Self-administered Therapies Research Articles

"ARVs is for HIV and cream is for HPV or precancer:" Women's Perceptions and Perceived Acceptability of Self-Administered Topical Therapies for Cervical Precancer Treatment: A Qualitative Study from Kenya.

Women in low- and middle-income countries (LMICs) bear a disproportionate burden of global incidence and deaths from cervical cancer, despite being a preventable disease. Prevention efforts in LMICs are hindered in part by lack of access to cervical precancer treatment, due to weak health infrastructure and a lack of adequate human resources to deliver current provider-administered precancer treatments. Innovative strategies are urgently needed to close the cervical precancer treatment gap in LMICs, including the use of self-administered topical therapies for which efficacy evidence is available from high-income settings. We investigated African women's perceptions and perceived acceptability of these therapies for cervical precancer treatment. Between November 2022 and April 2023, we conducted five focus group discussions (FGDs) with women ages 25-65 years undergoing cervical cancer screening or precancer treatment in Kisumu, Kenya. The FGDs explored women's experiences with screening and precancer treatment, their acceptability of topical therapies for precancer treatment, and perceived barriers and facilitators to uptake. The FGDs were moderated by local qualitative research assistants, conducted in local languages, transcribed, coded, and analyzed using qualitative description using NVIVO software. Twenty-nine women participated, with a mean age of 35.4 years (SD 6.5). All had undergone cervical cancer screening, and 25 (83%) had a history of precancer treatment with ablation or excision. Multiple themes were identified related to women's perceptions of topical therapies. Participants were highly receptive of topical treatments, with many favoring the option of self-administration compared to provider-administration of such therapies. Self-administration of topical therapies was felt to help address challenges associated with current treatment methods, including difficulty in access, pain with procedures, cost, and lack of privacy with pelvic exams. Participants had a preference for topical therapies that are used less frequently compared to those used daily. Among Kenyan women with a history of cervical precancer treatment, self-administered topical therapies for precancer are acceptable and have the potential to address barriers, including access, privacy, and cost, that hinder precancer treatment in LMICs. If supported by efficacy studies in LMICs, self-administered topical therapies offer a scalable approach to closing the precancer treatment gap in LMICs. Not applicable.

Applying Machine Learning Models Derived From Administrative Claims Data to Predict Medication Nonadherence in Patients Self-Administering Biologic Medications for Inflammatory Bowel Disease.

Adherence to self-administered biologic therapies is important to induce remission and prevent adverse clinical outcomes in Inflammatory bowel disease (IBD). This study aimed to use administrative claims data and machine learning methods to predict nonadherence in an academic medical center test population. A model-training dataset of beneficiaries with IBD and the first unique dispense of a self-administered biologic between June 30, 2016 and June 30, 2019 was extracted from the Commercial Claims and Encounters and Medicare Supplemental Administrative Claims Database. Known correlates of medication nonadherence were identified in the dataset. Nonadherence to biologic therapies was defined as a proportion of days covered ratio <80% at 1 year. A similar dataset was obtained from a tertiary academic medical center's electronic medical record data for use in model testing. A total of 48 machine learning models were trained and assessed utilizing the area under the receiver operating characteristic curve as the primary measure of predictive validity. The training dataset included 6998 beneficiaries (n = 2680 nonadherent, 38.3%) while the testing dataset included 285 patients (n = 134 nonadherent, 47.0%). When applied to test data, the highest performing models had an area under the receiver operating characteristic curve of 0.55, indicating poor predictive performance. The majority of models trained had low sensitivity and high specificity. Administrative claims-trained models were unable to predict biologic medication nonadherence in patients with IBD. Future research may benefit from datasets with enriched demographic and clinical data in training predictive models.

Men's perceptions and perceived acceptability of their female partner's use of self-administered intravaginal therapies for treatment of cervical precancer in Kenya.

Cervical cancer continues to be a major health issue in low- and middle-income countries (LMICs). Despite increasing access to screening, access to precancer treatment remains a significant challenge in LMICs, highlighting a need for innovative, accessible and resource-appropriate treatment approaches, including self-administered therapies. A cross-sectional mixed-methods study was conducted among men aged 25-65 with a current female partner in Kisumu County, Kenya. Participants were sequentially recruited and surveyed to evaluate their understanding of human papillomavirus and cervical cancer, their views on screening and treatment and their attitudes toward self-administered therapies. Focus group discussions (FGDs) with a subset of the survey participants further explored their treatment preferences and perceptions. Two hundred fourteen men participated in the survey, and 39 men participated in FGDs. The median age was 39 years, and 51% had a primary school education or less. Most (96%) were in a committed relationship, and 74% earned $10 or less daily. There was strong support for self-administered topical therapies, with 98% willing to support their partners using such treatments if available. Additionally, most participants were open to supporting necessary abstinence or condom use, though 76% believed their partners might hesitate to request condom use. When given an option, most preferred their partner to self-administer such therapies at home compared to provider administration at a health facility, citing convenience, cost-effectiveness and privacy. Preferences varied between two potential therapies, 5-Fluorouracil and Artesunate, based on their administration frequency, duration and abstinence requirements. Qualitative findings largely supported the quantitative analysis. The study demonstrates strong support for self-administered topical therapies for cervical precancer among Kenyan men. Additional research on acceptability, feasibility and efficacy in different LMICs could pave the way for these therapies to help bridge current cervical precancer treatment gaps in these settings.

"There is nothing that can prevent me from supporting her:" men's perspectives on their involvement and support of women's use of topical therapy for cervical precancer treatment in Kenya.

Cervical cancer disproportionately impacts women in low- and middle-income countries (LMICs). The World Health Organization's (WHO) 90/70/90 strategy aims to eliminate cervical cancer by 2030 by increasing HPV vaccination coverage to 90%, screening 70% of eligible women, and effectively treating 90% of those with abnormal results by 2030, potentially preventing 62 million deaths in LMICs. LMICs, however, struggle with limited access to cervical precancer treatment, in part due to a lack of trained professionals and weak health systems. Effective non-surgical, self-administered, which have demonstrated efficacy in high-income countries, could bridge the treatment gap in LMICs and may be more scalable and cost-effective than provider-administered therapies. To inform feasibility studies in LMICs, data are needed on the role of male partners in influencing the acceptability and uptake of self-administered topical therapies, including their support of recommended abstinence and contraception guidelines associated with these therapies. Between November 2022 and April 2023, we conducted five focus group discussions (FGDs) with men aged 25 to 65 years in Kenya to explore their perspective and perceived support regarding their female partners using topical self-administered therapies for cervical precancer treatment. The FGDs were moderated by local qualitative research assistants and conducted in local languages, transcribed, coded, and analyzed using qualitative description. Thirty-nine male participants meeting the eligibility criteria participated in five FGDs. The mean age of participants was 42.5 years. Most participants, 79.5%, had a female partner with a history of cervical precancer treatment, 5.1% did not, and 15.4% were unsure of their female partner's prior precancer treatment history. The study aimed to assess men's support of their female partners' use of topical therapies for treating cervical precancer. We find that male participants strongly express acceptance and willingness to support their wives or partners in using such therapies, if available. Reported supportive behavior included permitting the use of the therapies and support of maintaining abstinence during the recommended times. Additionally, participants desired male involvement in clinic and community-based education about topical therapies to facilitate widespread support. The use of self-administered topical therapies for cervical precancer treatment, if supported by efficacy studies in LMICs, may support achieving the WHO's 2030 goal of 90% treatment access. We find that with adequate education, men express overwhelming support of their female partner's use of topical therapies, including adherence to abstinence and contraception guidelines.

Paroxysmal Nocturnal Hemoglobinuria: Current Management, Unmet Needs, and Recommendations.

Paroxysmal nocturnal hemoglobinuria (PNH) is an ultra-rare, acquired clonal abnormality, which renders hematopoietic cells exquisitely sensitive to complement-mediated destruction. Classical features of PNH include intravascular hemolytic anemia, increased thrombotic risk, and manifestations related to end-organ damage (eg fatigue, chest pain, dyspnea, renal failure, and pulmonary hypertension). With supportive care alone, mortality rate of patients with PNH is approximately 35%. The anti-C5 monoclonal antibody, eculizumab, was the first targeted therapy approved for PNH, and led to improved hemoglobin, quality of life, reduced transfusion need, reduced thrombosis, and greater overall survival. More recently, therapeutics such as longer acting anti-C5 (ravulizumab) and anti-C3 (pegcetacoplan) medications have been approved, along with other novel therapeutics in late-stage clinical trials. Biosimilars of eculizumab are also now available. Proximal inhibitors (against C3, factor B, and factor D) have shown significant improvements in hemoglobin and transfusion-avoidance in patients who remain anemic despite C5 inhibition. Despite these novel therapies, some unmet challenges remain, including management of breakthrough hemolysis, clinically significant iatrogenic extravascular hemolysis, optimal management in pregnancy, and infection risk mitigation as new targets in the complement system are blocked. In addition, the use of self-administered subcutaneous and oral therapies raises concerns around treatment adherence and the risks of uncontrolled terminal complement. Given the ultra-rare nature of PNH, development is underway of a centralized international registry to capture and analyze the data as they mature for various new therapies and characterize the clinical challenges related to PNH management.

Comparison of the Effects of Self-Administered Moxibustion versus Acupressure on Blood Pressure, Stress, Sleep Quality, and Quality of Life in Hypertensive Patients: A Randomized Parallel Trial.

This study aimed to evaluate the effects of an 8-week self-administered moxibustion program on blood pressure, stress, sleep quality, and quality of life in hypertensive patients. We compared its effects with those of self-acupressure to assess the feasibility of using moxibustion as a self-management method for hypertension. Forty-six subjects were recruited and randomly assigned to a moxibustion group and an acupressure group. The moxibustion group applied moxa sticks to seven acupoints by themselves five times a week for 8 weeks, while the acupressure group placed acupressure patches on the same acupoints by themselves. Systolic and diastolic blood pressures were measured. Stress was assessed with plasma epinephrine, plasma norepinephrine, and the Perceived Stress Scale (PSS). Sleep quality and quality of life were evaluated using the Pittsburgh Sleep Quality Index (PSQI) and the World Health Organization Quality of Life-Brief Version (WHOQOL-BREF), respectively. Systolic and diastolic blood pressures decreased in the moxibustion and acupressure groups to a similar extent after the 8-week intervention. Plasma epinephrine and norepinephrine levels and PSQI variables were not changed in both groups. PSS decreased only in the moxibustion group. Quality of life related to physical health and environmental health, as assessed by the WHOQOL-BREF, significantly improved to a similar degree in both groups. Both self-administered moxibustion and acupressure therapies were effective in reducing blood pressure in hypertensive patients.

Adherence and persistence to self-administered disease-modifying therapies in patients with multiple sclerosis: A multisite analysis.

Though there are several disease-modifying therapy (DMT) options for patients with multiple sclerosis (MS), treatment outcomes rely on patient adherence and persistence. Previous studies have demonstrated suboptimal adherence rates and high rates of early treatment discontinuation. Health-system specialty pharmacies (HSPPs) are a growing practice model that have demonstrated adherence and persistence benefits through single site evaluations. Research is needed across multiple HSSPs to understand and validate the outcomes of this practice model. A multisite prospective cohort study was performed including patients with at least three fills of a DMT between January 2020 and June 2021 at an HSSP. Patients were excluded due to pregnancy or death. Enrollment occurred for 6 months followed by 12 months of follow-up. Adherence was measured using pharmacy claims to calculate proportion of days covered (PDC) during the follow-up period. Time to non-persistence was calculated as the time from an index DMT fill to the first date of a gap of >60 days between medication exhaust and fulfillment dates. Adherence and persistence calculations were assessed at the therapeutic class level (any self-administered DMT dispensed by the HSSPs). The Kaplan-Meier method was used to present the probability of being persistent, and Cox proportional hazards regression analysis was used to estimate hazard ratios of factors associated with non-persistence, which included age, sex, study site, insurance type, and whether the patient switched medication as potential factors. The most common self-administered DMTs filled among 968 patients were glatiramer acetate (32%), fingolimod (18%), and dimethyl fumarate (18%). Most patients (96%) did not switch DMT during the study period. The median PDC was 0.97 (interquartile range 0.90-0.99), which was similar across all sites. Patients who had at least one DMT switch were 76% less likely to have a higher PDC than those who did not have any switch after adjusting for other covariates (Odds ratio: 0.24, 95% confidence interval [CI]: 0.14-0.40, p<0.001). Most patients (86%) were persistent to DMT over the 12-month study period. Among those non-persistent, median time to non-persistence was 231 (IQR 177-301) days. Patients who switched medications were 2.4 times more likely to be non-persistent (95% CI: 1.3 - 4.5, p=0.005). The most common reasons for non-persistence were discontinuation/medication held for an extended period (30%), often due to patient or prescriber decision (75%). High rates of DMT adherence and persistence were seen among patients serviced by HSSPs, indicating potential benefits of this model for patients with MS. Switching DMTs was associated with lower adherence and persistence and may be an opportunity for added care coordination or resources to optimize therapy transitions.

TB treatment using family members, treatment supporters and self-administered therapies in rural Papua New Guinea.

Papua New Guinea (PNG) has one of the world's highest TB incidence rates. It is difficult for patients to access TB care in remote provinces due to insufficient infrastructure and challenging terrain, making varied, targeted delivery models for treating TB necessary. To assess treatment outcomes using self-administered treatment (SAT), family-supported treatment and community-based directly observed therapy (DOT) via treatment supporter (TS) in the PNG context. A retrospective, descriptive analysis of routinely collected data from 360 patients at two sites in 2019-2020. All patients were assigned a treatment model based on risk factors (adherence or default) and offered patient education and counselling (PEC), family counselling and transportation fees. End-of-treatment outcomes were assessed for each model. Treatment success rates among drug-susceptible TB (DS-TB) were good overall: 91.1% for SAT, 81.4% for family-supported treatment and 77% for DOT patients. SAT was strongly associated with favourable outcomes (OR 5.7, 95% CI 1.7-19.3), as were PEC sessions (OR 4.3, 95% CI 2.5-7.2). By considering risk factors when determining their treatment delivery model, strong outcomes were seen in all three groups. Multiple modes of treatment administration, tailored to individuals' needs and risk factors, is a feasible, effective, patient-centred care model for hard-to-reach, resource-limited settings.

Design Development of the SMARTCLIC®/CLICWISE® Injection Device for Self-Administered Subcutaneous Therapies: Findings from Usability and Human Factor Studies.

An easy-to-use, multiuse, single-patient, electromechanical autoinjector, the SMARTCLIC®/CLICWISE® injection device, was recently developed to improve the self-administration options available to patients with chronic inflammatory disease treated with biologic agents. An extensive series of studies were conducted to guide the design and development of this device and to ensure its safety and effectiveness. Participants in two user preference studies and three formative human factor (HF) studies evaluated evolving iterations of the autoinjector device, dose dispenser cartridge, graphical user interface, and informational materials; participants in a summative HF test subsequently assessed the final proposed commercially representative product. In the user preference studies, rheumatologists and patients with chronic inflammatory disease, interviewed online and in-person, provided feedback on the design and functionality of four prototypes. In the HF studies, the safety, effectiveness, and usability of adapted prototypes were assessed under simulated-use conditions by patients with chronic inflammatory disease, caregivers, and healthcare professionals (HCPs). The safety and effectiveness of the final refined device and system were confirmed in a summative HF test by patients and HCPs in simulated-use scenarios. Rheumatologists (n=204) and patients (n=39) interviewed in the two user preference studies provided feedback on the device size, feature ergonomics, and usability that guided prototype development in the subsequent formative HF studies. Observations from patients, caregivers, and HCPs (n=55) participating in the latter studies yielded additional critical design revisions that culminated in development of the final device and system. Of 106 injection simulations conducted in the summative HF test, all resulted in successful medication delivery, and no potential harms were associated with injection-related use events. Findings from this research facilitated development of the SmartClic/ClicWise autoinjector device and demonstrated that it could be used safely and effectively by participants representative of the intended-use population of patients, lay caregivers, and HCPs.

Abstract NG13: Feasibility of topical self-administered therapies to improve cervical precancer treatment outcomes among women living with HIV in low-and middle-income countries

Abstract Global trends of invasive cervical cancer (ICC) represent a dire global health inequity, with 85 percent of incident cases and 90 percent of deaths occurring in low- and middle-income countries (LMICs).1 ICC is the leading cause of cancer death among women living with HIV (WLWH) in sub-Saharan Africa, which accounts for 71% of the global burden of HIV infection, despite being home to only 12% of the global population.2 Compared to HIV-negative women, WLWH have increased incidence and persistence of human papillomavirus (HPV),3 have a shorter time from HPV infection to development of precancerous lesions,4 and have a six to eightfold increased risk of developing invasive cancer.5 In 2020, the World Health Organization (WHO) launched the 90/70/90 global strategy for cervical cancer elimination, which aims for 90% human papillomavirus (HPV) vaccination rate, 70% screening coverage, and 90% of precancerous lesions adequately treated by 2030. Current efforts towards this elimination agenda include scaling up HPV-based screening programs as well as improving access to precancer treatment using portable ablation and excisional devices in LMICs. However, among WLWH, current precancer treatment methods are limited by high rates of treatment failure. In a randomized trial of WLWH with cervical intraepithelial neoplasia grade 2/3 (CIN2/3), recurrence at 24 months was 30% in the ablation arm and 19% in the excision arm.6 These high rates of treatment failure, demonstrated in multiple studies, are driven by persistent HPV infection following treatment,7 and are highly consequential in LMICs settings follow-up mechanisms are weak. This highlights an urgent need for studies on feasible, innovative, yet accessible strategies to improve HPV clearance following precancer treatment for WLWH in LMICs. Use of self-administered topical therapies with anti-viral properties as adjunct treatment could be a feasible and highly scalable strategy to address this limitation. Several studies, have demonstrated the safety, and efficacy of 5-Flourouracil (5FU), a readily available topical drug as primary or adjuvant therapy for CIN2/3 among both HIV-positive and HIV-negative women in the U.S. In a Phase III multicenter trial of U.S WLWH with CIN2/3 randomized to self-administered intravaginal 5-Flourouracil (5FU) versus observation following standard treatment, participants in the 5FU arm had an 8% CIN2/3 recurrence rate at 18 month follow-up, compared to 31% in the observation arm (p=0.04).8 In another randomized trial of self-administered 5FU as primary treatment versus 6-month observation for CIN grade 2 (CIN2) among U.S women without HIV infection, 93% in the 5FU arm had disease regression, compared to 56% in the observation arm (p=0.01).9 In this study, 50% of participants in the 5FU arm cleared HPV at follow-up, compared to 22% in the observation arm (p&amp;lt;0.05). In both studies, 5-FU, used once every other week for 8 applications, was safe, with no grade 3 or 4 adverse events, and compliance and adherence to treatment was high. However, there are no studies evaluating whether self-administered therapies would be culturally acceptable to WLWH and their male partners in LMICs, or whether topical 5FU may be in this population. To fill this gap, with the support of the 2022 Victoria’s Secret Global Fund for Women’s Cancers Career Development award, in partnership with Pelotonia &amp; the American Association for Cancer Research, using in-depth-interviews and focus group discussions, I am carrying out a mixed-methods qualitative study among WLWH with HPV and their male partners in Kenya and Malawi to investigate their perceptions towards using self-administered therapies for HPV and cervical precancer treatment, as well as perceived barriers and facilitators to uptake. Additionally, I will conduct a Phase I trial to evaluate the safety and adherence of self-administered intravaginal 5-FU following primary treatment among WLWH with CIN2/3 in Kenya. These studies will generate key preliminary data to support future randomized trials to investigate the efficacy of 5FU as adjuvant therapy to improve current precancer treatment strategies for WLWH in LMICs.

Role and Impact of a Clinical Pharmacy Team at an Inflammatory Bowel Disease Center

There is limited literature describing the role of a clinical pharmacy team within a tertiary academic inflammatory bowel disease (IBD) center. The goal of this paper is to describe and showcase the clinical and operational impact of an integrated clinical pharmacy team. This was a retrospective study evaluating the referral outcomes for all patients referred to University of Chicago Medicine Specialty Pharmacy for self-administered advanced IBD therapies covered by prescription insurance from October 1, 2020 to October 31, 2021. A total of 1800 referrals were received for advanced IBD therapies. Prior authorizations (PAs) were required and submitted for 1700 referrals. Of those 1700 PA submissions, 297 (17%) were denied by insurance. To overturn the denials, 344 appeals, including second-level appeals and external reviews, were submitted. Manufacturer patient assistance programs were obtained for 69 patients. From the 1800 referrals, 98% of patients were successfully started on the intended therapy. Clinically, there were 2141 pharmacist-initiated interventions by 2 IBD pharmacists. The most common interventions were prevention in interruption of therapy and providing patient education. Clinical pharmacy teams are well positioned to streamline care within a tertiary academic IBD center. Their unique skillset and ability to provide high yield medication access supports the use of this model as a best practice in IBD centers.

Nurse-guided patient self-treatment in integrative oncology: a randomized controlled trial

Nurses are increasingly becoming involved in integrative oncology (IO) programs. This study examined the additive effect of nurse-provided guidance for self-administered IO therapies on cancer-related fatigue and quality of life (QoL). The study was randomized and controlled, enrolling patients undergoing active oncology treatment with IO interventions for fatigue and other QoL-related outcomes. IO practitioner guidance on self-treatment with manual, relaxation, and/or traditional herbal therapies was provided to patients in both the intervention and control arms. However, patients in the intervention arms also received additional guidance on self-treatment by IO-trained palliative care nurses. All participants were assessed for fatigue and QoL at baseline and at 24-h follow-up, using the Edmonton Symptom Assessment Scale (ESAS) and the Measure Yourself Concerns and Wellbeing (MYCAW) questionnaire tools. Of 353 patients recruited, 187 were randomized to the intervention and 166 to the control group. Both groups had similar demographic and oncology-related characteristics. Patients in the intervention arm reported significantly greater improvement in ESAS scores for fatigue (p = 0.026) and appetite (p = 0.003) when compared to controls. The addition of nurse-provided guidance on self-administration of IO treatments to that provided by IO practitioners further reduced short-term scores for fatigue and improved appetite. The relationship between palliative and IO-supportive cancer care requires further study.

Patient experience of chronic illness care and complementary integrative health use: a cross-sectional study of patients with hypermobility spectrum disorders (HSD) and Ehlers–Danlos syndromes (EDS)

Purpose Hypermobility spectrum disorders (HSD) and Ehlers–Danlos syndromes (EDS) are frequently underdiagnosed, contributing to patient dissatisfaction in the healthcare system. This study evaluated the health service utilization, care, and subjective experiences of living with chronic illness among adults with HSD and EDS in the United States and Canada. Methods This was an anonymous, web-based, cross-sectional healthcare survey. The survey obtained basic demographic information, the Patient Assessment of Chronic Illness Care (PACIC+), as well as responses to questions on the use of healthcare and integrative medicine. Results A total of 353 surveys were received. The most common complementary therapies used were physical therapy (82%), massage (68%), yoga (58%), chiropractic (48%), and meditation (43%). Mean (SD) summary PACIC and PACIC 5 As scores were 2.16 (0.77) and 2.25 (0.83), respectively. Across all PACIC domains, mean scores of individuals whose typical doctor visit was 30 min or at least an hour were significantly higher than those of individuals who indicated typical visits of 15 min (all p < 0.0001 by one-way ANOVA). There was widespread agreement on the importance of patient-provider relationship and trust, physicians’ understanding of the individual’s complete medical history, and prioritization of physical and emotional safety (>95% agree or strongly agree to each). Conclusion Individuals with HSD or EDS report low satisfaction with chronic illness care and commonly seek out complementary and self-administered therapies, likely in an attempt to manage symptoms. Respondents reported a desire for greater time and attention from physicians. Results from this study could educate the healthcare community to improve support mechanisms for HSD and EDS populations. IMPLICATIONS FOR REHABILITATION Patients with hypermobility spectrum disorders (HSD) or Ehlers–Danlos syndromes (EDS) express a desire for patient-centered care and peer support from other individuals with HSD or EDS. Individuals with HSD or EDS have typically seen multiple doctors for their condition and their satisfaction with chronic care, as measured by the Patient Assessment of Chronic Illness Care (PACIC+), is low. The use of various complementary and integrative health treatments, as well as specialized diets, is common in this population, and might be beneficial for symptom management. Healthcare delivery for HSD and EDS may require a multidisciplinary healthcare team, as complementary and self-care modalities are typically used in addition to physical therapy, pain medication, and other conventional care.

Recent trends in skin directed and self-administered systemic treatment costs in the United States for Cutaneous T-cell Lymphoma

To the Editor: Cutaneous T-cell lymphoma (CTCL) is a rare disease requiring chronic treatment. Skin-directed therapies (SDTs) and self-administered systemic therapies (STs) are used to treat CTCL. However, the exponential increase in the cost of medications has reduced access and increased cost burden.1,2 In 2016, cutaneous lymphoma was considered the costliest skin disease per person, averaging annually $3182/person and a total medical cost of $180 million.3 To better understand the costs and cost trends of CTCL medications, an exploratory analysis was conducted evaluating costs over a 15-year interval.

Objective medication adherence and persistence in people with multiple sclerosis: a systematic review, meta-analysis, and meta-regression.

BACKGROUND: Medication adherence is critical for the realization of pharmacotherapy benefits and reduced healthcare expenditure. Studies have shown up to 60% of people with Multiple sclerosis (MS) experience suboptimal medication adherence, which is associated with poorer health outcomes and subsequent discontinuation. The current systematic review reported on objectively measured adherence and discontinuation rates for self-administered oral and injectable disease-modifying therapies (DMTs). OBJECTIVES: To identify whether, in people with MS, the introduction of oral DMTs has improved medication adherence when compared with injectable DMTs. The secondary aim was to report synthesized objectively measured medication adherence and persistence rates for both oral and injectable DMTs in MS across varying study durations. METHODS: Literature searches were conducted through PubMed, Web of Science, Scopus, and PsycINFO. Inclusion criteria were limited to English, peer-reviewed, objective, self-administered DMT articles, published between July 1993 to December 2019. Publications reporting combined intravenous and self-administered DMT data, or that did not account for DMT switching in discontinuation rates, were excluded. Data were synthesized into observation lengths ranging from less than 8 months to greater than 36 months. Meta-analysis and meta-regression were undertaken on both oral and injectable 12-month adherence and discontinuation data. RESULTS: In total, 61 articles were included; 46 articles examined adherence and 26 examined discontinuation. Twelve-month adherence ranged between 53.0% to 89.2% for oral (N = 7) and 47.0% to 77.4% for injectable DMTs (N = 7). Results from the meta-analysis and meta-regression show significantly higher pooled mean medication possession ratio (MPR) adherence for oral DMTs (91.0%) when compared to injectable DMTs (77.0%) over 12 months (β = -0.146; 95% CI: -0.263 to -0.029). Results indicate major asymmetry across studies (LFK index: -5.18), proposing the presence of significant publication bias. Mean discontinuation over 12 months was between 10.5% to 33.3% for oral (N = 7) and 15.2% to 50.8% for injectable DMTs (N = 10), with meta-analysis results indicating the presence of significant heterogeneity (I2 Injectable: 99.5%; I2 Oral: 93.1%) between studies included in each subgroup. However, no appreciable difference in mean discontinuation rates across groups (Injectable: 27%; 95% Cl: 19.0%-34.0%; Oral: 24%; 95% CI: 17.0%-31.0%) was found. CONCLUSIONS: Medication adherence for oral DMTs suggests a significant improvement compared to adherence for injectable DMTs. No significant difference in discontinuation rates between oral and injectable DMTs was found. Oral DMT adherence and persistence studies are limited, given their relatively recent introduction. Suboptimal medication adherence and discontinuation issues remain present for both oral and injectable DMTs. Future studies would benefit from improved consistency in methodology, such as comparable adherence and persistence definitions. DISCLOSURES: The authors did not receive any funding for this study. Mardan and Hussain have nothing to disclose. Grech reports grants from Merck Pharmaceutical, outside the submitted work. Allan reports grants received from Merck Pharmaceutical outside the submitted work. Allan holds advisory board and consulting positions with Merck and advisory board positions for Bristol Myers Squibb and Novartis, for which Monash Institute of Neurological Diseases receives consulting fees.

Self-administered EMDR therapy: potential solution for expanding the availability of psychotherapy for PTSD or unregulated recipe for disaster?

Post-traumatic stress disorder (PTSD) carries a high disease burden worldwide, yet significant barriers exist to providing and accessing treatment for PTSD, particularly in refugee populations and in low- and middle-income countries. There is emerging evidence that self-administered psychological therapies, such as those accessed via online and mobile applications, are efficacious for many mental illnesses and increase access to treatment. Online and mobile applications offering self-help tools for eye movement desensitisation reprocessing (EMDR) therapy, an internationally recommended treatment for PTSD, are already widely distributed to the public. To present a commentary evaluating the potential benefits and risks of self-administered EMDR therapy: first, by conducting a search for existing peer-reviewed evidence relating to self-administered EMDR therapy; second, by presenting existing evidence for other self-help psychotherapies and evaluating what additional insight this could provide into the potential efficacy, safety, tolerability and accessibility of self-administered EMDR therapy; and, third, by describing the conflicting views of EMDR experts on the topic. A search was conducted for articles related to internet, mobile, book or computerised self-help EMDR therapy. The following databases were searched systematically: Medline, PsycInfo, EMBASE, AMED, CINAHL, Psychology and Behavioural Sciences, Cochrane Database and the EMDR Library. Only one small primary research study was found relating to self-administered EMDR therapy. The results indicated significantly reduced symptoms of PTSD, depression, anxiety, distress and disability between pre-treatment and 3 month follow-up. No serious adverse events were reported. However, substantial methodological issues were discovered. There is evidence that self-administered psychotherapies, in general, can be safe, effective and highly accessible. However, controversies persist regarding the safety and potential efficacy of self-administered EMDR therapy, and more robust research is needed. It is vital that methods are found to improve worldwide access to effective PTSD treatment, particularly given the current scale of migration to flee civil unrest.

Trends in List and Net Prices of Self-administered Systemic Psoriasis Therapies Manufactured by US-Based Pharmaceutical Companies

This economic evaluation reviews the trends in list and net price data from SSR Health for the 2007 to 2019 period of self-administered systemic psoriasis medications manufactured in the United States.

Provider perspective: The clinical value of a novel digital medicine program in gastrointestinal oncology.

76 Background: The differences in colorectal cancer (CRC) treatment between infusion and oral chemotherapy have challenged clinical teams to maintain clinical quality and patient communications with self-administered therapies. The complexity of many regimens, such as capecitabine, creates challenges with dosing and adverse event (AE) management. The first novel Digital Medicine Program (DMP), aimed at providing support to patients and providers, was integrated into CRC treatment at Fairview Health Services and University of Minnesota Health. The DMP consists of DigiMeds (medications co-encapsulated with ingestible sensors), a wearable patch, and a mobile app to facilitate passive collection of actual medication ingestion data and biometrics over time. Methods: Beginning in September 2018, patients with CRC were offered the DMP to augment standard of care. Clinical pharmacists monitored medication adherence and biometrics in near real-time through a secure web portal. This data was used to address barriers to adherence and adjust therapy when appropriate. Qualitative data regarding provider experiences with the DMP and their interactions with patients were collected via a 5-question survey. Results: Eleven patients used the DMP (age: 66.9 ± 9.9 years (mean ± SD); patch wear: 89.9 ± 11.6%; average adherence: 91.0 ± 5.6%) for 140 ± 137 days. Providers reported that the DMP enabled data-driven decision-making by helping identify non-adherence, prompted timely dose modification for AE management, and allowed personalized care and targeted counseling. Integration of the DMP data into the Electronic Medical Record system improved utility, but providers called the DMP a “time-saver”, creating a “proactive rather than reactive” care process in “ways no other technology can do”. Providers stated patients felt more ownership of their care, and that DMP revealed newly “quantifiable positive changes” in their cancer care. Conclusions: Use of the DMP in this small cohort enabled proactive decision-making and facilitated patient-focused and efficient care. Future pragmatic, large real-world studies are underway to assess the impact of DMP on adherence, AE management, and clinical and economic outcomes.

P669 Adherence to self-administered biologic therapies in inflammatory bowel disease: Experience in a tertiary hospital

Abstract Background Nonadherence to medications is common in patients with inflammatory bowel disease (IBD) and can result in disease complications, therapy escalation, and the need for corticosteroids. The aim of this study was to assess adherence to self-administered (subcutaneous) biologic medications prescribed for IBD and to identify risk factors for biologic nonadherence. Methods A retrospective cohort study was performed on IBD patients starting and receiving subcutaneous biologic therapies from January 2016 to July 2019. Medical records were retrospectively reviewed and demographic and IBD data were collected. A modified medication possession ratio (mMPR) was calculated for the first 12-month treatment and at the end of follow-up (global-42 months). Nonadherence was defined as mMPR of less than 90%. Multiple regression analysis was performed to assess risk factors associated with non-adherence therapy Results A total of 154 patients (84M/70F; mean age starting biologic treatment 36 ±14 years; Crohn’s disease n = 118/ ulcerative colitis n = 31/ indeterminate colitis n = 5) were included; 121 received Adalimumab (ADA) and 33 were on Ustekinumab (UST); 63% of patients were naive to anti-TNF and 16.9% had received &amp;gt;2 previous biological treatment. Mean time from IBD diagnosis to use of subcutaneous biological agent was 16 ± 10 months. Mean time of subcutaneous agents use was 17.6(SD11.0) and 17.08 (SD6.8)months for ADA and UST, respectively. Global nonadherence (n = 154) (≤90% mMPR) was 6.6% for all patients receiving subcutaneous treatment and 6.3% for ADA and 6.5% for UST. Nonadherence during first 12-month treatment (n = 98) was 6.1% for all patients and 2.7 % for ADA and 16% for UST, respectively. In the multivariate analysis, Ustekinumab use was independently associated with higher nonadherence only for first 12-months adherence (OR 6.7, 95% CI 1.1–39.5). Conclusion Self-administered biologic treatment showed adequate global adherence in our study. Using subcutaneous administration for biologic agents in IBD patients forces us to monitor and control their adherence to ensure the therapeutic benefit.

Adherence to biologic therapy – Does it vary with ethnicity?

BackgroundPoor adherence to therapy remains a significant barrier to improving clinical outcomes in rheumatic diseases and carries a major financial burden. It has been linked to medication related patient beliefs, which were reported to differ between ethnic groups. Little is known about these variations in biologic therapies cohorts. The purpose of this study was to identify potential determinants of adherence to biologic drugs including an assessment of the influence of beliefs about medicines and compare determinants of adherence between patients of Caucasian versus other ethnicities (OE). Relationship of adherence to disease outcome was further explored.MethodsA prospective survey was undertaken of patients with inflammatory arthritis prescribed self-administered subcutaneous biologic therapies at our centre. Data were collected using a) self reported adherence b) five item compliance questionnaire for Rheumatology (CQR5) and c) Beliefs about Medications questionnaire (BMQ) specific-five items each for necessity and concern scales. The replies were assessed against the disease activity score measured on the day of recruitment to the survey.Results80 patients contributed to the survey. 90% were prescribed TNF inhibitors. 40 patients were of Caucasian origin and 40 belonged to OE-predominantly of South Asian descent (85%). Disease activity score (DAS) was significantly higher in OE patients with 3.7 (standard deviation (SD) 1.3) compared to Caucasian patients with a DAS of 2.9 (1.6) (p = 0.031). Negative beliefs (i.e. higher concern scale scores) about therapy were significantly more prevalent (24/40) (60%) in the OE group compared to the Caucasian cohort (14/40 (35%) (p = 0.043). 17/40 (42.5%) of OE patients were poorly adherent to biologic therapy compared to 12/40 (30%) of Caucasian participants (p = 0.308). Most respondents (68/80, 85%) agreed that their biologic therapies were necessary for their health. Amongst 12/80 (15%) who disagreed, only two were in the non-adherent group.ConclusionTo our knowledge, this is the first study to demonstrate ethnic differences in disease activity score and related negative beliefs regarding subcutaneous biologic therapies in people with rheumatic diseases.