Pharma/Regulatory

antibody (Keep)

NEJM: Obinutuzumab in Active Systemic Lupus Erythematosus

Jack Cush, MD

A phase 3 trial of obinutuzumab, an anti-CD20 monoclonal antibody, showed potent B-cell depletion and clinical efficacy active systemic lupus erythematosus without evidence of nephritis.

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Long-Term Hydroxychloroquine Retinopathy Risk

Jack Cush, MD

About one in 18 patients taking hydroxychloroquine (HCQ) for 15 years develop retinal damage, a new meta-analysis indicated.

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Update on FDA complete response letter to AZ regarding BLA hold for anifrolumab (Saphnelo) for SC use in SLE. CRL originally issued 10/10/25, but announced 2/3/26. FDA CRL cites critical data quality w/ key analyses in SC-TULIP study. A BLA decision expected in 1st half of 2026 https://t.co/zuwtsdL6I9
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Osteoporosis: Thinking outside the box Osteoporosis care keeps evolving. We have newer agents, newer sequencing strategies, and an increasing number of patients asking for “less medicinal” options that go beyond a prescription. https://t.co/1mGIrx8tm5 https://t.co/QVjeIwXESr

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Dr. John Cush @RheumNow( View Tweet )
Physician Assistant Workforce Grew 28% in USA (2020 To 2024), reaching 189,188 PAs; increased in every state (lease in Alaska 10%, most in SCarolina 48%,(to 2,984 in 2024). In 2024, there were 55.6 PAs/100,000 population https://t.co/VdXP3aM3ga https://t.co/qin2zfuUZe

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TYK2 Inhibitor Deucravacitinib FDA Approved for Psoriatic Arthritis

Jack Cush, MD

On Friday, March 6th, the FDA approved deucravacitinib (Sotyktu) for the treatment of adults with active psoriatic arthritis (PsA) based on the results of the pivotal Phase 3 POETYK PsA-1 and POETYK PsA-2 clinical trials. Deucravacitinib, an oral selective tyrosine kinase 2 (TYK2)
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FDA has approved deucravacitinib (Sotyktu) the Treatment of Adults with Active Psoriatic Arthritis based on the results of the pivotal Phase 3 POETYK PsA-1 and POETYK PsA-2 clinical trials. Sotyktu is the only tyrosine kinase 2 (TYK2) inhibitor to be approved for PsA https://t.co/8xBrgPfENH
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UBER Rheumatology Ride (3.6.2026)

Jack Cush, MD

Dr. Jack Cush reviews the news and journal reports from this week on RheumNow.com

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Open-label experience with upadacitinib in 27 Behcets pts (median 36 yrs) w/ median BDCAF 4 (2–7). At 6 mos overall response seen in 23/27 (85%) (16 CRs, 7 PRs) w/ signif reductions in BDCAF, CRP, ESR, & steroid dose by week 24. 3 pts relapsed during F/U https://t.co/VXkskVyWgT
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FDA has granted Fast Track designation to J&Js nipocalimab for use in #SLE based on the results of a Phase 2b JASMINE study in which nipocalimab demonstrated reduction in lupus disease activity and potential for steroid sparing https://t.co/puQN6ecScj https://t.co/au422eamLR

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Progress in GCA and Takayasu's Arteritis Despite carefully planned taper schedules, about 75% of GCA patients remain on glucocorticoids after 4 years, and 74% experience side effects. In rheumatology, prolonged steroid use often leads to expected toxicity. https://t.co/l65ER5rGU8
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CART

B cell Targeted CAR-T Therapy for Autoimmune Diseases

EurekAlert!

Chimeric antigen receptor T (CAR-T) cell therapy has emerged as a transformative approach in modern medicine, demonstrating remarkable efficacy in targeting pathogenic B-cell lineages with unprecedented specificity. Originally developed for B cell malignancies, this innovative immunotherapy

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Full read review of JAK inhibitors. JAK inhibitors have a reasonably rapid onset of action and a short half-life, which facilitates management of any adverse effects. The half-life of Tofacitinib, Baricitinib & Upadacitinib is 3 hrs, 13 hrs. & 9-14hrs. https://t.co/C9t2SQ3Juq
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Systematic Review of Targeted Rx for Systemic Sclerosis: from 32 RCTs & 2036 pts Rx w/ 23 targeted agents. Guselkumab had greatest effect on mRSS, followed by tofacitinib, inebilizumab, & baricitinib. For FVC, B-cell Rx (belimumab, RTX) had highest efficacy https://t.co/cXTQ2TWyHZ
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SATISFACTION (2.27.2026)

Jack Cush, MD

Dr. Jack Cush reviews the news and journal reports from this past week on RheumNow.com.

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A month ago the FDA Granted Breakthrough Designation to Ianalumab for Sjögren Disease . The drug targets BAFF and depletes B cells. Two recent positive RCTs (NEPTUNUS-1, NEPTUNUS-2). Novartis expects a regulatory decision in early 2026 https://t.co/PXVjGG1Cmd https://t.co/0s5livw1bg

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Dr. John Cush @RheumNow( View Tweet )
Danish DERMBIO registry of psoriasis pts Rx w/ biologics. Among 3790 bionaive pts ustekinumab had best 1-5 yr survival vs (ADA & SEC). In 3403 bioexperienced pts, bimekizumab, guselkumab, & risankizumab had highest 2-year drug survival rate. https://t.co/TInyLPMYkb https://t.co/UTPqa9erPU

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FDA Commissioner Marty Makary is seeking to make more drugs available without a prescription; and has stated “everything should be over-the-counter” unless the drug is addictive, unsafe, or requires monitoring. https://t.co/CGurlOWO8m https://t.co/bFwkpZ3kbn

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Dr. John Cush @RheumNow( View Tweet )
Full read review of JAK inhibitors. JAK inhibitors have a reasonably rapid onset of action and a short half-life, which facilitates management of any adverse effects. The half-life of Tofacitinib, Baricitinib & Upadacitinib is 3 hrs, 13 hrs. & 9-14hrs. https://t.co/jKO2LL2TVC
Dr. John Cush @RheumNow( View Tweet )
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Early vs Delayed Belimumab in Lupus

Jack Cush, MD

An economic evaluation of early vs delayed use of the Blys inhibitor, belimumab (BEL), in systemic lupus erythematosus (SLE) has shown both cost effectiveness and clinical utility of early BEL initiation in active lupus patients.

While most would advocate for using your best therapy

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Referral Rules to Live By (2.20.2026)

Jack Cush, MD

Dr. Jack Cush reviews the news and journal reports from this past week on RheumNow.com. Highlights include referral rules, combination biiologics in psoriasis and don't use JAK inhibitors in pregnancy.

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Population survey of 21 000 US adults, 62.3% reported recent use of any OTC or prescription meds. Past-7-day prevalence of any OTC medication was equal to RX med use (46%) and increased use with age among both male and female individuals. https://t.co/xeWBQ0DnlB https://t.co/c8lqXOmAaT

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Together PSO Trial - Combination Ixekizumab and Tirzepatide Today Lilly announced top line results of the TOGETHER-PsO open-label, Phase 3b trial demonstrating the significant benefits of concomitant ixekizumab (IXE: an IL-17A inhibitor) and tirzepatide (TIR: GLP-1agonist) over https://t.co/YWCjN2NyGM
Dr. John Cush @RheumNow( View Tweet )
Slim,waist,obese,obesity

Together PSO Trial - Combination Ixekizumab and Tirzepatide

Jack Cush, MD

Today Lilly announced top line results of the TOGETHER-PsO open-label, Phase 3b trial demonstrating the significant benefits of concomitant ixekizumab (IXE: an IL-17A inhibitor) and tirzepatide (TIR: GLP-1agonist) over IXE alone.

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FDA has Changed labels for 6 Menopausal Hormone Therapies (HRT) removing black box warnings for CV dz, breast CA, & dementia. 1st six HRTs includes estrogen-& progestogen-only Rx:Prometrium, Divigel, Cenestin, Enjuvia, & combo Rx Bijuva, & topical Estring. https://t.co/ZpcKkzYPKn https://t.co/f9XbmlKZNo

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Dr. John Cush @RheumNow( View Tweet )

Recent Blogs

Choice Overload (and the Way Out)

Jack Cush, MD
paint,choice,overload,color
I recently overheard a very good practicing rheumatologist complain, “why do I need yet another drug for psoriatic arthritis? I have more treatment choices than I have actual PsA patients who need a new or better drug”.
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Best of 2022: Methotrexate in PsA

Philip Mease, MD
Methotrexate
Until the publication of the SEAM trial, evidence in the medical literature for the efficacy of the most commonly used drug for psoriatic arthritis worldwide, methotrexate, has been lukewarm at best. Yet we all employ it commonly, either as monotherapy or in combination with biologic or targeted synthetic DMARD treatment. It is inexpensive and widely available, and only modestly toxic.
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A Domain-Based Approach to the GRAPPA Psoriatic Arthritis Treatment Recommendations

Laura Coates
heel enthesitis spur calcaneal

With their publication in June 2022 (1), the 3rd iteration of the Group for Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) Treatment recommendations for Psoriatic Arthritis (PsA) may have set a record or sorts.

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