Current medical research and opinion
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Multicenter Study Observational Study
Early dose optimization of golimumab induces late response and long-term clinical benefit in moderately to severely active ulcerative colitis.
Aim: To evaluate outcomes of early dose optimization of golimumab in ulcerative colitis (UC) patients with inadequate response to golimumab induction treatment. Methods: This observational, multicenter, cohort study included patients with moderate-to-severe active UC and with inadequate response to subcutaneous golimumab induction doses, in whom weight-based golimumab maintenance dose (European labeling) of 50 mg every 4 weeks (q4wk) was optimized before week 14 to 100 mg q4wk. At week 14, we assessed clinical response and remission using the partial Mayo score. ⋯ In none of the patients was golimumab dose de-escalated. There were no adverse events leading to golimumab withdrawal. Conclusion: Early optimization of golimumab dose induces clinical response at week 14 in two thirds of UC patients and leads to long-term clinical benefit in over half of patients.
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Objectives: The non-interventional study (NIS) NADIR (DRKS00005711) evaluated the effectiveness and safety of prophylaxis with lipegfilgrastim, a glycopegylated granulocyte-colony stimulating factor, in 2500 patients undergoing chemotherapy in routine clinical practice. Primary objective was the incidence of chemotherapy-induced severe neutropenia, febrile neutropenia (FN), and neutropenia-associated complications. Methods: NADIR was a prospective NIS conducted in 201 study centers in Germany. ⋯ Overall, most frequent lipegfilgrastim-related adverse events (AEs) included bone pain (8.0%), anemia (3.2%), leucocytosis (2.7%), and thrombocytopenia (2.5%). Of the patients, 18.0% had ≥1 documented serious AE; none of the fatal events (2.7%) was lipegfilgrastim-related. Conclusions: Lipegfilgrastim administered to patients with solid tumor/NHL undergoing chemotherapy in routine clinical practice showed similar effectiveness and safety compared to the pivotal trials.
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Normalizing serum thyroid stimulating hormone (TSH) levels by lifelong treatment with levothyroxine (LT4) remains the primary goal of therapy for patients with hypothyroidism. The reference ranges for TSH are derived from populations with (supposedly) normal thyroid function. But, TSH results are affected by a number of factors including alterations in TSH levels with age, concurrent illnesses, circadian rhythm, inter- and intra-assay differences, and some commonly used medications that interfere with thyroid function or the TSH test. ⋯ However, the new LT4 formulations are associated with manifold increases in the number of self-reported adverse events. Therefore, patients with hypothyroidism as well as the clinicians managing them need to better understand the utility as well as the limitations of the widely used TSH measurement. In addition, both pharmaceutical companies and the prescribing clinician need to take greater care when patients are switched from older to newer formulations.
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Objectives: Atopic dermatitis (AD) is a chronic, relapsing skin condition, with signs and symptoms that impact patients' lives and are best measured from the patient perspective. Therefore, there is a need for AD-specific questionnaires that are consistent with Food and Drug Administration guidance and best measurement practices, assessing sign and symptom severity and associated impacts, to support treatment efficacy in regulated trials. The objectives were to develop patient-reported outcome (PRO) questionnaires assessing sign and symptom severity, as well as impacts of moderate-to-severe adult AD. ⋯ During the patient interviews (n = 15), 19 sign and symptom and 41 impact concepts were reported, the majority of which were evaluated by the ADerm-SS and ADerm-IS, thus substantiating the content of both questionnaires. Additionally, patients interpreted both questionnaires as intended by the developers. Conclusions: The ADerm-SS and ADerm-IS can be regarded as content-valid PRO questionnaires for moderate-to-severe AD.
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Objective: Asthma is a common heterogeneous disease characterized by airway inflammation and bronchoconstriction. Current treatment guidelines provide recommendations for categorizing disease severity, asthma control and management. This paper reviews asthma assessment in primary care and describes the pathophysiology, clinical characteristics and new targeted treatments available for patients with severe eosinophilic asthma. ⋯ Conclusions: A new class of agents is available for patients with moderate to severe eosinophilic asthma. Four biologic therapies - mepolizumab, reslizumab, benralizumab and dupilumab - that interfere with the regulation and activity of eosinophils have been approved by the FDA for patients with moderate to severe asthma with an eosinophilic phenotype. Primary care physicians should be familiar with these medications to explain part of the rationale for referral to specialist care and manage patient expectations for treatment.