Breaking News
March 19, 2018 - Telediabetes program improves blood sugar control for veterans
March 19, 2018 - Morning Break: House Nixes ‘Right-to-Try’ Bill; Purdue’s PR Makeover; Air in the Brain
March 19, 2018 - Heart researchers develop a new, promising imaging technique for cardiac arrhythmias
March 19, 2018 - Mice study shows how BPA exposure during pregnancy can lead to altered brain development
March 19, 2018 - Breastfeeding mothers who overeat may increase risk of health problems in offspring
March 19, 2018 - New mobile application can detect atrial fibrillation that causes strokes
March 19, 2018 - Study finds low rates of preconception counseling among women of childbearing age with diabetes
March 19, 2018 - ObsEva SA Reports Positive Topline Results from IMPLANT2 Phase 3 Clinical Trial of Nolasiban in IVF
March 19, 2018 - D.C. Week: States Plead for Federal $$ in Opioid Fight
March 19, 2018 - Polycystic ovary syndrome – Genetics Home Reference
March 19, 2018 - Reducing co-payments improves patient, physician adherence to guideline-recommended treatment post-MI
March 19, 2018 - Normalizing estrogen levels can benefit female athletes with irregular menstrual periods
March 19, 2018 - Fitness trackers and virtual coaches motivate patients to exercise post cardiac rehab
March 19, 2018 - Atrial fibrillation patients could reduce risk of dementia by taking stroke prevention drugs
March 19, 2018 - Low sperm count more prevalent with other health problems finds study
March 19, 2018 - Male birth control pill taken once a day shows success
March 19, 2018 - AcelRx Announces Receipt of Type A FDA Meeting Minutes and Plans to Resubmit the DSUVIA New Drug Application in Q2 2018
March 19, 2018 - Eye Docs Adopt EHRs Despite Reservations
March 19, 2018 - CRISPR enhances cancer immunotherapy
March 19, 2018 - Study finds first evidence of delayed aging among Americans
March 19, 2018 - Aussies unaware of sun protection rules to prevent skin cancer
March 19, 2018 - Essential oils linked to abnormal breast development in boys
March 19, 2018 - ‘Tummy Tuck’ Relieved Postpartum Back Pain/Incontinence
March 19, 2018 - New biomarkers for neuroblastoma, a type of cancer in children
March 19, 2018 - Hookah Smoking Carries a Poisoning Risk
March 19, 2018 - Do Mood and Anxiety Affect MS Disability?
March 19, 2018 - Mean depth of ultrasonographic penetration greater in autism
March 19, 2018 - Platypus milk may help combat antibiotic resistance
March 19, 2018 - U.S. IDE study of THERMOCOOL SMARTTOUCH SF Catheter completes patient enrollment
March 18, 2018 - E-cigarette use exposes adolescents to potentially cancer-causing chemicals
March 18, 2018 - GOP Senator: Solve Opioid Crisis Through Community, Not Policy
March 18, 2018 - Why is ADHD more common in boys than girls?
March 18, 2018 - Measles alert after two passengers with the disease fly into US
March 18, 2018 - FDA looks to remove nicotine from cigarettes
March 18, 2018 - FDA moves to cut nicotine in cigarettes, helping smokers kick habit
March 18, 2018 - Athenex Announces Phase II Clinical Study Results for KX2-391 Ointment for the Treatment of Actinic Keratosis
March 18, 2018 - Surgery Tied to Better Outcomes in Kids with T2D
March 18, 2018 - Scientists use nanotechnology to detect molecular biomarker for osteoarthritis
March 18, 2018 - Research establishes use of chimeric cells as potential therapy for Duchenne muscular dystrophy
March 18, 2018 - Researcher working to develop improved endoscopic probe for colonoscopies
March 18, 2018 - Researchers develop way to sequence entire fetal genome by modifying prenatal testing method
March 18, 2018 - FDA Approves PDUFA Fee Waiver for Gimoti New Drug Application
March 18, 2018 - P2Y12 Tx Subsidy Yields Positive Response from Docs, Patients
March 18, 2018 - Are Proteins in Formula Linked to Type 1 Diabetes?
March 18, 2018 - Exercise does not seem to increase bone marrow edema in healthy people
March 18, 2018 - Researchers delineate architecture of nuclear pore complex in yeast cells
March 18, 2018 - ‘It’s Just Ghetto-izing People’: What We Heard This Week
March 18, 2018 - Alzheimer’s disease: Neuronal loss very limited
March 18, 2018 - Study reveals impact of intense, changing work schedules experienced by medical interns
March 18, 2018 - Jobs That Keep the Mind Sharp … Even Into Retirement
March 18, 2018 - Facial Scarring Improved with Botulinum Toxin
March 18, 2018 - Data detectives shift suspicions in Alzheimer’s to inside villain
March 18, 2018 - Shorter Preventive TB Tx Effective for HIV+ Patients
March 18, 2018 - New technique for identifying alcoholism puts treatment options at patients’ and providers’ fingertips
March 18, 2018 - Researchers uncover four microRNAs as potential biomarkers for atrial fibrillation
March 18, 2018 - IRX Therapeutics Announces Initiation of Phase 2 Clinical Trial of IRX-2 in Squamous Cervical or Vulvar Intraepithelial Neoplasia 3
March 18, 2018 - OncoBreak: Learning from Silence; ‘Rigged’ Drug System; NCCN Guidelines Questioned
March 18, 2018 - The coffee cannabis connection
March 18, 2018 - Novel centrifugal-flow pump for heart failure patients provides improved long-term outcomes
March 18, 2018 - U.S. FDA Accepts New Drug Application for Prucalopride (SHP555) for Chronic Idiopathic Constipation
March 18, 2018 - Cath Lab Recap: iFR vs FFR $$; Ridaforolimus-Eluting Stent
March 18, 2018 - Tree care workers need better training to handle dangers on the job, study finds
March 18, 2018 - Dementia patients do not undergo diagnostic evaluation at onset of disease, study finds
March 18, 2018 - Transplanting enhanced interneurons restores brain rhythms in mouse model of Alzheimer’s
March 18, 2018 - Gene Therapy Flops for Critical Limb Ischemia
March 17, 2018 - Study spotlights risks in anesthesiologist handoffs
March 17, 2018 - Verb fluency test may be useful tool for differential diagnosis of cognitive failure
March 17, 2018 - Health Tip: Suggestions to Improve Your Cholesterol
March 17, 2018 - Fructans Suspect in Non-Celiac Gluten Sensitivity
March 17, 2018 - Aspirin therapy appears safe before thyroid surgery
March 17, 2018 - Minimally invasive surgical device may one day provide lasting heart repair
March 17, 2018 - UIH and RaySearch enter into new partnership
March 17, 2018 - Is BMI Too Inexact? | Medpage Today
March 17, 2018 - Sleep apnea study finds male-female differences in cerebral cortex thickness, symptoms
March 17, 2018 - Leicester research could help identify people with asthma of different severities
March 17, 2018 - Biosense Webster enrolls and treats first AF patient in clinical study of new RF balloon catheter
March 17, 2018 - Participants in rogue herpes vaccine research take legal action
March 17, 2018 - Imara Doses First Patient in Phase 2a Clinical Trial of IMR-687 for Sickle Cell Disease
March 17, 2018 - AAP: Prevent Medication Errors by Improving Processes
March 17, 2018 - Severe sleep apnea during REM sleep tied to acute CV events
Factors ID’d That Predict RA Remission with Etanercept

Factors ID’d That Predict RA Remission with Etanercept

image_pdfDownload PDFimage_print

Action Points

  • Rheumatoid arthritis (RA) patients who were younger, had lower body mass index (BMI), better Health Assessment Questionnaire (HAQ) scores, and less baseine disease activity were most likely to achieve remission after combination etanercept (Enbrel) and methotrexate induction therapy, based on post hoc analysis of clinical trial data.
  • Note that the findings suggest that targeting sustained clinical remission in patients receiving full-dose combination etanercept-methotrexate therapy before considering dose or regimen changes may improve the likelihood that patients will remain in clinical remission.

Rheumatoid arthritis (RA) patients who were younger and who had lower body mass index (BMI), Health Assessment Questionnaire (HAQ) scores, and less disease activity at baseline were most likely to achieve remission after combination etanercept (Enbrel) and methotrexate induction therapy, a post hoc analysis of the PRESERVE trial found.

Patients who failed to achieve sustained remission with induction therapy and ones with worse disease activity and patient-reported outcomes soon after starting maintenance therapy were most likely to lose remission, reported Josef S. Smolen, MD, of the Medical University of Vienna, and colleagues.

“This result underscores and reinforces the current treat-to-target approach and the importance of adjusting treatment in patients who are not achieving the lowest levels of disease activity currently recommended in the American College of Rheumatology (ACR) and European League against Rheumatism (EULAR) treatment guidelines, as it suggests that the depth and duration of response are relevant,” they wrote online in Arthritis Research & Therapy.

In 2013, the PRESERVE trial showed that after etanercept was withdrawn, etanercept-methotrexate combinations were more effective in maintaining low RA disease activity than methotrexate alone. In this post hoc analysis, the researchers aimed to identify potential predictive markers that induced remission or caused it to fail over time.

When PRESERVE was designed, the new, more stringent ACR and EULAR remission criteria had not been published. While Disease Activity Score in 28 joints (DAS28) <2.6 no longer defines remission, the authors used it in this analysis to be consistent with the primary manuscript, also looking at Simplified Disease Activity Index (SDAI) and Clinical Disease Activity Index (CDAI) remission values.

The PRESERVE trial studied adults with active RA who had moderate disease activity (DAS28>3.2 and ≤5.1 at baseline). All patients enrolled in the initial open-label period were treated for 36 weeks with etanercept 50 mg once weekly plus methotrexate.

At the start of the open-label period, 83% of patients were women, average age was 48, and mean DAS28, SDAI, and CDAI scores were 4.4, 19.1, and 17.8.

After 36 weeks, patients who achieved sustained low disease activity (an average DAS28≤3.2 from weeks 12 to 36 and DAS28≤3.2 at week 36) were randomized to continue weekly subcutaneous injections of etanercept 50 mg, reduce the etanercept dose to 25 mg, or withdraw etanercept and receive placebo injections, all with background methotrexate, for a 52-week double-blind period.

While similar proportions of patients treated with etanercept 50 mg and etanercept 25 mg maintained remission in the double-blind period, withdrawing etanercept resulted in a loss of remission in many patients.

Several continuous baseline factors appeared to predict DAS28, SDAI, and CDAI remission after 36 weeks. Lower baseline DAS28, SDAI, and CDAI, younger age, BMI under 30,and lower HAQ score were significant predictors of all three endpoints.

For all three treatments, the strongest predictors of loss of DAS28 remission included failure to achieve sustained remission with induction therapy (DAS28<2.6 at weeks 12, 20, 28, and 36), higher DAS28, SDAI, and CDAI at randomization and at 1 month, increase in DAS28, SDAI, and CDAI at 1 month, and increase in DAS28, CDAI, SDAI components and patient-reported outcomes at 1 month. SDAI and CDAI remission had similar predictors.

“The lower the DAS28, and thus the lower the residual disease activity level, the greater the likelihood of sustained response,” the researchers wrote, noting that predictors for sustained SDAI and CDAI remission “further support the conclusion of a better outcome with lower disease activity and maintenance of a good response at the time of withdrawal.”

“These findings may help guide clinicians’ decision-making as they treat patients to remission and beyond,” they added.

The PRESERVE trial and its analyses have several limitations. The study excluded patients with mild or severe disease activity or with certain comorbid diseases. Predictors of remission analyses were limited to data collected in the first 36-week period of the PRESERVE trial.

Because SDAI and CDAI remission were more stringent endpoints, with fewer patients achieving them than DAS28 remission, analyses about SDAI and CDAI remission loss had less power to detect differences than analyses about the loss of DAS28 remission.

This post-hoc analyis of the PRESERVE trial was sponsored by Pfizer.

Study authors disclosed relationships with AbbVie, BMS, MSD, Pfizer, Roche, Astra-Zeneca, Boehringer Ingelheim, Celgene, Celtrion, GSK, ILTOO, Janssen, Lilly, Novartis-Sandoz, Samsung, and UCB. Some authors were contractors or employees of Pfizer.


Tagged with:

About author

Related Articles