FDA Approves a New Interleukin Inhibitor, Risankizumab (Skyrizi) for Patients with Psoriasis Arthritis (Psa)

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In a recent report, U.S Food and drug administration (FDA) approves risankizumab-rzaa (Skyrizi) as a new treatment drug for patients with active psoriasis arthritis (PsA).

Currently approved as a second indication medication, Abbvie is the manufacturer of Skyrizi. In April 2019, the company previously approved the use of risankizumab in patients with moderate to severe plaque psoriasis

Psoriatic arthritis (PsA) is a chronic, systemic inflammatory disease that affects the skin and joints. The immune system gets impaired resulting in inflammation. This causes skin lesions in addition to pain, psoriasis, joint stiffness, and fatigue. PsA affects a large portion of population affecting 30% of psoriasis patients.

The use of Skyrizi (risankizumab-rzaa) was successful in reducing joint symptoms such as pain, stiffness, tenderness and swelling.

The success of risankizumab-rzaa is based on two clinical trials: KEEPsAKE-1 and KEEPsAKE-2, investigating the safety and efficacy of drug among: 1) patients suffering from PsA; 2) patients responding inadequately to traditional drugs, including disease-modifying antirheumatic drugs (DMARDs).

Outcome assessment

In the KEEPsAKE, the primary endpoint was evaluation of the ACR20 (score for recording changes in arthritis symptoms) response at week 24. Both the clinical trials were effective as the ACR20 response in risankizumab group was 57% and 51% compared to 34% and 27% in placebo patients, in the KEEPsAKE-1 and KEEPsAKE-2 trials, respectively.

A significantly better secondary endpoints was seen in the risankizumab group than the placebo group. This includes improvements in physical activity, skin clearance, and less disease activity.

On comparing the serious adverse events between the risankizumab group and placebo group, 2.5% of patients in KEEPsAKE-1 and 4.0% in KEEPsAKE-2, whereas in the placebo group, it was 3.7% and 5.5%, respectively.

Clinical significance

Skyrizi is effective in managing dactylitis and enthesitis. This means it can reduce the inflammation of toes, fingers, and locations where the ligaments or tendons attach to bones.

It is the first IL-23 inhibitor indicated for adults with active psoriatic arthritis and moderate to severe plaque psoriasis.

Recommended dosage is a single subcutaneous injection of 150mg, four times a year. It is administered after two starter doses at 0 and 4 weeks. Skyrizi can be used alone or in combination with DMARDs.1

Mechanism of action

Skyrizi prevents the inflammatory processes by blocking the cytokine, IL-23 as it binds to the p19 subunit of the interleukin. IL-23 actively regulates various immune mediated diseases such as psoriasis.

Adverse reactions

Most common side-effects of risankizumab-rzaa are

  • Feeling of tiredness
  • Headache
  • Fungal skin infections
  • Upper respiratory infections
  • Reactions at injection site

Serious allergic reaction

In some situations, patient may encounter some serious allergic reactions. Stop using the drug immediately and visit the emergency department if any sign of serious allergic reaction occurs:

  • Skin rash
  • Swelling of the face, mouth, tongue or throat
  • Chest tightness
  • Itching
  • Dizziness
  • Fainting or Lightheadedness 
  • Throat tightness
  • Difficulty in breathing

Conclusion

Many patients are unaware that there could be a possible connection between the skin lesions and joint symptoms such as pain, stiffness and swelling. Due to this negligence, patients may often delay the treatment of PsA. SKYRIZI will improve the skin and joint symptoms. It has the potential to diminish the inflammatory processes that worsens patient’s well-being and quality of life. 

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