BIOLOGIC THERAPY

What are Biologic drugs?

Biologic drugs, also known as biologics or biological response modifiers, encompass a diverse range of products composed of sugars, proteins, nucleic acids, or combinations thereof, including living cells from humans, animals, or microorganisms. These drugs are developed using biotechnology methods and can be administered via subcutaneous injection, infusion (slow IV drip), or, in some cases, in tablet form.

One of the key advantages of biologics is their ability to target and block specific components of the immune system responsible for disease symptoms while leaving other areas unaffected. This targeted approach enhances their effectiveness and reduces the likelihood of side effects. Biologics are sometimes used for diseases that lack alternative treatments.

What is difference in biologics and other drugs?

Common drugs typically consist of well-understood chemically synthesized structures, whereas biologics are composed of complex mixtures that are not easily identified. Biologics are sensitive to heat and prone to microbial contamination.

What are the skin diseases where biologics are commonly used ?

Common diseases include:

• Psoriasis
• Pemphigus
• Hidradenitis Suppurativa
• Alopecia Areata
• Urticaria
• Atopic Dermatitis

What is the role of biologics in treatment of Psoriasis?

Psoriasis, an autoimmune disorder, involves accelerated multiplication of skin cells. Biologics target specific immune cells (T-cells, TNF-alpha, interleukins) responsible for this overgrowth and inhibit their activity. Administered subcutaneously or intravenously, biologics bypass digestive juices to prevent damage. While they don't cure psoriasis, biologics alleviate symptoms more effectively than traditional medical therapies. They are typically given weekly, biweekly, or with longer intervals between doses.

How do I know whether biologics are right for me?

Biologic treatment is effective yet costly and has drawbacks. Patients should focus on three key questions:

• What is my primary concern?
• What actions do I need to take?
• Why is it crucial for me to follow this treatment?

Patients must thoroughly discuss all aspects of biologic therapy with their doctor. Before initiating treatment, consider the following factors:

You maybe the right candidates for biologics if:

• Previous treatments failed to alleviate your symptoms.
• You experienced intolerable side effects with other medical therapies.
• Your condition hinders the use of conventional treatments.
• You prefer fewer doses over daily medication schedules.
• You can manage the financial aspect of the treatment.

You are not a good candidate for biologics if:

• You have tested positive for infections such as TB or HIV, or if you have an active infection.
• You have liver disease, cancer, heart failure, or multiple sclerosis.
• You are pregnant or breastfeeding.
• Your immune system is significantly weakened.
• You cannot afford the expensive treatments.

How biologics are given to patients?

• Subcutaneous injection, for example, Secukinumab
• Intravenous infusion, delivering into the bloodstream
• Oral tablet form, like Tofacitinib

What are the various types of Biologics used in treatment of Psoriasis?

Biologics are categorized according to the protein they target:

• Interleukin-17 Inhibitors: Examples include Secukinumab, Brodalumab, and Ixekizumab.
• Interleukin-12/23 Inhibitors: Such as ustekinumab (Stelara).
• Tumor necrosis factor alpha (TNF-alpha) inhibitors: Like Etanercept, Adalimumab, Infliximab, and Certolizumab.
• T-cell inhibitors: Such as abatacept.
• Interleukin 23 Inhibitors: Including Ilumya (tildrakizumab-asmn), Skyrizi (risankizumab-rzaa), and Tremfya (guselkumab).

Your doctor will choose the appropriate biologic drug based on your symptoms and individual requirements.

What investigations are required before biologics therapy for skin disease?

• Routine assessments comprise CBC, LFT, RFT, and urine microscopy.
• Tests to exclude infections: HIV, HbsAg, TB.
• Additional evaluations may include chest X-ray, ECG, and ECHO.
• Further investigations are tailored to the patient's comorbidities, specific disease, and prescribed biologic.

How scapho (secukinumab) is given to psoriasis patient?

The medication is available in injection form and is prepared with specific precautions during administration. It is supplied in a vial with a strength of 150 mg per injection. The typical dose is 300 mg per session, although the treating doctor determines the appropriate dosage. The injection is administered subcutaneously, typically in the thigh or abdomen. Initially, it is given weekly for 5 weeks, followed by monthly doses for 6 months. The continuation of therapy beyond this period is contingent upon the disease's status.

How long does it take for this medicine to show effect?

Many patients begin to experience the effects after their second dose. By the end of the weekly doses, a significant improvement in the skin condition is observed in most patients. The effects can last for up to 8 months to 1 year after completing the 6 monthly doses. Literature indicates the need for ongoing medication doses to maintain remission.

Which biologic is effective in pemphigus?

Biologics like Rituximab are utilized when traditional therapies such as steroids and other immunosuppressants prove ineffective or are contraindicated for patients with pemphigus. Rituximab, the first FDA-approved biologic therapy for pemphigus, is exceptionally efficacious. It is administered via intravenous infusion and requires basic monitoring of vital signs.

What are risks and side effects of biologics ?

Frequent infections include upper respiratory tract infections (URIs), pneumonia, urinary tract infections (UTIs), and skin infections. Opportunistic infections comprise tuberculosis (TB), hepatitis B, and deep fungal infections. Allergic reactions are also possible.

What are the precautions to be taken while taking biologics?

Biologics weaken your body's immune system, increasing susceptibility to infections. Be vigilant for these signs and promptly inform your doctor if you experience:

• Fever and chills
• Body aches
• Unusual fatigue
• Reappearance of symptoms of any previously controlled or in remission disease.