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Neurological involvement of sarcoidosis is a rare condition, and its occurrence in the context of transplantation is exceptional. Moreover, treatment can be challenging. We report the unusual case of a patient transplanted with a kidney for end-stage renal disease secondary to sarcoidosis who experienced a neurological recurrence of the disease under immunosuppressive treatment, translating in behavioural aggressiveness, social withdrawal and weight loss. He relapsed thrice under corticosteroids but responded finally to infliximab. This case highlights the potential of sarcoidosis to recur neurologically after kidney transplantation despite immunosuppressive treatment. Also, treatment of relapsing neurosarcoidosis can be challenging and may benefit from TNF-α blockers.

Background: No absolute data on the treatment of antiphospholipid antibodies (aPL) related to refractory obstetric complications exist to date. TNF-alpha play a major role in this disorder. Objective: To assess the effectiveness of TNF-alpha blockers in 18 aPL-positive women with recurrent infertility after therapy with low-molecular-weight heparin (LMWH) plus aspirin (LDA) plus hydroxychloroquine (HCQ). Methods: Prospective case-series of 12 women fulfilling Sydney criteria for obstetric antiphospholipid syndrome (OAPS) and 6 with incomplete forms (OMAPS). All women tested positive for aPL at least twice. Non criteria aPL were tested in 15/18. Complement, TNF-alpha and IL-10 were also evaluated. Women were closely monitored for fetal well-being and possible malformations throughout gestation and the postpartum period. Results: Sixteen patients were started on adalimumab and 2 on certolizumab. Twelve women completed gestation: 9 at term and 3 pre-term. Differences in laboratory categories and outcomes were observed when OAPS and OMAPS were compared. First trimester miscarriage or implantation failure recurred in 6 cases, all of the OAPS group. Malformations were not seen in the newborns. Conclusions: Overall, good obstetric results were obtained in 70% of previous LMWH-LDA+HCQ refractory cases. TNF-alpha blockers were well tolerated without adverse effects. The combination of LMWH plus LDA plus TNF-alpha blockers appears to be a promising treatment for refractory obstetric complaints related to aPL; nevertheless, outcome differences between OAPS and OMAPS do exist. (C) 2019 Published by Elsevier Inc.

OBJECTIVE: We evaluated the incidence of and the main risk factors associated with cutaneous adverse events in patients with chronic inflammatory arthritis following anti-TNF-α therapy. METHODS: A total of 257 patients with active arthritis who were taking TNF-α blockers, including 158 patients with rheumatoid arthritis, 87 with ankylosing spondylitis and 12 with psoriatic arthritis, were enrolled in a 5-year prospective analysis. Patients with overlapping or other rheumatic diseases were excluded. Anthropometric, socioeconomic, demographic and clinical data were evaluated, including the Disease Activity Score-28, Bath Ankylosing Spondylitis Disease Activity Index and Psoriasis Area Severity Index. Skin conditions were evaluated by two dermatology experts, and in doubtful cases, skin lesion biopsies were performed. Associations between adverse cutaneous events and clinical, demographic and epidemiological variables were determined using the chi-square test, and logistic regression analyses were performed to identify risk factors. The significance level was set at p

Background: Biological products are subject to constant reappraisal by regulatory agencies and pharmaceutical companies once they have entered the market, since every improvement in their manufacturing process has the potential to alter the basic properties of these molecules. Methods: Narrative review focusing on scientific literature as well as legal documents from regulatory agencies. Results: Evaluating the impact of each manufacturing change of these drugs requires rigorous analyses in proportion to the anticipated risk of inducing more or less molecular micro-heterogenicity. There are currently more than 30 biosimilars of TNF-alpha blockers at different stages of testing, each with a specific manufacturing process. Although the initial demonstration of biosimilarity is now a well-established exercise, it does not guarantee that successive manufacturing changes will not result in a widening gap between drifted/evolved innovators and drifted/evolved biosimilars, as well as among the different biosimilars of a given original biologic. Conclusion: Given the structural complexity of TNF-alpha blockers-as well as of other biologic drugs included in the armamentarium of systemic inflammatory diseases-regulatory agencies should make available to the practitioner, in a simple and constantly updated way, all available data regarding quality standards of both original molecules and biosimilars. Furthermore, they should strive to guarantee that, once a compound has received approval, it maintains a level of consistency throughout its commercial life in order to maintain and increase confidence in these valuable drugs.

Objectives. To determine whether tumour necrosis factor (TNF)-� blockers may reduce carotid intima-media thickness (cIMT) in patients with active rheumatoid arthritis (RA) steadily responsive to such therapy. Methods. From 287 consecutive RA patients attending our out-patient clinic and diagnosed on the basis of the American College of Rheumatology (ACR) criteria, 49 without traditional cardiovascular risk factors and meeting the requirements for TNF-� blockers therapy were selected. Among them, 39 actually started TNF-� blockers, but only 30, who reached at least a response on the ACR 20% improvement criteria at 14 weeks, maintained during the whole year of treatment, were finally considered (group A). The remaining 10/49, homogeneous for age, sex, traditional cardiovascular risk factors, socioeconomic status, disease activity and duration, who did not consent to TNF-�-blocker administration, were used as controls (group B). Disease activity score in 44 joints (DAS44), erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) were evaluated before starting the study, and 3, 6, 12 months thereafter; cIMT was measured by ultrasound before and 12 months thereafter only. Results. Patients in group A showed a very significant cIMT reduction (P