Several posters at the 2017 American College of Rheumatology Annual Meeting in San Diego, California, compared the efficacy of originator and biosimilar infliximab in the treatment of rheumatic diseases.
Several posters at the 2017 American College of Rheumatology Annual Meeting in San Diego, California, compared the efficacy of originator and biosimilar infliximab in the treatment of rheumatic diseases.
Non-medical Switch from Originator to Biosimilar Infliximab in AS
Czech researchers found no consistent trend of change in disease activity measures and patient-reported outcomes (PROs) after a non-medical switch from originator (INX; Remicade) to biosimilar infliximab (CT-P13; Remsima) in patients with ankylosing spondylitis (AS) that would suggest a decrease in efficacy within 6 months of the switch. The mild decrease in patients’ satisfaction that was not correlated with other PROMs may have been caused by a so-called nocebo effect, suggests Sarka Forejtová, MD, and colleagues.1
Thirty-six patients with AS in 1 clinical center were observed for 3 months prior to the switch and 3 months after the switch for measures of disease activity, quality of life, and patient satisfaction with treatment. Prior treatment duration with INX was 86.2±34.7 months.
There were no serious adverse events (SAEs) reported; 1 patient requested a reverse switch to INX.
The researchers acknowledge the limited time frame of their study but say it supports the results of other real-world studies indicating no decrease in efficacy after a non-medical switch from originator to biosimilar infliximab.
CT-P13 Effective, Well-Tolerated in Korean Study of CT-P13 in Routine Care
CT-P13, an infliximab biosimilar, is efficacious and well-tolerated in patients with rheumatoid arthritis (RA), AS, psoriatic arthritis (PsA), and plaque psoriasis (PS) based on the results of a Korean study of CT-P13 by Dong-Wook Kim, MD, and colleagues2 in which it was used in the routine care of 940 patients (RA, 400; AS, 531; PsA, 3; and PS, 6). Of these, 338 (36%) switched to CT-P13 (RA, 108; AS, 228; and PS, 2).
The study included patients who were both biologic-naïve (naïve group) and patients who switched from other anti—tumor necrosis factor (TNF) medications, such as infliximab, adalimumab, golimumab, and etanercept, to CT-P13 (switch group).
Effectiveness was evaluated based on reports of remission and response, and AEs were collected over 6 months.
The researchers concluded that CT-P13 was well tolerated. Only 11% of patients experienced infection. Results from the switch group showed that CT-P13 provides a useful alternative to other anti-TNFs, they note.
SB2 Comparable With Reference Infliximab in Study Using Radiographic Evidence
The proportion of RA patients achieving remission or low disease activity (LDA) was comparable up to week 54 in a study by Josef S. Smolen, MD, and colleagues comparing patients taking INX and biosimilar infliximab, SB2. The study assessed simplified disease activity index (SDAI) and clinical disease activity index (CDAI) and radiographic progression of disease.3
The study assessed SDAI and CDAI at weeks 14, 30, and 54 in 562 patients treated with SB2 or INX and assessed the radiographic disease progression at week 54 in patients by disease activity states (remission, LDA, moderate disease activity [MDA], or high disease activity [HDA]).
Up to week 54, comparable proportions of patients achieved ACR-EULAR—index remission between SB2 and INF. The proportions of radiographic non-progressors by disease activity were comparable between SB2 and INF at week 14, 30, and 54.
Patients treated with SB2 as well as INX also had the lowest progression of radiographic damage in remission and the largest progression in HDA, but also very small increases in measures of radiographic progression of disease in LDA and MDA, in line with previous findings on INF.
Efficacy of PF-06438179/GP1111 Compared With Reference Infliximab in RA
PF-06438179/GP1111, a proposed infliximab biosimilar, and EU-sourced reference infliximab, showed similar efficacy, safety, and immunogenicity in patients with moderate-to-severely active RA after 30 weeks of treatment.4 All the patients in the study were receiving background methotrexate and had not more than 2 doses of 1 non-depleting, non-infliximab biologic.
The trial followed 650 patients stratified by geographic region, who were randomized 1:1 to PF-06438179/GP1111 or infliximab-EU. The study’s primary endpoint was ACR20 response rate at week 13; secondary efficacy endpoints included RA response rates measured by the ACR20, DAS28-C-Reactive Protein (CRP), and other measures of clinical response or remission up to week 30.
References
Data Show Promise for Adalimumab Biosimilars to Deliver on Safety, Cost Savings
May 16th 2024Two posters from the Academy of Managed Care Pharmacy’s annual meeting provided hope that despite low uptake so far, adalimumab biosimilars can deliver on the promise of comparable safety and efficacy with the originator in multiple disease states, as well as cost savings.
Biosimilars Policy Roundup for April 2024—Podcast Edition
May 5th 2024On this episode of Not So Different, The Center for Biosimilars® glances back at all the major biosimilar policy updates from April, including 2 FDA approvals, 1 European approval, and several insights into possible policy changes from the Festival of Biologics USA conference.
Challenges and Guidance in Biosimilar Assessment: An ISPOR Report on HTA Agency Approaches
May 14th 2024The ISPOR report highlights the urgent need for clear guidance on when and how to conduct health technology assessments (HTAs) for biosimilars, emphasizing the challenges faced by HTA agencies and the evolving role of HTAs in evaluating biosimilar value.
Patients With IBD Experience Nocebo Effect Post Mandatory Switch to Biosimilar
May 11th 2024In Canada, a study on patients with inflammatory bowel disease (IBD) switching to infliximab or adalimumab biosimilars found no change in clinical remission or antidrug antibodies after 24 weeks, but 13% experienced the nocebo effect, leading to one-fifth discontinuing therapy.
Partnering for Biosimilar Security: India's Role in US Health Care Savings, Supply Chain Stability
May 9th 2024As Indian pharmaceutical companies supplied 4 of every 10 prescriptions in the US in 2022, generating $1.3 trillion in health care savings, a new IQVIA report highlights concerns about supply chain risks and advocates for partnerships to bolster biosimilar security and overall supply chain resilience.