Psoriatic Disease Drugs in the Pipeline

Thanks to the diligent efforts of science, psoriatic disease (PD) treatments are continuously emerging. And the search is continuing for even safer and more effective treatments in the effort improve the lives of people living this very debilitating condition.  

There is no cure for psoriatic disease and current treatment aims to relieve pain, reduce inflammation and swelling, keep joints working properly, and prevent and reduce joint and/or skin damage. Doctors recommend treatments based on the severity of the disease and a person’s reaction to treatment. Specific therapies for psoriatic disease include NSAIDs, corticosteroids, DMARDs, biologics, and topical treatments. 

Non-steroidal Anti-Inflammatory Drugs (NSAIDs), including over-the-counter (OTC) medications such as ibuprofen and aspirin, as well as prescription NSAIDS, can help with decreasing inflammation, swelling, joint pain, and stiffness. They can also manage pain and inflammation associated with skin symptoms.

Some NSAIDs, when taken over long periods or in high dosages, can cause stomach problems, including ulcers and gastrointestinal bleeding. NSAIDs called COX-2 inhibitors, only available as a prescription, seem to cause fewer problems than other NSAIDs and have proven successful in treating symptoms of various forms of autoimmune arthritis, including psoriatic disease. They are also more effective for pain management and inflammation reduction. But they are more expensive and have risks associated with them, including an increased risk for heart attack and stroke in some people.

Corticosteroids are medications given either by mouth or injection to reduce severe joint and tendon inflammation and swelling. They are usually prescribed for short periods to shorten flare-ups of PD. Doctors try to prescribe them only as necessary with PD because they can worsen skin lesions after treatment has stopped.

Disease-Modifying Antirheumatic Drugs (DMARDs) are prescribed when NSAIDs fail to work and disease progression is evident. They may relieve more severe symptoms and attempt to slow down and stop joint and tissue damage and PsA progression. They can also help to reduce inflammation associated with psoriasis.

DMARDs that have been helpful to people with psoriatic disease include antimalarials, immunosuppressive drugs, biologics, and sulfasalazine. 

Antimalarials

Antimalarials are often prescribed for people with rheumatoid arthritis, as they been successful in treating this chronic systemic (body-wide) inflammatory condition. They have also been successful for some cases of psoriatic disease. However, some antimalarials, such as Plaquenil (Hydroxychloroquine), are not recommended for people who have skin symptoms, as they can promote severe skin flares.

Immunosuppressive Drugs

Immunosuppressive drugs are DMARDs that inhibit the overactive response of the immune system. 

Methotrexate is a DMARD and an immunosuppressive drug. It has been successful in treating both skin and joint symptoms of PD. It may help prevent joint destruction and disability.

Imuran is another immunosuppressive drug with potent anti-inflammatory effects. Both skin and joint symptoms of PD respond well to Imuran.

Biologics

Injectable biologics, such as Humira and Enbrel, are also considered DMARDs. Some biologics must be administered by intravenous (IV) infusion. These medications contain compounds that target specific chemicals in the immune system responsible for causing psoriasis and PsA symptoms.

Acthar is another type of biologic injection. It helps the body to produce its own steroid hormones to regulate inflammation. Acthar is designed for short-term use and as an add-on to your current PD therapies. 

Sulfasalazine

Azulfidine (sulfasalazine) is a type of sulfonamide drug (a class of drugs that includes both antibiotics and non-antibiotics), but it is also considered a DMARD. It should be not be taken by people with sulfa allergies. According to the National Psoriasis Foundation, at least one-third of people with PsA respond rapidly to sulfasalazine. 

Topical treatments are medicines applied directly to the skin. They are typically first-line treatments for psoriasis. They are designed to slow down and/or normalize skin growth and reduce inflammation. Topical treatments are available over-the-counter, as a prescription, and as a doctor-prescribed corticosteroid. 

New oral treatments for psoriatic disease work differently than previous pills because they selectively target molecules in the immune system. They work to adjust the process of inflammation within cells to correct the overactive inflammatory response in people with PD.

Otezla (apremilast) is one of these new molecule medicines and it treats PD by regulating inflammation within specific cells. It is available as a 30-milligram pill to be taken twice daily, and must be taken continuously to maintain symptom improvement.

Drugs in the pipeline for psoriatic disease are those currently being developed and tested, and are yet to be approved by the Food and Drug Administration (FDA). Every drug must go through three phases of clinical trials before the FDA can even make a decision whether to approve it.

BMS-986165, is an oral, selective tyrosine kinase 2 (TYK2) inhibitor for treating psoriatic disease. Research has been presented showing it is a bioequivalent to Humira.

Phase II studies revealed treatment was effective in up to 75 percent of the study participants by the 12^th week.  In phase III, researchers confirmed BMS-986165 is equivalent to Humira, as there were no meaningful differences in effectiveness, safety or immune system response. The next step in Phase III is to look at 24-week data.

BCD-085, or Patera, is a biologic and type of monoclonal antibody being tested for people with psoriasis and psoriatic arthritis. In phase I trials, researchers determined the safest dose for people with psoriatic disease. In phase II, researchers found the majority of patients were meeting the American College of Rheumatology Criteria for improvement. In Phase III, researchers plan to evaluate the effectiveness and safety of BCD-0085 in comparison to a placebo. Phase III is currently in the recruiting stage and the study should be fully completed by January 2021.

UCB4940, or Bimekizumab, is a biologic being tested for the treatment of psoriatic arthritis and chronic plaque psoriasis. Previous research shows promising response rates and symptom improvement. The drug is designed to selectively and potently neutralize both IL-7A and IL-17F, two proteins involved in the inflammatory process.

Following phase IIb, researchers determined that 46 percent of the patients who took the drug were showing at least 50 percent symptom improvement for both joint and skin, and the improvement continued through week 48. Bimekizumab is currently in phase III clinical trials.

BI655066, or Risankizumab, contains an antibody to target interleukin 23A (IL-23A), a chemical that triggers inflammation in the body. All phase studies are complete, but it has not yet been approved by the FDA for the treatment of any medical condition. It has previously been studied for the treatment of psoriasis and psoriatic arthritis. 

In the clinical trials, researchers found Risankizumab was associated with improvement of psoriatic disease skin symptoms from as early as week 2 and maintained for up to 66 weeks after the start of treatment. Phase III trials confirmed it was effective and tolerable for PD patients. An application has been placed with FDA by the drug manufacturer and Risankizumab's patent is pending. 

Upcoming treatment options for psoriatic disease mean more options for relief from joint and skin symptoms for the millions affected by this often-debilitating autoimmune disease. And while there are a lot of options out there, researchers know there is more they can do. This is important because PD is a condition that is experienced differently by each person affected. Some people have mild symptoms that aren’t life-altering while others have severe symptoms that affect them on a daily basis. 

No matter what symptoms you have, work with your doctor to find the right treatments to improve your outlook and quality of life. The future of PD treatment continues to be bright and researchers are hopeful that one day, PD can be cured, or in the least, the number of people in remission will be higher than the number of people struggling with daily symptoms.