Cumulative Retention Rate Research Articles

Long-term efficacy and safety of tofacitinib in patients with ulcerative colitis: 3-year results from a real-world study.

The efficacy and safety of tofacitinib for the treatment of refractory ulcerative colitis (UC) has been demonstrated in clinical trials. Although, a series of reports with real-world evidence of its short-term efficacy and safety profiles have already been published, reports of long-term real-world data have been limited. We aimed to show our 3-year evidence on the clinical use of tofacitinib for the treatment of UC, focusing on its efficacy and safety profiles. A retrospective observational study was conducted on patients who started tofacitinib for active refractory UC at our hospital. The primary outcome was the retention rate until 156 weeks after initiating tofacitinib. The secondary outcomes were short-term efficacy at 4, 8, and 12 weeks; long-term efficacy at 52, 104, and 156 weeks; prognostic factors related to the cumulative retention rate; loss of response; and safety profile, including adverse events. Forty-six patients who were able to be monitored for up to 156 weeks after tofacitinib initiation, were enrolled in this study. Continuation of tofacitinib was possible until 156 weeks in 54.3%, with > 50% response rates and > 40% remission rates. Among patients in whom response or remission was achieved and tofacitinib was deescalated after 8 weeks of induction treatment, 54.3% experienced relapse but were successfully rescued by and retained on reinduction treatment, except for 1 patient. No serious AEs were observed in the study. Tofacitinib is effective and safe as long-term treatment in a refractory cohort of UC patients in real-world clinical practice.

The 24 months clinical evaluation of class II bulk fill composite restorations

Background: Resin Composite materials are widely used in daily clinical dentistry because of their moderate cost compared with ceramics, easy placement, adequate esthetics, ability to bond with enamel and dentine, and physico-chemical properties. Bulkfill composite materials were introduced to reduce chairside time. These materials have properties such as optimal bond strength, decreased polymerization shrinkage, and reduced cuspal deflection. This in-vivo study compared the clinical performance of three different class II resin composite restorations. Methods: Seventy-one patients (41 females and 30 males) aged 20–43 years with at least three approximal caries were included in the present study. Two hundred twenty-three teeth with approximal caries were restored with two bulk-fill composites (Tetric-N Ceram Bulk fill [TEC], Filtek Bulk Fill [FB]) and a posterior resin composite (Gradia Direct Posterior [GDP]). Two experienced dentists clinically evaluated the restorations with a 5x magnification loupe using the modified United States Public Health Service (USPHS) criteria at baseline and at 24 months. Results: The chi-square test was performed for statistical analysis. The cumulative retention rate for all restorations at 24 months was 90.5%. Retention loss was observed for three TEC (6.1%), four FB (8.2), and seven GDP (14%) restorations. There was no statistically significant difference among the three resin composite restoration groups in color match, marginal adaptation, surface roughness, marginal discoloration, anatomical form, and secondary caries criteria (P>0.05). Conclusion: Bulk-fill composite restorations in class II slot cavities have the same clinical results as traditional posterior composite restorations.

Retention rate of vagus nerve stimulation for the treatment of drug-resistant epilepsy: A single-centre, retrospective study.

The aim of this single-centre, retrospective, observational study was to evaluate long-term effectiveness of vagus nerve stimulation (VNS) in drug-resistant epilepsy (DRE) by using retention rate as a surrogate measure for seizure reduction. We included all patients with DRE, treated at the adult neurology department of the University Hospitals Leuven and who started VNS therapy from January 1, 1994, until May 1, 2021, with follow-up data cutoff on January 1, 2023. Retention rate of VNS was defined as the percentage of patients who maintain VNS at established time points. We estimated cumulative retention rate and battery replacement rate and correlated these with seizure reduction, using Kaplan-Meier analysis. Statistical analysis of potential predictors of VNS outcome (age, sex and epilepsy duration at implantation) was performed using mono- and multivariate analyses. VNS was started in 110 patients with DRE, with a mean follow-up of 8.7 years (SD 6.5). VNS was discontinued in 55 patients (50%), with ineffectiveness as the main reason for discontinuation (98%). The battery was replaced at least once in 42 patients (38%). Estimated retention rates were 70%, 52%, 45% and 33% after 5, 10, 15 and 20 years, respectively. Estimated first battery replacement rates were 16%, 42% and 47% after 5, 10 and 15 years, respectively. Both estimates showed a statistically significant correlation with seizure reduction. No independent predictors of long-term outcome of VNS were found. This is the first long-term study using retention rate of VNS to assess effectiveness. VNS is a well-tolerated therapy, but retention rates decline with long follow-up.

Comparison of visual outcomes between medical treatment alone and Ahmed glaucoma valve implantation in Shiba dogs with primary angle closure glaucoma.

The objective of the study was to evaluate visual outcomes between medical treatment alone (MED) and Ahmed glaucoma valve implantation (AGVI) in Shiba dogs with primary angle closure glaucoma (PACG). Records of 65 Shiba dogs (104 eyes) with PACG were retrospectively reviewed. Vision was assessed qualitatively using both the menace response and maze testing. The significance of age, sex, intraocular pressure (IOP), and duration of clinical signs (≤72 h or >72 h) at first presentation (V1) was assessed. Eyes with vision at V1 were divided into groups according to subsequent treatment method (MED versus AGVI), and vision as a survival outcome was compared between group by the Kaplan-Meier method. At V1, 65 eyes (62.5%) of 54 dogs had vision. There was no statistically significant difference in age or sex on the presence of vision at V1. Median IOP was higher in blind (52 mmHg) compared to sighted eyes (28 mmHg) (p < .001). Eyes presenting in ≤72 h of the onset of clinical signs were more likely to have vision (86.7%) compared to those presenting after 72 h (44.1%) (p < .001). By the Kaplan-Meier analysis, the cumulative visual retention rate was significantly higher with AGVI than with MED (69.2% vs. 7.7%; p < .01) at 12 months. The median time to visual loss was 39.9 months with AGVI vs. 1.7 months with MED. AGVI resulted in better visual outcomes than MED and should be considered in Shiba dogs with PACG that are visual at the time of presentation and suitable for surgery.

Long-term efficacy, safety, and cumulative retention rate of antitumor necrosis factor-alpha treatment for patients with Behcet's uveitis: A systematic review and meta-analysis.

This study aims to evaluate the long-term efficacy, safety, and cumulative retention rate of antitumor necrosis factor-alpha (anti-TNF-α) therapy for patients with Behcet's uveitis (BU) using meta-analysis. We searched the Web of Science and PubMed databases for eligible studies up to December 1, 2022. The quality of each identified study was assessed using the Joanna Briggs Institute's case series literature quality assessment tool. Statistical analysis was conducted using Stata 16.0 software with a random-effects model. Twelve studies comprising 1156 patients with BU were included in our analysis. We found that 85.0% of patients achieved ocular inflammation remission after receiving anti-TNF-α treatment, with a 95% confidence interval (CI) ranging from 78.7% to 90.5%. Additionally, 77.4% (95% CI: 57.5%-92.5%) experienced an improvement in visual acuity (VA). Moreover, the pooled dose reduction of glucocorticoids (GCs) was 11.08 mg (95% CI: -13.34 mg to -8.83 mg). Throughout the follow-up period, the cumulative retention rate of the medication was 67.3% (95% CI: 53.7%-79.6%). Serious adverse events occurred in 5.8% (95% CI: 3.1%-8.9%) of cases, with the three most common types being severe infusion or injection reactions (2.7%; 95% CI: 0.8%-5.4%), tuberculosis (1.3%; 95% CI: 0.0%-3.9%), and bacterial pneumonia (1.3%; 95% CI: 0.1%-3.4%). Subgroup analysis revealed that ocular inflammation remission rates were 89.3% (95% CI: 81.2%-95.5%) for adalimumab treatment and 83.7% (95% CI: 75.3%-90.8%) for infliximab treatment. The drug retention rate after adalimumab therapy was 70.3% (95% CI: 62.0%-78.0%) compared to 66.4% (95% CI: 48.6%-82.2%) for infliximab treatment. Furthermore, the incidence of severe infusion or injection reactions was 2.2% (95% CI: 0.1%-5.8%) following adalimumab treatment and 3.5% (95% CI: 0.7%-7.7%) following infliximab treatment. Anti-TNF-α therapy represents an effective treatment for BU patients with favorable safety profile and high drug retention rate and a potential advantage of adalimumab over infliximab in terms of ocular inflammation remission, drug retention, and the incidence of severe infusion or injection reactions.

Efficacy, retention rate and safety of adalimumab treatment in patients with non-infectious uveitis and scleritis: a real-world, retrospective, single-centre study.

To evaluate the outcomes of adalimumab (ADA) treatment of patients with non-infectious uveitis and scleritis, focusing on efficacy, retention rate, and safety. This retrospective, clinical cohort study included 62 patients (104 eyes) with active ocular inflammation treated with ADA. Primary outcomes were efficacy and cumulative drug retention rate (DRR) of ADA. The secondary outcomes included changes in ocular inflammatory parameters, changes in best-corrected visual acuity (BCVA) and central macular thickness (CMT), corticosteroid-sparing effect, impact of concomitant use of disease-modifying antirheumatic drug (DMARD) and ADA as first or ≥2nd biotherapy line on DRR, and adverse events. Forty-five patients (72.6%) achieved inactive disease at the end of follow-up. DRR at 6, 12, 24, and 48 months was 96.8%, 89.2%, 63.1%, and 63.1%, respectively. Of the 18 patients whose bi-weekly ADA treatment was escalated to weekly ADA due to primary or secondary inefficacy, 10 patients had inactive disease finally. BCVA improved (p < 0.001) and CMT decreased (p < 0.001) significantly at 6, 12, and 24 months after ADA therapy compared to baseline. Percentage of patients treated with ≥10 mg/day corticosteroid (61.3% vs. 6.4%) and DMARDs combined with ADA (46.8% vs. 37.1%) were lower at 6 months than at baseline. Concomitant DMARDs (p = 0.579) and use of ADA as first or ≥2nd biotherapy line (p = 0.527) had no significant effect on DRR. Most common adverse event was tuberculosis-related infections. ADA seems to be effective and safe with good DRR to control ocular inflammation. Escalation to weekly ADA treatment may be an effective option in patients with primary or secondary inefficacy.

Efficacy and safety of tocilizumab in adult-onset Still's disease: Real-life experience from the international AIDA registry

Background/objectivesLong-term efficacy and safety of tocilizumab (TCZ) in adult-onset Still's disease (AOSD) mostly derive from small case series. Herein we report a registry-based study investigating TCZ efficacy and safety in a cohort of patients with AOSD evaluated by clinical and serum inflammatory markers as well as drug retention rate analysis. MethodsThis is an international multicentre study analyzing data from patients with AOSD regularly enrolled in the AIDA registry. TCZ efficacy was evaluated between baseline and last follow-up assessment in terms of changes in the Pouchot score and laboratory findings. Drug-retention rate was estimated by the Kaplan-Meier method, while Cox-regression analysis was employed to detect potential predictive factors of treatment withdrawal. ResultsData from 31 patients (15 men, 16 women) refractory to the conventional therapies and treated with TCZ were extracted from the AIDA registry. Mean ± SD time of treatment duration with TCZ was 24.32 ± 20.57 months. Median (IRQ) Pouchot score significantly decreased throughout the study period (p=0.001) with a significant difference between baseline [2.00 (4.00)] and 6 month-follow-up [0.00 (0.00)] (p=0.003) and between baseline and last follow-up assessment [0.00 (0.00)] (p=0.032), while no differences were observed between 6 month-evaluation and last follow-up assessment (p=0.823). Similarly, laboratory parameters significantly decreased from baseline to the last follow-up visit. With regard to drug survival, cumulative TCZ retention rate at 12-, 24-, and 36-month follow-up visit were 83.1%, 71.7% and 63.7%, respectively, without significant differences between biologic naïve patients and those previously treated with other biologics (p=0.329). Likewise, no significant differences were observed between chronic articular course of AOSD and other types of disease course (p=0.938) or between patients co-administered with conventional immunosuppressants and patients receiving TCZ as monotherapy (p=0.778). Cox-regression analysis identified no variable associated with a higher hazard of treatment withdrawal. Treatment was discontinued in 9 patients due to long-term remission (n=4), adverse events (n=2), loss of efficacy (n=1), non-medical reason (n=1) and unspecified cause (n=1). Mean glucocorticosteroids daily dose significantly decreased from baseline (18.36 ± 24.72 mg) to the last follow-up assessment (4.02 ± 4.99 mg, p=0.003). ConclusionsTCZ allows control of disease activity as well as normalization of serum inflammatory markers in both systemic and chronic articular form of AOSD. Additionally, TCZ displays an excellent drug retention rate while minimizing the risk of long-term exposure to corticosteroids.

Efficacy and Safety of Tramadol Hydrochloride Twice-Daily Sustained-Release Bilayer Tablets with an Immediate-Release Component for Chronic Pain Associated with Knee Osteoarthritis: A Randomized, Double-Blind, Placebo-Controlled, Treatment-Withdrawal Study.

Background and ObjectivesKnee osteoarthritis pain is a chronic form of pain for which conventional non-steroidal anti-inflammatory drugs may provide insufficient analgesia. Twice-daily tramadol hydrochloride (65% sustained-release/35% immediate-release) bilayer tablets are a novel formulation of tramadol developed for managing chronic pain. The objectives of this study were to examine the effectiveness and safety of this formulation in patients with chronic knee osteoarthritis pain.MethodsThis was a multicenter, randomized, placebo-controlled, double-blind, parallel-group, treatment-withdrawal study. Patients with a reduction in Numeric Rating Scale (NRS) for pain of ≥2 points during a 1–3-week, open-label, tramadol dose-escalation period (100–300 mg/day) were randomized to continue tramadol or switched to placebo for 4 weeks (double-blind period). Patients with inadequate efficacy (increase in NRS ≥2 points/patient request) were withdrawn. Outcomes included the time to inadequate analgesic efficacy from randomization (primary endpoint), the cumulative retention rate, and safety.ResultsOverall, 249 and 160 patients entered the dose-escalation and double-blind periods, respectively (tramadol 79; placebo 81). Kaplan–Meier analysis revealed superiority of tramadol (log-rank p = 0.042), and a hazard ratio of 0.50 (95% confidence interval [CI] 0.25–0.99). Documentation of an inadequate analgesic effect was less frequent in the tramadol group (15.4%, 95% CI 8.2–25.3% vs. 30.9%, 95% CI 21.1–42.1%). The cumulative retention rate was greater in the tramadol group (83.7% vs. 69.0%). Adverse events occurred in 80.6% (200/248) of patients in the open-label period, and in 38.5% (30/78) and 13.6% (11/81) of patients in the tramadol and placebo groups, respectively, in the double-blind period. Opioid-associated adverse events, such as nausea, vomiting, constipation, somnolence, and dizziness, were the most frequent events.ConclusionThis study demonstrated the analgesic efficacy and safety of sustained-release tramadol tablets with an immediate-release component for chronic knee osteoarthritis pain.Trial registrationJapicCTI-132103 (Japan Pharmaceutical Information Center; registration date February 25, 2015)Supplementary InformationThe online version contains supplementary material available at 10.1007/s40261-022-01139-5.

Effectiveness of SB5, an Adalimumab Biosimilar, in Patients With Noninfectious Uveitis: A Real-Life Monocentric Experience.

Several concerns have arisen with biosimilars in terms of immunogenicity, safety issues, loss of efficacy, and extrapolation to other indications. The study aim was to evaluate the efficacy of SB5, an adalimumab biosimilar, in noninfectious uveitis (NIU). Retrospective nonrandomized study. Data from patients with refractory NIU treated with SB5 (Imraldi, Biogen) were analyzed at baseline, 3 months after SB5 initiation and at the last follow-up in terms of uveitis relapses, occurrence of retinal vasculitis, resolution of uveitic macular edema (UME), best-corrected visual acuity, glucocorticoids (GCs)-sparing effect and drug survival. Uveitis relapses decreased from 121 relapses/100 patients/year in the 12 months before SB5 initiation to 4 relapses/100 patients/year during the first 12 months of treatment (P = 0.0004). Uveitis was inactive in 46/47 eyes at the end of the study period. The number of eyes with active retinal vasculitis decreased during the study period (P < 0.0001). At baseline, 6 eyes presented UME, whereas no eye had UME at the last follow-up. Mean best-corrected visual acuity increased from 7.7 ± 3.41 at baseline to 8.9 ± 2.46 at the last follow-up (P = 0.0045). Mean GCs daily dosage decreased from 18.33 ± 10.33 mg at baseline to 5.75 ± 2.29 mg at the last follow-up (P = 0.018). The cumulative SB5 retention rate was 91.8% at both 12- and 20-month follow-up. SB5 biosimilar is effective in NIU by drastically reducing uveitis relapses and the occurrence of retinal vasculitis. Moreover, SB5 biosimilar improved visual acuity, allowed a significant GCs-sparing effect and showed an excellent drug retention rate.

CLINICAL AND RADIOGRAPHIC EVALUATION OF INTENTIONAL REPLANTATION OF TEETH UTILIZING ATRAUMATIC EXTRACTION TECHNIQUE AND BIODENTIN AS ROOT END RESTORATIVE MATERIAL. AN IN VIVO STUDY

Aims: Aim is to evaluate the clinical and radiographic outcome of Intentional Replantation of teeth utilizing Atraumatic extraction technique and Biodentin as root end restorative material&#x0D; Materials and Methods: Any patients irrespective of age &amp; sex who reported to the Department of Conservative Dentistry &amp; Endodontics, D. J. College of Dental Sciences &amp; Research with the post endodontic treatment periapical pathology where orthograde retreatment and apical surgery was unfeasible or declined by patients and where extraction be the last resort was selected for the procedure. Informed consent was taken. Retention and healed status without complications (periapical radiolucency, external root resorption, ankylosis, signs/symptoms, probing &lt;6 mm) was recorded and analyzed with Kaplan-Meier survival analysis and Cox proportional hazard regression model (P &lt; .05). Bivariate associations of the investigated variables with the main complications (ankylosis, periapical radiolucency, external root resorption) evaluated. &#x0D; Results: Cumulative healed rates from 60% at 6 months to 92% at 12months seen. Complications leading to extraction observed in 1 of 15 attending teeth. The Kaplan-Meier survival function suggested an expected 1-year cumulative retention rate of 92%. Among the 15 teeth, 1 tooth with complication was due to persistent periapical radiolucency and mobility.&#x0D; Null hypothesis was that IR is to preserve the natural dentition, there by upholding the main goal of Conservative treatment.&#x0D; Conclusions: Within the limitations of this study, after analyzing the results and obtaining a complete follow up of 12 months radiographically and clinically, it can be concluded that Intentional replantation is an alternative treatment and should be included in the savior procedures as it has shown a success rate of 92%.&#x0D; Keywords: endodontic complications, intentional replantation, physics forceps, Biodentin

Clinical Efficacy of Mixing Natural Teeth and Implant Supported Denture Sleeve

Objective: To analyze the clinical efficacy of Mixing natural teeth and implant supported denture sleeve, and provide reference for clinical treatment. Methods: 46 patients with Molarless in hospital from December 2010 - December 2014 were selected, patients were randomly divided into observer group and control group, two groups of patients were designed and planted natural teeth fixed bridge and natural teeth and implants mixed support sleeve denture, regular follow patients and the surrounding alveolar bone height changes, 5-year cumulative retention rate, clinical efficiency and other indicators. Results: During clinical observation, patients with no obvious symptoms, the use of feel good, no loose superstructure situation. Two groups of patients were 2 cases of patients with implant loosening occurs, the amount of bone resorption annual observation group (0.22 ± 0.10) mm less than the control group (0.24 ± 0.08) mm, but no significant difference (P&gt; 0.05), clinical observation group efficiency (100%) was significantly higher (72.3%) (P &lt;0.05), the observation group study implants 5-year cumulative retention rate was 94.4%. Conclusion: Mixing natural teeth and implant - supported telescopic denture success rate of 100% was observed during the clinical results were satisfactory, with use value.

OP29 Tofacitinib in ulcerative colitis: Real-world evidence from Eneida Registry

Abstract Background Our aim was to evaluate the effectiveness and safety of tofacitinib in ulcerative colitis (UC) in real life. Methods Patients from the prospectively maintained ENEIDA registry treated with tofacitinib due to active UC were included. Clinical activity and effectiveness were defined based on Partial Mayo Score (PMS). The short-term response was assessed at week 4, 8 and 16. The last-observation-carried-forward method was used in patients that stopped tofacitinib before the time-points for clinical assessment. Variables associated with short-term remission at week 8 were identified by logistic regression analysis. The cumulative retention rate and the cumulative incidence of relapse over time were assessed by survival curves. Cox-regression analysis was performed to identify predictive factors of tofacitinib discontinuation or relapse over time. Data quality was assessed by remote monitoring. Results 113 patients were included (Table 1 and Figure 1) and exposed to tofacitinib a median of 44 (interquartile range = 30–66) weeks. Response and remission at week 8 were 60% and 31%, respectively (Figure 2). In multivariate analysis, higher PMS at week 4 [odds ratio (OR)=0.2; 95% confidence interval (CI) = 0.1–0.4] was the only variable associated with the likeliness of achieving remission at week 8. Higher PMS at week 4 (OR = 0.5; 95% CI = 0.3–0.7) and higher PMS at week 8 (OR = 0.2; 95% CI = 0.1–0.5) were associated with lower probability of achieving remission at week 16. Twenty per cent of those without remission at week 4, and 12% of those without remission at week 8, achieved remission at week 16. A total of 45 patients (40%) discontinued tofacitinib over time (Figure 3); the discontinuation rate was 34% and 46% at 24 and 52 weeks, respectively. PMS at week 8 was the only factor associated with tofacitinib discontinuation [Hazard ratio (HR) = 1.5; 95% CI = 1.3–1.6)]. A total of 33 patients had remission at week 8; from them, 65% relapsed 52 weeks after achieving remission; 9 patients increased the dose to 10 mg /12 h and 5 reached remission again. No factors associated with relapse over time were identified. Eighteen patients had adverse events (4 hypercholesterolaemia, 2 herpes zoster, 3 infections, 2 dyspnoea, 1 neoplasia, 1 lymphopenia, 1 headache, 1 hypertriglyceridaemia and 4 others). No thromboembolic events were reported. Conclusion Tofacitinib is relatively effective in UC patients in real practice even in a highly refractory cohort. Only 10% of the patients without remission at week 8 reached remission at week 16. A relevant proportion of patients discontinue the drug over time, mainly due to primary failure. Over 60% of patients that achieve remission, relapse over time. Safety was consistent with the known profile of tofacitinib

Anakinra Drug Retention Rate and Predictive Factors of Long-Term Response in Systemic Juvenile Idiopathic Arthritis and Adult Onset Still Disease.

Background and Objective: Only a few studies have reported long-term efficacy of interleukin (IL)-1 inhibition in systemic juvenile idiopathic arthritis (sJIA) and adult-onset Still disease (AOSD). Herein we report on the effectiveness of anakinra (ANA), expressed in terms of drug retention rate (DRR), and evaluate the predictive factors of drug survival in a cohort of patients with sJIA and AOSD. Patients and Methods: This is a multicenter study reviewing retrospectively the medical records from 61 patients with sJIA and 76 with AOSD, all treated with ANA in 25 Italian tertiary referral centers. Results: The cumulative retention rate of ANA at 12-, 24-, 48-, and 60-month of follow-up was 74.3%, 62.9%, 49.4%, and 49.4%, respectively, without any significant differences between sJIA and AOSD patients (p = 0.164), and between patients treated in monotherapy compared with the subgroup coadministered with conventional disease-modifying antirheumatic drugs (cDMARDs) (p = 0.473). On the other hand, a significant difference in DRR was found between biologic-naïve patients and those previously treated with biotechnologic drugs (p = 0.009), which persisted even after adjustment for pathology (p = 0.013). In the regression analysis, patients experiencing adverse events (AEs) {hazards ratio (HR) = 3.029 [confidence interval (CI) 1.750–5.242], p < 0.0001} and those previously treated with other biologic agents [HR = 1.818 (CI 1.007–3.282), p = 0.047] were associated with a higher HR of ANA discontinuation. The median treatment delay was significantly higher among patients discontinuing ANA (p < 0.0001). Significant corticosteroid-sparing (p = 0.033) and cDMARD-sparing effects (p < 0.0001) were also recorded. Less than one-third of our cohort developed AEs, and 85% were deemed mild in nature, with 70% of them involving the skin. Conclusions: Our findings display an overall excellent DRR of ANA on the long run for both sJIA and AOSD, that may be further optimized by closely monitoring patient’s safety issues and employing this IL-1 inhibitor as a first-line biologic as early as possible. Moreover, ANA allowed a significant drug-sparing effect and showed an overall good safety profile.

Treatment of symptomatic adenomyosis with the levonorgestrel-releasing intrauterine system.

To determine the long-term effects of using the levonorgestrel-releasing intrauterine system (LNG-IUS) to treat symptomatic adenomyosis. A prospective longitudinal study was conducted among 1100 women who received the LNG-IUS at a tertiary teaching hospital in China between December 10, 2006, and December 24, 2014. All participants had symptomatic adenomyosis (visual analogue scale [VAS] ≥7 and/or pictorial blood loss assessment chart [PBAC] score >100) diagnosed by transvaginal sonography. Follow-up was at 3, 6, 12, 24, 36, 48, and 60months after LNG-IUS placement. The primary outcome was symptom relief. Secondary outcomes included LNG-IUS retention status; changes in uterine volume; serum levels of cancer antigen 125 (CA125); menstruation pattern; and adverse events. In all, 374 (33.7%) participants completed 60months of LNG-IUS treatment. The VAS, verbal rating scale, PBAC score, hemoglobin level, uterine volume, and serum CA125 level all showed marked improvements at this time point when compared with baseline (P<0.05 for all comparisons). The cumulative retention rate of LNG-IUS was 56.2%. Changes in menstruation pattern at 60months included amenorrhea (n=97, 25.9%) and shortened periods (n=82, 21.9%). The incidence of adverse events was <10% and not considered notable. Long-term use of LNG-IUS was effective and acceptable for the treatment of symptomatic adenomyosis. Registered at clinicaltrials.gov (NCT03027648).

Drug Retention Rate and Predictive Factors of Drug Survival for Interleukin-1 Inhibitors in Systemic Juvenile Idiopathic Arthritis.

Background and Objectives: Few studies have reported the drug retention rate (DRR) of biologic drugs in juvenile idiopathic arthritis (JIA), and none of them has specifically investigated the DRR of interleukin (IL)-1 inhibitors on systemic JIA (sJIA). This study aims to describe IL-1 inhibitors DRR and evaluate predictive factors of drug survival based on data from a real-world setting concerning sJIA.Methods: Medical records from sJIA patients treated with anakinra (ANA) and canakinumab (CAN) were retrospectively analyzed from 15 Italian tertiary referral centers.Results: Seventy seven patients were enrolled for a total of 86 treatment courses. The cumulative retention rate of the IL-1 inhibitors at 12-, 24-, 48-, and 60-months of follow-up was 79.9, 59.5, 53.5, and 53.5%, respectively, without any statistically significant differences between ANA and CAN (p = 0.056), and between patients treated in monotherapy compared to the subgroup co-administered with conventional immunosuppressors (p = 0.058). On the contrary, significant differences were found between biologic-naive patients and those previously treated with biologic drugs (p = 0.038) and when distinguishing according to adverse events (AEs) occurrence (p = 0.04). In regression analysis, patients pre-treated with other biologics (HR = 3.357 [CI: 1.341–8.406], p = 0.01) and those experiencing AEs (HR = 2.970 [CI: 1.186–7.435], p = 0.020) were associated with a higher hazard ratio of IL-1 inhibitors withdrawal. The mean treatment delay was significantly higher among patients discontinuing IL-1 inhibitors (p = 0.0002).Conclusions: Our findings suggest an excellent overall DRR for both ANA and CAN that might be further augmented by paying attention to AEs and employing these agents as first-line biologics in an early disease phase.

Long-term prognosis of Japanese patients with biologic-naïve Crohn's disease treated with anti-tumor necrosis factor-α antibodies.

Background/AimsFew reports have described the long-term treatment outcomes of the anti-tumor necrosis factor-α antibody for Japanese Crohn’s disease (CD) patients. The aim of this study was to evaluate them and clarify the clinical factors that affect the long-term prognosis of the anti-tumor necrosis factor-α treatments.MethodsThis was a retrospective, observational, single-center cohort study. Japanese CD patients treated with either infliximab or adalimumab as a first-line therapy were analyzed. The cumulative retention rates of the biologics, relapse-free survival, and surgery-free survival were analyzed using Kaplan-Meier methods. The clinical factors associated with the long-term outcomes were estimated by both the log-rank test and Cox proportional hazard model.ResultsThe cumulative retention rate was significantly higher in the group with a concomitant elemental diet of ≥900 kcal/day, baseline C-reactive protein (CRP) levels <2.6 mg/dL, and baseline serum albumin levels ≥3.5 g/dL, respectively. The baseline serum albumin levels were also associated with both relapse-free and surgery-free survival. The lack of concomitant use of an elemental diet ≥900 kcal/day was identified as the only independent risk factor for the withdrawal of the biologics.ConclusionsBaseline CRP levels and serum albumin levels could affect the long-term outcomes in CD patients. Concomitant elemental diet of ≥900 kcal/day could have a positive influence on clinical treatment course.

Glass-ionomer fissure sealants: Clinical observations up to 13 years

ObjectivesThe aim of this study was to clinically examine the retention and caries-preventive effect of a glass-ionomer material for fissure sealing in newly erupted permanent molars. MethodsA total of 1736 newly erupted permanent molars were sealed in 480 children aged 5–15 years. Sealants were evaluated yearly and recorded as “completely retained”, “partially retained”, or “completely lost”. Teeth were also evaluated for presence of caries. ResultsSealants were observed for 2–13 years. The mean follow-up time was 5 years. After one year, 69% of the sealants were fully retained and 21% were partially retained. Thereafter, the cumulative retention rate decreased. Starting from 8th year of follow-up, no “completely retained” sealant could have been observed. At the end of the 13-year follow-up period, 76% of sealants were “completely lost”. On the other hand, 99% and 65% of observed occlusal surfaces were caries-free after one and 13 years, respectively. During the observation period, 62 teeth developed caries in surfaces other than occlusal. Survival rates were significantly better for second permanent molars than for first permanent molars (p < 0.001). No influence of caries risk on caries incidence has been noted. ConclusionsAlthough the retention rate of the glass-ionomer material for fissure sealing was low, it appears to have prevented dental caries in 65% of newly erupted permanent molars evaluated after thirteen years of placement. Clinical significanceThe present study reports long-term clinical performance of glass-ionomer fissure sealants in patients with low, moderate and high caries-risk. The study shows that caries risk does not influence survival of glass-ionomer sealants, which proved to be beneficial for long-term caries protection.

Variation Overtime among Patients of the Six Methadone Maintenance Treatment Clinics in Thai Nguyen from 2011 to 2015.

Background Methadone Maintenance Treatment (MMT) program's success depends on the likelihood of reducing drop-out rate and keeping patients remaining in the program. There have been neither comprehensive studies about variation among patients who have been experiencing MMT for long period nor prediction of MMT period in which the risk of drop-out would be the highest in Thai Nguyen, a northern mountainous province where the MMT was established in 2011. Objectives To analyze variation of the MMT population through indicators of drop-out and death, re-enrolment, and retention rate in the six Thai Nguyen MMT clinics. Methods A retrospective study by reviewing daily treatment notebooks of the six MMT clinics in Thai Nguyen to identify events of drop-out, death, reenrolment among 2,567 patients registered from 12 May 2011 to 6 September 2015. Results Cumulative hazard of drop-out over period from the first to the fourth year of MMT treatment has an increasing trend at 0.15; 0.31; 0.46; and 0.61, respectively. The cumulative probability of re-enrolment among 740 patients who have already quit the MMT program and then returned slightly increased from 0.07 to 0.16 between the first years and the fourth year in which the highest returning rate occurred within the first 2 years after drop-out. The cumulative retention rate decreased annually and stayed at 71.7% after 4 years of running the MMT. Conclusions MMT patients and their families should be informed and consulted about the highest risk period of drop-out and also about period when drop-out patients are most likely to reenter the MMT. Counseling adherence for patients should be conducted not only at the beginning but also during the ongoing MMT and play an extremely important role in reducing drop-out of the program while special counseling should also be reenforced for the re-enrolment patients of MMT.

Antiretroviral treatment discontinuation and its influencing factors among HIV-infected patients who initiated ART from 2012 to 2015 in Wenshan prefecture, Yunnan Province

Objective: To understand the antiretroviral treatment (ART) discontinuation rate and its influencing factors among HIV infected patients who initiated ART between 2012 and 2015 in Wenshan prefecture, Yunnan province. Methods: Demographic characteristics, baseline informations of ART, initial treatment regimens and follow-up status of a total of 4 354 patients who initiated ART from 2012 to 2015 in Wenshan prefecture were collected. A historical cohort study was used to describe the discontinuation incidence rate of ART. Life table was used to estimate cumulative retention rate and Cox proportional hazard model was used to determine the influencing factors of ART discontinuation. Results: The percentage and incidence rate of discontinuation were 25.1% (1 092/4 354) and 14.53 per 100 person-years among patients who initiated ART from 2012 to 2015 in Wenshan prefecture. ART retention rates were 88%, 83%, 78%, 74% at 6(th) month, 12(th) month, 18(th) month, 24(th) month, respectively. The multivariate Cox proportional hazard regression model showed that male patients were at a higher risk of discontinuation (HR=1.24, 95%CI: 1.09-1.41) than female patients, patients aged ≥50 years were at a higher risk of discontinuation (HR=1.27, 95%CI: 1.06-1.53) than patients aged<30 years, discontinuation hazard among patients who were unmarried or divorced or widowed was 1.30 times (HR:1.30, 95%CI: 1.14-1.48) as patients who were married or cohabitation, discontinuation hazard among patients infected with HIV through injection drug use (IDU) was 1.49 times (HR:1.49, 95%CI: 1.23-1.82) as those infected through heterosexual transmission, patients with a baseline CD4 cell count<350/μl (HR=1.34, 95%CI: 1.13-1.58) or ≥500/μl (HR=1.36, 95%CI: 1.09-1.71) were at a higher risk of discontinuation than those with a baseline CD4 cell count from 350/μl to 500/μl, patients initiating ART in 2014 (HR=1.25, 95%CI: 1.04-1.50) or in 2015 (HR=1.26, 95%CI: 1.02-1.55) were at a higher risk of discontinuation than those initiating ART in 2012. Conclusion: There is an uptrend for ART discontinuation rate in Wenshan prefecture. Male, 50 years or older, unmarried or divorced or widowed, transmission route as IDU, baseline CD4 count <350/μl or ≥500/μl are risk factors of ART discontinuation.

Cumulative retention rate of adalimumab in patients with Behçet’s disease-related uveitis: a four-year follow-up study

Background/aimsAdalimumab (ADA) has been shown to be an effective treatment for Behçet’s disease (BD)-related uveitis. We aimed at evaluating the cumulative retention rate of ADA during a 48-month follow-up period...