What is the information about Copaxone (Glatiramer acetate)?

From the Guidelines

Copaxone (glatiramer acetate) is a viable treatment option for relapsing forms of multiple sclerosis (MS), with a relatively favorable safety profile and efficacy in reducing relapse rates, as evidenced by studies such as the PRECISE trial 1.

Key Considerations

• The standard dosing regimens for Copaxone include either 20 mg injected subcutaneously daily or 40 mg injected three times per week, with at least 48 hours between injections.
• Patients should rotate injection sites among arms, thighs, hips, and abdomen to minimize injection site reactions.
• Common side effects include injection site reactions (redness, pain, swelling), post-injection reaction (flushing, chest pain, anxiety, difficulty breathing), and less commonly, lipoatrophy at injection sites.

Efficacy and Safety

• Copaxone has been shown to be effective in reducing the frequency of MS relapses and potentially slowing disease progression, as demonstrated in studies such as the Sormani et al. trial 1.
• The medication works by mimicking myelin basic protein, which diverts the immune system from attacking the body's own myelin.
• Copaxone is generally well-tolerated compared to other MS medications and doesn't require regular blood monitoring.
• It's pregnancy category B, making it one of the safer MS treatments for women considering pregnancy.

Comparison to Other Treatments

• The choice of Copaxone versus other disease-modifying therapies (DMTs) for MS should be individualized based on patient-specific factors, including disease severity, treatment history, and tolerability.
• Recent studies, such as the autologous haematopoietic stem cell transplantation for treatment of multiple sclerosis and neuromyelitis optica spectrum disorder recommendations from ECTRIMS and the EBMT 1, highlight the importance of considering various treatment options for MS patients.

Clinical Recommendations

• Healthcare providers should consider Copaxone as a treatment option for patients with relapsing forms of MS, particularly those who have failed or are intolerant to other DMTs 1.
• Patients should be closely monitored for injection site reactions and other potential side effects, and dosing regimens should be adjusted as needed to minimize adverse effects.
• Regular follow-up appointments and MRI monitoring can help assess treatment efficacy and guide adjustments to the treatment plan.

From the FDA Drug Label

Glatiramer acetate injection is a prescription medicine that is used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. The main use of Copaxone (Glatiramer acetate) is to treat relapsing forms of multiple sclerosis (MS) in adults, including:

• Clinically isolated syndrome
• Relapsing-remitting disease
• Active secondary progressive disease 2

From the Research

Overview of Copaxone

• Copaxone, also known as glatiramer acetate, is a disease-modifying therapy (DMT) used to treat relapsing-remitting multiple sclerosis (RRMS) 3.
• It is administered subcutaneously and has been shown to reduce relapses and delay disability progression in patients with RRMS 4.

Efficacy of Copaxone

• Studies have demonstrated that Copaxone is effective in reducing relapse rates and slowing disability progression in patients with RRMS 4, 5.
• A network meta-analysis found that Copaxone probably moderately decreases people with relapses at 24 months, with a relative risk of 0.84 (95% CI 0.76 to 0.93) 5.
• Another study found that Copaxone reduced relapses and clinical progression compared to placebo or standard treatment, with a relative net benefit-risk difference of 10.2% in favor of Copaxone compared to placebo 4.

Safety of Copaxone

• Copaxone has been shown to have a favorable safety profile, with serious adverse events (SAEs) reported in a similar frequency to placebo 5.
• However, treatment discontinuation due to adverse events was probably slightly increased with Copaxone, with an odds ratio of 1.48 (95% CI 1.01 to 2.14) 5.
• A study found that study discontinuations due to adverse events were similar for Copaxone and interferons, with a relative risk of 0.89 (95% CI 0.57 to 1.41) 4.

Comparison to Other DMTs

• Copaxone has been compared to other DMTs, including interferon beta-1a, natalizumab, and fingolimod, in terms of efficacy and safety 5.
• The network meta-analysis found that natalizumab, cladribine, and alemtuzumab were more effective than Copaxone in reducing relapses, but Copaxone had a more favorable safety profile 5.
• Another study found that Copaxone had comparable persistence and relapse outcomes to subcutaneous interferon beta-1a, but better safety outcomes 6.