Spesolimab approved in Malaysia for the treatment of Generalized Pustular Psoriasis flares in adults

• The National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia, has approved SPEVIGO® (generic name: Spesolimab) for the treatment of generalized pustular psoriasis (GPP) flares. 

• Spesolimab is the first treatment specifically approved for treating GPP flares in adults. 

• GPP is a rare and severe form of psoriasis¹. GPP flares, when left untreated, can cause life-threatening complications such as sepsis and kidney, liver, respiratory and cardiovascular failure².     

• The landmark EFFISAYIL® 1 Clinical Trial demonstrated that after just one week, 54% of patients treated with SPEVIGO® (Spesolimab) intravenous injection showed no visible pustules³. 

12 December 2024, Kuala Lumpur – The National Pharmaceutical Regulatory Agency (NPRA) Malaysia has approved Spesolimab (marketed as SPEVIGO®) for the treatment of flares in adults with generalized pustular psoriasis (GPP), the first indicated treatment of its kind in Malaysia. 

Spesolimab is a novel, humanized, selective antibody which inhibits the activation of the interleukin-36 receptor (IL-36R), a signalling pathway within the immune system that is involved in the pathogenesis of GPP4,5. 

Impact of GPP on Patients    

Generalized pustular psoriasis (GPP) is a rare, unpredictable, and potentially life-threatening neutrophilic skin disease, which is distinct from plaque psoriasis6,7. It is characterised by recurrent, sudden flares of widespread painful, red, inflamed skin with numerous sterile pustules. These pustules may coalesce to form ‘lakes’ of pus and may disappear, leaving behind peeling or scaling skin².  

According to Dr Azura Mohd Affandi, Head of Dermatology Subspecialty in the Ministry of Health, Malaysia, and Head of Department and Consultant Dermatologist, Hospital Kuala Lumpur, “GPP is distinct from plaque psoriasis in disease mechanism and severity6,8. GPP flares can erupt suddenly and escalate quickly. It is also associated with fever, chills, malaise, nausea and severe pain9, as well as mental and emotional distress10. If left untreated, it may lead to serious and life-threatening complications, including multisystem organ failure and sepsis8. Patients with GPP can experience flares lasting from two weeks to three months, with some flares so severe, it requires hospitalisation. Hence, urgent treatment is needed for patients with GPP flares.”

In Malaysia, the prevalence of GPP is 198 per million, affecting 267 women compared to 127 men. It has a particularly high prevalence among the Chinese population in Malaysia, affecting 271 per million, compared to Malay and Indian ethnicities at 186 per million and 179 per million respectively². 

Misdiagnosis, Treatment Delays are Common 

GPP can often be mistaken for an infection11 and lead to the initiation of inappropriate treatment or delays in referral to a specialist12. This does not only delay the patient’s recovery but may exacerbate their symptoms and further reduce their quality of life³. 

“Due to the rarity of the disease, recognising its signs and symptoms can be challenging, resulting in frequent misdiagnosis and delays in receiving appropriate treatment. Patients with GPP often struggle to hold on to their jobs, and experience very poor quality of life,” says Dr Tang Jyh Jong, Head of Department and Consultant Dermatologist, Hospital Raja Permaisuri Bainun, Perak.   

Landmark EFFISAYIL® 1 Clinical Trial 

The approval of Spesolimab (marketed as SPEVIGO®) in Malaysia follows the breakthrough findings of the EFFISAYIL® 1 trial, which demonstrated that after just one week, 54% of patients treated with Spesolimab showed no visible pustules, compared to those treated with placebo (6%)³.

Dr Mohd Azhar Ahmad, Head of Medicine, Boehringer Ingelheim Malaysia, Singapore and Indonesia, says, “GPP has a devastating impact on patients, and their families. Until Spesolimab, there were no approved therapies in Malaysia designed specifically to treat GPP flares in adults, which may have resulted in poor management of the disease with potentially life-threatening complications. Spesolimab is an innovative treatment that works by inhibiting the mechanism that causes the flares in the first place, thus helping patients to manage the impact of their flares and significantly improving their quality of life⁵.” 

KKLIU 3460 / EXP 28.05.2025

References

1. Reynolds KA, Pithadia DJ, Lee EB, et al. Generalized Pustular Psoriasis: A Review of the Pathophysiology, Clinical Manifestations, Diagnosis, and Treatment. Cutis. 2022; 110(2 Suppl):19-25. https://pubmed.ncbi.nlm.nih.gov/36219603/ 
2. Choon SE, Wright AK, Griffiths CEM, et al. Incidence and prevalence of generalized pustular psoriasis in multiethnic Johor Bahru, Malaysia: a population-based cohort study using routinely captured electronic health records in the Teleprimary Care (TPC®) clinical information system from 2010 to 2020. BJD. 2023; 189(4):410–418. https://academic.oup.com/bjd/article/189/4/410/7159128?login=false 
3. Bachelez H, Choon SE, Marrakchi S, et al. Trial of Spesolimab for Generalized Pustular Psoriasis. NEJM. 2021; 385:2431-2440. https://www.nejm.org/doi/full/10.1056/NEJMoa2111563 
4. Blair HA. Spesolimab: First Approval. Drugs. 2022; 82(17): 1681–1686. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9744699/ 
5. Gwillim EC, Nichols AJ. Spesolimab for generalized pustular psoriasis: a review of two key clinical trials supporting initial US regulatory approval. Front Immunol. 2024; 15:1359481. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11298804/ 
6. Zheng M, Jullien D, Eyerich K. The Prevalence and Disease Characteristics of Generalized Pustular Psoriasis. Am J Clin Dermatol. 2022; 23(1): 5-12. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8801400/
7. Choon SE, Navarinin AA, Pinter A. Clinical course and Characteristics of Generalized Pustular Psoriasis. Am J Clin Dermatol. 2022; 23(Suppl 1):21-22. https://pubmed.ncbi.nlm.nih.gov/35061227/ 
8. Crowley JJ, Pariser DM, Yamauchi PS. A brief guide to pustular psoriasis for primary care providers. Postgrad Med. 2021; 133(3):330-344. https://www.tandfonline.com/doi/full/10.1080/00325481.2020.1831315 
9. Benjegerdes KE, Hyde K, Kivelevitch D, et al. Pustular psoriasis: pathophysiology and current treatment perspectives. Psoriasis (Auckl). 2016; 6131-6144. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5683122/ 
10. Bhutani T, Farberg AS. Clinical and Disease Burden of Patients with Generalized Pustular Psoriasis: A Review of Real-World Evidence. Dermatol Ther (Heidelb). 2024; 14(2):341–360. https://pmc.ncbi.nlm.nih.gov/articles/PMC10891013/ 
11. Mirza HA, Badri T, Kwan E. Generalized Pustular Psoriasis. StatPearls Publishing; 2024. https://www.ncbi.nlm.nih.gov/books/NBK493189/.  
12. Strober B, Leman J, Mockenhaupt M, et al. Unmet Educational Needs and Clinical Practice Gaps in the Management of Generalized Pustular Psoriasis: Global Perspectives from the Front Line. Dermatol Ther (Heidelb). 2021; 12(2):381–393. https://pmc.ncbi.nlm.nih.gov/articles/PMC8850517/