptoms prior to etanercept initiation was ≤10 or >10 years (10 years represented the mean duration for the entire analysis population); and according to whether duration of RA symptoms prior to etanercept initiation was ≤1, >1 to ≤4, >4 to ≤10, >10 to ≤20, or >20 years. The evaluated outcomes were mean change from baseline in Clinical Disease Activity Index (CDAI) and 28-joint Disease Activity Score (DAS28) after 1 year of etanercept treatment.ResultsA total of 979 patients were included. CDAI and DAS28 were significantly reduced (p<0.001 for both) after 1 year of etanercept treatment irrespective of whether duration of RA symptoms prior to treatment was ≤10 or >10 years. Patients with RA symptoms for ≤1 year prior to etanercept initiation showed a significant reduction in CDAI after 1 year of treatment (p=0.01).ConclusionIraqi patients with RA who received earlier treatment with etanercept had superior outcomes compared with those who received later treatment.

P55 Carcinoid syndrome on etanercept and subsequent treatment with secukinumab in a patient with psoriatic arthritis

Abstract Background Psoriatic arthritis requires early recognition and treatment for prevention of disease progression. Conventional disease modifying drugs are first-line agents followed by biologic DMARDs for patients with active disease. TNF-alpha blockers are first line biologic agents in the UK. Th17 inhibitors are used since the elucidation of Th17 pathway. Safety and efficacy profiles of biologic agents inhibiting the Th17 pathway, including secukinumab (IL-17A) and ustekinumab (IL-12/23p40) have been studied. Methods We report a case of carcinoid syndrome in a lady on etanercept for psoriatic arthritis, carcinoid as a potential TNF alpha side effect. We also report safety of Th17 (secukinumab) inhibitors in the patient to date (&amp;gt;1 year). Results A female with a history of acne rosacea, was diagnosed with psoriatic arthritis in 2000 age 32. Initial sulphasalazine failed, then received methotrexate until 2011, when her arthritis flared. She was commenced on etanercept which proved effective. After 4 years of etanercept and methotrexate, her liver profile became deranged. Investigations off treatment included ultrasound abdomen demonstrating a liver mass, which resembled focal nodular hyperplasia on magnetic resonance imaging. Further screening revealed high urinary 5HIAA (527 umol/24h) and raised chromogranin A &amp; B levels (1574 pmol/L and 373 pmol/L respectively). She had no symptoms suggestive of carcinoid, although facial flushing could have been camouflaged by her rosacea. Octreotide scan was positive, CT enterogram showed a distal ileal neuroendocrine tumour with adjacent lymphadenopathy. She underwent right hemihepatectomy and hemicolectomy. Her liver profile deteriorated again on methotrexate, leflunomide was ineffective. In November 2017 she was started on ustekinumab, which was ineffective and was withdrawn after 8 months. There was no alteration in carcinoid blood markers and no CT changes. In July 2018, she was commenced on secukinumab, which has allowed reduction in steroids. The patient is aware of lack of safety data in her circumstances. Regular surveillance has shown no recurrence of carcinoid with serial negative 5HIAA and chromogranin levels. There are no progressive CT changes at 1 year. Conclusion This is a case of carcinoid tumour occurring on TNF-alpha blockers and may represent a rare complication. Screening biomarkers including 5HIAA and chromogranin levels can be useful if disease is suspected. We could not find other similar case reports to guide further management. Within time limited data available - ustekinumab had no effect on the carcinoid. Th17 inhibitors can be safe options for treating psoriatic arthritis and psoriasis with highly sustained efficacy and favourable safety profile seen in large clinical trials. In this case, after &amp;gt; one year of secukinumab treatment - there is no adverse effect on carcinoid syndrome. Disclosures A.S.F. Sheikh None. S.G. Srivastva None. F. Wood None.

Etanercept Increases Bone Mineral Density in Ankylosing Spondylitis, but Does Not Prevent Vertebral Fractures: Results of a Prospective Observational Cohort Study

Ankylosing spondylitis (AS) is characterized by chronic inflammation leading to ankylosis, but also to low bone mineral density (BMD) and vertebral fractures (VFx). Treatment with tumor necrosis factor-α blockers decreases inflammation and has shown to be effective in increasing BMD. We studied the effects of etanercept (ETN) on BMD and VFx in patients with AS after 2 years of treatment. Further, we studied changes in bone turnover markers and radiological damage. Patients with active AS, treated with ETN for 2 years, were included. BMD lumbar spine and hip were measured at baseline and after 2 years, as well as radiological damage (modified Stoke Ankylosing Spondylitis Spinal Score with the addition of the thoracic spine), VFx (Genant method), and change in bone turnover markers. Forty-nine patients with AS were included. After 2 years of ETN, hip BMD increased by 2.2% (p = 0.014) and lumbar spine BMD by 7.0% (p < 0.001). The Bath Ankylosing Spondylitis Disease Activity Index decreased significantly (p < 0.001), as well as C-reactive protein and erythrocyte sedimentation rate (p < 0.001). Despite ETN therapy, the number of patients with VFx more than doubled (from 6 to 15 patients, p = 0.003). Also, the radiological damage increased significantly over time (from 12.1 to 18.5, p < 0.001); however, no significant change in bone turnover markers was found. This prospective longitudinal observational cohort study showed that after 2 years of ETN, BMD of the hip and spine increased significantly, but the number of patients with VFx and the severity of VFx increased as well. Besides that, radiological progression, including the thoracic spine, increased significantly. Thus, the favorable bone-preserving effect is accompanied by unfavorable outcomes on VFx and radiological damage.

FRI0270 Does Immunogenicity Influence on Drug Survival of Anti-TNF?

BackgroundBiological therapies have improved the treatment of Rheumatoid Arthritis (RA) in the last decade. The development of anti-TNF antibodies has been found crucial to drug efficacy and survival. All monoclonal...

SAT0359 Etanercept Increases Bone Mineral Density in Ankylosing Spondylitis, but Does not Prevent Vertebral Fractures

BackgroundAnkylosing spondylitis (AS) is characterized by chronic inflammation often leading to ankylosis of the spine, but also by a decrease of bone mineral density (BMD) and high prevalence of vertebral...

THU0358 Constant Clinical Response in Patients with Early Axial Spondyloarthritis after Continuous Treatment with Etanercept - 4 Year Data of the Esther Trial

ObjectivesIn patients with early axial spondyloarthritis (SpA) with a disease duration of < 5 years and evidence of active inflammation on whole-body magnetic resonance imaging in the spine and/or sacroiliac-joints...

Post-approval trials of new medicines: widening use or deepening knowledge? Analysis of 10 years of etanercept

Objective: To investigate the main aims of the post-approval randomized controlled trials (RCTs) on etanercept and the extent to which they were designed to gain more comparative information.Methods: A search of the literature (Medline, Embase), trial registries (Clinical Trials.gov, Controlled Trials.com), and market authorization reports from the Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) was carried out to identify all RCTs. A comparison of trial data identified unpublished trials and multiple publications relating to the same study. All RCTs completed and/or published after initial market approval was regarded as post-approval.Results: Up until 2008, we found 84 post-approval trials, 11 (13%) trials on approved extensions of indication, another 30 (36%) trials on the approved indications, and 43 (51%) trials on indications not (yet) approved. Nearly half of the studies on indications not yet approved were initiated and funded by independent sponsors. After the initial approval of etanercept, six head-to-head trials were conducted on the approved indications. Overall, the main objectives of post-approval trials with etanercept were found to confirm efficacy and safety in new indications, and to gather additional information for optimal use on the approved indications.Conclusion: Post-approval RCTs on etanercept focus more on studies searching for new indications than on deepening knowledge about use. Ten years after the market entry of etanercept, one of the reasonable demands of clinical practice, for more comparative information, still remains unanswered.

Combining systemic retinoids with biologic agents for moderate to severe psoriasis

Moderate to severe psoriasis, which is defined as psoriasis affecting more than 20% of the body surface area, often requires a combination of therapies to achieve remission. Although numerous data exist regarding the use of acitretin and biologic agent therapy alone for psoriasis, little is known about the efficacy, safety, and tolerability of acitretin combined with biologic agents. Fifteen patients with psoriasis treated with concomitant acitretin and a biologic agent were identified, and their charts were reviewed for response to therapy, additional therapy necessary for disease management, side-effects, and laboratory abnormalities whilst on combination therapy. The Institutional Review Board did not require approval for this chart review. Twenty-nine per cent of patients showed clearance of psoriasis, 43% of patients showed an improvement of 90%, 14% showed an improvement of 75%, and 7.1% showed no change. During treatment with acitretin and biologic agent, five patients required no adjunctive treatment. Three patients were able to stop narrow-band ultraviolet-B (UV-B) therapy after an average of 2.33 months of combination therapy. Only one patient continued to require phototherapy (UV-B) in addition to the biologic agent. Three patients developed squamous cell carcinoma (SCC) whilst on combination therapy, but all patients had a previous history of SCC. One patient developed non-Hodgkin's lymphoma after 3 years of etanercept and acitretin, and the etanercept was discontinued. Acitretin combined with biologic agents offers a promising method of managing refractory psoriasis. More research is needed to determine the long-term safety and efficacy of this combination.

Development of sarcoidosis in etanercept-treated rheumatoid arthritis patients

We report two rheumatoid arthritis patients developing sarcoidosis possibly induced by etanercept. Both women, aged 46 and 53, had erosive, rheumatoid-factor-positive rheumatoid arthritis (RA) for 7 and 6 years, respectively. The eldest had received infliximab for over a year with good response, which was stopped because of a perfusion reaction. She developed a cough and dyspnea after 6 months of etanercept treatment. The other developed erythema nodosum and a plaque lesion on the right arm after 1 year of etanercept. Imaging showed, in both cases, mediastinal adenopathies. Biopsies were compatible with sarcoidosis. Etanercept withdrawal led to a complete remission. Recently, there have been reports of noninfectious granulomatous syndromes in patients receiving etanercept for a variety of diseases. In our cases, the temporal association with etanercept therapy and the complete remission after suspension of etanercept suggest a triggering role of this agent. Possible mechanisms of action and supporting evidence are discussed.