Undergoing Maintenance Treatment Research Articles

The relationship between personality traits and coping strategies with permanence in the treatment process in patients undergoing methadone maintenance treatment

ABSTRACT Background The increasing tendency to use drugs, especially with the lowering of the age of addiction and its prevalence among young people, is one of the major social problems, and many efforts have been made to investigate the relationship between drug use and personality structures. Methods This cross-sectional study was conducted in 2020–2022 on opioid-addicted men who were referred to an addiction treatment clinic undergoing maintenance treatment with methadone for at least 6 months. Demographic information, the NEO personality characteristics questionnaire, and Lazarus’s coping strategies were completed by the patients. Results 150 patients with an average age of 36.78 ± 9.03 years were investigated. The results showed that the score of the personality dimension of conscientiousness had a significant relationship with the rate of persistence in treatment (P-value < .05). The score of accepting responsibility had a significant inverse relationship with the rate of persistence in treatment (P-value < .05). However, other components of personality traits and coping strategies didn’t have a significant relationship with the rate of persistence in treatment (P-value > .05). Conclusion Different personality dimensions and different levels of self-efficacy and the choice and pattern of coping style are effective factors in the tendency or non-tendency of people to use drugs and addiction.

Investigation of the Demographic Characteristics of Patients Addicted to Opioids Undergoing Drug Maintenance Treatment in Addiction Treatment Centers in Bojnurd City

Introduction: Opium addiction is one of the most significant problems in Iran. This study investigates demographic information of opium-addicted patients undergoing maintenance treatment in Bojnurd addiction treatment centers. This study aims to identify high-risk groups and those who need therapeutic and psychosocial interventions to maintain treatments. Method: This cross-sectional study was conducted from 2016 to 2021 on 300 addicted patients referring to Bojnurd addiction treatment centers. These patients participated in the opioid maintenance treatment program for at least six months. The investigation utilized a checklist of demographic information and examined the files of addicted people undergoing maintenance treatment in eight addiction treatment centers in the city. The data were analyzed in SPSS23 software using the Chi-square statistical test. Results: The mean age (standard deviation) of the participants was 52.17±14.13 years. Besides, 76.6% of the participants were male, 70.0% resided in the city, and 73.6% were married. The majority of the participants had a primary education level and were self-employed. Opium juice was the most consumed substance, and smoking was the most common method of use. Conclusion: It appears that married and middle-aged individuals constitute the largest population undergoing maintenance treatment in Bojnurd city. The high frequency of individuals with low or no literacy in the studied population underscores the importance of education.

Predicting Psychological Well-being based on Brain-Behavioral Systems and Metacognitive in Substance-Dependent People Undergoing Maintenance Treatment

Predicting Psychological Well-being based on Brain-Behavioral Systems and Metacognitive in Substance-Dependent People Undergoing Maintenance Treatment

Impact of treatment adherence and inhalation technique on asthma outcomes of pediatric patients: a longitudinal study.

Introduction: We aimed to evaluate the longitudinal relationships, both at between- and within-person levels, that adherence to inhaled corticosteroid-based maintenance treatment and inhalation technique present with symptom control, exacerbations, and health-related quality of life (HRQoL) in children and adolescents with asthma. Methods: Participants (6-14years old) from the ARCA (Asthma Research in Children and Adolescents) cohort-a prospective, multicenter, observational study (NCT04480242)-were followed for a period from 6months to 5years via computer-assisted telephone interviews and a smartphone application. The Medication Intake Survey-Asthma (MIS-A) was administered to assess the implementation stage of adherence, and the Inhalation Technique Questionnaire (InTeQ) was used to assess the five key steps when using an inhaler. Symptom control was measured with the Asthma Control Questionnaire (ACQ), and HRQL was measured with the EQ-5D and the Patient-Reported Outcomes Measurement Information System-Pediatric Asthma Impact Scale (PROMIS-PAIS). Multilevel longitudinal mixed models were constructed separately with symptom control, exacerbation occurrence, EQ-5D, and PROMIS-PAIS as the dependent variables. Results: Of the 360 participants enrolled, 303 (1,203 interviews) were included in the symptom control and exacerbation analyses, 265 (732) in the EQ-5D, and 215 (617) in the PROMIS-PAIS. Around 60% of participants were male subjects, and most of them underwent maintenance treatment with inhaled corticosteroids plus long-acting β-agonists in a fixed dose (73.3%). Within-person variability was 83.6% for asthma control, 98.6% for exacerbations, 36.4% for EQ-5D, and 49.1% for PROMIS-PAIS. At the within-person level, patients with higher adherence had better symptom control (p = 0.002) and HRQoL over time (p = 0.016). Patients with a better inhalation technique reported worse HRQoL simultaneously (p = 0.012), but they showed better HRQoL in future assessments (p = 0.012). The frequency of reliever use was associated with symptom control (p < 0.001), exacerbation occurrence (p < 0.001), and HRQoL (p = 0.042); and boys were more likely to present better symptom control and HRQoL than girls. Conclusion: Our results confirm longitudinal associations at the within-person level of the two indicators of quality use of inhalers: for adherence to maintenance treatment with symptom control and HRQoL, and for the inhalation technique with HRQoL. Although treatment adherence was shown to be excellent, a third of the participants reported a suboptimal inhalation technique, highlighting the need for actions for improving asthma management of the pediatric population.

P851 Therapeutic drug monitoring of infliximab and adalimumab versus clinical control during maintenance therapy in patients with Inflammatory Bowel Disease

Abstract Background Although it is known that the levels of infliximab or adalimumab are correlated with clinical response, there is controversy about the best strategy to follow in patients with Inflammatory Bowel Disease (IBD) in remission and undergoing maintenance treatment. Methods We conducted a randomized, prospective, single-blinded, and multicentre trial in patients with Crohn’s Disease (CD) or Ulcerative Colitis (UC) who have remained in clinical remission for at least 12 weeks and are receiving adalimumab (ADA) or infliximab (IFX) as maintenance treatment. Patients were assigned to two groups. In the first group, patient management was done considering therapeutic drug monitoring (TDM). In the second, according to usual clinical practice (CP). The optimal serum range was within 3-7µg/ml and 5-8µg/ml for IFX and ADA respectively, based on the use of Promonitor-IFX, and Promonitor-ADL kits. The primary endpoint was to maintain patients in clinical remission (target &amp;gt;16% between both groups at 12 months) and diminish the frequency of flare-ups. Results In total, 209 patients were randomized, 29 UC (27.6%), 76 CD (72.4%) as the clinical practice group, and 24 UC (23.1%), 80 CD (76.9%) as the drug monitoring therapeutic group. Infliximab was administered in 105 patients and adalimumab in 104. Remission at the end of the study was achieved in 98.1% of the proactive dosing group and 90.5% of the clinical practice group (p=0.02), with a difference between both groups of 7.6%. The number of flare-ups was 1.3/10 patient-years in the TDM group and 2.4/10 patient-years in the CP group. The IRR of flare-up throughout the study was 0.71 (95% CI 0.32 – 1.55). In the group with IFX: IRR = 0.56 (95% CI 0.08 – 3.81) and with ADA: 0.78 (95% CI 0.29-2.16). The changes made in the drug dose are shown in Table 1. Conclusion Differences were found in favour of the TDM group, with increasing remission rates (7.6%) and half number of flare-ups. However, the pre-established effectiveness remission target (16%) was not met. In the subgroup of patients with Infliximab, management through TDM seems to have an advantage over usual clinical control.

Tislelizumab plus zanubrutinib for Richter transformation: the phase 2 RT1 trial

In patients with chronic lymphocytic leukemia, Richter transformation (RT) reflects the development of an aggressive lymphoma that is associated with poor response to chemotherapy and short survival. We initiated an international, investigator-initiated, prospective, open-label phase 2 study in which patients with RT received a combination of the PD-1 inhibitor tislelizumab plus the BTK inhibitor zanubrutinib for 12 cycles. Patients responding to treatment underwent maintenance treatment with both agents. The primary end point was overall response rate after six cycles. Of 59 enrolled patients, 48 patients received at least two cycles of treatment and comprised the analysis population according to the study protocol. The median observation time was 13.9 months, the median age was 67 (range 45–82) years. Ten patients (20.8%) had received previous RT-directed therapy. In total, 28 out of 48 patients responded to induction therapy with an overall response rate of 58.3% (95% confidence interval (CI) 43.2–72.4), including 9 (18.8%) complete reponse and 19 (39.6%) partial response, meeting the study’s primary end point by rejecting the predefined null hypothesis of 40% (P = 0.008). Secondary end points included duration of response, progression-free survival and overall survival. The median duration of response was not reached, the median progression-free survival was 10.0 months (95% CI 3.8–16.3). Median overall survival was not reached with a 12-month overall survival rate of 74.7% (95% CI 58.4–91.0). The most common adverse events were infections (18.0%), gastrointestinal disorders (13.0%) and hematological toxicities (11.4%). These data suggest that combined checkpoint and BTK inhibition by tislelizumab plus zanubrutinib is an effective and well-tolerated treatment strategy for patients with RT. ClinicalTrials.gov Identifier: NCT04271956.

Long-term detoxification of opioid use disorder with opium tincture assisted treatment.

Retention in treatment, craving, and relapse rate are important indicators of the success rate in addiction maintenance therapy as they evaluate the effectiveness of the therapy and make necessary adjustments to the treatment plan. However, the rate of continuation in the treatment process and the rate of craving in patients with opioid use disorder undergoing maintenance treatment with opium tincture have not been studied. The present study aimed to investigate the rate of relapse, craving, and psychiatric disorders in patients with opioid use disorder undergoing treatment of gradual detoxification with opium tincture. Ninety patients with opioid use disorder who underwent treatment with the gradual detoxification method using opium tincture in the form of Congress 60 for 11 months were enrolled in the study. The level of craving based on the Desire for Drug Questionnaire (DDQ) and patients' self-report of drug use, the level of anxiety, depression, and sleep quality of patients were evaluated using the Beck Anxiety Inventory (BAI), Beck Depression Inventory (BDI), and Pittsburgh Sleep Quality Index (PSQI), respectively. Also, suicidal thoughts were assessed by Beck Scale for Suicidal Ideation and quality of life by the World Health Organization Quality of Life Questionnaire (WHOQOL-BREF). The study found that the treatment resulted in a relapse rate of 16.7% for relapse. We also found that all sub-scales of the desire for drug questionnaire (DDQ), depression, and anxiety were significantly lower at the end of the study compared to its beginning. Additionally, quality of life and sleep significantly increased at the end of the study. All areas of craving, anxiety, and depression significantly decreased in all follow-up sessions that took place 1, 5, and 11 months after the start of treatment. Moreover, sleep disorders were improved considerably at the end of the treatment. The current study presented a low relapse rate of Iranian patients with opioid use disorder under structured treatment of gradual detoxification with opium tincture in a one-year follow-up period. Opium tincture under the Congress 60 protocol may help to control carving, decrease psychological disorders, improve quality of life, and consequently, lower relapse rate.

A Retrospective Study on the Efficacy and Safety of Chidamide As a Maintenance Therapy for Peripheral T-Cell Lymphoma

Background: Peripheral T-cell lymphomas (PTCLs) are a set of rare and highly heterogeneous tumors of non-Hodgkin's lymphoma (NHL) with inferior outcomes. Chidamide is a novel benzamide class of histone deacetylase (HDAC) inhibitor (HDACi) that was approved by the Chinese Food and Drug Administration in 2014 for the treatment of relapsed or refractory (R/R) PTCL patients. This study aimed to assess the efficacy and safety of chidamide as a maintenance therapy after induction or salvage treatment in patients with PTCLs. Methods: The clinical data of 58 patients with different PTCL subtypes who received chidamide as a maintenance therapy after first-line or salvage treatment were collected. Progression-free survival (PFS), overall survival (OS), and safety were analyzed. Results: Fifty-eight patients enrolled in our study between January 2015 and July 2022, of whom 39 patients received chidamide as a maintenance therapy after first-line treatment and 19 patients after salvage treatment. All patients started chidamide maintenance after reaching at least partial response (PR). The median age was 66 (29-83) years. Patients with angioimmunoblastic T-cell lymphoma (AITL) represented the largest subgroup (34, 58.6%), followed by PTCL, not otherwise specified (PTCL-NOS) (10, 17.2%), anaplastic large cell lymphoma (ALCL) (8, 13.8%), NK/T cell lymphoma (NKTCL) (5, 8.6%) and monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL) (1, 1.7%). Thirty-four (58.6%) patients were stage III-IV, and 38 (65.5%) patients had intermediate or high risk (prognostic index for T-cell lymphoma (PIT) 2-4). Among the 39 patients who underwent chidamide maintenance after first-line treatment, 30/39 (76.9%) patients began maintenance after reaching complete response (CR) and 9/39 (23.1%) after achieving PR. Notably, 8/9 (88.9%) patients achieved CR from PR during maintenance treatment, with a median time of 6 (3-12) months. A total of 11/39 (28.2%) patients experienced disease progression during the maintenance treatment, and their median duration of remission was 6 (3-13) months. Among them, 2 patients experienced disease progression 2 to 3 months after drug withdrawal due to COVID-19 infection. A total of 19 patients who received maintenance treatment after salvage therapy, 9 (47.4%) received maintenance therapy after CR and 10 (52.6%) received maintenance therapy after PR. Among them, 9/19 (47.4%)had disease progression and their median duration of remission was 16 (2-25) months. The remaining 10 patients (8 CR and 2 PR) were still undergoing maintenance treatment and follow-up. The median maintenance treatment time for all patients was 16 (1-72) months, and the median maintenance dose was 20 (15-30) mg twice weekly. The median follow-up time was 39 (2-79) months, the median PFS was 33 months, and the median OS had not been reached (Figure 1 a, b) for all patients. The median PFS and OS of the patients who received first-line maintenance therapy were not reached, which were significantly better compared to patients who received chidamide as salvage treatment maintenance (the median PFS and OS were 7 and 67 months, P &amp;lt; 0.001, P = 0.009, respectively) (Figure 1 c, d). There was no statistical difference in PFS and OS among the different pathological subtypes, but AITL seemed to achieve better PFS (Figure 1 e, f). The most common toxicities were hematologic toxicities, including neutropenia (42, 72.4%), anemia (23, 39.7%), and thrombocytopenia (29, 50.0%), followed by fatigue (35, 60.3%), anorexia (31, 53.4%), liver dysfunction (10, 17.2%), and pneumonia (4, 6.9%). Most adverse events were grade 1 or 2, and the grade 3‒4 adverse events were neutropenia (15/42), thrombocytopenia (7/29), fatigue (1/35), and pneumonia (2/4). Twelve (20.7%) patients underwent a dose reduction and three patients discontinued treatment (two patients with severe pulmonary infections, and one patient had intolerable fatigue) due to adverse events. One patient stopped maintenance treatment after taking chidamide for 10 months for financial reasons and he is still in follow-up. Conclusion: The findings of this study showed that patients with chidamide maintenance therapy had a better PFS and OS with a manageable safety profile, especially as the first-line maintenance therapy. We conclude that chidamide can be used as a maintenance treatment to improve the survival of patients with PTCLs.

Minimal residual disease status is the prognostic determinant following high-dose treatment for patients with multiple myeloma.

The presence of minimal residual disease (MRD+) following autologous stem cell transplantation (ASCT) in multiple myeloma represents a poor prognostic factor for progression-free survival (PFS) and overall survival (OS). At our department, we recommend lenalidomide maintenance for patients who are MRD+ after ASCT, while MRD-negative (MRD-) patients, after information about the national guidelines, were not advised to follow this regimen. Out of the total 228 patients, 175 received ASCT following first-line induction (MRD- 92 (53%), MRD+ 83 (47%), at 2 months post-ASCT), while 53 underwent ASCT after second-line treatment (MRD- 27 (51%), MRD+ 26 (49%), at the same time point). Comparatively, MRD- patients who did not receive maintenance demonstrated better OS than MRD+ patients who received upfront ASCT and maintenance treatment (96% vs. 86%, p = 0.030, at 3 years). However, nonsignificant difference was found in PFS (76% vs. 62%, at 3 years). Furthermore, second-line ASCT, MRD- non-maintained patients exhibited significantly better PFS than MRD+ (71% vs. 27%, p > 0.001, at 3 years). However, OS was better but nonsignificant (96% vs. 76%, at 3 years). Fluorescence insitu hybridization (FISH) analysis was performed on 141 out of the 228 patients. Of these, 85 (60%) patients were deemed standard risk (SR), and 56 (40%) were classified as high risk (HR). In the SR cohort, MRD- patients exhibited better PFS and OS than MRD+ patients (71% vs. 59% and 100% vs. 85%, respectively). In the HR cohort, the MRD- patients showed superior PFS but similar OS compared to MRD+ patients (66% vs. 42% and 81% vs. 80%, respectively). Our results indicate that being MRD- is a more crucial prognostic factor for the 3-year PFS and OS than the presence of high-risk cytogenetic markers or undergoing maintenance treatment. The latter appears insufficient, particularly for MRD+ patients following ASCT in the second-line setting, suggesting that these patients may require a more intensive treatment approach.

Evaluation of the effects of periodontal status according to 2017 classifications on oral health-related quality of life and quality of life-related to general health: A cross-sectional study.

In patients with periodontal disease, various symptoms are observed along with inflammation. The impact of local and systemic inflammation on periodontal tissue is well-known; however, the impact of periodontal disease on the individual's quality of life is unclear. This study aimed to assess oral health-related and general health-related quality of life in patients undergoing maintenance treatment following treatment for periodontitis (RP-CPH), patients with gingivitis (G) and patients with Stage I periodontitis (SI-P) and to compare this with individuals with clinical periodontal health (IP-CPH). This study was comprised of cross-sectional periodontal assessment along with questionnaires. Oral health-related quality of life and general health-related quality of life were assessed using, respectively, the Oral Health Impact Profile-14 (OHIP-14) and Short-Form-36 (SF-36) questionnaires. Study participants were classified according to the classification of periodontal and peri-implant diseases and conditions established by the 2017 World Workshop. The OHIP-14 total scores for the 166 study participants (age range: 22-57) of the G (11.61 ± 3.21) and SI-P (13.03 ± 3.47) groups were significantly higher than the OHIP-14 total scores of the IP-CPH (1.09 ± 1.58) and RP-CPH (2.95 ± 2.58) groups. SF-36 scores were found to be significantly lower in the SI-P group in all subgroups compared to the G and IP-CPH groups. A correlation was found between early-stage periodontal disease and low levels of OHRQoL and GHRQoL. The health of periodontal tissues may have a positive effect on the quality of life.

Prevalence of COVID-19 outcomes in patients referred to opioid agonist treatment centers.

Background: Coronavirus disease (COVID-19) is a mild to severe infectious respiratory illness caused by the SARS-CoV-2 virus. Based on the numerous pieces of evidence regarding the role of opioids in immune function, viral replication, and virus-mediated pathology, we decided to assess the incidence and severity of COVID-19 outcomes in people undergoing opioid maintenance treatment. Methods: This is a prospective, descriptive, multi-center study that included 452 patients undergoing maintenance treatment in opioid agonist treatment (OAT) clinics in different cities of Iran. Demographic information, underlying disease, history of maintenance treatment, type of drug used, history of addiction, smoking, and the kind of substance abused, were recorded. A physician evaluated the COVID-19 symptoms, and the severity of the disease was defined based on the number of observed symptoms. Results: The results have not shown any significant difference in the severity of COVID-19 symptoms in different nationalities, gender, and treatment groups. Furthermore, the history of drug abuse, including time and type of abuse and smoking, has not indicated any significant association with the occurrence of symptoms. Only the severity of COVID-19 in the mentioned cities (first and second follow-up: p < 0.001) and individuals with a history of underlying disease (first follow-up: p = 0.020; second follow-up: p = 0.043) were significantly different. Conclusion: Our results have demonstrated that the severity of symptoms in people with the underlying disease was significantly higher than in others. But there is no association between sex, race, treatment groups, and abuse history with the severity of COVID-19 symptoms in methadone maintenance treatment (MMT) patients.

Une maladie de Rosai–Dorfman–Destombes de présentation laryngée trompeuse

Rosai-Dorfman-Destombes disease is a rare non-Langerhansian cell histiocytosis characterized by the accumulation of large activated histiocytes in the affected tissues with images of emperipolesis. The diagnosis is not really problematic in the classical forms, with a lymph node presentation, whose histology is very suggestive. However, it can be much more difficult in the extra-nodal forms, which are misleading in both their clinical and histological presentation. We report here a case illustrating this diagnostic difficulty. Firstly, clinically, the disease was revealed by an unusual laryngeal location, responsible for acute obstructive respiratory distress and requiring urgent surgical management. Secondly, histologically, the diagnosis was not evoked in the first instance by analysis of the laryngeal lesion. Indeed, there was a not specific appearing polymorphic infiltrate, associating small lymphocytes, plasma cells and numerous histiocytes, without evidence for a lymphoma after immunohistochemistry and lymphocyte clonality analysis. However, after re-examination of the slides, the histiocytes sometimes appeared large or xanthomised and have a PS100+, CD1a-, langerhine- phenotype, with rare images of emperipolesis. These aspects finally suggested the diagnosis of Rosai-Dorfman-Destombes disease, then confirmed by a cervical lymph node biopsy showing characteristic histological features. Simultaneously, NGS analysis of the laryngeal lesion showed a mutation in the MAP2K1 gene, in accordance with the diagnosis. The patient was treated with revlimid and dexamethasone for 6 months, with complete remission, and is currently undergoing maintenance treatment with revlimid.

Evolution of Electroconvulsive Therapy during the COVID-19 pandemic in the Regional ECT Unit of the Region of Murcia

IntroductionCovid-19 was declared a global pandemic by the WHO on 11 March 2020. From the beginning, the pandemic posed a challenge to the different health systems around the world, which were forced to prioritise and distribute their resources as efficiently as possible. During the period between 11 March 2020 and 28 April 2021, the Regional ECT Unit of the Region of Murcia remained closed.Objectives- Determine the clinical status of patients on maintenance ECT in the Regional ECT Unit during the Covid-19 pandemic.- Prioritise resumption of treatment in those who were clinically decompensated or at risk- Understand the consequences of discontinuation of maintenance ECT for these patients.MethodsA longitudinal descriptive study was conducted during the month of May 2020.ResultsThirty-seven patients were contacted by telephone. On the first call, a total of 15 patients were unstable or at risk of decompensation.Prior to the second call, CT was administered preferentially to a total of 8 patients and programmed to 2. On the second call, a total of 11 patients were at risk of decompensation.ConclusionsThe closure of the Regional ECT Unit had negative consequences for patients undergoing maintenance treatment. Electroconvulsive therapy is an essential part of the treatment of psychiatric patients both in acute episodes and in relapse prevention.DisclosureNo significant relationships.

Taste Alteration in Children With Acute Lymphoblastic Leukemia Undergoing Maintenance Treatment.

The purpose of the present study is to examine taste alteration in children with acute lymphoblastic leukemia (ALL) undergoing maintenance treatment. The population of the study was comprised of children with ALL between the ages of 7 and 18 who received maintenance treatment. The study sample was included 72 children (children with ALL:36 and healthy children: 36) determined by power analysis. This was a cross-sectional study. The children in both groups were applied to the taste test by the researcher. It was determined that there is a statistically significant difference ( P <0.05) between sweet (sucrose), salty (sodium chloride), sour (citric acid), and bitter (quinine hydrochloride) taste test score averages of the children with ALL and healthy children and that the 4 taste test score averages are lower in the experiment group. The taste alterations were determined in the present study for children with ALL undergoing maintenance treatment. Problems of children with cancer such as loss of appetite, negative attitude toward food or weight loss can be reduced or prevented when taste alteration is determined in children with cancer thereby improving the feeding of the children thereby increasing their quality of life.

P439 Stability of subcutaneous serum IFX (CTP13) levels between two injections and over two successive cycles in patients with Crohn’s disease

Abstract Background Under IFX sc, we do not know if there is a residual level of IFX. The aim of this work was to investigate this point by analyzing the intra-individual variability of the serum level of IFX sc. Methods This was an observational, prospective study that included patients with CD undergoing maintenance treatment with IFX sc (120mg every, 14 days). Patients had IFX determinations (i Track, 10; Theradiag (France) at visit, 1 (day, 4 to, 6 after SC injection), visit, 2 (day, 7 to, 9 after sc injection) and visit, 3 (day, 13 to, 14 after sc injection) on two consecutive cycles. The first determinations were made only after, 8 weeks of switching from IV to SC. All patients at inclusion were in clinical remission (CDAI &amp;lt;, 150) with calprotectin levels &amp;lt;, 250 µg/g stool. Results 20 patients (mean age:, 36 years, sex ratio M/F:, 1, mean duration of IFX IV:, 16 months) were included, i.e. meaning, 120 determinations., 8 patients were treated in combination with thiopurines. Mean residual levels before switch to sc were, 3.9 +/-1.2 µg/mL. Mean intraindividual levels between the two cycles were comparable (Visit, 1: cycle, 1:, 11.1 +/-, 4.4 µg/mL, cycle, 2:, 11.6 +/-, 4.6 µg/mL; p=0.65; Visit, 2: cycle, 1:, 12.0 +/-, 5.1 µg/mL, cycle, 2:, 11.3 +/-4.9 µg/mL; p=0.25; Visit, 3 cycle, 1:, 11.0 +/-4., 7 µg/mL, cycle, 2:, 10.9 +/-, 4.2 µg/mL; p=0.21. Serum IFX sc levels remained stable over the, 14 days between the two SC injections (p=0.36). Mean IFX levels at any dosing time were comparable in patients with and without thiopurines (IFX sc monotherapy: mean:, 11.5 +/-, 5.5 µg/mL versus IFX sc with thiopurines: mean:, 11.8 +/-, 4.6 µg/mL, p=0.54). Finally, residual IFX IV levels before switch did not influence the results of IFX sc serum concentrations (p=NS). Conclusion Measure of IFX levels for IFX SC can be proposed at any time between two injections. No residual levels were found. These data are important for our clinical practice.

P355 Exceeding treatment expectations in Crohn’s disease: transmural healing and a new definition of deep remission

Abstract Background While mucosal (MH) and transmural healing (TH) predict relevant clinical outcomes in Crohn’s disease (CD), little is known about the real significance and clinical impact of deep remission (DR). The aim of this study was to better explore the concept of DR, towards a direct correlation between MH, TH and biomarkers. Methods A real-world observational longitudinal study was performed to evaluate the rate of clinical remission (CR), MH and TH, and the fecal calprotectin (FC)/C-reactive protein (CRP) levels in all consecutive patients with CD undergoing maintenance treatment with biologics. A ROC curve was constructed to define the best FC and CRP cut-offs associated with MH and TH. Finally, CD patients achieving CR, MH and TH, in association with the target FC and CRP values, were considered in DR. Results Among, 118 CD patients, CR, MH and TH were achieved in, 74 (62.7%), 52 (44.1%) and, 38 patients (32.2%), respectively. After, 2 years, the mean FC levels decreased from, 494 ±, 515.4 μg/gr to, 260 ±, 354.9 μg/gr (p&amp;lt;0.01). Using the ROC curve analysis, a FC cut-off value of, 94 μg/gr was associated with both MH (sensitivity, 94.2%, specificity, 84.8%, PPV, 83.05%, NPV, 94.92%, AUC, 0.95) and TH (sensitivity, 92.1%, specificity, 70%, PPV, 64.4%, NPV, 94.9%, AUC, 0.88). The MH/FC and TH/FC k of agreement was, 0.81 (p&amp;lt;0.01) and, 0.58 (p&amp;lt;0.01), respectively. CRP &amp;lt;, 5 mg/L was associated with both MH (sensitivity, 96.1%, specificity, 62.1%, PPV, 66.7%, NPV, 95.35%, AUC, 0.85) and TH (sensitivity, 97.4%, specificity, 52.5%, PPV, 52%, NPV, 95.35%, AUC, 0.78). When considering CD patients with concomitant CR, MH and TH associated with a FC level &amp;lt;, 94 μg/gr and CRP &amp;lt;, 5 mg/L, DR was identified in, 33 patients (27.9%). Conclusion A FC cut-off of, 94 μg/gr and a normal CRP could be included in the definition of DR in association with CR, MH and TH. Thus, DR can be achieved in approximately, 30% of CD patients during maintenance treatment with biologics.

Defining phenotypes of long-term lithium and valproate response, including combination therapy: a modified application of the Alda scale in patients with bipolar disorders

BackgroundWhen evaluating the long-term treatment response to mood stabilizers using the Alda scale, mood stabilizer combination therapy is typically considered a confounding factor, and patients receiving combination therapy are excluded from the analysis. However, this may result in bias if those under combination therapy are worse treatment responders. This study aims to explore whether the Alda scale is applicable to patients taking lithium and valproate combination therapy. We compared long-term treatment response in patients receiving monotherapy and combination therapy of the two drugs, and investigated clinical correlates of the responses to each drug.MethodsThe study subjects consisted of 102 patients with bipolar I (BD-I) or bipolar II (BD-II) disorder who had been undergoing maintenance treatment with lithium and/or valproate for more than 2 years at a single specialized bipolar disorder clinic. Long-term treatment response was measured using the Alda scale and compared among the lithium monotherapy group, the valproate monotherapy group, and the mood stabilizer combination group. Clinical correlates of long-term treatment response were evaluated in lithium users and valproate users separately.ResultsThere were no significant differences in terms of baseline illness characteristics among groups. The combination group showed the worst treatment response for all the response measurements applied. This group also had the higher rate of ‘poor responder’ with a statistically significant difference compared to valproate group. Older age at onset and (hypo)manic episode at onset showed significant positive associations with total Alda score in lithium users, while comorbid anxiety disorders, obsessive–compulsive disorder and mixed episode showed significant negative associations in valproate users.ConclusionsThe combination group had poorer long-term treatment response but did not show distinct clinical characteristics compared to the monotherapy groups. When exploring the long-term effects of mood stabilizers, excluding patients undergoing combination treatment could result in bias because they may represent a poor response group. The long-term treatment responses of lithium and valproate had different clinical correlates.

The Influence of an Attachment-Related Stimulus on Oxytocin Reactivity in Poly-Drug Users Undergoing Maintenance Therapy Compared to Healthy Controls.

BackgroundSubstance use disorders (SUDs) have been described as a dysfunctional way to compensate for deficiencies in that person’s underlying attachment system. Furthermore, the neuropeptide oxytocin (OT), which is a critical component of the neurobiology of the attachment system, has been shown to effectively reduce addictive behavior and therefore has been discussed as a potential medication in SUD treatment. This study investigates variation in peripheral OT plasma levels as a function of exposure to an attachment-related stimulus in SUD patients compared to healthy controls (HCs).MethodsA total sample of 48 men, 24 inpatients in maintenance treatment who were diagnosed with poly-drug use disorder (PUD) and 24 HC, was investigated. A 15-min exposure to the Adult Attachment Projective Picture System (AAP) was used as an attachment-related stimulus and coded for attachment status. Blood samples before and after the AAP-assessment were taken and assayed for OT levels. Variation in baselines level of OT was examined in relation to the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST), the Adult Attachment-Scale (AAS), and the Brief Symptom Inventory (BSI).ResultsFollowing the AAP stimulus controls showed no significant difference in OT levels elevation from baseline compared to the PUD group’s OT levels. Furthermore, in the PUD group only OT-baseline-levels may be negatively associated with the AAS subscale “Comfort with Closeness” and “Anxiety” and lifetime substance use.DiscussionOur results suggest that peripheral OT levels in poly-drug users undergoing maintenance treatment are not significantly different in responsiveness to an attachment related stimulus compared to HC. With regard to non-significant tendencies observed in this study which hint toward decreased OT-reactivity in the PUD group, further research is needed to explore this hypothesis with increased statistical power.

Intravesical BCG: Possible Protective Impact Against COVID-19 in NMIBC P atients

Purpose: To determine the incidence of COVID 19 in a series of registered patients with non-muscle invasive bladder cancer, treated by TUR-BT and intravesical BCG. Patients and method: We analysed 127 patients with non-muscle invasive bladder cancer, in the medium/high risk group, registered between 2001-2020. The patients and families have been contacted by phone. In this interval, 32 patients deceased (cardiovascular pathologies, non-urologic neoplasia, tumour progression), 95 patients are still alive, 24 women and 71 men. The average age was 61.7 (16-86), the majority being over 50, included in the high-risk group for COVID-19. The patients were resected endoscopically and received a cytostatic instillation within the first 6 hours. Reresection of the tumour bed was practiced in pT1patients. The adjuvant treatment with BCG was used in the induction form at each relapse and maintenance (22 patients), respectively. Until 2005, we used the local strain (Cantacuzino Clinical Institute), after that, the strain from Bulgaria (Calgevax) and Medac (Germany). Results: 95 patients are still alive. Tumour relapses were registered in 34 patients. 3 patients registered tumour progression, resolved through radical cystectomy (2) and irradiation. In 3 cases, upper tract urothelial tumours were registered (nephroureterectomy with perimeatic cystectomy). 63 patients underwent induction treatment, while 22 underwent maintenance treatment. Complications: Intolerance to BCG in 4 patients, BCG cystitis in 5 patients, arthritis in 1 patient, septic status in 2 patients. In the analysed batch of patients, no COVID-19 cases have been registered. Conclusions: It appears that the intravesical administration of BCG represents an immunologic booster (confirmable through PPD), resulting in a reduction of the COVID-19 infection incidence. © 2019 Journal of Innovation Management. All rights reserved.

Single course of intravesical Bacillus Calmette-Guerin versus single course with maintenance therapy in the management of nonmuscle invasive bladder cancer: A prospective randomized study.

Objective:The objective of the study was to compare maintenance versus single course of intravesical Bacillus Calmette–Guerin (BCG) in the management of high-risk nonmuscle invasive bladder cancer (NMIBC) regarding recurrence, progression, survival, and complications.Patients and Methods:After transurethral resection of bladder tumor (TURBT), Group I patients (33) received weekly doses of 90 mg of live attenuated Pasteur strain of BCG. The course was started 14 days after the second TURBT for 6 consecutive weeks. In Group II: 35 patients, the induction schedule was followed by 3 weekly instillations at months 3, 6, and 12 as a maintenance course. Recurrence, progression rates, survival, and toxicity were assessed in both the groups.Results:Patients with induction therapy alone had significantly higher recurrence rate than those received maintenance therapy (55.6% vs. 19.2%, P = 0.01). The 5-year recurrence-free survival rate was 41% and 78% in both the groups, respectively. There was no significant difference regarding the progression rate for both the groups. The mean 5-year progression-free time was comparable between the two groups. The 5-year progression-free survival was 69.8% for patients who underwent induction therapy alone compared to 70.7% for maintenance therapy. Overall local adverse events were significantly higher in patients who underwent maintenance treatment protocol.Statistical Analysis Used:SPSS package version 20 and Kaplan–Meier curves were used to evaluate the survival rate.Conclusions:Maintenance doses of BCG significantly decrease and delay the recurrence of high-risk NMIBC. However, there is no significant favor as regards tumor progression. Maintenance doses of BCG are significantly associated with a higher incidence of local adverse effects than induction doses alone.