0:04
Hi everyone, Jack Cush. It's ACR 2026. I'm here in Orlando, Florida.
0:12
It's been a busy first day. A lot of great things, but I ended the day by going to the annual ACR FDA safety update.
0:23
It's always chaired by Michael Weissman.
0:26
Always a good session. FDA officers come and tell us all the things that they've been working on in the past year that are important to us in the practice of rheumatology.
0:37
I got there for the latter half of it, came in when they started talking about new products that were approved.
0:43
I'm going to just only talk about two. One: biosimilars that were approved in 2026.
0:48
There were five of them. There was a new biosimilar for golimumab, another rituximab — I think that makes the third or fourth rituximab, actually two rituximabs, that's now the fourth or fifth rituximab — and two denosumabs that were FDA approved.
1:03
As you know, like two years ago it was a bunch of adalimumab biosimilars, and the last two years a whole lot of ustekinumab biosimilars.
1:13
The other interesting thing that was put forward as new was generic tofacitinib.
1:19
And you know it's available, right? If you look up generic tofacitinib you'll see prices ranging from $25 a month to like a few thousand dollars a month.
1:28
I couldn't figure that out. I do know that generic tofacitinib is available from Mark Cuban's Cost Plus pharmacy at $25 a month, which is incredible.
1:38
That's 5 milligrams tofacitinib given BID, right?
1:41
That's not the same as taking two 5 milligrams once a day, which is equal to 11 milligrams of Xeljanz XR. That's not the same.
1:52
But anyway, the FDA has approved generic tofacitinib in the following forms: a 5 milligram tablet, a 10 milligram tablet, an 11 milligram XR, a 22 milligram XR, and the oral solution at 1 milligram per ml.
2:08
If you want the cheap stuff, that's 5 milligram generic tofacitinib.
2:12
I think that the higher-priced tofacitinib that are out there being offered to your patients as alternatives — some of them could well be generic tofacitinib 11 milligrams in the extended release formula.
2:25
So think about which one you want your patient to take, and if cost is an issue, there is the $25 option out there.
2:35
There was a long presentation by Dr. Kimmy Chan, a medical officer with the FDA, on safety issues on a number of rheumatologic disorders.
2:45
I got a lot of them that I can go through here.
2:50
She talked about the basis upon which these decisions are made and it's an extensive process.
2:56
First was the removal of REMS — risk management strategies — for mycophenolate.
3:01
The REMS happened with the introduction of mycophenolate, the problem being mycophenolate is a true teratogen and should not be used in pregnant women.
3:09
They showed that their efforts to get that information out there has led to very little mycophenolate being used in and around pregnancy.
3:20
Hence the removal of the REMS program for mycophenolate.
3:23
Next, JAK inhibitors being associated with hypoglycemia.
3:27
What? I didn't know about this. It's been really described with baricitinib, and these are patients who had RA, almost always with diabetes, often on higher doses of either tofacitinib or of JAK inhibitors, and they go hypoglycemic and their insulin requirements may change.
3:48
That's a new thing and it's made it into the warnings on the label for various JAK inhibitors.
3:55
So it says something like hypoglycemia being seen in patients with diabetes — check section five of your favorite JAK inhibitor.
4:05
A few other things before I get to the big thing.
4:10
They did publish the long-term safety update and the risk for VTE events with baricitinib.
4:15
You know, that's the RA-BRANCH and whatnot study that was presented at EULAR, was withdrawn from being presented here at ACR for unclear reasons, but it's in the label.
4:25
The risk of DVTs with baricitinib. PML being associated with tofacitinib — that's been reported.
4:34
Fractures being possibly slightly increased with the use of tofacitinib.
4:41
Stevens-Johnson syndrome and TEN being associated with belimumab, and that's been added to the label for belimumab.
4:51
Bisphosphonates — they wanted to change the labeling and the safety warning about atypical femoral shaft fractures.
5:03
They changed that because now it's a number of bones; it's not just the hip and long bones that have that problem. So they changed that.
5:13
And then ustekinumab — some serious hypersensitivity reactions including anaphylaxis in patients who also have the alpha-gal syndrome.
5:24
If you've had alpha-gal and you get ustekinumab, there's a risk of anaphylaxis. That's a new thing and really crazy.
5:31
I want to end with the FDA actually putting up some positive, slightly positive information about use of allopurinol during pregnancy.
5:41
It's not definitive, it's not a study, but they now have reports that were required by the company to come forward, and that's changed in the label for allopurinol.
5:53
The big news, I think, is really what's going on with avacopan.
5:58
The director of the arthritis division of the FDA said they've already come out, made several announcements, made several analyses that they believe the safety of the drug may not be as was originally intended, and that some of the primary endpoints are no longer considered effective.
6:19
They've requested in the Federal Register that the drug be withdrawn.
6:23
The maker of the drug — used to be ChemoCentryx, now it's Amgen — has petitioned the FDA to have a hearing on this.
6:30
They are going through the withdrawal process at the FDA.
6:35
They've said over and over, strongly: we do not believe the drug should be on the market.
6:38
It's been removed from the market by the EMA.
6:42
It's been halted for use in the UK. The ADVOCATE study was retracted from the New England Journal. It's not a good story.
6:51
And interestingly, since the FDA has had their campaign to withdraw this drug — based on wrong data from the ADVOCATE trial, and that started in January of 2026 — there have been reports about continued real-world use, and you know, they're not damning.
7:10
There's not a lot of liver disease. The vanishing bile duct syndrome has largely been seen only in Japan and not here.
7:17
So the question is: what is the FDA going to do to get to a withdrawal of this drug from the market?
7:25
They're in process of doing it. They got to the microphone and said, we are in process — don't ask us about what we're doing, you'll find out when we're done — and ultimately it's going to be the decision of the FDA commissioner.
7:39
A lot of interesting stuff on safety here at ACR 2026. Tune in for more on RheumNow.
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