Risankizumab, sold under the brand name Skyrizi, is a humanized

monoclonal antibody A monoclonal antibody (mAb, more rarely called moAb) is an antibody produced from a cell Lineage made by cloning a unique white blood cell. All subsequent antibodies derived this way trace back to a unique parent cell. Monoclonal antibodies ca ...

targeting interleukin 23A (IL-23A). Risankizumab is part of a collaboration between

Boehringer Ingelheim C.H. Boehringer Sohn AG & Co. is the parent company of the Boehringer Ingelheim group, which was founded in 1885 by Albert Boehringer in Ingelheim am Rhein, Germany. As of 2018, Boehringer Ingelheim is one of the world's largest pharmaceutical ...

and

AbbVie AbbVie is an American publicly traded biopharmaceutical company founded in 2013. It originated as a spin-off of Abbott Laboratories. History On October 19, 2011, Abbott Laboratories announced its plan to separate into two publicly traded compan ...

. Risankizumab has been approved in the European Union, the United States, and Canada for the treatment of moderate to severe

plaque psoriasis Psoriasis is a long-lasting, noncontagious autoimmune disease characterized by raised areas of abnormal skin. These areas are red, pink, or purple, dry, itchy, and scaly. Psoriasis varies in severity from small, localized patches to complete ...

in adults who are candidates for systemic therapy, and moderate to severe

Crohn's disease Crohn's disease is a type of inflammatory bowel disease (IBD) that may affect any segment of the gastrointestinal tract. Symptoms often include abdominal pain, diarrhea (which may be bloody if inflammation is severe), fever, abdominal distension ...

in the United States. In Japan, it is approved for treating plaque psoriasis,

generalized pustular psoriasis Generalized pustular psoriasis (GPP) is an extremely rare type of psoriasis that can present in a variety of forms. Unlike the most general and common forms of psoriasis, GPP usually covers the entire body and with pus-filled blisters rather than p ...

, erythrodermic psoriasis and

psoriatic arthritis Psoriatic arthritis is a long-term inflammatory arthritis that occurs in people affected by the autoimmune disease psoriasis. The classic feature of psoriatic arthritis is swelling of entire fingers and toes with a sausage-like appearance. Thi ...

in adults who have an inadequate response to conventional therapies.

Clinical trials

Psoriasis

In a phase I clinical trial, thirty-nine patients received single-dose risankizumab, eighteen of which received the drug intravenously, thirteen subcutaneously, and eight received the placebo drug. There were several instances that adverse effects occurred but in the same frequency for the placebo and the experimental groups. Four serious adverse events occurred in the risankizumab treated patients, all of which were judged not treatment related. Risankizumab was associated with clinical improvement in individuals treated with the drug, from week 2 and maintained for up to 66 weeks after treatment. At week 12 of treatment, 75%, 90%, and 100% decreases in the

Psoriasis Area and Severity Index Psoriasis Area and Severity Index (PASI) is the most widely used tool for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to ...

(PASI) were achieved by 87%, 58%, and 16% of risankizumab treated patients, regardless of dose, respectively, versus individuals receiving placebo. Significant correlation between treatment-associated molecular changes and PASI improvement was observed in the risankizumab treated patients. The efficacy, safety and tolerability was further investigated in a phase III program comprising four clinical trials which compared risankizumab to

ustekinumab Ustekinumab, sold under the brand name Stelara is a monoclonal antibody medication developed by Janssen Pharmaceuticals, for the treatment of Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis, targeting both IL-12 an ...

adalimumab Adalimumab, sold under the brand name Humira, among others, is a monoclonal antibody used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativ ...

and

placebo A placebo ( ) is a substance or treatment which is designed to have no therapeutic value. Common placebos include inert tablets (like sugar pills), inert injections (like Saline (medicine), saline), sham surgery, and other procedures. In general ...

in the indication of plaque psoriasis. The results of these trials confirmed the efficacy and tolerability of risankizumab.

History

Risankizumab was approved by the U.S.

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...

(FDA) for treatment of moderate-to-severe plaque psoriasis in April 2019. The FDA approved risankizumab based on evidence primarily from five clinical trials (Trial 1/NCT0202684370, Trial 2/NCT02684357, Trial 3/NCT02672852, Trial 4/ NCT02694523 and Trial 5/NCT02054481) of 1606 patients with moderate to severe plaque psoriasis. The trials were conducted in Asia, Canada, Europe, Mexico, South America, and the United States.

References

External links

* Antipsoriatics Immunosuppressants Monoclonal antibodies AbbVie brands {{antineoplastic-drug-stub