25 research outputs found
A longâterm, openâlabel trial of the safety and efficacy of etanercept (Enbrel) in patients with rheumatoid arthritis not treated with other diseaseâmodifying antirheumatic drugs
OBJECTIVE: To evaluate the longâterm safety and efficacy of etanercept in patients with rheumatoid arthritis. METHODS: 549 patients entered this 5âyear, openâlabel extension study and received etanercept 25â
mg twice weekly. All patients showed inadequate responses to diseaseâmodifying antirheumatic drugs before entry into the doubleâblind studies. Safety assessments were carried out at regular intervals. Primary efficacy end points were the numbers of painful and swollen joints; secondary variables included American College of Rheumatology (ACR) response rate, Disease Activity Score and acuteâphase reactants. Efficacy was analysed using the lastâobservationâcarriedâforward approach. RESULTS: Of the 549 patients enrolled in the openâlabel trial, 467 (85%), 414 (75%) and 371 (68%) completed 1, 2 and 3â
years, respectively; 363 (66%) remained in the study at the time of this analysis. A total exposure of 1498 patientâyears, including the doubleâblind study, was accrued. In the openâlabel trial, withdrawals for efficacyârelated and safetyârelated reasons were 11% and 13%, respectively. Frequent adverse events included upper respiratory infections, flu syndrome, rash and injectionâsite reactions. Rates of serious infections and malignancies remained unchanged over the course of the study; there were no reports of patients with central demyelinating disease or serious blood dyscrasias. After 3â
years, ACR20, ACR50 and ACR70 response rates were 78%, 51% and 27%, respectively. The Disease Activity Score score was reduced to 3.0 at 3â
months and 2.6 at 3â
years from 5.1. A sustained improvement was found in Health Assessment Questionnaire scores throughout the 3âyear time period. CONCLUSION: After 3â
years of treatment, etanercept showed sustained efficacy and a favourable safety profile
Improvement in patient-reported outcomes for patients with ankylosing spondylitis treated with etanercept 50 mg once-weekly and 25 mg twice-weekly
Rates of serious infections, opportunistic infections, inflammatory bowel disease, and malignancies in subjects receiving etanercept vs. controls from clinical trials in ankylosing spondylitis: a pooled analysis
Pathophysiology and treatment of rheumatic disease
Assessment of long-term safety and efficacy of etanercept in a 5-year extension study in patients with rheumatoid arthritis.
peer reviewe
RATES OF SERIOUS INFECTIONS, OPPORTUNISTIC INFECTIONS, INFLAMMATORY BOWEL DISEASE, AND CANCERS IN SUBJECTS RECEIVING ETANERCEPT VERSUS CONTROLS FROM CLINICAL TRIALS IN ANKYLOSING SPONDYLITIS
Pathophysiology and treatment of rheumatic disease
Once-weekly administration of etanercept 50 mg improves patient-reported outcomes in patients with moderate-to-severe plaque psoriasis.
Item does not contain fulltextOBJECTIVE: To assess baseline patient-reported outcomes (PROs) and PRO improvement in patients with psoriasis administered etanercept 50 mg once weekly (QW). METHODS: Adult patients with moderate-to-severe plaque psoriasis participated in a 12-week, double-blind, controlled trial in which they received etanercept 50 mg QW (n = 96) or placebo QW (n = 46), followed by a 12-week, open-label extension in which they received etanercept 50 mg QW (etanercept-etanercept, n = 90; placebo-etanercept, n = 36). Patients completed the Dermatology Life Quality Index (DLQI), EuroQoL-5D (EQ-5D) and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at baseline and subsequent study visits. RESULTS: At baseline, DLQI and EQ-5D scores indicated significant quality of life (QoL) impairment, and FACIT-F scores suggested more fatigue than in the general population. At week 12, etanercept 50 mg QW provided statistically significantly (p < 0.05) and clinically meaningfully greater improvement in DLQI and EQ-5D utility scores than placebo, but not in FACIT-F scores. After 24 weeks of etanercept, the mean DLQI suggested psoriasis had a small effect on QoL, while EQ-5D and FACIT-F scores were comparable to population norms. CONCLUSIONS: Patients with moderate-to-severe psoriasis entered this trial with serious PRO impairment. At week 12, etanercept 50 mg QW provided significant QoL improvements compared with placebo. After 24 weeks of etanercept, the patients' serious PRO impairment had largely abated
Clinical and Imaging Efficacy of Etanercept in Early Non-radiographic Axial Spondyloarthritis; 48-Week Treatment Data
Pathophysiology and treatment of rheumatic disease
Etanercept and sulfasalazine, alone and combined, in patients with active rheumatoid arthritis despite receiving sulfasalazine: a doubleâblind comparison
OBJECTIVE: To compare the efficacy and safety of etanercept and sulfasalazine, alone and in combination, in patients with active rheumatoid arthritis despite sulfasalazine treatment. METHODS: A doubleâblind, randomised study in adult patients with active rheumatoid arthritis despite stable sulfasalazine (2â3â
g/day) treatment. The primary end point was a 20% response by the American College of Rheumatology (ACR) criteria at 24â
weeks. RESULTS: At baseline, the three treatment groups (sulfasalazine, nâ=â50; etanercept, nâ=â103; etanercept and sulfasalazine, nâ=â101) were comparable for demographic variables and disease activity. Lack of efficacy was the primary reason for discontinuation (sulfasalazine, nâ=â12; etanercept, nâ=â1; etanercept and sulfasalazine, nâ=â4; p<0.001). Significantly more patients receiving etanercept, alone or in combination (74% for each), achieved ACR 20 responses at 24â
weeks than those receiving sulfasalazine (28%; p<0.01). Similarly, more patients in the etanercept groups achieved ACR 50 and ACR 70 responses than those in the sulfasalazine group (p<0.01). In the groups receiving etanercept, significant differences in the ACR core components were observed by week 2 compared with those receiving sulfasalazine alone (p<0.01). The incidences of several common adverse events (headache, nausea, asthenia) were lower with etanercept alone than with the combination (p<0.05), but infections and injection site reactions were higher with etanercept alone (p<0.05). The safety profiles of both etanercept treatment groups were comparable with previous experience of etanercept. CONCLUSIONS: For all efficacy variables assessed, etanercept alone or in combination with sulfasalazine resulted in substantial and similar improvement in disease activity from baseline to week 24 compared with sulfasalazine alone in patients with active rheumatoid arthritis despite their sulfasalazine treatment. All three treatments were generally well tolerated
Efficacy/safety of etanercept in moderate-to-severe asthma: a randomised, controlled trial
Increased tumour necrosis factor (TNF)-? levels have been observed in bronchial biopsies and induced sputum from subjects with severe asthma. We investigated etanercept (ETN) as a therapeutic option for treating moderate-to-severe persistent asthma. In this 12-week, randomised, double-blind, placebo-controlled, phase 2 trial, subjects (n=132) with moderate-to-severe persistent asthma received subcutaneous injections of ETN 25&emsp14;mg or placebo twice weekly and were evaluated at baseline and at weeks 2, 4, 8, and 12. The primary end-point was the change from baseline to week 12 in pre-bronchodilator forced expiratory volume in 1 second (FEV1) % predicted. Secondary end-points included morning peak expiratory flow; FEV1 % predicted; Asthma Control Questionnaire; asthma exacerbations; PC20 assessed by methacholine challenge; and the Asthma Quality of Life Questionnaire. No significant differences were observed between ETN and placebo for any of the efficacy end-points. ETN treatment was well tolerated, with no unexpected safety findings observed during the study. Clinical efficacy of ETN was not shown in subjects with moderate-to-severe persistent asthma over 12 weeks. However, ETN treatment was a well-tolerated therapy. Studies in specific subsets of patients with asthma with longer-term follow-up may be needed to fully evaluate the clinical efficacy of ETN in this population