Adalimumab Biosimilar Transition Studies Reported at ECCO'21 Congress

Studies of adalimumab biosimilars in the European Union and the United Kingdom evaluated comparability and patient acceptance following a switch from the originator product (Humira).

Comparability by Trough Levels

In a study of patients with inflammatory bowel disease who switched to an adalimumab biosimilar (SB5, Hadlima) after achieving stability on Humira, investigators concluded adalimumab trough levels were comparable at up to 1-year post-switch.

Trough levels describe the lowest concentration of drug prior to repeat dosing. “Adalimumab trough levels remain within the therapeutic range after switch from originator to [Hadlima],” authors of the study wrote.

Also, the proportion of patients with secondary loss of response (SLOR), or who lost response to the drug during maintenance treatment, was comparable to reported data for the originator drug. No changes in disease activity were observed for patients on Hadlima, based on disease activity scores and biochemical parameters.

The study, conducted in Belgium, enrolled 110 patients with Crohn disease (n = 84) and ulcerative colitis (n = 26). At 12 months from baseline, Hadlima treatment was discontinued in 5 patients because of high adalimumab antidrug antibodies. Investigators said 9 patients presented with SLOR, 3 of whom discontinued treatment.

Mean trough levels for Hadlima were 9.21 μg/mL at baseline, 9.16 μg/mL at week 8 (P = .058), 7.98 μg/mL at month 6 (P = .001), and 7.68 μg/mL at month 12 (P = .001).

Reference

Deprez N, De Somer T, Baert d, et al. Evaluation of trough level and disease activity after switch from adalimumab originator to biosimilar in patients with inflammatory bowel disease. Presented at: ECCO’21 Congress; July 2-3 and 8-10, 2021. Poster 281.

Switch Acceptance

Patients with inflammatory bowel disease (N = 110) were gauged according to their acceptance of a switch to an adalimumab biosimilar (SB5, Hadlima) after achieving disease stability on the originator product (Humira). Investigators reported an acceptance-of-switch rate of 79.3%.

The switch was optional and patient satisfaction was assessed at baseline and at 8 weeks, 6 months, and 1-year post-switch.

The most common reasons given for refusal to switch were fear of a disease flare (n = 8), ease for staying on the originator drug (n = 4), and lack of trust in biosimilars (n = 3). Patients who declined to switch numbered 15.

Investigators said no demographic factors were associated with a refusal to switch. At the end of the 1-year term, 28 patients had discontinued the biosimilar and the most common reasons given were high antidrug antibodies at baseline (n = 5), SLOR (n = 3), injection site pain (n = 8), and other adverse events not causally related to the biosimilar (n = 10).

Authors of the study reported that at the 1-year point, 74.5% of patients were still receiving treatment with the biosimilar.

Visual analogue scales (VAS), which are used to measure patient sentiment in cases where more reliable quantitative findings cannot be obtained, were used to measure local discomfort up to 30 minutes after injection. “The median VAS for local discomfort after 30 minutes was between 0 and 1/10 at all time points, which was not significantly different compared to the originator,” investigators wrote.

“Satisfaction with the decision to switch was high and remained stable over the different time points,” they wrote.

Reference

De Somer T, Deprez N, Deceuninck M, et al. Acceptance of switch, patient satisfaction and adverse events after switch from adalimumab originator to biosimilar SB5 in patients with inflammatory bowel disease in a real-life setting. Presented at: ECCO’21 Congress; July 2-3 and 8-10, 2021. Poster 469.

PROPER Study

An interim analysis of the PROPER study of patients with Crohn disease who transitioned to an adalimumab biosimilar (SB5, Hadlima) following treatment with the reference product (Humira) demonstrated that most patients had no meaningful difference in disease activity or Hadlima dosing regimen by week 48 following transition to the biosimilar.

Investigators also concluded that the COVID-19 pandemic had no apparent effect on Hadlima use in this cohort (n = 459) and no new safety concerns were detected.

Investigators said 45 patients discontinued Hadlima and 10 withdrew from the study by week 48. Disease flare was reported for 29 (6.3%) patients, 7 of whom changed biologic treatment and 22 did not; 2 had SLOR.

Investigators said 12 patients reported 13 serious adverse events, of which 4 were considered related to use of the biosimilar (anal fistula, 2 perianal abscesses, and subileus).

Reference

Dignass A, Gisbert J, Freudensprung U, Addison J. The PROPER study: interim analysis of a pan-European real-world study of SB5 adalimumab biosimilar after transition from reference adalimumab in patients with Crohn’s disease. Presented at: ECCO’21 Congress; July 2-3 and 8-10, 2021. Poster 469.

Biosimilar Transition

Based on an ongoing crossover study enrolling patients with Crohn disease (N = 112) transitioning between Humira and the adalimumab biosimilar Imraldi, investigators concluded that despite limited knowledge and concerns about transitioning, patients generally accept the principals of biosimilars and can be reassured about receiving them.

The study is being conducted at University Hospital Southampton in the United Kingdom.

Among patients enrolled in the trial, investigators interviewed 35 on such topics as motivation to switch to a biosimilar, initial concerns, “reassuring factors,” and patient reflections on the experience.

Investigators noted that patients generally had little prior awareness of biosimilars but generally would accept a switch to biosimilar to minimize drug expense. “Prior to undertaking biosimilar transition away from the [originator brand], efficacy and adverse effects were common concerns for patients.”

Investigators reported that for patients to have confidence in biosimilars, they need to trust in their health care providers. They also stated that having a contact person on the health care team, education about biosimilars, and specific monitoring also provide reassurance.

“When reflecting on the experience, participants noted little subjective difference in efficacy or tolerability (although 22 participants specifically mentioned injection pain) following brand transition,” authors of the study wrote. “The majority feel comfortable with future transition to another adalimumab biosimilar.”

The investigators concluded that a tailored, patient-centered approach to using biosimilars is key to a successful switch.

Reference

Young D, Latter S, Harvey J, et al. IBD Reference and Biosimilar adalimumab CroSS over Study (iBaSS): a mixed methods clinical trial of patients transitioning between originator and biosimilar adalimumab. Qualitative findings from an interim analysis presenting the patient perspective. Presented at: ECCO’21 Congress; July 2-3 and 8-10, 2021. Poster 585.