2025 Rheumatology Year in Review Save
Transcription
It's the 16th of January, 2026, and this is the RheumNow year in review. This is going to be a long one. Obviously, there's a lot to cover on all the great things that happened in 2025, hence the 2025 year in review. I want to remind you that RheumNow Live is coming. RheumNow Live, we've been running, this is our eighth year. I want to tell you why RheumNow Live is different than other CME meetings. I know you go to a lot of CME meetings and it's great to go to them. I go to a lot of them as well. I really appreciate them. But I can tell you that I want you to come to RheumNow Live because it's a good CME. But when you come, I want you to walk away saying, "You know what? That meeting was different. That was kind of cool." So in addition to having like great speakers, look at the agenda. Great topics. Look at the agenda. I think we have things that you won't find anywhere else. Top five reasons why RheumNow Live should be your meeting. Number one, better than any other meeting, we have shorter lectures. Our lectures are not an hour, they're a half hour. Wait, they're not a half hour. They're 25 minutes. Shorter lectures mean more time for Q&A. We have about 40% of our time is for Q&A and discussions with the faculty. It's really incredible in that regard. Moreover, we've got a bunch of these step talks. These are like TED talks, shorter talks that are mini lectures or meant to be inspirational. And the ones we have this year are just fabulous.
Number two, when you register, you have full access to all the materials. You can download the slides. You can download the podcasts and listen to them. You get full access to all the meeting materials either before the meeting, after the meeting. There's pre-meeting reads that you should get and can round out your education.
Number three, we've got a killer reception. Not on one night, but on Friday night when you get there. And on Saturday night, for those of you that are going to watch from home, sorry, you're not invited. For those of you that are going to be there, it's great. It's fun. Saturday night, we have live entertainment with a concert by Colin Boyd, a friend, a real good favorite Texas performer, a sort of like a favorite of Artie Kavanaugh and Jack Cush.
Number four, you can attend on site and there'll be about 150, 160 people on site and there's going to be about 300 or 350 or more that are going to be online. If you're on site, you'll get to meet our pre-learn director, Mike Putman, who's running our pre-learns. If you're online, you'll be sort of guided and shepherded by Dr. Janet Pope with the online virtual presentation.
And number five, if you register, you have access to our review questions from the meeting. And if you register for this year, we'll give you our review questions, aka board questions, from the last two meetings, about 150 in each data set. These are good practice questions and you can find out your own score. Five good reasons to attend RheumNow Live — registration at rheumnow.live. Go there now.
2025 year in review. The year in review can be put together in a lot of different ways. You know, we're looking to cover groundbreaking new drugs and new indications, drug developments, guidelines, changes in practice. There are a lot of ways to go about this. You know, RheumNow, as you know, sort of every July, every December, we give you a best of listing. Those are things that are hot, things that you like, things that you liked that we covered this year that should be on your list. The VEXUS syndrome, methotrexate — you love things about methotrexate — vitamin D and disease prevention, steroids and lupus, that whole thing is changing, contraception and lupus and reproductive guidelines, and the new European and EULAR guidelines for CTD-related ILD.
Another great source of learning about what's happening in rheumatology is to go to ACR Convergence. You know, one of the things that I dreamed up when I was on the planning committee was the year in review where you had a leader in rheumatology from basic science and from practice give you their top 10 things. This year it was Anne Davidson from New York and Brian England from Nebraska and they gave you their highlight choices. That included the pediatric COPA syndrome, advances in mRNA vaccines, T-cell therapies, predicting risk through single-cell proteomics, AI-assisted drug development. And then Brian covered things like low yield of routine lab testing in RA, modest benefits with the novel new indication of vagal nerve stimulation, a dual — another second dual IL-17A/F inhibitor, the first one being bimekizumab, now we have sonelokimab — a nanobody inhibitor, treatment advances in Sjögren's are really bouncing right now, a new anti-CD20 drug was approved, obinutuzumab for lupus nephritis, and iptacopan being approved for use in giant cell arteritis — that made his top 10 list. You know, I do my own list and my own list is a
less unscientific but then again I'm watching the news day to day every 365 days. And here's my list of the top 12 things that you should be aware of.
FDA indications. I always lead with this. This year, the FDA was down a few drugs, approving only 46 new drugs. This is down from 50 in 2024. It's been going down every year for the last few years. Most of these are small molecules. 14 of these were in oncology indications. 26 for orphan diseases. There were five new cellular or gene therapies. And that's down from 9 in 2024.
There's no big rheumatology drug that was approved, but there are a number of drugs that are related to rheumatology that were newly approved compounds. This includes narendomalas. Its trade name is Jaside — this was approved for idiopathic pulmonary fibrosis. Rembrin and Rzza brutinib. These look like BTK inhibitors for urticaria and chronic ITP respectively. A new drug I'm not familiar with, alotrammon, that's the generic, and Trip is a new drug for dry eye disease. Nipocalimab from J&J, its trade name is Amovi — Amma with two A's — was approved for myasthenia gravis this year. And a new non-opioid pain medicine with a long-acting effect being used for severe acute pain is called suzetrigine, or Jouax.
Now there were several new FDA approvals — new indications. One sort of big news was a device indication from SetPoint on its vagal nerve stimulator. It's indicated in patients with moderate to severe RA who have failed a biologic. This was a 242-patient trial, one-year trial, called the RESET RA trial, showing that it was better than sham implants into the neck. Now, this is not auricular vagal nerve. This is an implanted vagal nerve stimulator. And its value is of course that it's not minimally invasive — it's outpatient, it's non-medicinal, it's neuroimmune modulation, and the implanted device can last for 10 years. We need data to see how it goes because we only have the one trial.
The other new indications of previously approved drugs that will affect rheumatology: as I said earlier, obinutuzumab, called Gazyva, for lupus nephritis, comes from Roche and Genentech, was approved in October based on the phase 2 NOBILITY trial and the phase 3 REGENCY studies showing significant improvement in lupus outcomes — lupus renal endpoints, proteinuria, and reduced steroid use. It does look good. A lot of excitement in the lupus community about this. I've made a lot of fun of all of you who've used rituximab, which failed in lupus by the way. Now I can't make fun of you if you use this other anti-CD20 monoclonal antibody.
Guselkumab, the IL-23 inhibitor called Tremfya, was approved this year for use in children with either moderate to severe plaque psoriasis or active psoriatic arthritis — children over age six. As you know, upadacitinib — last year Rinvoq was approved for GCA; this year it was approved for active ulcerative colitis.
Emapalumab — I talked about that many times in the past — is an anti-interferon gamma monoclonal antibody previously approved for HLH, now approved for macrophage activation syndrome or HLH related to Still's disease in both kids and adults. That was approved in June.
Inebilizumab — this was a B-cell inhibitor also approved this year for generalized myasthenia gravis, but it has to be in people who have antibodies associated with myasthenia gravis, including acetylcholine receptor antibody.
Tonmya is sublingual cyclobenzaprine — the first new FDA approval in 15 years for fibromyalgia. It's cyclobenzaprine, it's meant to manage non-restorative sleep problems, and it's now on the market.
So the other big thing about drugs is that we're going to lose a few drugs coming up, and a lot of this relates to — you got a drug, it works, you fight the fight to keep the patent alive and get a patent extension on that. Such was the case with adalimumab for many many years. That went off patent and now we've got like nine adalimumab biosimilars. So again the rheumatology landscape is going to change. Future victims are probably going to be Enbrel, tofacitinib, and golimumab. Tofacitinib is definitely going to lose its patent this year and you're going to start seeing generic tofacitinib hitting the market.
But in 2025, denosumab went off patent and there are at least two if not three biosimilars — not biosimilars, generics — no, they're biosimilars that are available for the infusible denosumab or Prolia. I see three here that I've listed in the article.
Ustekinumab, as you know, has got many indications, and this year I think three or four new ustekinumab biosimilars entered the market with the same indications — Crohn's, psoriasis, psoriatic arthritis, ulcerative colitis.
Okay, my next category is B-cell targeted therapies are really shining. There's a lot of development in B-cell drugs, and this is different — you
know when I started biologics and clinical trials back in the late 80s — started doing clinical trials in 1984, and then mostly non-steroidal trials and a few DMARD trials — and started doing biologics I think it was around 87 or so or somewhere around there. We were focused on first on T-cells and later it was on cytokines and then the other subsets. You know, now we've got a lot of B-cell therapies. Here are the ones that are in the news, that are in studies, some that actually got approved.
Obexelimab, as we said, is an anti-CD20 approved for lupus nephritis and is already being used with great efficacy in oncology for hematologic malignancies. Ublituximab — ublituximab is the trade name — is a monoclonal antibody that's currently being used for neuromyelitis optica. It's also been approved for use in IgG4-related disease and had recent FDA approval for generalized myasthenia gravis.
Ianalumab — I-N-A-L-U-M-ab — got a lot of positive reports. Pre-clinical — I mean sort of the phase 2 data on lupus looked good. Phase 2 on Sjögren's looked good. This year they had two phase 3 trials that read out as a positive result: the NEPTUNE 1 and NEPTUNE 2 trials in Sjögren's syndrome — Sjögren's disease, excuse me — and that's now got a breakthrough accelerated approval process that will be reviewed by the FDA maybe by April of 2026.
Telitacicept made its way into the news in a New England Journal article that was published this year. This is a dual blocker of B-cells — both BLYS and APRIL — shown to have efficacy in lupus, and that's encouraging.
And of course there are numerous B-cell-targeted CAR T-cell therapies. You know, there's like 50 to 100 of them in development. There's no real data yet, so I'm not going to talk about it. We're 3 to 5 years away from significant CAR T-cell data that will be meaningful, reliable, and we can truly talk about with either gusto or disgust. Let's wait and see.
My next category is again the GLP-1s and the cardiometabolic and anti-inflammatory effects of these diabetes drugs — mainly the GLP-1 receptor agonists as well as the SGLT2 inhibitors, the sodium-glucose cotransporter 2 inhibitors. Both of these drugs, when given for diabetes, have been shown to cause weight loss — more with GLP-1 than SGLT2 — and have reduced cardiovascular deaths, which is good news, and seem to show some benefits when they're used in our patients, including knee osteoarthritis, gout, RA, PsA, and lupus.
There are now future trials in progress where these drugs are going to be used alongside your arthritis drugs to see: do they do the same thing in clinical trials as opposed to observational data, which has been reported before. So there are good trials with the SGLT2 drugs that show not just cardioprotective and nephroprotective effects and weight loss, but they've been linked to the prevention of developing autoimmune disease and having better outcomes, especially in lupus nephritis. Now again, these are not well-designed clinical trials head-to-head. These are observational trials — Trinetix, EHR, large data trials that are prone to bias and whatnot.
The GLP-1s — the same thing. Largely observational studies. You know, a retrospective analysis of 2,500 RA patients on JAK inhibitors: half of them go on a GLP-1, the other half not. And guess what? The GLP-1s have less coronary artery syndromes, MI, less DVTs, but no difference in survival. Other GLP-1 studies have shown significant differences in survival. So again, we're looking for — and then a few good reports this year — well-designed trials of GLP-1 drugs showing benefit in both knee osteoarthritis, rheumatoid arthritis, and also psoriatic arthritis.
Category five on my list is the expanding role of TYK2 drugs. As you know, TYK2 is part of the Janus kinase family — there's JAK1, 2, and 3, and then TYK2. The good news is that these are being developed largely in psoriatic disease, but also there are trials going — and that means both psoriasis, where for instance deucravacitinib is approved in psoriasis and may get approved in 2026 for psoriatic arthritis — but they're also being studied in other conditions: inflammatory bowel disease, Sjögren's syndrome, dermatomyositis, and uveitis.
So as I said, deucravacitinib, based on the data — the phase 3 POET-TK PsA1 trial — showed significant benefits in psoriatic arthritis joint and skin outcomes. Good ACR20s at week 16: 54% on deucravacitinib versus 34% on placebo. This is up for FDA decision this year.
On its heels is another TYK2 inhibitor, zasocitinib — with a Z — shown effective in a phase 2 trial, two different doses versus placebo. Week 12 looked great: 54 and 53% responses versus 29% in placebo. Again, we'll see more TYK2 development going forward.
Category six: lessons learned from the COVID pandemic. I keep asking people, what do you learn from the COVID pandemic? I'm just glad it's over. I wish it never happened. That was a miserable time. I'm going to give you some
reminders here that there were important lessons from the pandemic that could shape your future. Five years later there's still a flood of data coming in from COVID. So I'm going to start with I think the main benefit during COVID — you learned how to do telemedicine, you got good at telemedicine or you got okay at telemedicine, and since COVID is over you've all abandoned telemedicine. What are you thinking? It's a tremendous addition to your practice for your patients. We have again — you've heard about this horrible manpower issue. How are you going to manage it on your end? I think telemedicine is an important part and you are built to do it. COVID telemedicine — great. I can't do a joint exam. Look at my YouTube video on how to do a joint exam over the virtual visit. Your diagnosis, your decisions are rooted in pattern recognition and data. You don't need to be in the office to collect data. So again, that's what we learned during COVID, but no one's now doing it.
Other things — autoimmune rheumatic disease patients were at higher risk. They had worse outcomes when it came to COVID-19 infection, especially patients that were on rituximab, maybe mycophenolate, and certainly high-dose steroids had worse COVID outcomes. There's basically no evidence that COVID infection or the COVID vaccine increase the risk of autoimmune disease or the severity of pre-existing autoimmune disease. There's some reports saying occasionally, but when you look at all the data, not really. Meaning that you had your patients well controlled, which was another lesson from COVID — patients who were well controlled on your drugs could stay on your drugs despite a severe infection. The only drugs that I mentioned that they probably shouldn't be on is rituximab, mycophenolate, high-dose steroids.
So again that's the sort of — we also have this other issue for which we're concerned about, and that's long COVID. A lot of research about this. There are a lot of insights into the fact that maybe an infection triggered immune dysregulation that could result in long-term consequences. These people have a myriad of symptoms. I'm sorry, when I look at it, it's all fibromyalgia to me. Not everybody agrees with me, but there's a lot of research going on about long COVID. And by the way, this phenomenon was also noted in other viral infections noted in the past.
And then lastly, the emergence of the MIS-C pediatric disorder showing similarities and significant differences between it and Kawasaki syndrome — Kawasaki being more important in children, the MIS-C being more important in adolescents, and a lot of other lessons about treatment and whatnot.
Number seven on my list, nurse practitioners and physician assistants. Big roles, big futures. As you know, in December on RheumNow, we did a big thing about NPs and PAs. I want you to look at that. I want you to look at the data. They're going to be very important in our future and in meeting the needs of a manpower shortage. The challenges going forward are training, independence, and how they practice at your site, retention, and education.
Number eight on my list, new guidelines for lupus. In 2024, we saw the lupus nephritis guidelines. But in 2025, we had the non-renal lupus guidelines presented at the ACR meeting where there were guidelines — mainly 65 recommendations. They're all conditional expert opinion except for three, but guidelines specifically on mucocutaneous, musculoskeletal, serositis, hematologic, neuropsychiatric, cardiac, vasculitis. There were again three strong recommendations. One being everybody's got to be on hydroxychloroquine, two to wean off steroids or get off steroids, and three, if they're not doing well on a DMARD, you need to change and escalate your DMARD therapy.
There were also 2025 EULAR updated recommendations on the management of lupus nephritis where they basically said the standard of care has changed from mycophenolate and steroids to now involving other new therapies like voclosporin, belimumab, and anifrolumab, and now obinutuzumab being FDA approved. They advocate strongly for renal biopsy and quadruple therapy with glucocorticoids, hydroxychloroquine, and an immunosuppressant or a biologic or calcineurin inhibitor. Immunosuppressant — mycophenolate or cyclophosphamide. Calcineurin inhibitor as you know is voclosporin, cyclosporin, tacrolimus. Voclosporin makes sense to me.
Number nine, gene therapy for osteoarthritis. Osteoarthritis is sort of the stepchild of rheumatology. Tons of them and we got nothing for them. I like these studies although they're very early. Phase one/two trials, three new compounds using gene therapy delivering IL-1 receptor antagonist as anti-inflammatory therapy with a viral vector or other vectors intra-articularly into the joint. And you know what? IL-1 gets
continues to get produced inside the joint for a long period of time. The early data shows safety. Their early efficacy data shows efficacy. Three different makers of this as best I know. This is exciting.
Number 10, ILD was big this year. We did a campaign on it back in September. The big news is that we had a bunch of guidelines coming from the American Thoracic Society. We had the previous ACR guidelines and the new EULAR European guidelines that were really important and different, with really specific guidelines for each of the autoimmune diseases associated with ILD — that includes scleroderma, RA, myositis, Sjögren's, lupus, and MCTD. They were big on saying these people need to have screening high-res CTs and be followed up with high-res CTs if they have disease. They tell us about when to use immunosuppressives and when to use these new anti-fibrotic therapies — nintedanib, pirfenidone, and the new one nerandomilast. The big study I think this year was the New England Journal with the FIBRONEER trial, which was a study in IPF and ILD using nerandomilast showing efficacy over placebo, with efficacy mainly being stabilization and a slowing of the FVC decline in patients with autoimmune-related progressive ILD.
My last two items are AI advances in rheumatology. If you haven't noticed it, then you mustn't be going to work. It's there. It's making a big difference. The world is split in medicine about whether this is a big advance or not. You're either part of the future or you're going to be left behind in the past. You know, you don't know what you don't know — that's where you're going to stay. I think you need to be using AI. We're using a lot of AI on RheumNow. I like the Meiro system. That's a video thing that shows you movement of fingers and actually digitizes it and can tell you when there's a change visit to visit. Large language model AI is being applied to large data sets, especially EMRs and systems, to identify new patients before they've been diagnosed, get them referred, and get them treated earlier — enroll them in clinical trials that are hard to enroll. I hear lupus trials are really, really hard to enroll because they've been in all the trials and we now have to go overseas to do our trials. Not if you're using AI to identify new lupus patients who could be in trials.
Ambient dictation documentation — you just go in the room and you look the patient in the eye and you talk to them, and you know Siri's up there recording your visit and sending it back to you for approval and signage after the visit. Major advance — will make a big difference when it comes to your administrative burden and your rising risk of burnout. There are challenges about adoption. Three-quarters of you have never used AI in practice. How to integrate it into your practice? What's the accuracy of AI? Especially you're worried about hallucinations. There are concerns about privacy, security, and costs that are going to get better as time goes on.
And lastly, I'd say there were a lot of new guidelines in rheumatology that were exciting this year. There are guidelines in renal lupus, non-renal lupus, ILD from multiple societies. And then there were single society guidelines on Still's disease from EULAR, from BSR — the British Society of Rheumatology — doing a lot of good guidelines on ANCA-associated vasculitis including GPA, MPA, and EGPA, axial spondyloarthritis, the use of conventional DMARDs and monitoring of conventional DMARDs. There are guidelines on perioperative DMARD use, drug monitoring, JIA in general and Still's disease as well, and then there are also EULAR guidelines on reproductive health that came out in 2025. A real busy year. You've been a real busy rheumatologist. Come to RheumNow Live. We'll see you there.
Number two, when you register, you have full access to all the materials. You can download the slides. You can download the podcasts and listen to them. You get full access to all the meeting materials either before the meeting, after the meeting. There's pre-meeting reads that you should get and can round out your education.
Number three, we've got a killer reception. Not on one night, but on Friday night when you get there. And on Saturday night, for those of you that are going to watch from home, sorry, you're not invited. For those of you that are going to be there, it's great. It's fun. Saturday night, we have live entertainment with a concert by Colin Boyd, a friend, a real good favorite Texas performer, a sort of like a favorite of Artie Kavanaugh and Jack Cush.
Number four, you can attend on site and there'll be about 150, 160 people on site and there's going to be about 300 or 350 or more that are going to be online. If you're on site, you'll get to meet our pre-learn director, Mike Putman, who's running our pre-learns. If you're online, you'll be sort of guided and shepherded by Dr. Janet Pope with the online virtual presentation.
And number five, if you register, you have access to our review questions from the meeting. And if you register for this year, we'll give you our review questions, aka board questions, from the last two meetings, about 150 in each data set. These are good practice questions and you can find out your own score. Five good reasons to attend RheumNow Live — registration at rheumnow.live. Go there now.
2025 year in review. The year in review can be put together in a lot of different ways. You know, we're looking to cover groundbreaking new drugs and new indications, drug developments, guidelines, changes in practice. There are a lot of ways to go about this. You know, RheumNow, as you know, sort of every July, every December, we give you a best of listing. Those are things that are hot, things that you like, things that you liked that we covered this year that should be on your list. The VEXUS syndrome, methotrexate — you love things about methotrexate — vitamin D and disease prevention, steroids and lupus, that whole thing is changing, contraception and lupus and reproductive guidelines, and the new European and EULAR guidelines for CTD-related ILD.
Another great source of learning about what's happening in rheumatology is to go to ACR Convergence. You know, one of the things that I dreamed up when I was on the planning committee was the year in review where you had a leader in rheumatology from basic science and from practice give you their top 10 things. This year it was Anne Davidson from New York and Brian England from Nebraska and they gave you their highlight choices. That included the pediatric COPA syndrome, advances in mRNA vaccines, T-cell therapies, predicting risk through single-cell proteomics, AI-assisted drug development. And then Brian covered things like low yield of routine lab testing in RA, modest benefits with the novel new indication of vagal nerve stimulation, a dual — another second dual IL-17A/F inhibitor, the first one being bimekizumab, now we have sonelokimab — a nanobody inhibitor, treatment advances in Sjögren's are really bouncing right now, a new anti-CD20 drug was approved, obinutuzumab for lupus nephritis, and iptacopan being approved for use in giant cell arteritis — that made his top 10 list. You know, I do my own list and my own list is a
less unscientific but then again I'm watching the news day to day every 365 days. And here's my list of the top 12 things that you should be aware of.
FDA indications. I always lead with this. This year, the FDA was down a few drugs, approving only 46 new drugs. This is down from 50 in 2024. It's been going down every year for the last few years. Most of these are small molecules. 14 of these were in oncology indications. 26 for orphan diseases. There were five new cellular or gene therapies. And that's down from 9 in 2024.
There's no big rheumatology drug that was approved, but there are a number of drugs that are related to rheumatology that were newly approved compounds. This includes narendomalas. Its trade name is Jaside — this was approved for idiopathic pulmonary fibrosis. Rembrin and Rzza brutinib. These look like BTK inhibitors for urticaria and chronic ITP respectively. A new drug I'm not familiar with, alotrammon, that's the generic, and Trip is a new drug for dry eye disease. Nipocalimab from J&J, its trade name is Amovi — Amma with two A's — was approved for myasthenia gravis this year. And a new non-opioid pain medicine with a long-acting effect being used for severe acute pain is called suzetrigine, or Jouax.
Now there were several new FDA approvals — new indications. One sort of big news was a device indication from SetPoint on its vagal nerve stimulator. It's indicated in patients with moderate to severe RA who have failed a biologic. This was a 242-patient trial, one-year trial, called the RESET RA trial, showing that it was better than sham implants into the neck. Now, this is not auricular vagal nerve. This is an implanted vagal nerve stimulator. And its value is of course that it's not minimally invasive — it's outpatient, it's non-medicinal, it's neuroimmune modulation, and the implanted device can last for 10 years. We need data to see how it goes because we only have the one trial.
The other new indications of previously approved drugs that will affect rheumatology: as I said earlier, obinutuzumab, called Gazyva, for lupus nephritis, comes from Roche and Genentech, was approved in October based on the phase 2 NOBILITY trial and the phase 3 REGENCY studies showing significant improvement in lupus outcomes — lupus renal endpoints, proteinuria, and reduced steroid use. It does look good. A lot of excitement in the lupus community about this. I've made a lot of fun of all of you who've used rituximab, which failed in lupus by the way. Now I can't make fun of you if you use this other anti-CD20 monoclonal antibody.
Guselkumab, the IL-23 inhibitor called Tremfya, was approved this year for use in children with either moderate to severe plaque psoriasis or active psoriatic arthritis — children over age six. As you know, upadacitinib — last year Rinvoq was approved for GCA; this year it was approved for active ulcerative colitis.
Emapalumab — I talked about that many times in the past — is an anti-interferon gamma monoclonal antibody previously approved for HLH, now approved for macrophage activation syndrome or HLH related to Still's disease in both kids and adults. That was approved in June.
Inebilizumab — this was a B-cell inhibitor also approved this year for generalized myasthenia gravis, but it has to be in people who have antibodies associated with myasthenia gravis, including acetylcholine receptor antibody.
Tonmya is sublingual cyclobenzaprine — the first new FDA approval in 15 years for fibromyalgia. It's cyclobenzaprine, it's meant to manage non-restorative sleep problems, and it's now on the market.
So the other big thing about drugs is that we're going to lose a few drugs coming up, and a lot of this relates to — you got a drug, it works, you fight the fight to keep the patent alive and get a patent extension on that. Such was the case with adalimumab for many many years. That went off patent and now we've got like nine adalimumab biosimilars. So again the rheumatology landscape is going to change. Future victims are probably going to be Enbrel, tofacitinib, and golimumab. Tofacitinib is definitely going to lose its patent this year and you're going to start seeing generic tofacitinib hitting the market.
But in 2025, denosumab went off patent and there are at least two if not three biosimilars — not biosimilars, generics — no, they're biosimilars that are available for the infusible denosumab or Prolia. I see three here that I've listed in the article.
Ustekinumab, as you know, has got many indications, and this year I think three or four new ustekinumab biosimilars entered the market with the same indications — Crohn's, psoriasis, psoriatic arthritis, ulcerative colitis.
Okay, my next category is B-cell targeted therapies are really shining. There's a lot of development in B-cell drugs, and this is different — you
know when I started biologics and clinical trials back in the late 80s — started doing clinical trials in 1984, and then mostly non-steroidal trials and a few DMARD trials — and started doing biologics I think it was around 87 or so or somewhere around there. We were focused on first on T-cells and later it was on cytokines and then the other subsets. You know, now we've got a lot of B-cell therapies. Here are the ones that are in the news, that are in studies, some that actually got approved.
Obexelimab, as we said, is an anti-CD20 approved for lupus nephritis and is already being used with great efficacy in oncology for hematologic malignancies. Ublituximab — ublituximab is the trade name — is a monoclonal antibody that's currently being used for neuromyelitis optica. It's also been approved for use in IgG4-related disease and had recent FDA approval for generalized myasthenia gravis.
Ianalumab — I-N-A-L-U-M-ab — got a lot of positive reports. Pre-clinical — I mean sort of the phase 2 data on lupus looked good. Phase 2 on Sjögren's looked good. This year they had two phase 3 trials that read out as a positive result: the NEPTUNE 1 and NEPTUNE 2 trials in Sjögren's syndrome — Sjögren's disease, excuse me — and that's now got a breakthrough accelerated approval process that will be reviewed by the FDA maybe by April of 2026.
Telitacicept made its way into the news in a New England Journal article that was published this year. This is a dual blocker of B-cells — both BLYS and APRIL — shown to have efficacy in lupus, and that's encouraging.
And of course there are numerous B-cell-targeted CAR T-cell therapies. You know, there's like 50 to 100 of them in development. There's no real data yet, so I'm not going to talk about it. We're 3 to 5 years away from significant CAR T-cell data that will be meaningful, reliable, and we can truly talk about with either gusto or disgust. Let's wait and see.
My next category is again the GLP-1s and the cardiometabolic and anti-inflammatory effects of these diabetes drugs — mainly the GLP-1 receptor agonists as well as the SGLT2 inhibitors, the sodium-glucose cotransporter 2 inhibitors. Both of these drugs, when given for diabetes, have been shown to cause weight loss — more with GLP-1 than SGLT2 — and have reduced cardiovascular deaths, which is good news, and seem to show some benefits when they're used in our patients, including knee osteoarthritis, gout, RA, PsA, and lupus.
There are now future trials in progress where these drugs are going to be used alongside your arthritis drugs to see: do they do the same thing in clinical trials as opposed to observational data, which has been reported before. So there are good trials with the SGLT2 drugs that show not just cardioprotective and nephroprotective effects and weight loss, but they've been linked to the prevention of developing autoimmune disease and having better outcomes, especially in lupus nephritis. Now again, these are not well-designed clinical trials head-to-head. These are observational trials — Trinetix, EHR, large data trials that are prone to bias and whatnot.
The GLP-1s — the same thing. Largely observational studies. You know, a retrospective analysis of 2,500 RA patients on JAK inhibitors: half of them go on a GLP-1, the other half not. And guess what? The GLP-1s have less coronary artery syndromes, MI, less DVTs, but no difference in survival. Other GLP-1 studies have shown significant differences in survival. So again, we're looking for — and then a few good reports this year — well-designed trials of GLP-1 drugs showing benefit in both knee osteoarthritis, rheumatoid arthritis, and also psoriatic arthritis.
Category five on my list is the expanding role of TYK2 drugs. As you know, TYK2 is part of the Janus kinase family — there's JAK1, 2, and 3, and then TYK2. The good news is that these are being developed largely in psoriatic disease, but also there are trials going — and that means both psoriasis, where for instance deucravacitinib is approved in psoriasis and may get approved in 2026 for psoriatic arthritis — but they're also being studied in other conditions: inflammatory bowel disease, Sjögren's syndrome, dermatomyositis, and uveitis.
So as I said, deucravacitinib, based on the data — the phase 3 POET-TK PsA1 trial — showed significant benefits in psoriatic arthritis joint and skin outcomes. Good ACR20s at week 16: 54% on deucravacitinib versus 34% on placebo. This is up for FDA decision this year.
On its heels is another TYK2 inhibitor, zasocitinib — with a Z — shown effective in a phase 2 trial, two different doses versus placebo. Week 12 looked great: 54 and 53% responses versus 29% in placebo. Again, we'll see more TYK2 development going forward.
Category six: lessons learned from the COVID pandemic. I keep asking people, what do you learn from the COVID pandemic? I'm just glad it's over. I wish it never happened. That was a miserable time. I'm going to give you some
reminders here that there were important lessons from the pandemic that could shape your future. Five years later there's still a flood of data coming in from COVID. So I'm going to start with I think the main benefit during COVID — you learned how to do telemedicine, you got good at telemedicine or you got okay at telemedicine, and since COVID is over you've all abandoned telemedicine. What are you thinking? It's a tremendous addition to your practice for your patients. We have again — you've heard about this horrible manpower issue. How are you going to manage it on your end? I think telemedicine is an important part and you are built to do it. COVID telemedicine — great. I can't do a joint exam. Look at my YouTube video on how to do a joint exam over the virtual visit. Your diagnosis, your decisions are rooted in pattern recognition and data. You don't need to be in the office to collect data. So again, that's what we learned during COVID, but no one's now doing it.
Other things — autoimmune rheumatic disease patients were at higher risk. They had worse outcomes when it came to COVID-19 infection, especially patients that were on rituximab, maybe mycophenolate, and certainly high-dose steroids had worse COVID outcomes. There's basically no evidence that COVID infection or the COVID vaccine increase the risk of autoimmune disease or the severity of pre-existing autoimmune disease. There's some reports saying occasionally, but when you look at all the data, not really. Meaning that you had your patients well controlled, which was another lesson from COVID — patients who were well controlled on your drugs could stay on your drugs despite a severe infection. The only drugs that I mentioned that they probably shouldn't be on is rituximab, mycophenolate, high-dose steroids.
So again that's the sort of — we also have this other issue for which we're concerned about, and that's long COVID. A lot of research about this. There are a lot of insights into the fact that maybe an infection triggered immune dysregulation that could result in long-term consequences. These people have a myriad of symptoms. I'm sorry, when I look at it, it's all fibromyalgia to me. Not everybody agrees with me, but there's a lot of research going on about long COVID. And by the way, this phenomenon was also noted in other viral infections noted in the past.
And then lastly, the emergence of the MIS-C pediatric disorder showing similarities and significant differences between it and Kawasaki syndrome — Kawasaki being more important in children, the MIS-C being more important in adolescents, and a lot of other lessons about treatment and whatnot.
Number seven on my list, nurse practitioners and physician assistants. Big roles, big futures. As you know, in December on RheumNow, we did a big thing about NPs and PAs. I want you to look at that. I want you to look at the data. They're going to be very important in our future and in meeting the needs of a manpower shortage. The challenges going forward are training, independence, and how they practice at your site, retention, and education.
Number eight on my list, new guidelines for lupus. In 2024, we saw the lupus nephritis guidelines. But in 2025, we had the non-renal lupus guidelines presented at the ACR meeting where there were guidelines — mainly 65 recommendations. They're all conditional expert opinion except for three, but guidelines specifically on mucocutaneous, musculoskeletal, serositis, hematologic, neuropsychiatric, cardiac, vasculitis. There were again three strong recommendations. One being everybody's got to be on hydroxychloroquine, two to wean off steroids or get off steroids, and three, if they're not doing well on a DMARD, you need to change and escalate your DMARD therapy.
There were also 2025 EULAR updated recommendations on the management of lupus nephritis where they basically said the standard of care has changed from mycophenolate and steroids to now involving other new therapies like voclosporin, belimumab, and anifrolumab, and now obinutuzumab being FDA approved. They advocate strongly for renal biopsy and quadruple therapy with glucocorticoids, hydroxychloroquine, and an immunosuppressant or a biologic or calcineurin inhibitor. Immunosuppressant — mycophenolate or cyclophosphamide. Calcineurin inhibitor as you know is voclosporin, cyclosporin, tacrolimus. Voclosporin makes sense to me.
Number nine, gene therapy for osteoarthritis. Osteoarthritis is sort of the stepchild of rheumatology. Tons of them and we got nothing for them. I like these studies although they're very early. Phase one/two trials, three new compounds using gene therapy delivering IL-1 receptor antagonist as anti-inflammatory therapy with a viral vector or other vectors intra-articularly into the joint. And you know what? IL-1 gets
continues to get produced inside the joint for a long period of time. The early data shows safety. Their early efficacy data shows efficacy. Three different makers of this as best I know. This is exciting.
Number 10, ILD was big this year. We did a campaign on it back in September. The big news is that we had a bunch of guidelines coming from the American Thoracic Society. We had the previous ACR guidelines and the new EULAR European guidelines that were really important and different, with really specific guidelines for each of the autoimmune diseases associated with ILD — that includes scleroderma, RA, myositis, Sjögren's, lupus, and MCTD. They were big on saying these people need to have screening high-res CTs and be followed up with high-res CTs if they have disease. They tell us about when to use immunosuppressives and when to use these new anti-fibrotic therapies — nintedanib, pirfenidone, and the new one nerandomilast. The big study I think this year was the New England Journal with the FIBRONEER trial, which was a study in IPF and ILD using nerandomilast showing efficacy over placebo, with efficacy mainly being stabilization and a slowing of the FVC decline in patients with autoimmune-related progressive ILD.
My last two items are AI advances in rheumatology. If you haven't noticed it, then you mustn't be going to work. It's there. It's making a big difference. The world is split in medicine about whether this is a big advance or not. You're either part of the future or you're going to be left behind in the past. You know, you don't know what you don't know — that's where you're going to stay. I think you need to be using AI. We're using a lot of AI on RheumNow. I like the Meiro system. That's a video thing that shows you movement of fingers and actually digitizes it and can tell you when there's a change visit to visit. Large language model AI is being applied to large data sets, especially EMRs and systems, to identify new patients before they've been diagnosed, get them referred, and get them treated earlier — enroll them in clinical trials that are hard to enroll. I hear lupus trials are really, really hard to enroll because they've been in all the trials and we now have to go overseas to do our trials. Not if you're using AI to identify new lupus patients who could be in trials.
Ambient dictation documentation — you just go in the room and you look the patient in the eye and you talk to them, and you know Siri's up there recording your visit and sending it back to you for approval and signage after the visit. Major advance — will make a big difference when it comes to your administrative burden and your rising risk of burnout. There are challenges about adoption. Three-quarters of you have never used AI in practice. How to integrate it into your practice? What's the accuracy of AI? Especially you're worried about hallucinations. There are concerns about privacy, security, and costs that are going to get better as time goes on.
And lastly, I'd say there were a lot of new guidelines in rheumatology that were exciting this year. There are guidelines in renal lupus, non-renal lupus, ILD from multiple societies. And then there were single society guidelines on Still's disease from EULAR, from BSR — the British Society of Rheumatology — doing a lot of good guidelines on ANCA-associated vasculitis including GPA, MPA, and EGPA, axial spondyloarthritis, the use of conventional DMARDs and monitoring of conventional DMARDs. There are guidelines on perioperative DMARD use, drug monitoring, JIA in general and Still's disease as well, and then there are also EULAR guidelines on reproductive health that came out in 2025. A real busy year. You've been a real busy rheumatologist. Come to RheumNow Live. We'll see you there.
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