Biologics are a class of protein-based drugs manufactured through genetic engineering techniques, primarily used to modulate overactive immune systems to treat autoimmune diseases. Unlike traditional anti-inflammatory medications, biologics can precisely target specific immune pathways, such as blocking particular cytokines or suppressing immune cell activity, thereby reducing tissue damage. This therapy is especially suitable for patients who do not respond well to standard treatments or cannot tolerate side effects, offering a more targeted therapeutic option.
The core principle involves regulating abnormal immune activation rather than broadly suppressing immunity. This selective modulation allows biologics to effectively control disease activity while reducing the risk of systemic immunosuppression, making them a key treatment strategy for various autoimmune diseases.
Biologics are mainly divided into five categories: (1) Anti-TNF-α monoclonal antibodies, (2) IL-6 receptor antagonists, (3) B-cell depletion drugs, (4) IL-17/23 inhibitors, and (5) T-cell signaling blockers. Each type targets different inflammatory pathways; for example, anti-TNF-α drugs directly neutralize tumor necrosis factor-alpha, preventing its role in inducing arthritis and skin inflammation.
Biologics are approved for a variety of moderate to severe autoimmune diseases, including rheumatoid arthritis, Sjögren's syndrome, ankylosing spondylitis, and psoriatic arthritis. In Taiwan, health insurance coverage typically requires meeting specific disease activity criteria; for example, rheumatoid arthritis patients must have damage in two or more joints or insufficient response to traditional DMARDs.
In recent years, indications have expanded to include chronic inflammatory bowel diseases (such as Crohn’s disease) and systemic lupus erythematosus, especially in patients with positive specific biomarkers. Treatment response is often assessed through a combination of clinical symptom improvement and changes in blood biomarkers such as CRP and ESR.
Routes of administration vary depending on the drug's characteristics, including subcutaneous injection or intravenous infusion. For example, Adalimumab is administered via subcutaneous injection every two weeks, while infliximab is given as an intravenous infusion monthly. Dosages are adjusted based on patient weight or disease severity, and some drugs require tuberculosis testing before the initial dose.
Training for self-injection is an important part of therapy; healthcare staff will instruct patients on proper injection techniques and storage. Treatment cycles typically last from several months to several years, with regular monitoring of liver and kidney function and infection markers.
The main advantages of biologics include rapid suppression of inflammation, with some patients experiencing relief from joint pain and morning stiffness within weeks. Their targeted mechanism reduces systemic immunosuppression, decreasing the need for long-term steroid use.
The most common side effects include injection site redness or inflammation, with about 10-15% of patients experiencing mild allergic reactions. More serious risks involve increased infection susceptibility, particularly reactivation of latent tuberculosis and severe viral infections. Long-term use may slightly elevate the risk of certain malignancies such as lymphoma, but the incidence is below 1%.
Important Note: Screening for tuberculosis infection history is required before use; if positive, prophylactic treatment is necessary. Patients with a history of heart failure or severe infections should carefully evaluate the risk-benefit ratio.
Prior to treatment, tests for tuberculosis (TST or QuantiFERON), hepatitis B and C viruses, and HIV should be performed. Contraindications include active infections, uncontrolled severe cardiac disease, and hypersensitivity to drug components.
When used with non-steroidal anti-inflammatory drugs (NSAIDs), caution is needed for gastrointestinal bleeding risk. Combining with methotrexate may enhance efficacy. When undergoing radiation therapy or immunosuppressants (e.g., mycophenolate mofetil), immune suppression effects should be monitored.
Before starting biologic therapy, physicians will assess any herbal or supplement use, as some ingredients may affect immune regulation. During biologic treatment, live vaccines should be avoided, and inactivated vaccines are recommended.
Clinical trials show that 70-80% of rheumatoid arthritis patients achieve low disease activity after 6 months of treatment, with a joint destruction delay rate of up to 60%. Psoriatic arthritis patients using IL-17 inhibitors report 50-70% improvement in skin and joint symptoms simultaneously.
Long-term studies confirm that biologics can reduce the need for joint surgery and the risk of disability. However, efficacy may vary among different drugs and patient groups; for example, anti-TNF-α drugs are more effective for axial spondyloarthritis than IL-6 inhibitors.
Traditional treatments include conventional DMARDs (such as methotrexate), NSAIDs, and low-dose steroids. DMARDs take several weeks to months to act, whereas biologics offer rapid control of acute flares but are more costly and have fewer hepatotoxic or nephrotoxic effects.
Small molecule oral drugs (e.g., JAK inhibitors) are emerging options; they are convenient to take but may increase thrombosis risk. Treatment choices should be based on disease severity, organ involvement, and patient lifestyle considerations.
If symptoms such as fever, cough, or skin inflammation occur during biologic treatment, contact your healthcare provider immediately. The doctor may suspend therapy and perform infection marker tests; in severe cases, antibiotics or dose adjustments may be necessary. Patients should maintain good personal hygiene and receive influenza vaccination to reduce infection risk.
Do I need special preparation for biologic injections?Biologics are administered via subcutaneous injection or intravenous infusion. The first treatment should be performed under medical supervision to demonstrate proper technique. Before self-injection, patients should confirm the medication temperature (some require room temperature), rotate injection sites (e.g., abdomen or thigh), and follow strict aseptic procedures to prevent infection.
Can I receive vaccines during treatment? Which vaccines are safe?During treatment, live vaccines (e.g., varicella, MMR) should be avoided, but inactivated or subunit vaccines (e.g., influenza, pneumococcal) are safe. Timing of vaccination should be coordinated with your doctor; it is generally recommended to vaccinate before starting biologics or during treatment intervals to ensure safety and efficacy.
How long does it take to see the effects of biologic therapy?The response varies by disease type; rheumatoid arthritis patients typically see improvement within 6-12 weeks, while psoriasis may improve within 8-12 weeks. Some patients may require 3-6 months to reach optimal results. Doctors will monitor blood markers and symptoms to adjust treatment plans accordingly.
Do I need to modify my diet or exercise routine during biologic therapy?Maintain a balanced diet, avoiding high-sugar or processed foods to reduce inflammation. Moderate aerobic exercise (e.g., swimming, brisk walking) can improve joint flexibility, but overexertion should be avoided. If receiving subcutaneous injections, avoid vigorous activity at the injection site to prevent tissue damage.
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