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Chicago, IL, United States

McKeage K.,The Warehouse
Drugs | Year: 2014

Ustekinumab (Stelara®) is a human monoclonal antibody that binds to the shared p40 subunit of interleukin (IL)-12 and IL-23, blocking signalling of their cognate receptors. It is established in the treatment of moderate-to-severe plaque psoriasis, but recently received approval in adults with active psoriatic arthritis. Tumour necrosis factor (TNF) inhibitors remain first-line biological agents for the treatment of psoriatic arthritis, but alternative agents are needed. This article summarises the pharmacology of ustekinumab and reviews its use in phase 3 trials in psoriatic arthritis. In these trials, subcutaneous ustekinumab 45 or 90 mg was significantly more effective than placebo, as determined by American College of Rheumatology response criteria at week 24. The drug was also associated with significantly greater efficacy than placebo with regard to secondary endpoints, including the Psoriasis Area and Severity Index ≥75 % response, enthesitis and dactylitis scores, radiographic progression and Health Assessment Questionnaire-Disability Index scores. Response to ustekinumab was maintained during long-term therapy (up to week 100), and was achieved with and without concomitant methotrexate. Ustekinumab was generally well tolerated, and the tolerability profile in psoriatic arthritis was similar to that reported in plaque psoriasis. Throughout long-term ustekinumab treatment, serious infection or major cardiovascular adverse events occurred rarely. More data are needed to clearly define the place of ustekinumab in psoriatic arthritis treatment algorithms. Meanwhile the drug is a valuable additional option for patients with psoriatic arthritis in whom the response to previous non-biological disease-modifying antirheumatic drugs has been inadequate, or for those who have failed anti-TNF therapy. © 2014 Springer International Publishing Switzerland. Source


Elkinson S.,The Warehouse
Drugs | Year: 2014

Vorapaxar [Zontivity® (US)], an orally active protease-activated receptor-1 (PAR-1) receptor antagonist, has been developed by Merck & Co for the reduction of thrombotic cardiovascular events in patients with a history of myocardial infarction (MI) or peripheral arterial disease (PAD). Vorapaxar has received its first global approval for this indication in the US. This article summarizes the milestones in the development of vorapaxar leading to this first approval for the reduction of thrombotic cardiovascular events in patients with a prior MI or PAD. © 2014 Springer International Publishing Switzerland. Source


Quadrivalent human papillomavirus (HPV) [types 6, 11, 16, 18] recombinant vaccine (Gardasil®; Silgard®) is composed of virus-like particles formed by self-assembly of recombinant L1 capsid protein from each of HPV types 6, 11, 16 and 18. It is indicated for use from the age of 9 years as a two- or three-dose vaccination course over 6 months for the prevention of premalignant anogenital lesions, cervical and anal cancers, and genital warts caused by the vaccine HPV types. In placebo-controlled trials, quadrivalent HPV vaccine provided high-level protection against infection or disease caused by the vaccine HPV types over 2-4 years in females aged 15-45 years who were negative for the vaccine HPV types, and provided a degree of cross-protection against certain non-vaccine HPV types. The vaccine also provided high-level protection against persistent infection, anogenital precancerous lesions and genital warts caused by the vaccine HPV types over 3 years in susceptible males aged 16-26 years. Protection has been demonstrated for up to 8 years. In subjects who were negative for the vaccine HPV types, high seroconversion rates and high levels of anti-HPV antibodies were observed in females of all age ranges from 9 to 45 years and in males aged 9-26 years. The vaccine was generally well tolerated and was usually predicted to be cost effective in girls and young women. Therefore, quadrivalent HPV vaccine offers an effective means to substantially reduce the burden of HPV-related anogenital disease in females and males, particularly cervical cancer and genital warts. © 2014 Springer International Publishing. Source


Eslicarbazepine acetate (Aptiom®, Zebinix®) is approved for the adjunctive treatment of partial-onset seizures in adults aged ≥18 years. Adjunctive therapy with oral eslicarbazepine acetate 800 or 1,200 mg once daily was associated with a significantly lower standardized seizure frequency (primary endpoint) than placebo in patients aged ≥18 years with refractory partial-onset seizures in three, randomized, double-blind, multinational, phase III trials. In a fourth randomized, double-blind, multinational, phase III trial in patients aged ≥16 years with refractory partial-onset seizures, adjunctive eslicarbazepine acetate 1,200 mg once daily, but not 800 mg once daily, was associated with a significantly lower standardized seizure frequency (primary endpoint). Responder rates were significantly higher with eslicarbazepine acetate 1,200 mg once daily than with placebo in these four trials, and with eslicarbazepine acetate 800 mg once daily than with placebo in two trials. The efficacy of eslicarbazepine acetate was maintained in the longer term, according to the results of 1-year extension studies. Adjunctive therapy with oral eslicarbazepine acetate was generally well tolerated in patients with refractory partial-onset seizures, with most adverse events being of mild to moderate severity. In conclusion, eslicarbazepine acetate is a useful option for the adjunctive treatment of patients with refractory partial-onset seizures. © 2014 Springer International Publishing. Source


Lo J.H.,The Warehouse
Drugs | Year: 2014

Delamanid, a nitro-dihydro-imidazooxazole derivative, has been developed by Otsuka Pharmaceutical for the treatment of multidrug-resistant tuberculosis (MDR-TB). Delamanid received its first global approval for the treatment of MDR-TB in the European Union (EU), for use in combination with optimised background therapy. It is also under review for marketing in Japan for MDR-TB, the first drug application filed in Japan for this indication. Delamanid has been granted orphan drug status in both the EU and Japan. This article summarizes the milestones in the development of delamanid leading to this first approval for MDR-TB. © 2014 Springer International Publishing Switzerland. Source

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