1b) We're launching with an important topic for #physicians #nurses #nursepractitioners #physicianassociates #pharmacists who provide care for individuals with #rheumatologic_disease: the use of #biosimilars. This program was also presented at the 2023 @amcporg annual meeting. pic.twitter.com/Mn4Xp2z8ET
— @rheum_ce (@rheum_ce) April 27, 2023
2) This educational program is intended for healthcare providers and is supported by an unrestricted educational grant from Pfizer. Statement of accreditation and faculty disclosures are at https://t.co/hcXCNQQRBv.
— @rheum_ce (@rheum_ce) April 27, 2023
3b) #Biosimilars are NOT #generics. Understanding this starts w/ the differences between #biologics and #small_molecule drugs. Small molecules are the most common type of pharmacotherapies. They are small by atomic size (e.g. Aspirin, 21 atoms). pic.twitter.com/rg0J52IHqc
— @rheum_ce (@rheum_ce) April 27, 2023
3d) Biologics such as #vaccines, #hormones (eg #epoetin alfa) & #monoclonal #antibodies (eg infliximab) are large (~103–104 atoms) and structurally complex, usually derived from living systems (e.g. cultured cells or organisms) . . . pic.twitter.com/GIJXfxpmRx
— @rheum_ce (@rheum_ce) April 27, 2023
3f) As such, the process of ‘replicating’ a reference small molecule product (to make a #generic) is much more straightforward and less expensive than the analogous process for a reference biologic (to make a #biosimilar). pic.twitter.com/Nn70AsAvgt
— @rheum_ce (@rheum_ce) April 27, 2023
5a) Unlike #generics, lot-to-lot variation can be 🔑 in evaluating #biosimilars. Per @US_FDA, biosimilar manufacturers must assess for variability between lots of the reference product and lots of the proposed biosimilar to ensure they are within an acceptable range. pic.twitter.com/36GCalAFsk
— @rheum_ce (@rheum_ce) April 27, 2023
5b) In fact, 2023 #infliximab is not the same infliximab that was originally approved by @US_FDA for #rheumatoid arthritis #RA (with #methtrexate) in 1999. Variations in #biologics occur and accumulate over time. pic.twitter.com/NfHhTO7mOu
— @rheum_ce (@rheum_ce) April 27, 2023
6b) . . . in terms of quality characteristics, biological activity, efficacy and safety, and to exclude any clinically relevant differences that might exist between the reference product and the biosimilar.
See 🔓https://t.co/2Fr2HNORO3— @rheum_ce (@rheum_ce) April 27, 2023
8) And this again is quite different from the #regulatory pathway for a #generic #small_molecule drug. pic.twitter.com/dXpj14JUdX
— @rheum_ce (@rheum_ce) April 27, 2023
10) So we are considering here the potential availability and utility of #biosimilars for #inflammatory disorders. It is an active space. pic.twitter.com/2RUDJTorX5
— @rheum_ce (@rheum_ce) April 27, 2023
11b) This was a 52-week #RDB trial in adult patients with a dx of #Crohn’s dz #CD, #ulcerative_colitis #UC, #spondyloarthritis, #rheumatoid arthritis #RA, #psoriatic arthritis #PsA, or chronic #plaque_psoriasis on stable treatment with reference #infliximab for at least 6 mos.
— @rheum_ce (@rheum_ce) April 27, 2023
12a) Disease worsening occurred in 26% of pts in the #infliximab reference group & 30% in the #biosimilar #CT_P13 group. Adjusted treatment difference –4·4%, 95% CI –12·7 to 3·9). pic.twitter.com/A5EfGmOqgF
— @rheum_ce (@rheum_ce) April 27, 2023
12c) The authors concluded that switching from infliximab reference to CT-P13 was not inferior to continued treatment with #infliximab reference (prespecified non-inferiority margin of 15%).
— @rheum_ce (@rheum_ce) April 27, 2023
13b) Pts were assigned 1:1 to receive 2 h intravenous infusion of either 3 mg/kg of #biosimilar #CTP13 or reference #infliximab at weeks 0, 2 and 6 and then q8 weeks up to week 30. Weekly MTX (12.5 – 25mg/week) and folic acid (≥5 mg/week, oral dose) were co-administered.
— @rheum_ce (@rheum_ce) April 27, 2023
13d) The primary endpoint was to demonstrate equivalent efficacy of CT-P13 to #infliximabat week 30, as determined by #ACR20 response criteria.
See https://t.co/3R18thaXBQ
Equivalence of efficacy was concluded if the 95% CIs for treatment difference were within ±15% at week 30.— @rheum_ce (@rheum_ce) April 27, 2023
13f) Results of this equivalence study? The primary EP, ACR20 response at wk30, was equivalent btwn treatment groups & achieved in 60.9% & 58.6% in ITT (n=606, 95% CI −6% to 10%) &73.4% & 69.7% in PP population (n=499, 95% CI −4% to 12%) for CT-P13 & #infliximab, respectively pic.twitter.com/D6L1wiAuEp
— @rheum_ce (@rheum_ce) April 27, 2023
14) Follow-on study to #PLANETRA included open-label extension #CT_P13 in
🦴#RA: 🔓 https://t.co/vpRfOeMZpV pic.twitter.com/tpzAZbzL1c— @rheum_ce (@rheum_ce) April 27, 2023
15b) CT-P13 (3 mg/kg) was administered IV q 8wk, wks 62-102. All patients rec'd MTX. Endpoints included ACR20 response, ACR50, ACR70, immunogenicity & safety. Data were analyzed for maintenance group (CT-P13 x 102wk & switch group (ref product x 54wk, then #biosimilar.
— @rheum_ce (@rheum_ce) April 27, 2023
15d) #antidrug antibodies comparable between groups (week 102: 40.3% vs 44.8%, respectively). #TEAEs similar during the extension study (53.5% and 53.8%, respectively).
— @rheum_ce (@rheum_ce) April 27, 2023
16a) For #ankylosing_spondylitis #AS, #PLANETAS recruited pts w/AS:
🔓 https://t.co/DeZxJfdyqz
🔓https://t.co/Gm0yNstQz7
which had shown comparable safety & efficacy between reference #infliximab & biosimilar #CT_P13 over 54 weeks: pic.twitter.com/WHgdm2ChsD— @rheum_ce (@rheum_ce) April 27, 2023
16c) 174 of 210 pts who completed 54wks of #PLANETAS in extension study: 88 maintained on CT-P13, 86 switched to CT-P13 from reference #infliximab. CT-P13 given IV q 8wks, wk 62-102. Efficacy: % of pts achieving Assessment of SpondyloArthritis international Society (#ASAS)20.
— @rheum_ce (@rheum_ce) April 27, 2023
17) #Immunogenicity was not encountered as a problem between #biosimilar and #reference meds: pic.twitter.com/2WhPvuJzrw
— @rheum_ce (@rheum_ce) April 27, 2023
19a) So let's consider a case. 62 ♂️ w/ severe #RA x 7 years. He has been on numerous courses of prednisone, but is now currently in remission on reference #infliximab.
— @rheum_ce (@rheum_ce) April 27, 2023
19c) Must start with reassurance and education (courtesy of Dr Adam Cheifetz of @BIDMChealth): pic.twitter.com/pa2gHjNFzI
— @rheum_ce (@rheum_ce) April 27, 2023
19e)
4⃣ Patients who use biosimilars should benefit from out-of-pocket cost savings and receive cost-sharing protections, including but not limited to the use of co-pay assistance.
See https://t.co/U0DAExkCfK— @rheum_ce (@rheum_ce) April 27, 2023
21) Barriers to better implementation have been identified:https://t.co/GL7cNEb6vS pic.twitter.com/ld0nTjqBtV
— @rheum_ce (@rheum_ce) April 27, 2023
23) And in this #accredited program we are trying to address #HCP concerns, but these feed into patient concerns as well: pic.twitter.com/5eWjl71udf
— @rheum_ce (@rheum_ce) April 27, 2023
25) We have data specifically on impressions of / concerns about #biosimilars among #rheumatology specialists: pic.twitter.com/KYiPHKZZyI
— @rheum_ce (@rheum_ce) April 27, 2023
27) The benefits to “the system” may be quite significant, as per the experience of our authors: pic.twitter.com/eJNj5ApsnP
— @rheum_ce (@rheum_ce) April 27, 2023
29) It is essential that #HCPs familiarize themselves with data and policies, and use that knowledge to educate patients and maintain expected clinical outcomes at lower costs.
— @rheum_ce (@rheum_ce) April 27, 2023
30b) It's d, totality of evidence. Biosimilars don't require Ph 3 trials, but there has to be clear similarity to reference product in such measures as purity, chemical identity, and bioactivity.
— @rheum_ce (@rheum_ce) April 27, 2023
31b) It's d, all of the above . . . but you knew that, right?!? pic.twitter.com/PORBp4UdrP
— @rheum_ce (@rheum_ce) April 27, 2023
32) And you just earned 0.75hr 🆓CE/#CME! Claim your certificate at https://t.co/z5cW9aqkc8 and FOLLOW US for more education in the #rhuematology space. Expert authors, always free, wholly on Twitter. @AmanRheumPharm and @GI_PharmD and thank you for joining us!
— @rheum_ce (@rheum_ce) April 27, 2023
