Miscellaneous Immune Disorders

Baricitinib Gets Fast Track Status for Systemic Lupus Erythematosus

By December 14, 2018

Data from a Phase 2 trial of baricitinib for the treatment of SLE supporting the Fast Track designation were published in The Lancet and presented at the European Congress of Rheumatology earlier this year.

Opioid Use High in Patients With Systemic Lupus Erythematosus

October 26, 2018

Patients with SLE who experienced high pain levels and had a visit to the emergency department the previous year were more likely to use opioids.

Jakafi Granted Priority Review for Acute Graft-Versus-Host Disease

By October 25, 2018

The sNDA included data from the REACH1 study (N=71) which evaluated ruxolitinib in combination with corticosteroids in patients with steroid-refractory acute GVHD.

Researchers Debate Hydroxychloroquine Dosing in SLE

October 24, 2018

Experts at the 2018 ACR/ARHP Annual Meeting discuss whether hydroxychloroquine dosing should be more than 5 mg/kg in patients with systemic lupus erythematosus.

Rituxan Labeling Updated With Follow Up Treatment Info for Patients With GPA/MPA

By October 19, 2018

The approval for follow up treatment was based on data from an open-label, prospective, active-controlled study (MAINRITSAN) involving 115 patients in disease remission (86 with GPA, 24 with MPA, 5 with renal-limited ANCA-associated vasculitis)

Treatment for WHIM Syndrome Gets Orphan Drug Designation

By October 16, 2018

X4 Pharmaceuticals is developing the drug, which is currently in a Phase 2/3 clinical trial involving patients with WHIM syndrome.

Lupus Is a Leading Cause of Death in Young Women

April 25, 2018

For females between 5 and 64 years of age, SLE ranked among the top 20 leading causes of death; it ranked 10th for those aged 15 to 24 years, 14th for those aged 25 to 34 years and 35 to 44 years, and 15th for those aged 10 to 14 years.

Belimumab Aids Anti-dsDNA+, Hypocomplementemic Lupus

April 23, 2018

Patients were randomized to weekly subcutaneous (SC) belimumab or placebo (248 and 108 patients, respectively), plus standard SLE therapy for 52 weeks. SLE Responder Index (SRI4) at week 52 was assessed as the primary end point.

Firdapse NDA Submitted for Lambert-Eaton Myasthenic Syndrome

By April 02, 2018

Results from the Phase 3 trial showed that the Quantitative Myasthenia Gravis (QMG) score at baseline to day 14 changed from 6.4 to 6.7 in the amifampridine group vs. 5.6 to 7.9 for the placebo group.

Hizentra Approved for Chronic Inflammatory Demyelinating Polyneuropathy

By March 16, 2018

The PATH study demonstrated that the percentage of patients experiencing CIDP relapse or withdrawal for any other reason during SCIg treatment was significantly lower with Hizentra

Rituxan Granted Priority Review for Rare Autoimmune Disease

By February 16, 2018

The disease can be life threatening. Phase 3 study results released last March demonstrated Rituxan substantialy improved pemphigus vulgaris remission rates and successful tapering.

Are Patients With ITP at Increased Risk for Cardiovascular Disease?

January 09, 2018

The elevated risk of developing CVD in the ITP cohort (adjusted incidence rate ratio [IRR], 1.38) remained even after a sensitivity analysis which included only incident cases of ITP.

Autologous stem-cell transplantation improves survival in scleroderma patients: The SCOT trial

January 05, 2018

Scleroderma patients treated with myeloablative autologous stem-cell transplantation experienced significantly higher rates of disease-free survival at 52 months post-treatment compared to those treated with cyclophosphamide.

Rituximab Effective for Lupus-Associated Cytopenia

December 27, 2017

Overall initial response rate of 86% in 71 patients, with complete response for 60.5%

Nucala Approved to Treat Rare Autoimmune Disease That Causes Vasculitis

By December 12, 2017

EGPA (formerly known as Churg-Strauss syndrome) is a condition characterized by asthma, high levels of eosinophils (a type of white blood cell that helps fight infection), and inflammation of small- to medium-sized blood vessels.

Newly Approved Prophylaxis Assessed in CMS-Seropositive Transplant Recipients

December 08, 2017

The researchers found that among 495 patients with undetectable CMV DNA at randomization, fewer patients in the letermovir group had clinically significant CMV infection or were classified as having a primary end point event by week 24 after transplantation, compared with the placebo group.

Prevymis Approved for Prevention of Cytomegalovirus Infection and Disease

By November 09, 2017

Prevymis, a non-nucleoside CMV inhibitor (3,4 dihydro-quinazoline), inhibits viral replication through targeting the viral terminase complex.

What Are the Clinical Characteristics of Hepatic Sarcoidosis?

By September 18, 2017

Most patients were asymptomatic and the diagnosis was discovered in pursuit of other abnormal biochemical tests and imaging studies. In the majority of patients, alkaline phosphatase (ALP) and gamma-glutamyl transferase (GGT) were elevated (88 and 90%, respectively).

Privigen Approved for Chronic Inflammatory Demyelinating Polyneuropathy

By September 15, 2017

The FDA approval was based on data from two Phase 3 studies, PATH and PRIMA.

Benlysta FDA-Approved as New Self-Injectable Formulation

By July 21, 2017

The FDA approval was supported by data from the BLISS-SC Phase 3 study (n>800) in patients with active SLE.

Giant Cell Arteritis Treatment Gets FDA Approval

By May 22, 2017

In the study, Actemra given weekly and bi-weekly combined with a 6-month glucocorticoid regimen, more effectively sustained remission through Week 52 than placebo combined with a 26-week steroid taper and a 52-week steroid taper.

Plant Found to Harbor Drug-Resistant Fungal Pathogen

By May 18, 2017

Results showed that 5 of the 6 bulb packages tested positive for triazole-resistant A. fumigatus.

Progress Made in Possible First Treatment for Lymphedema

May 11, 2017

Based on the lab findings, a clinical trial testing bestatin against lymphedema is underway, Dr. Stanley Rockson lead author of the research.

Updated Review of Discoid Lupus Erythematosus Treatments

By May 09, 2017

For each of the five studies, researchers found a potential for bias through conducting a 'Risk of bias' assessment; none of the trials were deemed 'high quality'

Insulin Autoimmune Syndrome Treated with Rituximab

May 05, 2017

Following treatment with rituximab, decreases seen in total insulin, anti-insulin antibody concentration

Powder Form of Ilaris Permanently Discontinued

By April 28, 2017

Ilaris for Injection will be replaced by Ilaris Injection (solution) for subcutaneous use.

Tissue-Based Tx Granted Breakthrough Status for Complete DiGeorge Syndrome

By April 19, 2017

The FDA has granted Breakthrough Therapy and Regenerative Medicine Advanced Therapy (RMAT) designations for the investigational tissue-based therapy, RVT-802 (Enzyvant), for the treatment of complete DiGeorge Syndrome (cDGS).

FDA to Review Fostamatinib for Chronic, Persistent ITP

By April 18, 2017

Rigel announced its submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) for fostamatinib for the treatment of patients with chronic and persistent immune thrombocytopenic purpura (ITP).

Novel Budesonide Prep May Treat Rare GI Disorder

March 28, 2017

A trial involving 93 eosinophilic esophagitis patients aged 11 to 40 years with dysphagia were randomly allocated to receive either budesonide oral suspension or placebo twice daily.

Rituxan Gets Breakthrough Therapy Status for Rare Autoimmune Skin Disorder

By March 24, 2017

Genentech announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Rituxan (rituximab) for the treatment of pemphigus vulgaris.