The infliximab biosimilar in the treatment of moderate to severe plaque psoriasis

Biosimilarity and Interchangeability: Principles and Evidence: A Systematic Review

“…Of 16 studies that reported statistical analyses, 13 found no statistically significant differences for main efficacy parameters [43, 46–49, 58, 62, 67, 68, 71, 77, 79, 87], although six of these observed changes for some parameters (in favour of the pre-switch and post-switch treatments in five studies and one study, respectively). There was a need for additional medication to control increased disease activity after switching from originator to biosimilar infliximab in four of 83 patients with inflammatory bowel disease (IBD) [68] and in 13 of 28 patients undergoing chemotherapy and switching epoetins [77]; a significant increase in median C-reactive protein values (from 1.95 to 4.0 mg/L; P  < 0.05) and median pain scores (from 28.8 to 38.1 mm on a scale of 0–100; P  < 0.05) in patients with IBD switching from originator to biosimilar infliximab [43]; a significant increase in disease activity (mean Bath Ankylosing Spondylitis Activity Index, from 3.8 to 4.3; P  < 0.05) in patients with spondyloarthritis after switching to biosimilar infliximab [71]; a small, significant increase in total daily insulin dose (from 0.62 to 0.65 U/kg/day; P  < 0.05) in patients with type 1 or type 2 diabetes mellitus switched to a biosimilar insulin [87]; but a significant decrease (i.e.…”

“…In terms of safety data after switching, eight studies reported no concerns or similar safety profiles before and after switching [43, 44, 47, 50, 62, 63, 79, 87, 89], six studies reported no general safety data [45, 51, 72, 77, 83, 90], and 12 studies reported adverse events such as injection site pain, acute hypersensitivity reactions, rash and infusion reactions after switching (although most did not provide comparative data from before switching) [46, 48, 49, 52, 54, 58, 65–68, 71, 88]. …”

“…No significant change in CRP, Hb, FC, INX dose, dose interval or plasma INX levels post-switch. All P NSPost-switch: AEs in 17 patients (3 with UC, 14 with CD); 5 infusion reactions (leading to treatment discontinuation in 1 patient)Baseline vs new post-switch: n  = 2 vs n  = 3 patientsDapavo et al 2016 [49]With plaque psoriasis ( N  = 35)30INX RP, median duration 237 weeksCT-P13, median follow-up 23 weeks with median 4 cyclesPre- vs post-switch (end of follow-up), PASI score: P NS (actual values NR); VAS scores: P NS (actual values NR)Post-switch: herpes zoster (1 patient)NRFiorino et al 2017 [50]With IBD ( N  = 547)97INX RP, duration NR; mean number of infusions 18 [study also included patients with no treatment (naive) or other biologic pre-switch]CT-P13 switch group, median follow-up 6.6 monthsINX RP/CT-P13 vs naive/CT-P13 vs other/CT-P13, estimated probability of response at 24 weeks: 79 vs 74 vs 63%. Primary failure: 0 vs 10 vs 11% ( P  = 0.005).…”

Switching Between Reference Biologics and Biosimilars for the Treatment of Rheumatology, Gastroenterology, and Dermatology Inflammatory Conditions: Considerations for the Clinician

“…Many clinical and observational studies involving a switch between reference infliximab and its biosimilars CT-P13 [24, 25•, 26, 27•, 28, 29, 30•, 31•, 32•, 33•, 34•, 35–64, 65•, 66•, 67–72] (EMA/FDA-approved), SB2 [73•, 74•] (EMA-approved), and NK [75] (Japanese Pharmaceuticals and Medical Devices Agency-approved) have been conducted or are ongoing (Table 2). Some studies report switching data but do not identify the biosimilar used [76, 77].…”

“…Data have been published from 26 studies of reference infliximab → CT-P13 switching (23 completed, 3 ongoing) in various indications: rheumatic disease [24, 25•, 26, 27•, 28, 29, 30•, 31•, 32•, 33•, 34•, 35–43] ( n  = 11); inflammatory bowel disease [44–63] ( n  = 12); psoriasis (PsO) [64] ( n  = 1); and multiple disease areas [65•, 66•, 67] ( n  = 2). All these studies are transition studies (single switch from reference → biosimilar), although the precise designs used vary (Table 2].…”