Publications by Amy E Bock

Publications by authors named "Amy E Bock"

RMD Open

September 2022

The study explored how the multibiomarker disease activity (MBDA) score can assess the similarity of biosimilars, comparing them to their reference products in patients with rheumatoid arthritis.
Two randomized controlled trials were conducted, with patients receiving either biosimilar infliximab (IFX-qbtx) or adalimumab (ADL-afzb) versus their EU-sourced counterparts, measuring their MBDA scores at various points during treatment.
Results showed that the MBDA scores were very similar between the biosimilars and their corresponding reference products, suggesting that MBDA scores can objectively indicate biosimilarity compared to traditional assessment methods.

Rheumatol Ther

June 2022

The study aimed to assess how successful patients with rheumatoid arthritis (RA) were at self-administering a new adalimumab biosimilar using a prefilled pen during a specific treatment period in a clinical trial.
A total of 50 participants, mostly women with a mean age of about 55, were included in the analysis, with nearly all successfully completing their injections and achieving a 100% delivery success rate across 294 attempts.
Most participants preferred to continue using the prefilled pen for their injections instead of switching back to the older syringe option, indicating that the new method was well-received and effective.

Arthritis Res Ther

September 2021

The REFLECTIONS B538-02 study evaluated the long-term safety and efficacy of the adalimumab biosimilar PF-06410293 compared to the reference adalimumab sourced from the EU in patients with active rheumatoid arthritis (RA).
A total of 507 patients participated, with three groups: those who received the biosimilar from the start, those who switched to the biosimilar at week 26, and those who switched at week 52.
ACR20 response rates were high and consistent throughout the study, with overall treatment-emergent adverse events reported as relatively low and generally well tolerated across the different groups.

RMD Open

April 2021

- The study aimed to assess the effectiveness and safety of a biosimilar adalimumab (ADL-PF) compared to the reference drug (ADL-EU) in patients with active rheumatoid arthritis over a longer treatment period.
- Participants were initially randomized to receive either ADL-PF or ADL-EU, and after 26 weeks, those on ADL-EU were re-randomized to either continue with ADL-EU or switch to ADL-PF, while those on ADL-PF continued their treatment.
- Results showed comparable improvement rates and safety profiles between treatments, indicating that switching from ADL-EU to ADL-PF did not affect treatment outcomes, with similar ant

Clin Pharmacol Drug Dev

October 2021

This study investigated PF-06410293 (ADL-PF), a biosimilar to adalimumab, to assess its pharmacokinetics, safety, and tolerability when administered via a prefilled syringe (PFS) or prefilled pen (PFP).
A total of 164 healthy adults were randomly assigned to receive the drug, and results showed similar concentration-time profiles for both admin methods, meeting bioequivalence criteria.
Adverse events were comparable across both groups, indicating that ADL-PF can be safely administered through either device without significant differences in patient experience.

Arthritis Res Ther

August 2018

A 78-week study was conducted to compare the effectiveness and safety of PF-06410293, a biosimilar to adalimumab (Humira), in treating active rheumatoid arthritis (RA) in patients already on methotrexate.
The study involved 597 patients who were randomized to receive either PF-06410293 or the reference adalimumab (adalimumab-EU), measuring outcomes using the American College of Rheumatology (ACR) criteria at 12 weeks.
Results showed that the ACR20 response rates at week 12 were 68.7% for PF-06410293 and 72.7% for adalimumab-EU, indicating that the two