Advances in Therapy最新文献

Introduction

Relugolix is the only oral androgen deprivation therapy (ADT) approved for advanced prostate cancer (PC). Real-world evidence on treatment patterns and prostate-specific antigen (PSA) responses of relugolix, especially as a function of race, remain limited. This study assessed these outcomes and compared differences between Black and White patients.

Methods

Veterans Health Administration data were analyzed to identify male adults with PC who initiated relugolix between December 2020 and December 2023. Adherence to relugolix was assessed for up to 1 year after treatment initiation and was compared between races using generalized linear models. Discontinuation of relugolix, switching to another ADT, and initiating an add-on PC treatment were assessed using Kaplan–Meier analyses and compared between races using Cox regressions. PSA responses during relugolix treatment, including ≥ 50% and ≥ 90% decline from baseline and achieving < 0.2 ng/mL, were assessed among ADT-naïve patients.

Results

A total of 507 patients were identified (141 Black and 313 White patients). During the first 12 months of treatment, both races had > 90% adherence to relugolix with no significant differences between them. During follow-up (median 10.7 and 12.6 months for Black and White patients, respectively), 27.0% Black and 21.1% White patients discontinued relugolix; 9.2% Black and 3.8% White patients switched to another ADT; and 11.3% Black and 10.5% White patients initiated an add-on PC treatment. Among ADT-naïve patients, 87.2% Black and 87.2% White patients achieved PSA decline ≥ 50% from baseline; 69.2% and 64.1% achieved ≥ 90% decline; 51.3% and 47.4% achieved PSA < 0.2 ng/mL.

Conclusion

Adherence to relugolix was very high during the first year of treatment. These data support that in the real world, patients can adhere to relugolix with PSA responses on par with clinical trials regardless of race. Black patients were more likely to discontinue or switch to another ADT than White patients, but the reasons for this require further study.

Trial registration

ClinicalTrials.gov identifier, NCT06462014.

For people living with eosinophilic granulomatosis with polyangiitis (EGPA), the journey to diagnosis can be long and complicated. EGPA is a rare inflammatory disorder, typically characterized by high levels of blood eosinophils and vasculitis in the lungs and/or other end organ(s). It is associated with asthma, pulmonary infiltrates, neuropathy, sinus disease and the presence of anti-neutrophil cytoplasmic antibodies. Patients can present with a number of symptoms and complications, which often go unrecognized or misdiagnosed and can result in considerable delays in appropriate treatment and worsening of underlying disease. Following correct diagnosis, patients are often treated with oral corticosteroids and other immunosuppressive drugs. While these treatments can be effective at controlling disease, they are also associated with significant side effects, which can lead to diminished quality of life. The emergence in recent years of anti-interleukin-5/receptor (anti-IL-5/R) therapies, such as benralizumab and mepolizumab, has revolutionized the management of EGPA. Interleukin-5 (IL-5) is a key cytokine in the maturation, proliferation and activation of eosinophils. Anti-IL-5/R therapies work by binding IL-5 or the receptor for IL-5, thereby significantly decreasing eosinophilic inflammation, the key pathogenic driver in EPGA. Not only are anti-IL-5/R therapies effective at controlling disease, but they are also well tolerated and can facilitate corticosteroid tapering. In this podcast, a patient and physician discuss the lived experience of EGPA, including difficulties with diagnosis, impact of disease on daily life and disease management with both traditional treatments and with the newer anti-IL-5/R therapies. The discussion highlights the importance of EGPA awareness and of physicians recognizing seemingly unconnected symptoms and different disease components, as well as the need to minimize corticosteroid use because of long-term risks. Furthermore, access to an experienced and coordinated healthcare team and establishing a strong support network are emphasized as essential to help patients manage this complex and rare disease.

Introduction

This study investigated the real-world clinical effectiveness and tolerability of adding a sodium-glucose cotransporter 2 inhibitor (SGLT2i) to gliclazide modified release (MR)-based therapy in a sample of patients with type 2 diabetes (T2D) across five countries, and its value as an effective and well-tolerated strategy in T2D management in a diverse patient population, including those at high risk.

Methods

This non-interventional, retrospective chart review study included patients with T2D treated with gliclazide MR-based therapy and an SGLT2i for at least 60 days. The primary outcome was change in glycated hemoglobin (HbA1c) levels. Secondary outcomes included treatment patterns, proportion of patients achieving an HbA1c target < 7%, changes in lipid profile, blood pressure, weight, new-onset comorbidities, and adverse events of special interest (AESI).

Results

A total of 537 patients (47.7% female, mean age of 59.2 years, mean disease duration 10.0 years) were included, of whom 75.4% were obese/overweight and 15.1% had atherosclerotic cardiovascular disease (ASCVD). At baseline, HbA1c was uncontrolled (≥ 7%) in 87.2% of patients (mean HbA1c of 8.7% [SD 1.7]). Mean HbA1c reductions were − 1.1% (SD 1.8) at 6 months, − 0.7% (SD 1.9) at 2.4 years, and − 0.6% (SD 1.7) at 3 years. The proportion of patients with HbA1c < 7% increased from 12.8% at baseline to 29.3% at least once during follow-up. Mean body weight decreased by 1.7 kg (95% CI − 2.2, − 1.3). AESIs were reported in 40 patients (7.4%) with urinary tract infections being the most common (6.8%).

Conclusion

The first real-world study of the long-term combination of gliclazide MR and SGLT2i demonstrated its value as an effective and well-tolerated strategy in T2D management, particularly in high-risk populations. This combination provided clinically meaningful and sustained HbA1c reductions and improved cardiometabolic parameters in a diverse T2D population, with very few adverse events. These results align with current guidelines emphasizing the importance of early combination treatment and multifactorial risk management in T2D and highlight the need to address late treatment intensification indicative of clinical inertia.

Trial Registration

ClinicalTrials.gov Identifier NCT06708091.

The multiple sclerosis (MS) treatment landscape has expanded over time, becoming increasingly complex with the availability of more advanced high-efficacy therapies (HETs). In this evolving context, shared decision-making (SDM) between healthcare providers (HCPs) and patients is crucial for optimizing treatment and ensuring personalized care. Cladribine tablets (CladT), a highly effective therapy with a well-established safety profile, are approved in the USA for treating adults with relapsing MS, including those aged ≥ 50 years. Globally, more than 89,000 patients have received CladT. HCPs have considered transitioning patients from HETs, such as anti-CD20 monoclonal antibodies, to CladT. Further research is needed to understand factors influencing the decision to switch from an anti-CD20 therapy to CladT. This podcast explores real-world insights and challenges from USA-based advanced practice providers who have switched patients with MS from anti-CD20 therapies to CladT. The discussion builds on the results from a real-world retrospective survey of 100 HCPs aimed at understanding their rationale for transitioning patients from anti-CD20 therapies (e.g., ocrelizumab, ofatumumab, rituximab, ublituximab) to CladT. The survey also assessed differences in rationale for discontinuing anti-CD20 therapies and switching from anti-CD20 therapies to CladT between patients aged < 50 and ≥ 50 years. Findings revealed that the most common reasons for transitioning from anti-CD20 therapy to CladT included perception of increased efficacy on relapses (55%) and disability progression (54%), while common reasons for discontinuing anti-CD20 therapy included relapses (41%) and continued clinical activity (26%). In patients aged > 50 years, desire to avoid long-term immunosuppression (45%) was a key factor in choosing CladT after anti-CD20 therapy. Notably, AEs suggestive of immunosuppression or opportunistic infections were not reported in patients who transitioned to CladT, and no new safety signals, infections, or immunoglobulin reductions were observed. This podcast also highlights the economic benefits of CladT, the role of SDM, and recommendations based on clinical experiences.