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Robinj

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Aurinia Pharmaceuticals Inc said there were no further deaths in patients given its experimental lupus drug in a mid-stage study, allaying safety concerns as the drug developer prepares to start a pivotal study later this year.

Two doses of the drug, voclosporin, were being tested against a placebo in a 48-week study in patients with lupus nephritis (LN) who were already on the standard-of-care therapy.

In August, the company had disclosed 13 trial deaths — 12 of which occurred in voclosporin-treated patients — after 24 weeks.

On Wednesday, the company reported full 48-week data, and said there were three more deaths, but all occurred in the placebo arm.

http://www.reuters.com/article/us-aurinia-pharma-lupus-idUSKBN1685P0


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Cakelady

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Hmmm interesting that is one drug i will not take. You need to pick your battles on the war with lupus and this is one I would not choose. It will more then likely mess up your liver. The gift that keeps on giving
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Robinj

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Yup
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lupuscommunity

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Keep in mind the eligibility criteria for participating in this study ... 

Diagnosis of systemic lupus erythematosus (SLE) according to the American College of Rheumatology criteria.

Kidney biopsy within 6 months prior to Screening (Visit 1) with a histologic diagnosis of lupus nephritis (International Society of Nephrology/Renal Pathology Society 2003 classification of lupus nephritis) Classes III, IV-S or IV-G, (A) or (A/C); or Class V, alone or in combination with Class III or IV.

Laboratory evidence of active nephritis at screening, defined as:

  • Class III, IV-S or IV-G: Confirmed proteinuria ≥1,500 mg/24 hours when assessed by 24 hour urine collection, defined by a UPCR of ≥1.5 mg/mg assessed in a first morning void urine specimen (2 samples).
  • Class V (alone or in combination with Class III or IV): Confirmed proteinuria ≥2,000 mg/24 hours when assessed by 24 hour urine collection, defined by a UPCR of ≥2 mg/mg assessed in a first morning void urine specimen (2 samples).
These were very ill patients when they entered the study with kidney disease.  The number of deaths that occurred in this study were similar to the numbers seen in LN trials of other study drugs.  The numbers were not unusual given the serious and life-threatening complications that are common in patients with LN.  

Second, of the deaths that occurred in the earlier 24-week study, none were attributed to the study medication.  From the company news release ... 
  • There were 13 deaths across the trial: (2) in the high-dose voclosporin arm; (10) in the low-dose voclosporin arm; and (1) in the control arm, with the majority of overall deaths (11/13) occurring in Asia. All deaths were assessed by the Investigator as being unrelated to study treatment. No dose relationship was observed for the deaths.
If the study drug were contributing to the number of deaths, one would expect to see a higher or at least equal number of deaths in the high dose group .  That was not the case as almost all of the deaths occurred in the low dose group (10/13). 

Additionally almost all of the deaths occurred among patients from Asian countries where the access to medical care is not as robust as it is in other parts of the world.

There were no additional deaths in the treatment arms of the 48-week study; the three additional deaths occurred in the placebo arm. So there is no strong evidence that the study drug has any serious safety concerns, based on the data that is available at this time.  

The exciting news is the high number of patients that achieved complete remission after 48 weeks; 49% in the low dose group and 40% in the high does group.  There also were high percentages of participants that had achieved at least partial remission: 68% in the low dose group and 72% in the high dose group.  These are the highest complete remission rates for any previous lupus nephritis trial.  

Also note that study participants had their steroids tapered to 5mg/day by week 8 and 2.5mg by week 16.  Steroid sparing by itself is a significant benefit of any lupus drug.  

We eagerly await the start of the phase III study which is expected to begin within the next four months.  

According to the company news release, "the Phase III AURORA trial will be a global 52-week double-blind, placebo controlled study of approximately 320 patients. Patients will be randomized 1:1: to either of 23.7mg voclosporin BID and MMF or MMF and placebo, with both arms receiving a stringent oral corticosteroid taper. The study population will be comprised of patients with biopsy-proven active LN who will be evaluated on the primary efficacy endpoint of renal response at 24 weeks, a composite which includes:
  • Urinary/protein creatinine ratio (UPCR) of ≤0.7mg/mg
  • Normal, stable renal function (≥60 mL/min/1.73m2 or no confirmed decrease from baseline in eGFR of >20%)
  • Presence of sustained, low dose steroids (≤10mg prednisone from week 16-24)
  • No administration of rescue medications.

If this phase III study successfully reaches its endpoints, it will represent a significant advance in efforts to bring greater options to people with lupus-related kidney disease, a major contributor to disability and mortality in lupus.  


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Robinj

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Thanks Duane :)
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Cakelady

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But here is what they don't tell you. This drug might be wonderful and help you your kidneys back on track but at what expense? My liver is shot because of cytoxin treatment which did save my life but mexotrexate and all of the other drugs that I have had to take because of lupus. So it's almost a dam if you dam if you don't kinda of thing.
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