Biosimilar Adalimumab Shows Improvement in Ankylosing Spondylitis For 24 Weeks

A 10-week course of adalimumab biosimilar demonstrated early improvements in difficult-to-treat ankylosing spondylitis (AS) that lasted about 24 weeks, according to the results of a study published in Cureus.

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This method has proven economically appealing, but further confirmation of these findings is needed, investigators said.

Typically, the long-term use of anti-tumor necrosis factor (TNF) agents in AS are deterred because of cost and drug toxicity, according to investigators.

They wanted to observe the long-term relief after the short-term administration of anti-TNF agents as an alternative to the long-term use.

Investigators conducted a 1-year single-center, uncontrolled trial with 50 individuals with symptomatic active and chronic AS who received rheumatology therapy and were anti-TNF naïve. The study was conducted between June 2016 and July 2018 at the Center for Rheumatic Diseases in Pune, India.

Fifty individuals were included in the study, 42 men and 8 women. According to their medical records, all individuals had taken multiple courses of more than 2 NSAIDs, typically under supervision, sometime before the study.

Every 2 weeks, 40 mg of a standard biosimilar adalimumab (Bs-ADA, Exemptia; Zydus) was administered subcutaneously for 6 injections, at a total of 10 weeks, or to continue with standard follow-up if they did not achieve an Assessment in Ankylosing Spondylitis Response Criteria (ASAS 20) index response by week 12.

Investigators used standard indicators from Assessment Spondylitis International Society/ASAS and Bath to evaluate progress. They also tested TNF-alpha, interleukin (IL)-6, and IL-17 using an enzyme-linked immunosorbent assay kit from Bio Legend in Bengaluru, India.

They found that individuals in the study experienced early and significant improvements in pain, non-steroidal anti-inflammatory drugs (NSAIDs) required, function, and several indices, which included ASAS 20 and 40, ASAS partial remission, Bath Ankylosing Spondylitis Disease Index, Bath Ankylosing Spondylitis Functional Index, and Ankylosing Spondylitis Disease Activity Score, after stopping the injection.

Additionally, at weeks 12 and 48, approximately 84% and 52% of individuals showed ASAS 20 improvement, respectively. Also, 34% and 24% demonstrated ASAS partial remission, respectively.

The ASAS 20 improved in 82% of individuals, and the ASAS 40 improved in 70% of individuals.

The proof of concept was provided by 42% of individuals who continued to demonstrate improvement on the ASAS 20 index at week 12, 24, and 36 weeks.

Approximately 56% of individuals were classified as having inactive/low disease activity at week 12, 36% at week 24, and 24% at week 36, and 20% at week 48. There were major improvements observed in 64%, 50%, 36%, and 28%, respectively.

Investigators reported that ASAS 40 patterns were similar.

There were no serious adverse events (AEs) reported in any of the individuals, according to investigators, and there were no fatalities.

However, 10 individuals experienced mild AEs, which were resolved with a standard of care. Three individuals had nasopharyngitis, 3 had dermatophytosis, 2 had non-specific body aches and pains, 2 had mild uveitis, 1 had itchy eczema in the ankle region, and 1 had nasal polyp bleed.

Reference

Chopra A, Khadke N, Saluja M, Kianifard T, Venugopalan A, Gharia M. The long-term effects of short-period adalimumab biosimilar usage in ankylosing spondylitis. Cureus. 2023;15(3):e36444. doi:10.7759/cureus.36444