Vol 93, No 5 (2017)

Cover Page

Full Issue


Efficacy and Safety of BCD-085, a Novel Interleukin-17 Inhibitor. Results of Phase II Clinical Trial in Patients with Moderate-to-Severe Plaque Psoriasis

Samtsov A.V., Khairutdinov V.R., Bakulev A.L., Kubanov A.A., Karamova A.E., Artem’eva A.V., Korotaeva T.V.


Recent studies on psoriasis confirmed that interleukin-17 (IL-17) plays a crucial role in the progression of the disease. Inhibition of this cytokine leads to significant improvement in the course of the disease. Russian biotechnology company BIOCAD have developed an innovative drug, a monoclonal antibody against IL-17, BCD-085. The main objective of the phase II study was to determine the optimal therapeutic dose of BCD-085 in patients with moderate-tosevere plaque psoriasis. The efficacy, safety, and pharmacokinetics of the drug have also been investigated.

Materials and methods

The study was an international multicenter, comparative, randomized, double-blind, placebo-controlled clinical trial of the efficacy and safety of multiple subcutaneous administration of various doses of BCD-085 to patients with moderate to severe plaque psoriasis. Patients were randomized into 4 groups in 1:1:1:1 ratio: group 1 received BCD-085 at a dose of 40 mg, group 2 – 80 mg, group 3 – 120 mg, and group 4 received placebo. Administration of BCD-085/placebo was performed subcutaneously on day 1 at weeks 0, 1, 2, and then on day 1 at weeks 4, 6, 8, 10.


All studied doses of BCD-085 demonstrated significant superiority over placebo and high efficacy in the treatment of plaque psoriasis. PASI 75 at week 12 was reached by 92.68% of patients in group 3 (120 mg of BCD-085), 83.33% in group 2 (80 mg of BCD-085), 80.0% in group 1 (40 mg of BCD-085), and 23.08% in group 4 (placebo) (p < 0.0001). In the course of the study, the dose-dependent effect of the drug was demonstrated. The drug showed favorable safety profile (no cases of serious adverse events or early withdrawal due to adverse events, no cases of adverse events with 4 grade of severity according to CTCAE 4.03). According to the results of pharmacokinetics study, the drug is characterized by a linear increase in serum BCD-085 concentration, reaching its maximum by the end of the first week of observation, and by slow elimination.


BCD-085 showed high efficiency, more than 90% of patients reached PASI 75 by the 12th week of treatment, and a favorable safety profile. Based on the results of the phase II study, the optimal therapeutic dose was 120 mg.

Vestnik dermatologii i venerologii. 2017;93(5):52-63
pages 52-63 views


Tuberous Sclerosis

Monahov K.N., Romanova O.L., Amelina P.O., Molodyh K.Y., Astahov Y.S., Nechiporenko P.A., Atlasova L.K.


Aetiology, pathogenesis, clinical and patomorphological criteria for diagnosis of tuberous sclerosis diagnosis are described in this paper. Clinical case of long undiagnosed tuberous sclerosis is presented. 

Vestnik dermatologii i venerologii. 2017;93(5):82-88
pages 82-88 views


Abnormalities of Psycho-Emotional State among Patients with Excoriated Acne

Il’chevskaya E.A., Krinitsyna Y.M., Sergeeva I.G.


The psychopathological features of patients with excoriated acne are analysed. An integrative anx-iety test among 43 patients (mean age 24.7±7.1 years) demonstrated borderline values and a high level of personal anxiety in 46.5% of cases; assessment according to the Beck Depression Inventory revealed subdepression among 25.6% and depression among 13.9% of patients; the Global Severity Index (GSI) of the Symptom Checklist-90-R (SCL-90-R) was in the zone of elevated and high val-ues among 31.1% of patients. The greatest deviations from the norm were observed in the areas of interpersonal sensitivity among 34.9% of patients; dev phobic anxiety – 30.2%; paranoia – 30.2%; while somatisation of complaints was observed among 27.9% of patients. The obsessive-compulsive subscale exceeded normative values among 21% of patients. 

Vestnik dermatologii i venerologii. 2017;93(5):64-69
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Hidradenitis Suppurativa: Modern Concepts of Pathogenesis and Therapy; Successful Experience of Adalimumab Therapy

Khobeish M.M., Shustov D.V., Sokolovsky E.V.


Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease that mainly affects the sites of the apocrine glands; HS is characterised by relapsing painful knots and abscesses, leading to the formation of fistulas and scarring. Modern ideas about the pathogenesis of HS allow us to consider it as a kind of inverse acne, since the mechanism of development of HS and inverse acne does not differ. Detailed studies of patients with HS in recent years have provided the basis for several authors to suggest that HS is a systemic, chronic, immune-mediated progressive disease. The key role of the proinflammatory cytokine tumor necrosis factor Į (TNF-Į) in the development of the inflammatory process during HS was determined. Elevated TNF-Į levels are found in the blood and HS lesions, having a positive correlation of the TNF-Į level with the severity of the disease. At the present time, the treatment with a TNF-Į blocker, adalimumab (the only one genetically engineered biological preparation approved for treatment of HS/inverse acne in the world and in Russia), is recommended as a first-line therapy in the absence of an adequate response to standard systemic therapy in the case of active HS of moderate or utmost severity. The presented clinical case confirms the fact that for HS patients it is very important to determine the correct diagnosis as quickly as possible and to prescribe the appropriate treatment according to the developed recommendations. Erroneous diagnoses, inadequate therapy (surgical treatment, short courses of antibiotics, etc.) contribute to the progression of the disease, to the appearance of common symptoms due to the attachment of secondary infection and increase in general intoxication, to limited working capacity, to the emergence of persistent and gross scars, as well as to the deformations of affected skin. Our clinical case of adalimumab (Humira) treatment of a patient with an extremely severe HS form demonstrated that the application of this medication can be effective and well tolerated. 

Vestnik dermatologii i venerologii. 2017;93(5):70-81
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Biological Therapeutic Treatment of Atopic Dermatitis

Kubanova A.A., Kubanov A.A., Karamova A.E., Proshutinskaya D.V.


Atopic dermatitis is a chronic recurrent inflammatory disease caused, inter alia, by violations of the barrier function of the skin and pathological immune response in the form of an imbalance of Th1 and Th2 lymphocytes with increased production of IL-4, IL-5, IL-13, IL-31. Treatment of severe forms of atopic dermatitis is not an easy task due to the variability of the individual response to treatment, the short duration of the therapeutic effect and the frequent development of undesirable phenomena associated with the use of existing methods of systemic immunosuppressive therapy. The study of the pathogenesis of atopic dermatitis made it possible to identify the spectrum of molecular targets, providing the basis for researching alternative variants to the previously used systemic therapy methods – genetic engineering biological preparations. Contemporary data on the pathogenesis of atopic dermatitis as well as potential molecular targets for innovative biological preparations, the efficacy of which has been evaluated through clinical trials, are presented in the review. 

Vestnik dermatologii i venerologii. 2017;93(5):34-46
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Purulent Hidradenitis. Part I

Rodionov A.N., Skrek S.V., Sobolev A.V., Yunovidova A.A., Chernova L.R., Wolkenstein P.


Until recently, the pathogenesis of purulent hidradenitis was a little- and sporadically studied issue, which invariably created difficulties in the therapeutic treatment of this disease. Its often severe recurrency rate, high incidence and the lack of effective treatment have predetermined the urgency of the problem and raised the scientific and practical interest in this field among the scientists worldwide. Recent data indicate a significant role of damage-associated molecular patterns (DAMP) and the activation of congenital immunity, associated with Th17 lymphocytes, in the development of inflammatory disease. Likewise, the violation of the transmission of the cellular Notch signaling pathway plays an important role in the development of purulent hidradenitis. 

Vestnik dermatologii i venerologii. 2017;93(5):47-51
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Incidence of Syphilis in the Russian Federation Over the Period 2006–2016

Kubanova A.A., Kubanov A.A., Melekhina L.E.


In the article, issues associated with the study of syphilis propagation among different age groups in the Russian Federation are elucidated along with the incidence dynamics of the clinical forms of syphilis in Russia over the period 2006-2016. The influence of gender factors on the transmission of syphilis in Russia was assessed. 

Vestnik dermatologii i venerologii. 2017;93(5):16-25
pages 16-25 views

Priority Mechanisms for the Provision of Pharmaceutical Care to the Population of the Russian Federation

Martynov A.A., Maksimkina E.A., Alexandrova O.Y., Vlasova A.V.


The main directions of modernisation of the pharmaceutical care provision of the population of the Russian Federation are systematised based on the results of the analysis of normative legal acts. 

Vestnik dermatologii i venerologii. 2017;93(5):26-33
pages 26-33 views


Signaling Рathway Blockers: Action Mechanism, Efficacy, Safety of Therapy for Patients with Psoriasis and Psoriatic Arthritis

Bakulev A.A.


In the literature review, contemporary data on immune pathogenesis of psoriasis and the emergence of comorbid states against the background of systemic chronic inflammation among patients is discussed. On the example of the apremilast medical preparation, the information on a new class of therapeutic agents for the treatment of psoriasis and psoriatic arthritis – “small molecules” is given, including their physicochemical properties and action mechanism, as well as on the key differences from immune-suppressive and genetically engineered biological preparations. Data on large-scale international randomised clinical trials of the efficacy and safety of the PDE4 inhibitor of apremilast among patients with moderate to severe psoriasis and psoriatic arthritis is presented. The published international clinical recommendations on the use of apremilast among patients with psoriasis and psoriatic arthritis, the criteria for evaluating the response to therapy, as well as the potential profile of patients for the use of apremilast in real clinical practice are discussed.
Vestnik dermatologii i venerologii. 2017;93(5):89-96
pages 89-96 views

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