Biosimilar versus originator etanercept: a real-life clinical study.

BACKGROUND: Over the last few years, novel therapeutic approaches based on the use of monoclonal antibodies against cytokines, or their cognate receptors, involved in psoriasis progression have shown remarkable results, being capable to reduce disease progression and increase patient's quality of life. Among these is etanercept (Enbrel®, Pfizer, Sandwich, UK) and its biosimilar compound SB4 (Benepali®, Samsung Bioepis, Delft, The Netherlands), both approved for the treatment of moderate to severe psoriasis. Aim of the present study was to evaluate in a less controlled environment, such as real-life, the actual bioequivalence between the etanercept (ETN) and the SB4 in term of safety, efficacy and patient's quality of life. METHODS: For this purpose, we analyzed a case study consisting of 65 patients affected by plaque psoriasis, with or without psoriatic arthritis at our dermatological outpatient center of Sant'Andrea Hospital in Rome, all of them under treatment with either ETN or the biosimilar SB4 drug for at least 3 months. The indicators used to evaluate the effectiveness of the therapies were the Psoriasis Area and Severity Index, the Visual Analogue Scale (VAS) for itch, the VAS for pain, and the Dermatology Life Quality Index. RESULTS: The results showed no significant differences among the two drugs in all the analyzed parameters confirming the equivalence between the ETN and its biosimilar SB4. CONCLUSIONS: Overall, we can confirm the overlapping clinical efficacy between ETN and its biosimilar SB4 drug and that even in an uncontrolled environment such as real-life, the biosimilar drugs are an excellent opportunity to reduce health costs allowing to expand the audience of patients who can benefit from these innovative treatments.

Vitiligo with Progressive Repigmentation during Secukinumab Treatment in a Patient with Psoriatic Arthritis: A Case Report.

The proposed role of interleukin (IL)-17 in vitiligo pathogenesis, as well as the possible action of anti-IL-17A drugs on vitiligo, are not fully understood. The appearance of vitiligo as a paradoxical effect of treatment with anti-tumor necrosis factor-α drugs is an event well known in the literature, but is rarely described with anti-IL-17A drugs. In this case report, we describe a 42-year-old woman who developed new-onset vitiligo with repigmentation during successful secukinumab therapy for psoriatic arthritis. After 1 year of secukinumab therapy, vitiligo affecting >85% of the skin was evident on clinical and dermatoscopic examination, together with small, repigmented lesions. In depigmented lesions, reflectance confocal microscopy (RCM) showed disappearance of the bright dermal papillary rings normally seen at the dermo-epidermal junction. In repigmented lesions, activated dendritic melanocytes were observed on RCM. The patient continued to receive secukinumab, and continued to experience a slow and progressive repigmentation. Our case shows that anti-IL-17A biological agents for chronic inflammatory diseases may be associated with the development of new-onset vitiligo that improves over time with ongoing therapy. Therefore, physicians should be aware of the possibility of this rare paradoxical skin reaction in patients receiving secukinumab, and that it may not be necessary to discontinue secukinumab to achieve repigmentation.

Treatment of refractory conjunctivitis associated to dupilumab with topical pimecrolimus applied to the eyelid skin.

Patients with atopic dermatitis commonly experience ophthalmic complications, and a higher incidence of conjunctivitis has been observed during treatment with dupilumab. We present the case of a 49-year-old woman with persistent severe atopic dermatitis who complained of refractory conjunctivitis associated with dupilumab. Ocular examination showed features of atopic conjunctivitis for which an external topical application to the eyelids of pimecrolimus 10 mg/g cream was prescribed. The patient showed substantial clinical remission after only 12 days. This case was remarkable as the medication applied externally to the eyelid skin was effective in treating the conjunctival involvement possibly due to penetration of pimecrolimus through the eyelid layers. Further studies are needed to support the use of this drug for dupilumab-related conjunctivitis.

Tridimensional Matryoshka Tattoo: An Important.

Dear Editor, Tattooing is a global and ancient practice that has endured until the present day. It was originally used to indicate religious beliefs, tribal affiliation, loyalty to a leader, or had a therapeutic function. Adverse reactions from tattooing are common, and cutaneous reactions to red pigment have been widely reported (1,2). Herein we report a case of a 30-year-old female patient admitted to our Department of Dermatology for a reaction to a tattoo localized at the violet and black areas of the tattoo on the upper part of her left leg. The patient reported that the tattoo had been made two years earlier, but the cutaneous alterations appeared after she decided to change the color from pink to violet. On physical examination, multiple erythematous nodular itching lesions were present at the areas of the tattoo in which the violet and black color were used (Figure 1). She had undergone antibiotic therapy without resolution after which topical corticosteroids were applied with temporary remission of signs and symptoms. Personal and familial medical history were negative. The patient reported a jewelry allergy that had never been investigated. Based on the suspicion of an allergic reaction we decided to execute a patch test SIDAPA series and patch test special tattoo series (copper sulfate 1% water, dimetilaminoazobenzene-p 1%, aminoazotoluene-o 1%, blue scattered 3 1%, blue scattered 124 1%, yellow scattered 3 1%, orange scattered 3 1%, red scattered 1 1%, gentian violet 2%, cadmium chloride 1% in water, nickel sulphate 5%, iron chloride 2% in water, potassium dichromate 0.5%, chromium trichloride 2%, aminoazobenzene-p 0.25%, cobalt chloride 1%, aluminum chloride 2%, titanium dioxide 0.1%, zinc 2.5%, mercury chloride 0.05% in water, kathon cg 0.01% in water, phenol 0.5%, ethylenediamine hydrochloride1%, phenylenediamine base-p 1%, formaldehyde 1% in water, phthalic anhydride 1%, rosin 20%, dibutyl phthalate 5%, hexamethylenetetramine 1%, benzophenone 5%). Both series of patch test showed positivity for nickel sulfate 5% at 48 hours (++) and 72 hours (+++). We then performed a 4 mm punch biopsy of the nodular lesions localized at the black and violet areas. The histological examination revealed dermal sclerosis characterized by inflammatory reaction with lympho-mononuclear infiltration in the perivasal zone. Macrophages with red and black pigment were present. The histological pattern was compatible with a granulomatous reaction. Tattooing can result in a wide variety of complications, whose prevalence and incidence still remain unclear. Some authors (3) classify such cutaneous complications in various ways, such as according to: - the length of their evolution: acute and chronic reactions; - the delay of onset after tattooing: early - during the healing phase - or delayed - after tattoo healing; - the type of reaction: infection, hypersensitivity reaction, etc. The practice of tattooing may have local or systemic complications. Dermatoses such as psoriasis, systemic erythematous lupus, sarcoidosis, lichen planus, and pseudo-epitheliomatous hyperplasia can be localized in the area of the tattoo, but allergic sensitivity to one of the pigments is the most frequent cause of dermatological reactions in the site of tattoo (4,5). In fact, adverse reactions to tattoo pigments, especially the red one, are well-described in literature. Furthermore, these compounds frequently contain components which are not systematically characterized. In our case, the granulomatous reaction did not correspond to an allergic reaction to the pigment. In fact, the patch test was negative for all pigments investigated, only showing a positive result for nickel sulfate. However, the specific and well-defined localization of the nodular lesions on the black and violet areas led us to hypothesize that the tattoo pigments in these areas contained some unknown component causing the reaction. In our opinion, a possible explanation could be that the new pigment that had been used contained a small amount of nickel sulfate, which caused the granulomatous reaction. In conclusion, we presented this clinical case to emphasize the widespread incidence of tattoo-related adverse effects, which are mostly caused by red pigment. Dermatologists should constantly strive familiarize themselves with current research on this practice and its complications. On the other hand, people with potential risk factors for adverse reactions should refer to a specialist before getting tattoos. Tattooists should use a checklist and informed consent to screen people with such potential risk factors. Furthermore, it is necessary to perform additional studies concerning ink and pigment components, with the aim of systemically characterizing the substances used in tattoos. Lastly, as emphasized by our case, patients at risk should referred to the dermatologist not only before getting a new tattoo but also in case of color changes in a pre-existing tattoo.