Migraine is considered one of the most disabling diseases. Currently, there are few studies on clinical migraine treatment based on sex-related differences, despite the important role of sex in migraine. Our aim was to evaluate gender bias in published clinical trials on monoclonal antibodies (erenumab, galcanezumab, fremanezumab and eptinezumab). We performed a systematic review of controlled clinical trials of erenumab, galcanezumab, fremanezumab and eptinezumab, searching the PubMed/MEDLINE database for articles published before December 2021. The search identified 760 articles, 25 of which met the inclusion criteria. Of all the patients included in these trials, 85.1% were women. Only one study had female lead authors. Two of the 25 studies included a sex-based analysis of the primary endpoint. None of the articles discussed the results separately for men and for women. The proportion of men recruited in trials is scarce and more studies are needed to guarantee the safety and tolerability of monoclonal antibodies used in male migraine. As observed in our study, despite the high number of women recruited, only 2 studies analysed the results separately by sex. Thus, a potential risk of gender bias was found in these clinical trials.

Aims: The study is aimed at assessing gender bias in Phase III clinical trials (CTs) of sodium–glucose cotransporter type 2 (iSGLT2) inhibitors in adults with Type 2 diabetes mellitus (T2DM). Methods: We searched PubMed and EMBASE databases until June 2023. To estimate sex bias in recruitment, the difference between F‐Particip (fraction of women recruited) and F‐Prev (prevalence fraction of women with T2DM) was calculated. A significant sex bias in recruitment was considered to exist when the difference between F‐Particip and F‐Prev was greater than 0.05, 0.1, and 0.2. The analysis was considered to have a sex bias when the efficacy variables were not analyzed by sex. Gender of the first, last, and corresponding author was also assessed. Results: In total, 70 articles met all inclusion criteria. Sex bias in recruitment showed variable results depending on the reference value. No significant sex bias in recruitment was found in the total number of included patients. Examining each CT individually, using values of significant sex bias in recruitment of ±0.05, ±0.1, or ±0.2, we found that 41.4%, 20%, and 5.7% of the trials, respectively, showed this bias. In 34.3% of the articles, women were the first, last, or corresponding authors. Sex‐based analysis of the results was performed in five studies. Conclusions: Although the proportion of women included in iSGLT2 CTs seems acceptable, gender bias persists in the analysis of variables and in the study authors. However, the lack of gender focus may be explained by the characteristics of the patients included in the CTs.

The off-label use of drugs requires scientific support to balance risk/benefit, being limited to exceptional cases in which there are no therapeutic alternatives. Retrospective descriptive study of the reports of the Pharmacy and Therapeutics Committee between 2018 and 2022 in a third level hospital; analyzing the requests, drugs, final opinion, reasons, level of evidence and economic impact. A total of 124 reports were analyzed, highlighting oncohematological (41.9%) and autoimmune (27.4%) diseases as main indications. Oncology (37.1%) and Pediatrics (18.5%) were the main applicants, with 87.9% for antineoplastic and immunomodulatory drugs. A total of 74.2% of the applications were approved due to lack of alternatives and solid evidence (phase II-III trials), while 25.8% were denied due to the availability of therapeutic options or insufficient evidence. In terms of cost, 53% of oncohematological drugs cost between €10,000-50,000/treatment and 62.1% of non-oncohematological drugs cost between €1,000-10,000/year. Approval of the rejected treatments would have generated an additional expenditure of €2,272,603. An increase of up to four times in the evaluation of off-label use drugs was evidenced, with a high approval rate.

Background and Importance Current treatment for Monkeypox’s disease (MPXV) is mainly symptomatic. However, in immunocompromised patients, hospitalisation and treatment with antiviral drugs may be necessary. With the recent outbreak of MPXV, new strategies have been proposed. Aim and Objectives The aim of the study was to describe our clinical experience with tecovirimat and cidofovir in the treatment of MPXV in a patient whose CD4+ lymphocyte level is less than 50 cells/ml. Material and Methods The effectiveness of tecovirimat-cidofovir was assessed by the evolution of the rash from macule to crusts that dry up and fall off. Results The patient was a 35-year-old man diagnosed with MPXV who presented skin lesions in the perineal area, extremities, face, trunk and back and severe proctitis. At admission, the patient was diagnosed with HIV (severely immunosuppressed with CD4+ lymphocyte levels of <40 cells/ml), so he was started on antiretroviral treatment (BIC/TAF/TDF). Sexually transmitted infection screening detected Chlamydia trachomatis infection, which was treated with doxycycline. In the context of MPXV proctitis, it was decided to apply for tecovirimat, the antiviral treatment of choice. The dosage for tecovirimat is weight-based, 600 mg was administered every 12 hours for 14 days (30/08/22–12/09/22). Regarding effectiveness, no new lesions were observed and those already present were regressing, except in the perianal area, where the lesions continued to progress. Therefore, it was decided to administer intravenous cidofovir 5 mg/kg twice weekly (09/09/22, 16/09/22). To avoid toxicity, oral probenecid was administered concomitantly: 2 g 3 hours before and 1 g 2 and 8 hours after completing the perfusion, in addition to 0.9% saline solution 1000 ml 1 h before. After the treatment, there was a progression of lesions in the right inguinal region, palpating left inguinal adenopathy and intense involvement of the testicle, groin and perineal area. Conclusion and Relevance In contrast to previous cases of patients whose CD4+ lymphocyte levels were above 500 cells/ml, the treatment with tecovirimat and cidofovir in this patient did not achieve a satisfactory response due to the continuous appearance of new lesions. The severe immunosuppression could probably explain the aggressive development of the disease. Conflict of Interest No conflict of interest