First reports of adverse drug reactions

Acknowledgement to referees

Vitamin D with calcium supplements: a new hope for the treatment of dengue infection

Correction to: Insulin glargine/lixisenatide in type 2 diabetes: a profile of its use The article Insulin glargine/lixisenatide in type 2 diabetes: a profile of its use, written by Emma Deeks, was originally published Online First without Open Access.

Adverse events and monitoring requirements associated with monoclonal antibody therapy in patients with multiple sclerosis Abstract Multiple sclerosis (MS) is treated with a variety of immunomodulatory and immunosuppressive drugs. Among the most potent therapeutic options are monoclonal antibodies (MAbs). So far, the MAbs natalizumab, alemtuzumab, and ocrelizumab have been approved for MS treatment. While their efficacy is indisputable, these drugs have safety issues not seen with previous MS drugs. MAbs are the ideal class of treatment for many patients with MS, but neurologists prescribing these MAbs need to be aware of their potential risks and monitor patients closely. Although rare, adverse events associated with MAbs may be fatal; opportunistic infections, tumors, and infusion-related events require planning and monitoring of patients before, during, and after MAb therapy. This review summarizes the type and management of adverse events associated with MAb treatment in patients with MS, and emphasizes the importance of evidence-based knowledge for all neurologists involved in MS therapy.

Manage vulvodynia using a multimodal and individualized approach Abstract Vulvodynia (i.e. vulvar pain lasting ≥ 3 months) is common, but is often not correctly diagnosed. Causative factors and pain profiles are varied and a multimodal approach to management, starting with non-pharmacological interventions, is recommended. Cognitive behaviour therapy and pelvic floor physical therapy are first-line treatments for most cases. Pharmacological options, including anti-nociceptive, anti-inflammatory and neuromodulating agents, warrant further investigation. Surgical vestibulectomy is an effective option in women with localized provoked vulvodynia.

Fremanezumab in the prevention of migraine: a profile of its use Abstract Fremanezumab (fremanezumab-vfrm; Ajovy®), a monoclonal antibody that targets calcitonin gene-related peptide (CGRP), is indicated for the prevention of migraine in adults in the EU and USA. Subcutaneous fremanezumab 225 mg once monthly or 675 mg once every 3 months was effective in reducing monthly migraine days or headache days in patients with episodic or chronic migraine in pivotal, 12-week clinical trials. Both regimens also reduce acute headache medication use and headache-related disability. Improvements were maintained through ≤ 52 weeks of additional treatment in a longer-term extension study. In a trial in treatment-resistant migraine, both fremanezumab regimens reduced monthly migraine days in patients who had failed 2–4 classes of preventive medications. Fremanezumab is generally well tolerated, with most adverse events (AEs) being injection site reactions of mild or moderate severity.

Fluticasone propionate/formoterol fumarate in children aged ≥ 5 years with asthma: a profile of its use Abstract The fluticasone propionate/formoterol fumarate (hereafter fluticasone/formoterol) 50/5 µg pressurized metered-dose inhaler (pMDI) [Flutiform®] is a fixed-dose combination of an inhaled corticosteroid (ICS) and a long-acting β2-adrenoceptor agonist (LABA) for the regular treatment of asthma where regular use of an ICS and a LABA combination product is appropriate. In the EU, the fluticasone/formoterol 50/5 µg pMDI is recommended for use in adults, adolescents and children aged ≥ 5 years, with the latter being a recent expansion of the indicated population and the focus of this review. Fluticasone/formoterol 50/5 µg, administered as two actuations (i.e. 100/10 µg) twice daily, provided benefit over fluticasone propionate 100 µg twice daily and was noninferior to fluticasone/salmeterol 100/50 µg twice daily, in improving lung function in patients aged 5 to < 12 or 4–12 years in randomized trials. Fluticasone/formoterol was generally similar to each of these comparator pMDI regimens in terms of asthma exacerbation rates and patient-reported measures and was generally well tolerated, with no evidence of clinically meaningful systemic adverse effects over up to 36 weeks of treatment. Longer-term data would be of interest.

Patchy evidence in skin-picking disorder supports management with combined behavioural and drug treatments Abstract Skin-picking disorder (SPD) is a common, repetitive, compulsive and distressing disorder with significant psychosocial effects. Data from relatively few clinical trials support behavioural therapies, especially habit-reversal therapy, as the first-line treatment. Depending on the individual’s SPD style and comorbidities, augmenting habit-reversal therapy with other behavioural therapies or pharmacological options, particularly glutamatergic modulators or specific serotonin-reuptake inhibitors, may enhance treatment outcomes.

Fluticasone propionate/salmeterol (Wixela ® Inhub ® ) dry-powder inhaler in asthma and COPD: a profile of its use in the USA Abstract Wixela® Inhub® is the first therapeutically equivalent, substitutable generic version of Advair Diskus® (fluticasone propionate/salmeterol) approved for the treatment of asthma and chronic obstructive pulmonary disease (COPD) in the USA. Wixela Inhub combines the inhaled corticosteroid fluticasone propionate and the long-acting β2-adrenoceptor agonist salmeterol in a single dry-powder inhaler. Each drug has a different mechanism of action, targeting different and complementary aspects of the pathophysiology of asthma and COPD. The in vitro performance of Wixela Inhub is comparable to that of Advair Diskus at all dosage strengths (100/50 μg, 250/50 μg, and 500/50 μg) and all flow rates. Wixela Inhub has pharmacokinetic and pulmonary therapeutic bioequivalence to Advair Diskus, which has well-established efficacy, tolerability, and safety profiles. The Wixela Inhub device is robust and easy to use without instruction. All three dosage strengths of Wixela Inhub will be offered at a wholesale acquisition cost of up to 70% less than Advair Diskus and the authorized generic equivalent.