#TenTweetNephJC returns in 2023! Catch-up rapidly with the biggest trials in nephrology.
Up first is NefIgArd.
We all say we hate steroids, but really we love their efficacy but hate their side-effects, right?
IgA nephropathy is again the subject of a steroid trial🧵
Up first is NefIgArd.
We all say we hate steroids, but really we love their efficacy but hate their side-effects, right?
IgA nephropathy is again the subject of a steroid trial🧵
2/10
What did I miss?
If gut mucosal IgA is implicated in IgAN, can a locally acting steroid show efficacy without systemic side-effects?
Enter Nefecon, a “targeted-release” oral budesonide. After promising Phase 2, now read 1st year of the 2 year RCT.
pubmed.ncbi.nlm.nih.gov
What did I miss?
If gut mucosal IgA is implicated in IgAN, can a locally acting steroid show efficacy without systemic side-effects?
Enter Nefecon, a “targeted-release” oral budesonide. After promising Phase 2, now read 1st year of the 2 year RCT.
pubmed.ncbi.nlm.nih.gov
3/10
1 tweet methods
✅ International, multi-center, industry-funded, phase 3 RCT
✅ 1:1 randomisation to either Nefecon 16mg/day for 9 months, or placebo
✅ Adults with biopsy-proven IgA, on max RASi
✅ Primary outcome: reduction in proteinuria at 9 months
1 tweet methods
✅ International, multi-center, industry-funded, phase 3 RCT
✅ 1:1 randomisation to either Nefecon 16mg/day for 9 months, or placebo
✅ Adults with biopsy-proven IgA, on max RASi
✅ Primary outcome: reduction in proteinuria at 9 months
4/10
1 tweet results
🔹199 patients randomised, 68% male
🔹 Mean: age 43, eGFR 55, uPCR 1.26 g/g (141 mg/mmol)
🔹31% uACR reduction with Nefecon 🆚 5% with placebo at 9m (& even better at 12m)
🔹Acute rise in eGFR seen with Nefecon, then similar slope decline after 3 months
1 tweet results
🔹199 patients randomised, 68% male
🔹 Mean: age 43, eGFR 55, uPCR 1.26 g/g (141 mg/mmol)
🔹31% uACR reduction with Nefecon 🆚 5% with placebo at 9m (& even better at 12m)
🔹Acute rise in eGFR seen with Nefecon, then similar slope decline after 3 months
5/10
A figure paints 1000 words
Their subgroup analysis of patients with uPCR >1.5g (though numbers small) - concerning that this analysis wasn’t pre-specified, or reason for optimism?
A figure paints 1000 words
Their subgroup analysis of patients with uPCR >1.5g (though numbers small) - concerning that this analysis wasn’t pre-specified, or reason for optimism?
6/10
Give me something clever to say
“Though budesonide has fewer side-effects than systemic steroids in IBD literature, Nefecon was far from benign; 27 events in 9 patients led to Nefecon discontinuation (about 9% of the Nefecon arm), whereas only 1 patient stopped placebo”
Give me something clever to say
“Though budesonide has fewer side-effects than systemic steroids in IBD literature, Nefecon was far from benign; 27 events in 9 patients led to Nefecon discontinuation (about 9% of the Nefecon arm), whereas only 1 patient stopped placebo”
7/10
Chat consensus?
1️⃣ Suspicious of ‘decrease in proteinuria’ now accepted by FDA - strong desire to see hard endpoints
2️⃣ Still don’t know if Nefecon definitely causes fewer side-effects than low dose methylpred
3️⃣ Flozins, flozins, we like flozins, use flozins
Chat consensus?
1️⃣ Suspicious of ‘decrease in proteinuria’ now accepted by FDA - strong desire to see hard endpoints
2️⃣ Still don’t know if Nefecon definitely causes fewer side-effects than low dose methylpred
3️⃣ Flozins, flozins, we like flozins, use flozins
8/10
Quote of the fortnight!
Quote of the fortnight!
9/10
I want more info
✅ NefIgArd #NephJC summary from @brian_rifkin
nephjc.com
✅ VA by @priti899👇
✅ Also check out @divyaa24’s great IgA trial infographic👇
I want more info
✅ NefIgArd #NephJC summary from @brian_rifkin
nephjc.com
✅ VA by @priti899👇
✅ Also check out @divyaa24’s great IgA trial infographic👇
10/10
Final thoughts
✳️ All looking forward to Part B NefIgArd results….
➡️ Up next (joint with @ipnajc!) = CARDINAL, the largest ever RCT in Alport syndrome, examining use of bardoxolone methyl.
pubmed.ncbi.nlm.nih.gov
See you 24/25 Jan!
Tweetorial by @jamiekwillows
Final thoughts
✳️ All looking forward to Part B NefIgArd results….
➡️ Up next (joint with @ipnajc!) = CARDINAL, the largest ever RCT in Alport syndrome, examining use of bardoxolone methyl.
pubmed.ncbi.nlm.nih.gov
See you 24/25 Jan!
Tweetorial by @jamiekwillows
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