Switching from originator adalimumab to biosimilar SB5 in a rheumatology cohort: persistence on treatment, predictors of drug interruption and safety analysis

Bruni, Cosimo; Gentileschi, Stefano; Pacini, Giovanni; Bardelli, Marco; Tofani, Lorenzo; Bartoli, Francesca; Baldi, Caterina; Cometi, Laura; Fiori, Ginevra; Nacci, Francesca; Cantarini, Luca; Guiducci, Serena; Moggi-Pignone, Alberto; Frediani, Bruno; Matucci‐Cerinic, Marco

doi:10.1177/1759720x211033679

Cited by 10 publications

(10 citation statements)

References 23 publications

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“…Similarly, Bruni C et al [14] reported no difference in the control of disease activity, everyday life disability, and safety after switching from the adalimumab originator to SB5 in patients with PsA. Another recent study carried out by the same researchers [15] on a population of 172 patients (59 with PsA) showed that patients who had switched from the adalimumab originator to SB5 maintained a satisfactory level of persistence in treatment. Among patients who switched back to the originator, there were 3 patients with PsA who achieved disease control once switched back.…”

Section: Main Outcomes Main Resultsmentioning

confidence: 94%

“…Fourteen studies [13][14][15][16][17][18][19][20][21][22][23][24][25]49] evaluated the effects in terms of the efficacy and safety derived from the switch among adalimumab products. All studies were carried out in Europe (10/14 in Italy).…”

Section: Adalimumab Switching Studiesmentioning

confidence: 99%

“…Bruni, [14] Efficacy (ESR, RCP, VAS pain, patient fatigue VAS, HAQ, DAS28(ESR), DAS28(CRP), DAPSA) and safety (AEs) Among PsA patients, at 6 months, no differences were found in efficacy markers compared to baseline. Most frequent AEs were infection and joint disease relapses, while no serious AE was recorded Bruni, [15] Efficacy (persistence on treatment with adalimumab biosimilar and predictors of drug interruption) and safety (AEs and prevalence)…”

Section: Adamentioning

confidence: 99%

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Switching between Originators and Biosimilars in Dermatology: A Systematic Review of Real-World Clinical Studies

Nicoletti

Pentella

et al. 2023

Biologics

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Background. Although biosimilars have been increasingly used over recent years, some concerns about a potential loss of efficacy and altered safety profile when switching from an originator to a biosimilar still exist. Interchangeability can be a challenge for dermatologists too. An extensive systematic review of published switching studies among originators and biosimilars was carried out in order to provide evidence regarding the effects derived from the switch in terms of efficacy and safety outcomes in real-life contexts. Results. Thirty-seven articles were included in this systematic review (14 studies related to adalimumab, 10 to etanercept, 12 to infliximab, and 1 each to adalimumab, etanercept, and infliximab). Studies were mainly carried out among European countries. Most of them were observational studies or register-based studies. The majority of studies enrolled patients diagnosed with psoriasis or psoriatic arthritis who underwent a single switch from the originator to the biosimilar. Overall, the studies’ results demonstrated that switching between adalimumab, etanercept, and infliximab originators and biosimilars is safe and effective in a real-life setting of patients with dermatological conditions. Only a few studies highlighted an increase in the risk of loss of efficacy as well as an increased rate of AEs, both of which were identified as the main causes of biosimilar discontinuation, probably associated with the well-known phenomenon of the nocebo effect. Conclusion. Switching from a biologic originator to its biosimilar is safe and effective. Only a few studies have evaluated the switch among biosimilars; thus, no firm conclusion can be drawn for this type of switch in terms of the efficacy and safety outcomes. Based on our results, we believe that biosimilars can be considered interchangeable with their reference products and that no additional switch studies are necessary to support switching among originators and biosimilars in clinical practice. However, the continuous monitoring of all biologics (both originators and biosimilars) in routine clinical practice is strongly needed given their peculiar safety profile.

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Section: Main Outcomes Main Resultsmentioning

confidence: 94%

Section: Adalimumab Switching Studiesmentioning

confidence: 99%

Section: Adamentioning

confidence: 99%

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Switching between Originators and Biosimilars in Dermatology: A Systematic Review of Real-World Clinical Studies

Nicoletti

Pentella

et al. 2023

Biologics

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“…Several observational studies were conducted in patients with rheumatologic diseases such as RA, AS, and PsA, who were treated with SB5 [ 21 – 23 ].…”

Section: Real-world Evidencementioning

confidence: 99%

“…Two observational studies investigated switching from ADL to SB5 [ 21 , 22 ]. The first (Bruni et al [ 21 ]), which focused on safety, enrolled 172 patients with inflammatory arthritis, including 34 patients with RA, 59 patients with PsA, and 61 patients with AS. All enrolled patients previously had received at least 6 months of treatment with ADL before switching to SB5.…”

Section: Real-world Evidencementioning

confidence: 99%

Review of Adalimumab Biosimilar SB5 in Immune-Mediated Inflammatory Diseases

Kay,

Cross,

Feldman

et al. 2023

Adv Ther

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SB5 is an approved biosimilar of adalimumab, a recombinant monoclonal anti-tumor necrosis factor (TNF) antibody. The approval of SB5 was based on the comparison with reference adalimumab in analytical studies, pharmacokinetic (PK) and immunogenicity assessments, and randomized controlled trials. Efficacy data was primarily obtained in patients with rheumatoid arthritis, and extended to include additional indications such as psoriasis, Crohn’s disease, or ulcerative colitis by extrapolation. Following its approval, additional post-marketing data have been collected comparing SB5 with reference adalimumab. This review summarizes the clinical data on SB5 from randomized controlled trials and provides a comprehensive overview of the available post-approval data. In “real-world” settings, SB5 was as effective as its reference product across different indications and countries, treatment persistence was well maintained throughout studies, and no new safety concerns were identified. In both controlled and “real-world” settings, switching from reference adalimumab to SB5 was not associated with altered efficacy or clinical complications. In post-approval studies, the quality of SB5 was consistent over time, independent of the batch and process changes, and the SB5 autoinjector was preferred over other autoinjectors by both healthcare professionals and patients. Taken together, these data support the use of SB5 whenever reference adalimumab is appropriate and demonstrate that switching from reference adalimumab to SB5 is feasible.

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The PROPER Study: A 48-Week, Pan-European, Real-World Study of Biosimilar SB5 Following Transition from Reference Adalimumab in Patients with Immune‐Mediated Inflammatory Disease

Müller-Ladner,

Dignass,

Gaffney

et al. 2023

BioDrugs

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Background The non-interventional PROPER study generated real-world evidence on clinical outcomes following transition in routine practice from reference adalimumab to the EMA-approved SB5 biosimilar adalimumab in patients with immune-mediated inflammatory disease. Methods Adults with rheumatoid arthritis (RA), axial spondyloarthritis (axSpA), psoriatic arthritis (PsA), Crohn’s disease (CD), or ulcerative colitis (UC) were enrolled at 63 sites across Europe. Eligible patients received ≥ 16 weeks of routine treatment with reference adalimumab before transitioning to SB5, and were followed for 48 weeks post-transition. The primary objective was to evaluate candidate predictors (clinically relevant baseline variables with incidence ≥ 15% by indication cohort) associated with persistence on SB5 at 48 weeks post-initiation. Key primary outcome measures were persistence on SB5 (estimated by Kaplan–Meier methodology) and clinical characteristics and disease activity scores at the time of transition to SB5 treatment (baseline). Results A total of 955 eligible patients were enrolled (RA, n = 207; axSpA, n = 127; PsA, n = 162; CD, n = 447; UC, n = 12), of whom 932 (97.6%) completed follow-up and 722 (75.6%) were still receiving SB5 at week 48. Kaplan–Meier estimates (95% confidence interval, CI) of persistence on SB5 at week 48 for RA, axSpA, PsA, and CD were 0.86 (0.80–0.90), 0.80 (0.71–0.86), 0.81 (0.74–0.86), and 0.72 (0.67–0.76), respectively. The single candidate predictor associated with probability of SB5 discontinuation before week 48 was female sex [RA, axSpA, and CD cohorts; HR (95% CI): 3.53 (1.07–11.67), 2.38 (1.11–5.14), and 2.21 (1.54–3.18), respectively]. Disease activity scores remained largely unchanged throughout the study, with proportions by cohort in remission at baseline versus week 48 being 59.2% versus 57.2%, 81.0% versus 78.0%, 94.7% versus 93.7%, and 84.0% versus 85.1% for patients with RA, axSpA, PsA, and CD, respectively. Similarly, the SB5 dosing regimen remained unchanged for the majority of patients from baseline to week 48, the most common regimen being 40 mg every 2 weeks. In total, 232 patients (24.3%) reported at least one adverse drug reaction, and most events were mild; eight patients (3.9%) in the RA cohort experienced nine serious adverse events (SAEs; two possibly related to SB5); eight patients (4.9%) in the PsA cohort experienced nine SAEs (one possibly related to SB5); 22 patients (4.9%) in the CD cohort experienced 27 SAEs (four possibly related to SB5); and no SAEs were observed in the UC cohort. Conclusions With the exception of female sex in RA, axSpA, and CD, none of the candidate predictors were associated with SB5 discontinuation. Persistence on SB5 was high, treatment effectiveness was maintained, and no safety signals were detected. ...

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Switching from originator adalimumab to biosimilar SB5 in a rheumatology cohort: persistence on treatment, predictors of drug interruption and safety analysis

Cited by 10 publications

References 23 publications

Switching between Originators and Biosimilars in Dermatology: A Systematic Review of Real-World Clinical Studies

Switching between Originators and Biosimilars in Dermatology: A Systematic Review of Real-World Clinical Studies

Review of Adalimumab Biosimilar SB5 in Immune-Mediated Inflammatory Diseases

The PROPER Study: A 48-Week, Pan-European, Real-World Study of Biosimilar SB5 Following Transition from Reference Adalimumab in Patients with Immune‐Mediated Inflammatory Disease

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