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Biosimilar Slow Growth in USA

Jack Cush, MD

A recent Forbes article, "Biosimilars Are Making Inroads In U.S., But It’s Still A Bumpy Ride", reviews the current state and reasons for slowish uptake of these significant cost-savings alternatives to biologic therapy in treating cancer and autoimmune disorders. The following are takeaway bullets from this informative article.

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Advances in the treatment of autoimmune hepatitis

EurekAlert!

Autoimmune hepatitis (AIH) is a chronic, progressive liver disease caused by immune system dysregulation that targets the liver. If untreated, AIH can lead to severe complications, including cirrhosis and liver failure. 

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Iberdomide Efficacy in Cutaneous Lupus

Jack Cush, MD

Iberdomide, a cereblon modulator that promotes degradation of transcription factors Ikaros and Aiolos, has been shown in a phase 2 trial to improve outcomes in subacute and chronic cutaneous lupus erythematosus (CLE).

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DPGN, lupus, nephritis, GN, glomerulonephritis, biopsy, kidney

SGLT2 Inhibitor Protective Effects in Lupus

Jack Cush, MD

Systemic lupus erythematosus (SLE) outcomes were assessed based on whether they received sodium-glucose co-transporter 2 inhibitors (SGLT2i), in the setting of comorbid type 2 diabetes (T2D).

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dupuytrens

Treatment Options for Dupuytren’s Contracture

Jack Cush, MD

The NEJM reports that in a randomized, controlled, head to head trial, collagenase injections were non-inferior to limited fasciectomy in the treatment of Dupuytren’s contracture.

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Blue Collar Arthritis (10.25.2024)

Jack Cush, MD

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

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Trends in DMARD Use in Juvenile Arthritis 2001-2022

Jack Cush, MD

Arthritis & Rheumatology reports that treatment trends in juvenile idiopathic arthritis (JIA) in the last two decades finds rising use of newer biologic and targeted synthetic DMARDs coupled with a decline in conventional DMARD use.

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Taiwan claims data study of 135 230 patients who received antineoplastic medications, found that immune checkpoint inhibitors use was associated with a 2-fold increased risk of developing psoriasis (HR 2.43). https://t.co/m5eGT56W12 https://t.co/h5FjQpHOpF

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Dr. John Cush RheumNow ( View Tweet)
Save the date! RheumNow will be covering #ACR24 from 11/14-11/19. Get ready for daily recaps, live streaming and much, much, more! https://t.co/rDMFH3wlbc
Dr. John Cush RheumNow ( View Tweet)
Survey of UK Rheumatology pts (n 876 found 55% take daily supplements costing £10 to £200 per month (most common: vit D, C, B complex, MVI Omega 3/6). 82% take Prescription, OTC, or non-prescription pain meds, 13% sleep aids. Half of NSAID pts also take OTC supplements… https://t.co/VpMG9SiE1E https://t.co/SJYUfogeVJ
Dr. John Cush RheumNow ( View Tweet)
Metanalysis of 26 RCTs suggests JAK inhibitors have a low, but signif. increased risk of infections (vs placebo) (RR 1.39; 1.096-1.76). No risk of tuberculosis or hepatitis, but an incr. risk of H. zoster was seen (RR 1.71; 0.84-3.51) https://t.co/kXOcldz46l https://t.co/Y5OWk4W1NZ

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Dr. John Cush RheumNow ( View Tweet)
FDA's perspective on the use of artificial intelligence in drug development. - FDA is committed to a risk-based regulatory framework that promotes innovation & protects Pt safety - Est. CDER AI Council to coordinate, develop, & support internal & external AI-related activities… https://t.co/BLCYmBBJMY https://t.co/fMie3oOfmn
Dr. John Cush RheumNow ( View Tweet)
An 11 yr study of 2187 #RA pts Rx w/ 3068 treatment courses of biologics or JAki, found 275 new cases of #CKD . Compared w/ CTLA4-Ig, TNFi significantly lower CKD rates (HR 0.67), whiile JAKi higher CKD rates (HR 2.16). https://t.co/2Y5BuDzJRs https://t.co/e81lOhOMjX

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Dr. John Cush RheumNow ( View Tweet)
Save the date! RheumNows will be covering #ACR24 from 11/14-11/19. Get ready for daily recaps, live streaming and much, much, more! https://t.co/uKc14y1fOm
Dr. John Cush RheumNow ( View Tweet)
Are seronegative RA and clinically suspect arthralgia pts represented in randomized clinical trials? Most RCTs (And prevention trials) predominantly enroll seropositive patients. - potentially overlooking seronegative individuals with arthralgia-at-risk. https://t.co/D1eOApgn1p https://t.co/IBCNtNW8uI

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Dr. John Cush RheumNow ( View Tweet)
Filgotinib Efficacy and Safety - 3 Years Later Filgotinib, the rheumatoid arthritis (RA) oral drug that never made it to the U.S. market but is sold across Europe, Great Britain, and Japan, remained effective for 3 years for most registration trial participants who continued in… https://t.co/eABIG1Kal6 https://t.co/7ZphZALniE
Dr. John Cush RheumNow ( View Tweet)
Treatment Options for Dupuytren’s Contracture The NEJM reports that in a randomized, controlled, head to head trial, collagenase injections were non-inferior to limited fasciectomy in the treatment of Dupuytren’s contracture. https://t.co/HTW9za8a10 https://t.co/gStCic7x2D

Links:

Dr. John Cush RheumNow ( View Tweet)
STAR study shows 102 RA pts in LDA > 3 mos & pred 5 mg/d did equally well with either prednisone taper or changing to hydrocortisone 20 mg/d and taperin HC. At 12 mos both wer able to D/C GC (55% HC vs 47% pred tapering; p=0.4). https://t.co/C6YTGiF0pN

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Dr. John Cush RheumNow ( View Tweet)

Long-term Tofacitinib in Juvenile Idiopathic Arthritis The long-term safety and efficacy of tofacitinib in patients with juvenile idiopathic arthritis (JIA) has been established in an ongoing long term extension (LTE) study. https://t.co/IKHM6z8iMB https://t.co/O6ig1lTQR4

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Dr. John Cush RheumNow ( View Tweet)
2 yr results from the PRAIRI study - 78 at-risk (for RA) pts Rx w/ placebo or 1000 mg IV RTX + I00 mg methylprednisolone (MP). While 1 yr result showed brief delay in RA development, at 2 yrs there was no benefit for QOL or RA development https://t.co/1CzEQn5zL4 https://t.co/Wvr2kWvDC5

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