Breakthrough Psoriasis Treatments: Newly Approved Medicines You Need to Know!

Psoriasis is an autoimmune condition that speeds up skin cell turnover, resulting in the development of red, scaly plaques that are painful and emotionally distressing.

Although there is no absolute cure for psoriasis, breakthroughs in medical science have resulted in the approval of a number of novel treatments that enhance symptom control and patients’ quality of life.

This article explores the newly approved medicines for psoriasis, their mechanisms of action, effectiveness, and how they compare to existing treatments.

Psoriasis Treatment Options

The treatment landscape for psoriasis includes topical treatments, systemic medications (oral or injectable), and phototherapy. The selection of therapy is based on the severity of the condition, patient preferences, and underlying health conditions.

1. Topical Therapies:
   • Used primarily for mild to moderate psoriasis. These include corticosteroids, vitamin D analogs, and calcineurin inhibitors.
2. Systemic Therapies:
   • Used for moderate to severe psoriasis. These include traditional oral medications (e.g., methotrexate, cyclosporine) and biologics that target specific components of the immune system.
3. Phototherapy:
   • Exposure to ultraviolet (UV) light can slow skin cell growth and reduce inflammation.

In recent years, new systemic and topical therapies have been approved to offer better safety and efficacy profiles than traditional options.

Newly Approved Medicines for Psoriasis:

Here are the latest FDA Approved Medications for Psoriasis:

These medications are not limited to one group of drugs. In fact all of these medications work differently on various immune-related pathways.

The mechanism of action and route of administration of these newly-approved medications for Psoriasis is summarized in the table below:

Efficacy of New Treatments (PASI90 Score)

The Psoriasis Area and Severity Index (PASI) is a standard tool to check the severity of psoriasis. Achieving a 90% improvement (PASI90) is considered a benchmark for high efficacy.

Recent clinical trials have ranked new medications based on their PASI90 responses:

• Bimekizumab:
  • One of the most effective biologics, showing PASI90 responses in over 70% of patients. [Ref]
• Deucravacitinib:
  • Provides a convenient oral option with an efficacy close to biologics, with 50% of patients reaching PASI75. [Ref]
• Tapinarof & Roflumilast:
  • Offer significant plaque reduction with fewer side effects than corticosteroids. [Ref]

These results suggest that newer biologics and small-molecule inhibitors offer improved symptom control compared to traditional therapies.

Table Summarizing the Efficacy of Newly Approved Medications for Psoriasis:

Newly Approved Psoriasis Medicines Vs. Existing Treatments

Biologics (Injectables)

• Older biologics (e.g., adalimumab, etanercept) target broader immune pathways.
• Newer biologics like bimekizumab specifically inhibit IL-17A and IL-17F, resulting in higher efficacy.

Oral Systemics

• Traditional oral treatments like methotrexate require regular liver monitoring.
• Deucravacitinib offers a targeted mechanism with fewer long-term risks.

Topical Treatments

• Corticosteroids have been mainstays but can cause skin thinning.
• Tapinarof and roflumilast provide effective non-steroidal alternatives with long-term safety benefits.

Combination Therapy in Psoriasis Treatment

Combination therapy, in which several treatment modalities are combined in one modality, is becoming a more popular method of treating psoriasis.

Some of the benefits of combination therapy include increased effectiveness, fewer side effects, and better patient compliance. Some of the most frequent strategies are:

• Biologics + Topicals:
  • Using a biologic such as bimekizumab in combination with topical agents like tapinarof or roflumilast can provide targeted relief while minimizing systemic exposure.

• Oral Systemics + Topicals:
  • Deucravacitinib combined with a corticosteroid or vitamin D analog can enhance treatment outcomes for moderate psoriasis.
• Phototherapy + Topicals/Systemics:
  • UV light therapy combined with topical agents or systemic treatments can help control stubborn plaques in severe cases.

Economic and Accessibility Considerations

New drugs for psoriasis have varying affordability, ranging from being very costly with some biologics to being cost-saving with biosimilars.

Furthermore, biosimilars such as Steqeyma minimize overall treatment expenditure without compromising on efficacy.

But still, newer treatments may not be widely available in developing countries because of regulatory authorization and affordability.

Safety Profiles and Side Effects

Safety is a key consideration when choosing psoriasis treatments. New medications have undergone rigorous testing to ensure patient safety:

• Bimekizumab:
  • May increase the risk of fungal infections due to IL-17 inhibition.
• Deucravacitinib:
  • Generally well tolerated, but long-term effects on the immune system require monitoring.
• Roflumilast & Tapinarof:
  • Fewer systemic side effects than corticosteroids, making them preferable for long-term use.

Scientific Evidence on Efficacy of Newly Approved Psoriasis Drugs

Bimekizumab (Bimzelx):

A recent retrospective review from a Canadian outpatient dermatology clinic evaluated 20 patients with moderate‐to‐severe psoriasis who were treated with bimekizumab.

The study reported an average 93.7% reduction in PASI scores within 4–6 months of treatment initiation.

Although 18.8% of patients experienced mild to moderate oral candidiasis, no serious adverse events were noted.

These early findings reinforce the high efficacy and manageable safety profile observed in clinical trials. [Ref]

Deucravacitinib (Sotyktu):

While real‐world data for deucravacitinib are still emerging, early clinician reports suggest that its oral formulation shows promising results.

Dermatologists note that patients who prefer oral medications are experiencing significant improvements in PASI scores, with minimal long‐term safety concerns observed during its first year of use.

Topical Agents (Roflumilast and Tapinarof):

For patients with mild-to-moderate disease or those who require steroid-sparing options, early real-world experience with non-steroidal topicals such as Zoryve (roflumilast) and Vtama (Tapinarof) has been encouraging.

Although adherence remains a challenge in everyday practice, these agents have demonstrated effective plaque reduction and a favorable safety profile, complementing traditional topical treatments. [Ref]

Biosimilars (e.g., Steqeyma):

Initial observational studies with biosimilars like Steqeyma—which offers a cost-effective alternative to Stelara—indicate comparable efficacy and safety.

Studies also suggest that switching to biosimilars shows similar treatment outcomes and may improve patient access due to low cost as compared to biologic drugs.

Here are the FDA-approved indications and the dosing schedule of the novel FDA-approved biologicals for psoriasis:

Conclusion

The recent approvals of bimekizumab, deucravacitinib, roflumilast, tapinarof, and ustekinumab biosimilars mark a significant advancement in psoriasis management.

These treatments offer enhanced efficacy, improved safety, and diverse administration options, allowing for more personalized treatment strategies.

Buy our wellness blend: Combined Oolong, Berberine, and Mint Tea