Objective. To investigate the dose tolerance and potential clinical activity of a humanized antilymphocyte monoclonal antibody, CAMPATH‐1H (C1H), in patients with active, refractory rheumatoid arthritis (RA). Methods. Thirty adult patients with active, refractory RA were treated in an open‐label, 3‐center, dose‐escalation study of subcutaneously injected C1H. Six patients were assigned to each of 5 dosage groups (0.3, 1.0, 3.0, 10.0 or 30.0 mg/day), and received 10 daily injections of C1H over a 12‐day period. Results. Side effects occurred primarily during the first 1–2 days of dosing, and included mild fever, chills, nausea, vomiting, headache, and, in a minority of patients, hypotension. All patients developed some discomfort at the injection site. Self‐limited infections occurred in 5 patients during the 6‐month study period. Peripheral blood lymphocyte counts fell promptly after initial dosing and recovered slowly, usually over 2–3 months. Serum antibodies to C1H developed in 54% of patients following treatment. Clinical improvement was observed in 56% of patients, based on the composite Paulus criteria, with a median time‐to‐response of 22 days and a median response duration of 32 days. Conclusion. C1H is a lymphocyte‐depleting antibody that exhibits biologic potency when administered subcutaneously to patients with refractory RA. Its use is associated with mild to moderate toxicity and short‐term amelioration of disease activity.

Background Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL) epidemiological studies focus on incidence and risk estimates. Objectives The aim of this manuscript is to perform a thorough review of scientific literature, and provide an accurate estimate of BIA-ALCL prevalence in Europe. Methods For the review, we searched PubMed, Web of Science, SCOPUS, and Google Scholar databases to identify publications regarding BIA-ALCL epidemiology. Research was conducted between November 2019 and August 2020. European prevalence was assessed as the ratio between pathology-confirmed cases and breast implant-bearing individuals. The Committee on Device Safety and Development (CDSD) collected data from National Plastic Surgery Societies, Health Authorities, and Disease-Specific Registries to calculate the numerator. The denominator was estimated combining European demographic data with scientific reports. Results Our research identified 507 manuscripts: 106 were excluded for not being relevant to BIA-ALCL. From the remaining 401 manuscripts, we selected 35 that discussed epidemiology and 12 reviews. CDSD reported 420 cases in Europe, with an overall prevalence of 1:13,745 cases in the European Union counting 28 members (EU-28). Countries, where specific measures have been implemented to tackle BIA-ALCL, account for 61% of EU-28 population and actively reported 382 cases with an overall prevalence of 1:9,121. Conclusion Countries where specific measures have been implemented show a higher prevalence of BIA-ALCL compared to mean European value, suggesting that they improve the detection of the condition and reduce underreporting that affects the numerator value. Other nations should adopt projections based on those measures to avoid underestimating how widespread BIA-ALCL is.

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Among children 3 months through 11 years of age, the 20 mg/kg dose of this formulation of valacyclovir oral suspension produces favorable acyclovir blood concentrations and is well tolerated. A dosing recommendation cannot be made for infants <3 months of age because of decreased clearance in this age group. Trial registration. ClinicalTrials.gov identifier: NCT00297206 .