Long-Term Effectiveness of Adalimumab in Patients with Rheumatoid Arthritis: An Observational Analysis from the Corrona Rheumatoid Arthritis Registry

INTRODUCTION: Current recommendations for the management of rheumatoid arthritis (RA) focus on a treat-to-target approach with the objective of maximizing long-term health-related quality-of-life in patients with RA. Published studies from randomized clinical trials have reported limited data regarding the long-term efficacy and safety of adalimumab in patients with RA. This study aims to evaluate the long-term (10+ years) persistency and effectiveness of adalimumab in patients with RA in a real-world setting. METHODS: Included in this study were biologic-naive adults with RA initiating adalimumab during follow-up enrolled in the Corrona RA registry. More than 10 years of data on persistency of adalimumab and rheumatologist-supplied reasons for discontinuation were examined. Among patients who persisted on adalimumab over the years, clinical [e.g., clinical disease activity index scores (CDAI), physician global assessment, tender joint count, and swollen joint count] and patient-reported outcomes (PRO), such as physical function, pain, fatigue, and morning stiffness, were examined. RESULTS: Of 1791 biologic-naive patients treated with adalimumab who had \u3e /=1 follow-up registry visit, 64.1% were still on therapy at 1 year and 10.2% were still on therapy by the end of year 12. Among patients who persisted on adalimumab for at least 1 year (77.1% female, mean age 53.9 years), 67.0% were in low disease activity (LDA)/remission (CDAI \u3c /=10) and had clinically meaningful improvements from baseline in all clinical assessments and PROs. Initial improvements in LDA/remission and in clinical and PRO assessments observed at year 1 were sustained in those patients who remained on adalimumab over 10 years of follow-up. Among patients who discontinued adalimumab, 61.6% were not in LDA/remission and 41.9% switched to another biologic within 12 months after discontinuing adalimumab. CONCLUSIONS: Real-world data demonstrate a sustained effectiveness of adalimumab in the treatment of RA for patients who remained on therapy for 10 years. FUNDING: Corrona, LLC and AbbVie

Impact of participation in the Adalimumab (Humira) patient support program on rheumatoid arthritis treatment course : results from the PASSION study

Introduction: Patients with rheumatoid arthritis (RA) who are treated with adalimumab (ADA) are offered a proprietary patient support program (PSP, AbbVie Care (R)). The main objective of this study was to examine the effectiveness of ADA on RA treatment course over time in the context of PSP utilization. Methods: PASSION was a 78-week post-marketing observational study of RA patients with an insufficient response to >= 1 DMARD newly initiating ADA in routine clinical care that was conducted in Europe, Israel, Mexico, Puerto Rico, and Australia. One prior biologic DMARD was allowed. The primary endpoint was percentage of patients achieving the minimal clinically important difference (MCID; improvement of >= 0.22 compared to baseline) in Health Assessment Questionnaire (HAQ) Disability Index (HAQ-DI) at week 78. Additionally, multiple clinical and patient-reported outcomes (PROs) were evaluated over time. Patients were categorized based on their participation in the PSP: ever (PSP users) vs. never (PSP non-users). Safety events were monitored throughout the study. Results: Overall, 42.8% of PSP users achieved the MCID in HAQ-DI at week 78 (improvement of at least 0.22 compared to baseline). From 1025 enrolled, 48.7% of patients were PSP users while treated with ADA. The percentage of patients achieving MCID in the HAQ-DI was higher in PSP users vs. PSP non-users (48.1 vs. 37.8%) at week 78 (p < 0.001, NRI). Most of the studied clinical outcomes and PROs showed significant improvements (p < 0.05) from baseline to week 78 favoring PSP users over PSP non-users. Conclusions: In patients with moderate-to-severe RA who initiated ADA, improvements in clinical, functional, and PROs were achieved in real-world settings with significantly greater improvements among PSP users in comparison with PSP non-users

Uncovering the burden of hidradenitis suppurativa misdiagnosis and underdiagnosis: a machine learning approach

Hidradenitis suppurativa (HS) is a chronic inflammatory follicular skin condition that is associated with significant psychosocial and economic burden and a diminished quality of life and work productivity. Accurate diagnosis of HS is challenging due to its unknown etiology, which can lead to underdiagnosis or misdiagnosis that results in increased patient and healthcare system burden. We applied machine learning (ML) to a medical and pharmacy claims database using data from 2000 through 2018 to develop a novel model to better understand HS underdiagnosis on a healthcare system level. The primary results demonstrated that high-performing models for predicting HS diagnosis can be constructed using claims data, with an area under the curve (AUC) of 81%–82% observed among the top-performing models. The results of the models developed in this study could be input into the development of an impact of inaction model that determines the cost implications of HS diagnosis and treatment delay to the healthcare system

Noninsulin pharmacological management of type 1 diabetes mellitus

The injectable nature and other shortcomings of insulin have stimulated interest in studying the noninsulin pharmacological therapies to manage type 1 diabetes mellitus (T1DM). The purpose of this study is to conduct a systematic literature review of noninsulin pharmacological therapies for the management of T1DM. For this, the following PubMed search was conducted: Diabetes Mellitus, Type 1/therapy”[Mesh] Limits: Review Sort by: Publication Date. After applying various inclusion and exclusion criteria, a total of 63 studies were reviewed. Based on this review, noninsulin pharmacological therapies can be divided into following classes: (1) Insulin-sensitizing agents (biguanides and thiazolidinediones), (2) gastrointestinal nutrient absorption modulators (α-Glucosidase inhibitors and amylin), (3) immunotherapeutic agents, (4) incretin-based therapies, (5) recombinant human insulin-like growth factors, and (6) other promising therapeutics. Some of these are already used either as monotherapy or adjuvant to insulin, whereas, to manage T1DM, the benefits and risks of the others are still under evaluation. Nonetheless, insulin still remains the cornerstone to manage the T1DM

Real-world switching patterns and associated characteristics in patients with psoriasis treated with biologics in the United States

Background Switching therapies is common for patients with psoriasis. Objective To quantify real-world switching rates and characteristics among patients initiating biologics over 24 months. Methods Patients aged ≥18 years with ≥2 confirmed psoriasis diagnoses who initiated a new biologic were identified from a US-payer claims database (Merative® MarketScan®) Switching rates were reported over 24 months using Kaplan–Meier survival analysis, and multivariable Cox regression analyses were performed to identify associated patient characteristics. Results A total of 7997 patients were included, with overall treatment switch rates at 14.4% at 12 months and 26.0% at 24 months. IL-23 inhibitors were associated with the lowest risk of switching compared with TNF, IL-17, and IL-12/23 inhibitors over 24 months (p < 0.0001). Switch rates varied between specific biologics, with the lowest switch rates observed for patients treated with risankizumab at 8.5% followed by guselkumab at 15.7% over 24 months. Prior targeted immune modulator use, age, and female gender were predictors of switching (adjusted hazard ratio; 1.23, 1.31, and 1.40, respectively; p ≤ 0.0005). Limitations Claims data may be subject to data errors and reasons for switching cannot be determined. Conclusion Switching was common in psoriasis patients using biologics over 24 months, with the lowest risk of switching observed with IL-23 inhibitors

Impact of psoriasis disease severity and special area involvement on patient-reported outcomes in the real world: an analysis from the CorEvitas psoriasis registry

AbstractBackground The impact of psoriasis in special areas (i.e., scalp, nails, palms, soles, genitals) on patient physical functioning, health-related quality of life (HRQoL), and work abilities has not been fully characterized. We assessed associations between disease severity and special area involvement in psoriasis symptoms, HRQoL, and work/activity impairment.Methods Patients with psoriasis from the CorEvitas Psoriasis Registry who initiated systemic treatment between 04/2015–06/2020 were included. Outcomes were change from baseline in psoriasis symptoms, Dermatology Life Quality Index (DLQI), and work/activity impairment at 6 months stratified by baseline disease severity and special area involvement.Results Among 2620 patients, increasing disease severity was associated with worsening patient-reported outcomes. Patients with (46.0%; N = 1205) versus without (54.0%; N = 1415) psoriasis in special areas reported greater HRQoL and work/activity impairment. Over 6 months, patients with unchanged or worsening disease severity had reduced HRQoL and increased symptom severity; incremental increases in patient HRQoL and decreases in symptom severity were associated with improved disease severity.Conclusions Higher disease severity and special area involvement was associated with worse outcomes and impaired work abilities. These data highlight the significant impact that adequate treatment of severe psoriasis and/or special area involvement may have on patient HRQoL and function

Real-world dose escalation of biologics for moderate-to-severe psoriasis in the United States

Aim To compare real-world dose escalation of risankizumab with other US Food and Drug Administration (FDA)-approved biologic treatments for management of moderate-to-severe psoriasis (PsO) in the United States. Methods The Merative® MarketScan® Research Database was used to identify adults with ≥2 medical claims for PsO, ≥3 claims of the index biologic medication in the maintenance period, and ≥6 months continuous enrollment pre-induction and ≥6 months after initiation of the maintenance period. Dose escalation was defined as ≥2 dosing intervals where the average daily dose was ≥30% higher than the expected daily dose (per FDA-approved dosing). Comparisons between risankizumab and other cohorts were made using chi-square tests and logistic regression models. Results At the 30% threshold, the percentage of patients with dose escalation in the full maintenance period was significantly lower with risankizumab (2.0%) compared with other drug classes (tumor necrosis factor, interleukin (IL)-12/23, IL-17, or other IL-23 inhibitors: 17.6%, 10.0%, 18.3%, or 7.1%, respectively; p < 0.0001 for each) and individual biologics (adalimumab, ustekinumab, secukinumab, ixekizumab, and guselkumab; 17.9%, 10.0%, 15.7%, 18.0%, and 7.2%, respectively; p < 0.0001). Conclusion A significantly lower proportion of risankizumab-treated patients with PsO had dose escalations compared with patients treated with other biologics

Is Patient Support Program Participation Associated with Longer Persistence and Improved Adherence Among New Users of Adalimumab? A Retrospective Cohort Study

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