Suchergebnisse

Biosimilars are new drugs, highly similar copies of biological medicines, equally effective and safe but at lower prices. The aim of this brief review is to provide the current status of biosimilars approved in the European Union for dermatological use. We used PubMed for literature search up to June 2018. The keyword 'biosimilars' was searched and 1,691 items were found. From the 1,691 studies, we included 34 articles in our review. Biologics, biosimilars and generics are different types of drugs. Biosimilars are complex molecules produced by a difficult manufacturing process, and changes in product quality may affect its safety and efficacy. Now, there are 9 biosimilar medicines approved by European Medicines Agency (EMA) for plaque psoriasis and hidradenitis suppurativa: Amgevita, Solymbic, Cyltezo, Imraldi, Benepali, Erelzi, Flixabi, Inflectra and Remsima, and the number is increasing. In 2005, EMA issued the first guidelines for approval of biosimilars. Next-generation biologics, called 'biobetters', have the same target or mechanism of action as previously approved biologics, but they have structural changes and an improved formulation. The debate over the future of biosimilars is far from being finished. The explosive development of biological therapy and the emergence of biosimilars represent a significant success in the effort to provide advanced healthcare to patients all over the world.

Psoriasis is a chronic inflammatory disease, with multisystemic implications and genetic predisposition, characterized by the development of erythematous, scaling plaques on the skin. Management of moderate to severe psoriasis vulgaris may involve a biological treatment that suppresses the immune system. Because of this, the patients with psoriasis on an immunosuppressive treatment are theoretically at an increased risk of infections, including SARS-CoV2 infection. SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2) is responsible for the current pandemic. In Romania, COVID-19 (Coronavirus Disease 19) was first reported on February 26, 2020, by confirming the first patient with SARS-CoV-2 by RT-PCR method. COVID-19 progression was divided into three phases: early infection, pulmonary phase, and hyperinflammatory phase. Although the inhibition of pro-inflammatory cytokines by biologic therapy is detrimental in the viral phase, it seems to be beneficial in the hyperinflammatory phase, by protecting the patients with psoriasis in progressing towards extra-pulmonary manifestations and death. Analyzing the evolution of the 8 cases of patients from our dermatology department – Colentina Clinical Hospital, with generalized psoriasis vulgaris on biologic immunosuppressive treatment and SARS-CoV-2 infection, we observed that they did not develop a more severe form of COVID-19 than the general population. Patients on biologic immunosuppressive treatment are more susceptible to the development of infections, including by SARS-CoV-2, but it was found that the biologic therapy can protect against a more severe type of COVID-19.

With recent advances in the understanding of psoriatic disease, it is increasingly considered a systemic inflammatory
condition rather than limited to the skin and joints. A variety of biologics are available today for the treatment of psoriasis, but
with them, characteristics such as rapidity of onset, long-term efficacy, safety profile, and effects on comorbidities differ. We
designed an observational, non-interventional, retrospective study of patients with severe psoriasis receiving biologic treatment
with IL-17 inhibitors and aimed to investigate the correlations between etiopathogenic factors and the efficacy and persistence
of these therapies in a group of psoriasis patients from Romania. Study results show that patients treated with ixekizumab had
better persistence and high adherence compared to those treated with secukinumab. In this study, ixekizumab demonstrated
lower risks of non-persistence, discontinuation, and switching and a higher likelihood of high adherence compared with
secukinumab. This study contributes to the understanding of the persistence of anti-IL17 biologic therapies in psoriasis and the
factors that may influence it.