Psoriatic Arthritis Drugs at a Glance, 2023

Biosimilars have become a therapeutic turning point for many patients who are living with rheumatic illnesses. Psoriatic arthritis (PsA) is a complex, multi-faceted chronic inflammatory musculoskeletal and skin disease where the treatment has changed considerably over the past few years. Psoriatic arthritis has an impact on about 30% of people with psoriasis.¹

In 2019, the ACR and the National Psoriasis Foundation (NPF) published their first joint guideline for treating psoriatic arthritis. It can be reviewed here.²

Although the impact of PsA on quality of life is comparable to rheumatoid arthritis (RA), there are fewer resources for patients living with PsA than there are for patients with RA.³ The treatment of PsA includes traditional or conventional disease-modifying anti-rheumatic drugs (DMARDs); biologic therapies, such as tumor necrosis factor inhibitors (TNFi’s), interleukin (IL) 17 receptor antagonists, IL-12/23 inhibitors (IL-12/23i); and targeted oral agents, including a phosphodiesterase-4 inhibitor (PDE4) and Janus kinase (JAK) inhibitors.

The U.S. Food & Drug Administration (FDA) has approved eight drugs that are biosimilar to adalimumab. Adalimumab-adbm (Cyltezo) is the first biosimilar for a rheumatic disease with an interchangeable designation. It is interchangeable for adalimumab (Humira), meaning it can be substituted for its reference product at the pharmacy without additional approvals from the prescribing physician, state law permitting.⁴

SUMMARY BY DRUG CLASS

Drug class: PDE4 inhibitor

Drug: apremilast (Otezla)

Adverse reactions: The most common adverse reactions (≥5%) are diarrhea, nausea and headache.

Drug class: TNFi’s

Drugs: etanercept (Enbrel), infliximab (Remicade), adalimumab (Humira), certolizumab (Cimzia), golimumab injection for subcutaneous use (Simponi), golimumab injection for intravenous use (Simponi Aria)

Biosimilars: etanercept-szzs (Erelzi), etanercept-ykro (Eticovo), infliximab-dyyb (Inflectra), infliximab-abda (Renflexis), infliximab-qbtx (Ixifi), adalimumab-atto (Amjevita), adalimumab-adbm (Cyltezo)*, adalimumab-adaz (Hyrimoz), adalimumab-fkjp (Hulio), adalimumabaqvh (Yusimry), adalimumab-afzb (Abrilada), adalimumab-aacf (Idacio), adalimumab-bwwd (Hadlima)

Boxed Warning: Serious Infections & Malignancies

• There is an increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (e.g., histoplasmosis) and infections due to other opportunistic pathogens. If these develop, discontinue the drug.
• Before starting treatment, perform a test for latent tuberculosis (TB); if positive, start treatment for TB prior to starting the drug. Monitor all patients for development of active TB during treatment, even if the initial latent TB test was negative.
• Lymphoma and other malignancies, some fatal, have been reported in children and adolescents treated with TNFi’s.
• Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have occurred in adolescent and young adults with inflammatory bowel disease treated with TNFi’s.

Adverse reactions: The most common adverse reactions (≥5%) are infections, injection-site reactions, headache, abdominal pain and rash.

Drug class: CLTA4-Ig

Drug: abatacept (Orencia)

Adverse reactions: The most common adverse reactions (≥10%) are headache, upper respiratory tract infection, nasopharyngitis and nausea.

Drug class: IL-12/23 inhibitor

Drug: ustekinumab (Stelara)

Adverse reactions: The most common adverse reactions (≥3%) are arthralgias and nausea.

Drug class: JAK inhibitor

Drug: tofacitinib (Xeljanz), upadacitinib (Rinvoq)

Boxed Warning: Serious Infections, Mortality, Malignancy and Thrombosis

• There is an increased risk of serious infections leading to hospitalization or death, including TB and bacterial, invasive fungal, viral, and other opportunistic infections.
• If a serious infection develops, discontinue treatment until the infection is controlled.
• Before starting treatment, perform a test for latent TB; if positive, start treatment for TB prior to starting the drug. Monitor all patients for development of active TB during treatment, even if the initial latent TB test was negative.
• Thrombosis, including pulmonary embolism, deep venous thrombosis and arterial thrombosis have occurred in patients treated with JAK inhibitors.
• Malignancies have been observed in patients treated with JAK inhibitors.

Adverse reactions: The most common adverse reactions (≥2%) are upper respiratory tract infection, nasopharyngitis, diarrhea and headache.

Drug class: IL-17 receptor antagonist

Drug: brodalumab (Siliq)—off-label, ixekizumab (Taltz), secukinumab (Cosentyx)

Boxed Warning for Brodalumab (Siliq): Suicidal Ideation and Behavior

• Suicidal ideation and behavior, including completed suicides, have occurred in patients treated with brodalumab.
• Prior to prescribing, weigh potential risks and benefits in patients with a history of depression and/or suicidal ideation or behavior.
• Patients with new or worsening suicidal thoughts and behavior should be referred to a mental health professional.
• Advise patients and caregivers to seek medical attention for manifestations of suicidal ideation or behavior, new onset or worsening depression, anxiety, or other mood changes.
• Brodalumab is available only through a restricted program called SILIQ REMS.

Adverse reactions: The most common adverse reactions (≥1%) are infections, nasopharyngitis and headaches.

Drug class: IL-23 inhibitor

Drug: guselkumab (Tremfya), risankizumab-rzaa (Skyrizi), tildrakizumab-asmn (Ilumya)—off label

Adverse reactions: The most common adverse reactions (≥1%) are upper respiratory infections, headache, fatigue, injection-site reactions and diarrhea.

IN SUM

TABLE 1. Click to enlarge.

See Table 1 for administration and other information for all of these drugs. Important note: All of these treatments carry the risk of severe side effects. Please refer to the full prescribing information (as indicated in the References section) for each drug.

Mary Choy, PharmD, BCGP, FASHP, is a medical writer and editor living in New York City. Dr. Choy is the co-author of Healthcare Heroes: The Medical Careers Guide.

References

1. Mease PJ, Gladman DD, Papp KA, et al. Prevalence of rheumatologist-diagnosed psoriatic arthritis in patients with psoriasis in European/North American dermatology clinics. J Am Acad Dermatol. 2013 Nov;69(5):729–735.
2. Singh JA, Guyatt G, Ogdie A, et al. 2018 American College of Rheumatology/National Psoriasis Foundation guideline for the treatment of psoriatic arthritis. Arthritis Rheumatol. 2019 Jan;71(1):5–32.
3. The National Psoriasis Foundation. About psoriatic arthritis. 2022 Jun 2. https://www.psoriasis.org/about-psoriatic-arthritis/.
4. FDA approves Cyltezo, the first interchangeable biosimilar to Humira [news release]. U.S. Food & Drug Administration. 2021 Oct 18. https://www.fda.gov/news-events/press-announcements/fda-approves-cyltezo-first-interchangeable-biosimilar-humira.
5. Otezla prescribing information. U.S. Food & Drug Administration. 2021 Dec. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205437s011lbl.pdf.
6. Enbrel prescribing information. U.S. Food & Drug Administration. 2022 Jun. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/103795s5591lbl.pdf.
7. Erelzi prescribing information. U.S. Food & Drug Administration. 2022 Nov. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761042s018lbl.pdf.
8. Eticovo prescribing information. U.S. Food & Drug Administration. 2019 Apr. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761066s000lbl.pdf.
9. Remicade prescribing information. U.S. Food & Drug Administration. 2021 Oct. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103772s5401lbl.pdf.
10. Inflectra prescribing information. U.S. Food & Drug Administration. 2021 Jun. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125544s018lbl.pdf.
11. Renflexis prescribing information. U.S. Food & Drug Administration. 2022 Jan. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761054Orig1s029lbl.pdf.
12. Ixifi prescribing information. U.S. Food & Drug Administration. 2020 Jan. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761072s006lbl.pdf.
13. Avsola prescribing information. U.S. Food & Drug Administration. 2021 Sep. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761086s001lbl.pdf.
14. Humira prescribing information. U.S. Food & Drug Administration. 2021 Feb. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125057s417lbl.pdf.
15. Amjevita prescribing information. U.S. Food & Drug Administration. 2022 Jul. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761024s010lbl.pdf.
16. Cyltezo prescribing information. U.S. Food & Drug Administration. 2022 Mar. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761058Orig1s011lbl.pdf.
17. Hyrimoz prescribing information. U.S. Food & Drug Administration. 2022 Jul. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761071s010s012lbl.pdf.
18. Hulio prescribing information. U.S. Food & Drug Administration. 2022 Jul. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761154s002lbl.pdf.
19. Yusimry prescribing information. U.S. Food & Drug Administration. 2021 Dec. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761216s000lbl.pdf.
20. Abrilada prescribing information. U.S. Food & Drug Administration. 2022 Jul. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761118s006lbl.pdf.
21. Idacio prescribing information. U.S. Food & Drug Administration. 2022 Dec. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761255s000lbl.pdf.
22. Hadlima prescribing information. U.S. Food & Drug Administration. 2022 Dec. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761059Orig1s007lbl.pdf.
23. Cimzia prescribing information. U.S. Food & Drug Administration. 2022 Dec. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125160s305lbl.pdf.
24. Simponi prescribing information. U.S. Food & Drug Administration. 2019 Sep. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125289s146lbl.pdf.
25. Simponi Aria prescribing information. U.S. Food & Drug Administration. 2021 Feb. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125433s032lbl.pdf.
26. Orencia prescribing information. U.S. Food & Drug Administration. 2021 Dec. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125118s240lbl.pdf.
27. Stelara prescribing information. U.S. Food & Drug Administration. 2022 Jul. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125261s161lbl.pdf.
28. Siliq prescribing information. U.S. Food & Drug Administration. 2017 Feb. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761032lbl.pdf.
29. Taltz prescribing information. U.S. Food & Drug Administration. 2022 Jul. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125521s024lbl.pdf.
30. Cosentyx prescribing information. U.S. Food & Drug Administration. 2021 Dec. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125504_S050_S051lbl.pdf.
31. Tremfya prescribing information. U.S. Food & Drug Administration. 2020 Jul. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761061s007lbl.pdf.
32. Skyrizi prescribing information. U.S. Food & Drug Administration. 2022 Sep. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761105s009s010lbl.pdf.
33. Ilumya prescribing information. U.S. Food & Drug Administration. 2022 Dec. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761067s014lbl.pdf.
34. Xeljanz prescribing information. U.S. Food & Drug Administration. 2021 Dec. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203214s028,208246s013,213082s003lbl.pdf.
35. Rinvoq prescribing information. U.S. Food & Drug Administration. 2022 Oct. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211675s010lbl.pdf.

*Designated by the FDA as interchangeable with adalimumab (Humira), meaning adalimumab-adbm (Cyltezo) can be substituted for its reference product at the pharmacy, without additional approvals from the prescribing doctor, state law permitting. This is the first biosimilar for the treatment of a rheumatic condition to receive approval for interchangeability.