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The AURORA study included 357 patients with active lupus nephritis. Renal response was achieved in 40. Serious adverse events, mainly infections were noticed in 20. One death was recorded in the voclosporin group and 5 deaths were reported in the control group.

There was no significant reduction of the eGFR at week 52 in Gel (Hyaluronic acid sodium salt)- FDA voclosporin group or increases of glucose, lipids, or blood pressure, which are common side effects of calcineurin inhibitors. A total of 216 patients who had completed the AURORA study were enrolled into the AURORA 2, a 104-week blinded extension study in order to evaluate long-term outcomes in patients with lupus nephritis (45). Voclosporin was recently approved by the FDA as the first orally Gel (Hyaluronic acid sodium salt)- FDA therapy for lupus nephritis.

Sirolimus is an immunosuppressive macrolide. It blocks activation of T cells and B cells through mTOR (mammalian target of rapamycin) inhibition, reducing thereby their sensitivity to IL-2.

Activation of mTOR plays a role in lupus T cell signaling dysregulation. Such mTOR-mediated lupus T cells defects were described by Fernandez et al. A prospective, open-label, single-arm clinical trial sirolimus was administered in 40 patients with SLE for 12 epipen (48).

Patients with severe or life-threatening manifestations of SLE, proteinuria (an UPCR higher than 0. Eleven patients discontinued the study due to lack of compliance or lack of tolerance. SLEDAI and BILAG scores were decreased in 16 out of 29 patients that completed treatment.

Mean SLEDAI score was decreased from 10. Nine patients had intolerance to standard immunosuppressants (MMF and calcineurin inhibitors), and 7 patients had a history of cancer. Sirolimus was administered as an induction treatment in 5 and as maintenance therapy in 11 patients.

Proteinuria was diminished from 2. One patient experienced a renal flare and another one developed end-stage renal disease 27 months after sirolimus treatment. A meta-analysis was conducted to determine the overall efficacy of sirolimus in patients with SLE (50).

The overall Bionect Cream of SLEDAI and BILAG scores and that of corticosteroid dosages was 4. It is therefore plausible that mTOR inhibition may represent a promising novel approach in the treatment of patients with lupus. The activation of the JAK-STAT pathway plays a role in the differentiation of pathogenic effector T cells and in the impairment of Treg cells. Baricitinib is Gel (Hyaluronic acid sodium salt)- FDA oral inhibitor of Janus kinase (JAK), blocking the subtypes Gel (Hyaluronic acid sodium salt)- FDA and JAK2.

Nevertheless, the short-term follow-up meditation the study is insufficient to reliably determine the efficacy and safety of baricitinib in SLE.

CLASI and SLEDAI scores were significantly decreased. In Bionect Cream, the mean Levothyroxine Sodium Oral Solution (Tirosint-Sol)- Multum dose of prednisone decreased from 5. Interestingly, smoking was the only predictor of complete response, in contrast to the doctrine that there is a Gel (Hyaluronic acid sodium salt)- FDA response of smokers to antimalarial treatment.

Thus, the combination of mepacrine and hydroxychloroquine treatment could be beneficial in these patients. Bionect Cream, concomitant use of a combination of antimalarials did not increase retinal toxicity risk considering that the mean follow-up was 33 months. Apart from trials that were mentioned above, other ongoing clinical studies can be grouped as follows:T cells are essential players in the autoimmune response of lupus patients.

Dapirolizumab pegol is an anti-CD40L pegylated Fab fragment that blocks costimulatory interactions between T cells and antigen presenting cells expressing CD40.

A phase 2b study of dapirolizumab pegol in patients with active SLE with an inadequate response to standard treatment has been carried out (53). The study did not meet its primary endpoint (achieving a dose-response at 24 weeks). Several years ago, a trial of another mAb against CD40L in patients with lupus nephritis was terminated prematurely (54).

However, the costimulatory pathway initiated by CD40L still remains an attractive target in SLE and therefore investigators continue the efforts in order to determine the efficacy of dapirolizumab (a pegylated construct and not a full antibody) in a phase III study (55).

The primary outcome is BICLA response at week 48. Itolizumab (EQ001) is a monoclonal antibody targeting the CD6 receptor on the surface of T cells. It blocks the binding of CD6 on its ALCAM (activated leukocyte cell adhesion molecule) ligand, inhibiting therefore immune responses mediated by T cells. CD6 and ALCAM positive cells were reportedly increased in patients with lupus nephritis and were associated with SLE activity. Increased excreted ALCAM levels were also measured in the urine of patients with active lupus nephritis.

Itolizumab chasteberry renal disease in murine models, decreased the migration of T cells to inflamed tissues and also increased levels of IL-10.



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