Biosimilars: An update on clinical trials (review of published and ongoing studies)

Biosimilars represent a new trend in the treatment of many immune-mediated inflammatory diseases. Regulatory requirements for approval of biosimilars are different from those of originators and rely mostly on the evidence generated from bioequivalence studies and in particular from RCTs. Our goal in this review was to search for relevant studies from randomized controlled trials on the biosimilars adalimumab, etanercept, infliximab and ustekinumab compared with their reference medication (publication in Medline) and ongoing studies in clinical trial registries. For infliximab biosimilars, we found data on patients with ankylosing spondylitis rheumatoid arthritis indicating no clinically relevant differences regarding efficacy and safety, as well as data on inflammatory bowel diseases and psoriasis. In addition, three registered studies of adalimumab biosimilars and just one study of an etanercept biosimilar were being carried out in patients with psoriasis. Ongoing studies on adalimumab, etanercept, and infliximab biosimilars in patients with rheumatoid arthritis were also identified. The conclusion seems to be that there are only 4 clinical trials on psoriasis (3 for the adalimumab biosimilar and 1 for etanercept biosimilar) and 1 clinical trial for Pso, CD, UC, RA, and AS (with the Infliximab biosimilar). Thus, the real and unique advantage of biosimilars is the low price derived from the special design studies despite the high technology used in fabrication process. Although not all ongoing biosimilar trials may have been registered, the present situation in terms of registered trials is quite unsatisfactory and provision of further clinical data and inclusion of patients in patient registries will be crucial.  </p

Spectral Characterization of Macro-Heterocyclic Compound RhTMPyP / ZnTSPc

Macro-heterocyclic compounds, such as porphyrins and phthalocyanines, are being studied extensively for their important physical and chemical properties. Their ability to absorb light throughout the spectrum and self-organization being adequate for the realization of several applications. Investigations of the spectral properties of the supramolecular assembly RhTMPyP/ ZnTSPc- 5,10,15,20 rhodium tetramethyl-pyridyl porphyrin / 2,9,16,23 zinc tetrasulfonated-phthalocyanine are registered by UV-Vis, FT-IR and Raman spectroscopic techniques

Piglets’ Intestinal Microflora Fed with a Plants Mix

The objective of this study was to evaluate the effect of a plant mix (bilberry, black currant, quince, peppermint and fennel essential oil) inclusion into the diets of piglets (18-45 kg) on intestinal microflora equilibrium. An experiment was performed on 8 castrated hybrid TOPIGS (18.69±1.25 kg) divided in 2 groups (C and E). The piglets were kept in an experimental house in individual metabolic cages. Compared to the conventional diet (18% crude protein and 3214 kcal/kg metabolic energy) of group C, the diet of E group had included 789 mg mixture of plants/kg feed. At the final of the experiment the piglets were slaughtered and digesta samples were collected from jejunum and ileum for microbiological analysis. For jejunum, a significant (P<0.05) decrease of Staphylococci spp. (log10 CFU/g) concentration in E group was noticed correlated strongly negative with a statistically significant (P<0.05) increasing concentration of Lactobacillus spp. (log10 CFU/g) concentration. The results were similar for ileum. This dietary mixture of plants had some effects on microbial population of piglets’ jejunum and ileum to help positively the intestinal changes of microbiota

Management of Nail Disease in Patients With Psoriatic Arthritis : An Updated Literature Review Informing the 2021 GRAPPA Treatment Recommendations

Copyright © 2023 by the Journal of Rheumatology. Publisher Copyright: Copyright © 2023 by the Journal of Rheumatology.OBJECTIVE: Nail psoriasis is common, impairs fine motor finger functioning, affects cosmesis, and is associated with a lower quality of life. This review updates the previous Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) treatment recommendations for nail psoriasis. METHODS: This systematic literature review of the PubMed, MEDLINE, Embase, and Cochrane databases examined the updated evidence since the last GRAPPA nail psoriasis treatment recommendations published in 2014. Recommendations are based on preformed PICO (Patient/Population - Intervention - Comparison/Comparator - Outcome) questions formulated by an international group of dermatologists, rheumatologists, and patient panel members. Data from this literature review were evaluated in line with Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology. RESULTS: Overall, there is insufficient evidence to make any recommendation for the use of topical corticosteroids, topical calcipotriol, topical tazarotene, topical cyclosporine, dimethyl fumarates/fumaric acid esters, phototherapy, and alitretinoin. There is a low strength of evidence to support the use of calcipotriol and corticosteroid preparations, topical tacrolimus, oral cyclosporine, oral methotrexate, intralesional corticosteroids, pulsed dye laser, acitretin, Janus kinase inhibitors, and apremilast. CONCLUSION: The highest strength of supporting evidence is for the recommendation of biologic agents including tumor necrosis factor inhibitors, and interleukin 12/23, 17, and 23 inhibitors.Peer reviewe

Impact of safety-related dose reductions or discontinuations on sustained virologic response in HCV-infected patients: Results from the GUARD-C Cohort

BACKGROUND: Despite the introduction of direct-acting antiviral agents for chronic hepatitis C virus (HCV) infection, peginterferon alfa/ribavirin remains relevant in many resource-constrained settings. The non-randomized GUARD-C cohort investigated baseline predictors of safety-related dose reductions or discontinuations (sr-RD) and their impact on sustained virologic response (SVR) in patients receiving peginterferon alfa/ribavirin in routine practice. METHODS: A total of 3181 HCV-mono-infected treatment-naive patients were assigned to 24 or 48 weeks of peginterferon alfa/ribavirin by their physician. Patients were categorized by time-to-first sr-RD (Week 4/12). Detailed analyses of the impact of sr-RD on SVR24 (HCV RNA <50 IU/mL) were conducted in 951 Caucasian, noncirrhotic genotype (G)1 patients assigned to peginterferon alfa-2a/ribavirin for 48 weeks. The probability of SVR24 was identified by a baseline scoring system (range: 0-9 points) on which scores of 5 to 9 and <5 represent high and low probability of SVR24, respectively. RESULTS: SVR24 rates were 46.1% (754/1634), 77.1% (279/362), 68.0% (514/756), and 51.3% (203/396), respectively, in G1, 2, 3, and 4 patients. Overall, 16.9% and 21.8% patients experienced 651 sr-RD for peginterferon alfa and ribavirin, respectively. Among Caucasian noncirrhotic G1 patients: female sex, lower body mass index, pre-existing cardiovascular/pulmonary disease, and low hematological indices were prognostic factors of sr-RD; SVR24 was lower in patients with 651 vs. no sr-RD by Week 4 (37.9% vs. 54.4%; P = 0.0046) and Week 12 (41.7% vs. 55.3%; P = 0.0016); sr-RD by Week 4/12 significantly reduced SVR24 in patients with scores <5 but not 655. CONCLUSIONS: In conclusion, sr-RD to peginterferon alfa-2a/ribavirin significantly impacts on SVR24 rates in treatment-naive G1 noncirrhotic Caucasian patients. Baseline characteristics can help select patients with a high probability of SVR24 and a low probability of sr-RD with peginterferon alfa-2a/ribavirin