Adalimumab Biosimilar MSB11022 Demonstrates Comparable Safety, Efficacy in RA

Among patients with rheumatoid arthritis (RA), treatment with the adalimumab biosimilar MSB11022 was shown to sustain the prior benefits reported in previous adalimumab treatment, according to data presented at the 2024 European Congress of Rheumatology (EULAR).¹ In some cases, treatment with the biosimilar led to greater improvements while maintaining a safety profile in line with previously described biosimilars.

“MSB11022 is a biosimilar of adalimumab that has been shown to have comparable bioequivalence, safety, tolerability, and immunogenicity profiles to the reference drug in healthy volunteers, patients with psoriasis, or patients with moderate-severe rheumatoid arthritis,” wrote a team of investigators led by Javier Garcia Miguel, MD, PhD, associated with the rheumatology department of Sagrat Cor University Hospital, Spain. “This is the first study conducted under clinical practice conditions evaluating the switch from adalimumab to MSB11022 in patients with rheumatoid arthritis.”

The retrospective, multicenter study used medical record data of patients with RA who switched from the bio-originator to either another biosimilar or MSB11022 who had sustained treatment for ≥ 6 months.

The primary endpoint was to assess the composite Disease Activity Score 28 in Rheumatoid Arthritis with C-reactive protein (DAS28-CRP) among this patient population. Secondary endpoints evaluated the Clinical Disease Activity Index (CDAI) after switching as well as the rates of remission and low disease activity based on DAS28-CRP (remission defined as < 2.6 and low disease activity defined as < 3.2) and CDAI (remission defined as < 2.8 and low activity defined as < 10.0). Safety was also assessed. Patients with inflammatory bowel disease (IBD) and psoriasis were excluded from analysis. Data were reported at both the baseline visit at switch and at follow-up visits post-switch.

A total of 86 patients were included in the study, of which the median age was 63.5 years, most (71.4%) were White, and 75.6% were female. Most (73.3%) were non-smokers, the median body mass index (BMI) was 27.2 kg/m2, and the median time since diagnosis of RA was 12 years. Approximately half (44.2%) had erosive RA.

Among the cohort, the most common comorbidities were hypertension (32.6%), cardiovascular disease (12.8%), and diabetes mellitus (9.3%). Most (54.7%) patients were being treated with a biologic therapy and concomitant disease-modifying antirheumatic drugs (DMARDs) at the time of switching. A small percentage (3.5%) of patients had received biologic treatment prior to adalimumab prescription. Among these patients, previous biologics included certolizumab-pegol (66.7%) and tocilizumab (33.3%).

At baseline, the median DAS28-CRP was 1.77 (1.24; 2.34), with 80.2% (n = 69) in remission and 96.5% (n = 83) categorized as having low disease activity. The median CDAI was 4.00 (1.00; 5.00), with 44.2% (n = 38) in remission and 90.7% (n = 78) with low disease activity.

After a median of 8 months follow-up, the median DAS28-CRP increased to 1.87 (1.22;2.29), with 86.0% (n = 74) of patients in remission and 94.2% (n = 81) with low disease activity. In this cohort, the median CDAI remained 4.00 (1.00; 5.00), with 39.5% (n = 24) of patients in remission and 95.3% (n = 82) reporting low disease activity.

Regarding adverse events, only 3 patients experienced pain, stinging, and swelling at the injection site or a locally extensive hematoma in the administration area.

References

1. ^{Garcia Migue J, Komsalova LY, Mata Arnaiz C, Alegre Sancho JJ, et al. Clinical Outcomes of Switching to Adalimumab Biosimilar (MSB11022) in Patients with Rheumatoid Arthritis: RESTART Spanish Registry. Presented at: EULAR. Vienna, Austria. June 12 – 15, 2024.}