乌鸦传媒

Biosimilars for adalimumab (Humira) had similar efficacy and safety profiles for psoriasis when compared to the original.

The meta-analysis appeared recently in the .

Researchers analyzed eight randomized controlled trials encompassing 2,589 patients. After 16 weeks, no significant differences emerged in response rates, defined as a decrease in the Psoriasis Area and Severity Index (PASI) of ≥75% (PASI 75) (P>0.05), or in the PASI 50, PASI 90, and PASI 100 measures (P>0.05). Similarly, after 16 weeks and 24 weeks of medication, there was no significant difference in the incidence rate of serious adverse events (SAEs) between adalimumab and its biosimilar agents (P>0.05).

The study was led by investigators at First Affiliated Hospital of Xi'an Jiaotong University in China. The following excerpts were edited for length and clarity.

What was the primary motivation for conducting this study?

Adalimumab, a fully human IgG1 monoclonal antibody, has been shown to be safe and effective in treating both arthritic psoriasis and moderate-to-severe psoriasis in multiple clinical trials.

Once the patent protection of Humira expired, many pharmaceutical companies developed biosimilars that are significantly less expensive and more accessible than adalimumab.

But do the efficacy and safety of adalimumab biosimilar agents differ from the original in the treatment of psoriasis? The current meta-analysis sought to evaluate differences in curative effect and safety between adalimumab and its biosimilars to provide evidence-based information for psoriasis medical treatment.

What were the key findings on efficacy?

PASI 50 values were compared in two studies, in which there was no statistical heterogeneity.

PASI 75 values were compared in six studies, in which there was no statistical heterogeneity (P=0.28). Subsequent analysis revealed no significant differences in PASI 75 between the groups (RR 0.99, 95% CI 0.94-1.04, P=0.72).

PASI 90 values were compared in two studies, in which there was no statistical heterogeneity (P=0.93) and no significant differences in PASI 90 between adalimumab biosimilars and reference agents (RR 1.00, 95% CI 0.85-1.17, P=1.00).

PASI 100 values were compared in two studies, in which there was no statistical heterogeneity (P=0.66). Subsequent analysis found no significant differences in PASI 100 between the two groups (RR 0.92, 95% CI 0.66-1.27, P=0.61).

What were the key findings on safety?

SAEs were compared in three studies, in which there was no statistical heterogeneity (P=0.21). The fixed-effects model analysis indicated that there were no significant differences in SAE between the adalimumab biosimilar agents and reference agents (RR 0.73, 95% CI 0.36-1.47, P=0.37).

Withdrawal rates due to AEs were compared in five studies, in which there was no statistical heterogeneity (P=0.34). Subsequent analysis indicated that there were no significant differences in study withdrawal rates due to AEs between the adalimumab and its biosimilars (RR 0.59, 95% CI 0.32-1.06, P=0.08).

What is the take-home message?

These results support adalimumab biosimilar agents as an effective and affordable option for patients with moderate-to-severe plaque psoriasis.

Clinical implications

• Adalimumab (Humira) biosimilars had similar efficacy and safety compared to the original in treating psoriasis.
• Meta-analysis findings support use of adalimumab biosimilars as an effective and affordable option for treating plaque psoriasis.