Buttonhole versus Stepladder Cannulation for Home Hemodialysis

Background and objectivesCanadian home hemodialysis guidelines highlight the potential differences in complications associated with arteriovenous fistula (AVF) cannulation technique as a research priority. Our primary objective was to determine the feasibility of randomizing patients with ESKD training for home hemodialysis to buttonhole versus stepladder cannulation of the AVF. Secondary objectives included training time, pain with needling, complications, and cost by cannulation technique.Design, setting, participants, & measurementsAll patients training for home hemodialysis at seven Canadian hospitals were assessed for eligibility, and demographic information and access type was collected on everyone. Patients who consented to participate were randomized to buttonhole or stepladder cannulation technique. Time to train for home hemodialysis, pain scores on cannulation, and complications over 12 months was recorded. For eligible but not randomized patients, reasons for not participating in the trial were documented.ResultsPatient recruitment was November 2013 to November 2015. During this time, 158 patients began training for home hemodialysis, and 108 were ineligible for the trial. Diabetes mellitus as a cause of ESKD (31% versus 12%) and central venous catheter use (74% versus 6%) were more common in ineligible patients. Of the 50 eligible patients, 14 patients from four out of seven sites consented to participate in the study (28%). The most common reason for declining to participate was a strong preference for a particular cannulation technique (33%). Patients randomized to buttonhole versus stepladder cannulation required a shorter time to complete home hemodialysis training. We did not observe a reduction in cannulation pain or complications with the buttonhole method. Data linkages for a formal cost analysis were not conducted.ConclusionsWe were unable to demonstrate the feasibility of conducting a randomized, controlled trial of buttonhole versus stepladder cannulation in Canada with a sufficient number of patients on home hemodialysis to be able to draw meaningful conclusions.

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Optimizing chair time in infusion centers using intravenous cetirizine premedication for the prevention of hypersensitivity infusion reactions.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.e13508 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. e13508-e13508

Author(s):

Julio Antonio Peguero ◽

Ahmed Ayad ◽

Stacia Young-Wesenberg ◽

Teresa Yang ◽

Janine North ◽

...

Keyword(s):

Controlled Trial ◽

Quality Care ◽

Primary Objective ◽

Double Blind ◽

Acute Urticaria ◽

Number Of Patients ◽

Study Results ◽

Secondary Endpoints ◽

Infusion Reactions ◽

Anti Cd20

e13508 Background: Oncology infusion centers are increasingly focused on improving operational efficiencies and patient satisfaction, while maintaining quality care. One key component is optimizing chair time, which has been especially important for patient safety during the COVID-19 pandemic to reduce risk of transmission. Many infusions require antihistamine premedication to reduce the risk of hypersensitivity infusion reactions (IRs). The two IV options are IV diphenhydramine and IV cetirizine, which have a quicker onset than oral options and can be administered IV push. In treating acute urticaria, IV cetirizine was shown to be comparable to IV diphenhydramine, with fewer side effects, and it may be effective for preventing IRs with improved chair time. Methods: A randomized, double-blind phase 2 study evaluating premedication with single dose IV cetirizine 10 mg versus IV diphenhydramine 50 mg was conducted in 34 patients receiving paclitaxel, rituximab, its biosimilar or obinutuzumab (first cycle, retreatment after 6 months or with persistent IRs). The primary objective was the incidence of IRs after premedication. Secondary endpoints included sedation due to antihistamines and time to readiness for discharge. Sedation was reported by patients on a scale of 0-4 (0 = none to 4 = extremely severe). No formal statistical analyses were planned given the exploratory nature of the study. Results: Adults primarily with cancer (n = 31 [91%]) were enrolled during the COVID-19 pandemic, from March 25 to November 23, 2020. The median age was 65 and 67 years in the IV cetirizine and diphenhydramine groups, respectively. The number of patients with IRs was 2/17 (11.8%) with IV cetirizine versus 3/17 (17.6%) with IV diphenhydramine. The mean sedation score in the IV cetirizine group compared to the IV diphenhydramine group was lower at all time points, including at discharge (0.1 vs 0.4, respectively). Mean time to discharge was 24 minutes less with IV cetirizine (4.3 hours [1.5]) versus IV diphenhydramine (4.7 hours [1.2]). This difference was greater (30 minutes less) in those ≥65 years of age (4.4 [1.3] vs 4.9 [1.0] hours). Regardless of whether patients received paclitaxel (n = 9) or an anti-CD20 (n = 25), patients had less chair time when premedicated with IV cetirizine. There were fewer treatment-related adverse events (AEs) with IV cetirizine (2 events) than with IV diphenhydramine (4 events). Conclusions: This was the first randomized, controlled trial evaluating IV antihistamine premedication for IRs and chair time. It was shown that IV cetirizine can prevent IRs, with less sedation, fewer related AEs and reduced chair time compared to IV diphenhydramine. This improves infusion center operations and patient experience. Clinical trial information: NCT04189588.

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Intravenous oxycodone compared to morphine for post-operative opioid-related adverse events in opioid naïve patients: a prospective randomized controlled trial

10.21203/rs.2.16541/v1 ◽

2019 ◽

Author(s):

philippe cuvillon ◽

Sandrine Alonso ◽

Joel L’Hermite ◽

Vanessa Reubrecht ◽

Lana Zoric ◽

...

Keyword(s):

Adverse Events ◽

General Anesthesia ◽

Controlled Trial ◽

Group Versus ◽

Patient Characteristics ◽

Morphine Group ◽

Pain Scores ◽

Primary Endpoints ◽

Number Of Patients ◽

Prospective Randomized Controlled Trial

Abstract Bacground As intravenous oxycodone is as potent as morphine for pain relief, the purpose of this study was to assess opioid-related adverse events (ORAEs) of oxycodone vs morphine (1mg/1mg) in opioid naïve patients after general anesthesia and surgery.Methods Patients schedulled for total hip arthroplasty under general anesthesia were randomized in a 1:1 ratio to receive oxycodone or morphine (titration in PACU followed by intravenous PCA: bolus 1 mL, lockout time 7 min). Primary endpoints was number of patients with ≥1 ORAEs at H24 (at least one of the following complications: nausea, vomiting, respiratory depression, pruritus (itch), urinary retention requiring evacuation, allergy (skin reaction), hallucination (perception without object)). Patients were followed up to 4 months.Results Among 241 patients included in the ITT analysis, there was no difference in patient characteristics. At H24, there were 55 patients with at least one ORAEs in oxycodone group versus 46 in morphine group (48% vs 40%, p=0.19; relative risk RR (oxycodone vs morphine) = 1.22 [0.91; 1.63]). Oxycodone vs Morphine requirements were respectively: 6 [0-11] vs 8 [0-12] mg for titration in PACU (p=0.06) and 15 [8-26] vs 8 [5-16] mg during PCA period at H24 (p=0.001). The total dose of morphine administered within the first 24 h was 22 [12-37] vs 19 [11-28]mg for oxycodone (p=0.048). Pain scores (rest, movement: H0-H48) and neuropathic pain score after 4 months were similar in both groups.Conclusion Even if lower doses of oxycodone were required for PACU titration and over the first 24h, it did not lead to less ORAEs.

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Barriers to Home Hemodialysis Across Saskatchewan, Canada: A Cross-Sectional Survey of In-Center Dialysis Patients

Canadian Journal of Kidney Health and Disease ◽

10.1177/2054358120948293 ◽

2020 ◽

Vol 7 ◽

pp. 205435812094829

Author(s):

Lucas Diebel ◽

Maryam Jafari ◽

Sachin Shah ◽

Christine Day ◽

Connie McNaught ◽

...

Keyword(s):

Primary Objective ◽

Survey Study ◽

Treatment Modalities ◽

Cross Sectional Survey ◽

Home Hemodialysis ◽

Chi Square ◽

Cross Sectional ◽

Dialysis Unit ◽

Training Time ◽

Dialysis Vintage

Background: Despite clinical and lifestyle advantages of home hemodialysis (HHD) compared with in-center hemodialysis (ICHD), it remains underutilized in our province. The aim of the study was to explore the patients’ perception and to identify the barriers to use of HHD in Saskatchewan, Canada. Objectives: The primary objective of the study was to evaluate and explore patient perceptions of HHD and to identify the obstacles for adoption of HHD in Saskatchewan. The secondary objective was to examine variations in the patients’ perceptions and barriers to HHD by center (main dialysis units vs satellite dialysis units). Design: This is a cross-sectional observational survey study. Setting: Two major centers (Regina and Saskatoon) and 5 associated satellite units attached to each center across the province of Saskatchewan. Patients: We approached all prevalent ICHD patients across Saskatchewan, 398 agreed to participate in the study. Measurements: Self-reported barriers to HHD were assessed using a questionnaire. Methods: A questionnaire was designed to determine the patients’ perceived barriers to HHD. Descriptive statistics was used to present the data. Chi-square and Mann-Whitney U test were used to compare the patients’ responses between main and satellite units Results: Satisfaction with current dialysis care (91%), increase in utility bills (65%), fear of catastrophic events at home (59%), medicalization of one’s home (54%), and knowledge deficits toward treatment modalities (54%) were the main barriers to HHD uptake. Compared with patients dialyzing in our main units, satellite patients chose not to pursue HHD more frequently because they had greater satisfaction with their current dialysis unit care (97% vs 87%, P < .001), felt more comfortable dialyzing under the supervision of medical staff (95% vs 86%, P < .007), could not afford additional utility costs (92% vs 45%, P < .001), were unaware of the risks and benefits of HHD (83% vs 33%, P < .001), had concerns over time commitments for training to HHD (69% vs 32%, P < .001), and had concern for family burnout (60.8% vs 40.6%, P < .001). Limitations: We used questionnaires to quantify known barriers, and this prevents inclusion of additional barriers that individual patients may consider important. Cross-sectional data can only be used as a snapshot. Only 398 patients agreed to participate, and the results cannot be generalized to 740 prevalent HD patients. We did not capture data on demographics (age, income, and literacy level), comorbidities, and dialysis vintage, which would have been helpful in interpretation of the results. Conclusions: Satisfaction with in-center care, lack of awareness and education, specifically in the satellite population, concerns with family burnout, expenses associated with utilities, and training time will need to be addressed to increase the uptake of HHD. Trial Registration: The study was not registered on a publicly accessible registry as it did not involve any health care intervention on human participants.

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Epoetin delta in the management of anaemia in cancer patients

Journal of Clinical Oncology ◽

10.1200/jco.2007.25.18_suppl.19555 ◽

2007 ◽

Vol 25 (18_suppl) ◽

pp. 19555-19555

Author(s):

K. Zajda ◽

M. Krzakowski

Keyword(s):

Cancer Patients ◽

Controlled Trial ◽

Gene Activation ◽

Human Cell Line ◽

Primary Objective ◽

Open Label ◽

Double Blind ◽

Target Sample Size ◽

Number Of Patients ◽

Transfusion Requirements

19555 Background: Cancer is often associated with anaemia. Epoetin delta (Shire plc) differs from recombinant erythropoietins as it is produced in a human cell line using gene-activation technology. We report data from a controlled trial of epoetin delta (ED) and an extension study. Methods: Cancer patients with anaemia (haemoglobin [Hb] = 10.5 g/dL) were randomized to 12-weeks’ treatment with ED (150 or 300 IU/kg) or placebo (double blind). Treatment was given subcutaneously, three-times weekly. Patients were included if they were receiving chemotherapy and had at least two cycles remaining when randomized. Primary objective was to demonstrate a difference between ED and placebo in Δ Hb from baseline and the number of patients requiring blood transfusions. Target sample size was 100 patients per arm (99% power for a 1.6 g/dL difference in Δ Hb and a 29% difference in the percentage of patients requiring transfusions). Patients completing the study entered an open-label, 12-week extension in which all initially received ED 150 IU/kg. Dose could be increased to 300 IU/kg if Hb levels were < 12 g/dL after 4 weeks. Results: In total, 313 patients were randomized (100, 103 and 99 to ED 150 and 300 IU/kg, and placebo, respectively). Mean change ± SD in Hb from baseline was 2.47 ± 2.39, 2.46 ± 2.56 and 0.57 ± 1.7 in the ED 150 and 300 IU/kg, and placebo groups respectively (P < 0.0001 for both comparisons). There was no difference in the proportion of patients requiring transfusions (26.0, 21.9 and 26.9%, respectively). In the second study, Hb levels were maintained in those previously on ED and increased in those previously on placebo (2.55 g/dL). In those previously on ED, transfusion requirements were lower. ED was well tolerated. Conclusions: Epoetin delta was effective in increasing Hb levels in patients with anaemia related to cancer and longer treatment was associated with fewer transfusions. No significant financial relationships to disclose.

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Self-Managing Postoperative Pain with the Use of a Novel, Interactive Device: A Proof of Concept Study

Pain Research and Management ◽

10.1155/2016/9704185 ◽

2016 ◽

Vol 2016 ◽

pp. 1-6 ◽

Cited By ~ 2

Author(s):

Luke Mordecai ◽

Frances H. L. Leung ◽

Clarissa Y. M. Carvalho ◽

Danielle Reddi ◽

Martin Lees ◽

...

Keyword(s):

Postoperative Pain ◽

Controlled Trial ◽

Primary Objective ◽

Self Report ◽

Secondary Outcome ◽

Pain Scores ◽

Prospective Randomized Controlled Trial ◽

Pain Ratings ◽

The Difference ◽

Patient Use

Background. Pain is commonly experienced following surgical procedures. Suboptimal management is multifactorial.Objectives. The primary objective was to assess whether patients used a device (Navimed) to self-report pain over and above a normal baseline of observations. Secondary outcome measures included comparison of pain scores and patient use of and feedback on the device.Methods. In a prospective randomized controlled trial, elective gynaecological surgery patients received standard postoperative pain care or standard care plus the Navimed, which allowed them to self-report pain and offered interactive self-help options.Results. 52 female patients, 26 in each of device and standard groups, did not differ in the frequency of nurse-documented pain scores or mean pain scores provided to nurses. The device group additionally reported pain on the device (means 18.50 versus 11.90 pain ratings per day,t(32)=2.75,p<0.001) that was significantly worse than reported to nurses but retrospectively rated significantly less anxiety. 80% of patients found the device useful.Discussion and Conclusion. This study demonstrates that patients used the Navimed to report pain and to help manage it. Further work is required to investigate the difference in pain scores reported and to develop more sophisticated software.

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Analgesia Nociception Index-Guided Remifentanil versus Standard Care during Propofol Anesthesia: A Randomized Controlled Trial

Journal of Clinical Medicine ◽

10.3390/jcm11020333 ◽

2022 ◽

Vol 11 (2) ◽

pp. 333

Author(s):

Nada Sabourdin ◽

Julien Burey ◽

Sophie Tuffet ◽

Anne Thomin ◽

Alexandra Rousseau ◽

...

Keyword(s):

Postoperative Analgesia ◽

Controlled Trial ◽

Primary Objective ◽

Gynecologic Surgery ◽

Standard Group ◽

Standard Practice ◽

Randomized Controlled ◽

Pain Scores ◽

Standard Management ◽

Clinical Benefits

The clinical benefits to be expected from intraoperative nociception monitors are currently under investigation. Among these devices, the Analgesia Nociception-Index (ANI) has shown promising results under sevoflurane anesthesia. Our study investigated ANI-guided remifentanil administration under propofol anesthesia. We hypothesized that ANI guidance would result in reduced remifentanil consumption compared with standard management. This prospective, randomized, controlled, single-blinded, bi-centric study included women undergoing elective gynecologic surgery under target-controlled infusion of propofol and remifentanil. Patients were randomly assigned to an ANI or Standard group. In the ANI group, remifentanil target concentration was adjusted by 0.5 ng mL−1 steps every 5 min according to the ANI value. In the Standard group, remifentanil was managed according to standard practice. Our primary objective was to compare remifentanil consumption between the groups. Our secondary objectives were to compare the quality of anesthesia, postoperative analgesia and the incidence of chronic pain. Eighty patients were included. Remifentanil consumption was lower in the ANI group: 4.4 (3.3; 5.7) vs. 5.8 (4.9; 7.1) µg kg−1 h−1 (difference = −1.4 (95% CI, −2.6 to −0.2), p = 0.0026). Propofol consumption was not different between the groups. Postoperative pain scores were low in both groups. There was no difference in morphine consumption 24 h after surgery. The proportion of patients reporting pain 3 months after surgery was 18.8% in the ANI group and 30.8% in the Standard group (difference = −12.0 (95% CI, −32.2 to 9.2)). ANI guidance resulted in lower remifentanil consumption compared with standard practice under propofol anesthesia. There was no difference in short- or long-term postoperative analgesia.

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Intravenous oxycodone compared to morphine for post-operative opioid-related adverse events in opioid naïve patients: a prospective randomized controlled trial

10.21203/rs.2.22154/v1 ◽

2020 ◽

Author(s):

philippe cuvillon ◽

Sandrine Alonso ◽

Joel Lhermite ◽

Vanessa Reubrecht ◽

Lana Zoric ◽

...

Keyword(s):

Adverse Events ◽

Urinary Retention ◽

Postoperative Care ◽

Pain Treatment ◽

Controlled Trial ◽

Group Versus ◽

Potency Ratio ◽

Pain Scores ◽

Number Of Patients ◽

Secondary Outcomes

Abstract Bacground: Intravenous oxycodone compared to morphine for postoperative pain relief is controversial. The purpose of this study was to assess opioid-related adverse events of oxycodone versus morphine in opioid-naive patients after orthopaedic surgery. Methods: Patients scheduled for total hip arthroplasty under general anesthesia combined with a multimodal analgesia (acetamnophen, nonsteroidal anti-inflammatory) were randomized in a triple-blinded trial to postopertaive pain treatment with either intravenous oxycodone or morphine (potency ratio 1:1). After surgery, patients received similar drug regimen for titration in the postoperative care unit (bolus 2-3 mg, 5 min period, when pain score was >3/10) followed by an intravenous patient controlled analgesia (bolus 1 mg, lockout time 7 min) postoperatively. The primary outcome was number of patients with ≥1 opioid-related adverse events within the first 24 hours (at least one of the following complications: nausea, vomiting, respiratory depression, pruritus, urinary retention requiring evacuation, allergy, hallucination). Secondary outcomes included pain scores, opioid consumption. Patients were followed up to 4 months. Results: The intention-to-treat analysis included 241 patients with similar characteristics. There were 55 patients with at least one opioid-related adverse events in oxycodone group versus 46 in morphine group (48% vs 40%, p=0.19; relative risk= 1.22 [0.91; 1.63]). Oxycodone versus morphine requirements were respectively: 6 [0-11] versus 8 [0-12] mg (p=0.06) for titration, 15 [8-26] versus 8 [5-16] mg (p=0.001) for PCA dose, and 22 [12-37] mg versus 19 [11-28] mg for the titration and PCA accumulated consumption (p=0.048). During the first 24 hours, there were no other differences in secondary outcomes between both drugs for (respectively oxycodone versus morphine in %): nausea (15 versus 13), vomiting (5 versus 5 ), urinary retention (20 versus 12 ) and pain scores. Conclusion: This study demonstrated that oxycodone required lower doses for titration in postoperative care unit, but did not significantly reduce opioid-related adverse events within the first 24 hours compared to morphine.

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Impact of Temperature on Injection-Related Pain Caused by Subcutaneous Administration of Ustekinumab: A Three-arm Crossover Open-label Randomized Controlled Trial

SKIN The Journal of Cutaneous Medicine ◽

10.25251/skin.1.3.2 ◽

2017 ◽

Vol 1 (3) ◽

pp. 117-127

Author(s):

Yasaman Mansouri ◽

Yasmin Amir ◽

Michelle Min ◽

Raveena Khanna ◽

Ruiqi Huang ◽

...

Keyword(s):

Controlled Trial ◽

Subcutaneous Administration ◽

Open Label ◽

Post Dose ◽

Subcutaneous Injections ◽

Pain Scores ◽

Observational Cohort ◽

Vas Scores ◽

Pre Treatment ◽

To Receive

Background: Adherence to subcutaneous biologic agents for the treatment of psoriasis can be negatively influenced by injection pain.Objective: To explore the differences in injection site pain when patients are pre-treated with heat or cold, versus no pre-treatment prior to administration of a subcutaneous biologic agent.Methods: In an observational cohort study, patients receiving subcutaneous injections of ustekinumab were randomly assigned to receive pretreatment with ice, heat, or no intervention over three visits. Post-dose, patients rated pain on a 100 mm visual analogue scale (VAS).Results: There was an increase in the VAS score for both heat (2.51, P=0.30) and ice (3.33, P=0.16), compared to no intervention. No differences were found between the two intervention groups (-0.83, P=0.73). On average, females had the same VAS scores with ice compared to that of no intervention (-0.12, P=0.97) and a non–significant decrease of 3.29 points (P=0.38) with heat. Males had increased pain scores by 5.65 points (P=0.07) with ice and by 6.39 points (P=0.04) with heat.Limitations: Pain is a subjective measurement and objective quantification is difficult.Conclusions: On average, neither heat nor cold application reliably reduced pain. Our results do not support the application of heat or cold prior to ustekinumab injection.

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Intrauterine lidocaine and naproxen for analgesia during intrauterine device insertion: randomized controlled trial

Contraception and Reproductive Medicine ◽

10.1186/s40834-019-0094-0 ◽

2019 ◽

Vol 4 (1) ◽

Cited By ~ 1

Author(s):

Shana M. Miles ◽

Katerina Shvartsman ◽

Susan Dunlow

Keyword(s):

Pain Assessment ◽

Controlled Trial ◽

Intrauterine Device ◽

Self Medication ◽

Double Blind ◽

Clinical Trial Registration ◽

Treatment Groups ◽

Pain Scores ◽

Post Procedure ◽

Treatment Medication

Abstract Background This study evaluates oral naproxen and intrauterine instillation of lidocaine for analgesia with intrauterine device (IUD) placement as compared to placebo. Methods This was a randomized, double-blind, placebo-controlled trial. Patients desiring levonorgestrel 52 mg IUD or Copper T380A IUD were randomized into treatment groups. Patients received either oral naproxen 375 mg or placebo approximately 1 h prior to procedure in conjunction with 5 mL of 2% lidocaine or 5 mL of intrauterine saline. The primary outcome was pain with IUD insertion measured on a visual analog scale immediately following the procedure. Prespecified secondary outcomes included physician pain assessment, post procedure analgesia, satisfaction with procedure, satisfaction with IUD, and pain assessment related to IUD type. Results From June 4, 2014 to October 28, 2016 a total of 160 women desiring Copper T380A or levonorgestrel 52 mg intrauterine device insertion and meeting study criteria were enrolled and randomized in the study. Of these, 157 (78 in the Copper T380A arm, 79 in the levonorgestrel 52 mg) received study treatment medication. There were 39 in naproxen/lidocaine arm, 39 in placebo/lidocaine arm, 40 in naproxen/placebo arm, and 39 in placebo/placebo arm. There were no differences in the mean pain scores for IUD placement between treatment groups (naproxen/lidocaine 3.38 ± 2.49; lidocaine only 2.87 ± 2.13; naproxen only 3.09 ± 2.18; placebo 3.62 ± 2.45). There was no difference in self-medication post procedure or in satisfaction with the procedure and IUD among women in the treatment arms or by type of IUD. Conclusion Naproxen with or without intrauterine lidocaine does not reduce pain with IUD placement. Clinical trial registration Clinicaltrials.gov, NCT02769247. Registered May 11, 2016, Retrospectively registered

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Early combination therapy with etanercept and methotrexate in JIA patients shortens the time to reach an inactive disease state and remission: results of a double-blind placebo-controlled trial

Pediatric Rheumatology ◽

10.1186/s12969-020-00488-9 ◽

2021 ◽

Vol 19 (1) ◽

Author(s):

Ekaterina Alexeeva ◽

Gerd Horneff ◽

Tatyana Dvoryakovskaya ◽

Rina Denisova ◽

Irina Nikishina ◽

...

Keyword(s):

Combination Therapy ◽

Controlled Trial ◽

Randomized Study ◽

Primary Objective ◽

Disease State ◽

Inactive Disease ◽

Open Label ◽

Standard Regimen ◽

Double Blind ◽

Early Combination Therapy

Abstract Background Remission is the primary objective of treating juvenile idiopathic arthritis (JIA). It is still debatable whether early intensive treatment is superior in terms of earlier achievement of remission. The aim of this study was to evaluate the effectiveness of early etanercept+methotrexate (ETA+MTX) combination therapy versus step-up MTX monotherapy with ETA added in refractory disease. Methods A multi-centre, double-blind, randomized study in active polyarticular JIA patients treated with either ETA+MTX (n = 35) or placebo+MTX (n = 33) for up to 24 weeks, followed by a 24-week open-label phase. The efficacy endpoints included pedACR30 criteria improvement at week 12, inactive disease at week 24, and remission at week 48. Patients who failed to achieve the endpoints at week 12 or at week 24 escaped to open-label ETA+MTX. Safety was assessed at each visit. Results By intention-to-treat analysis, more patients in the ETA+MTX group reached the pedACR30 response at week 12 (33 (94.3%)) than in the placebo+MTX group (20 (60.6%); p = 0.001). At week 24, comparable percentages of patients reached inactive disease (11 (31.4%) vs 11 (33.3%)). At week 48, 11 (31.4%) and eight (24.2%) patients achieved remission. The median (+/−IQR) times to achieve an inactive disease state in the ETA+MTX and placebo+MTX groups were 24 (14–32) and 32 (24–40) weeks, respectively. Forty-four (74/100 patient-years) adverse events (AEs) were reported, leading to treatment discontinuation in 6 patients. Conclusions Early combination therapy with ETA+MTX proved to be highly effective compared to the standard step-up regimen. Compared to those treated with the standard regimen, more patients treated with a combination of ETA+MTX reached the pedACR30 response and achieved inactive disease and remission more rapidly.

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