The Janssen Pharmaceutical Companies of Johnson & Johnson have announced new data that show considerable improvements in long-term patient-reported outcomes (PRO) in patients with psoriasis switched to TREMFYA® (guselkumab) after an initial inadequate response to adalimumab.
In addition, PRO measurement tools such as the Psoriasis Symptom and Sign Diary (PSSD) may provide a more accurate representation of the impact of psoriasis on the patient in comparison to current clinical measurement tools. These long-term findings from the Phase III VOYAGE 1 & 2 clinical trial programmes are part of six abstracts Janssen presented today at the European Academy of Dermatology and Venereology (EADV) 2018 Congress in Paris, France.
Study findings showed a switch to guselkumab at Week 28, after an inadequate response to Humira® (adalimumab), led to a sustained improvement in patient reported outcomes in both the PSSD and DLQI (Dermatology Life Quality Index) score at Week 100. The proportion of patients with a PSSD score of 0, i.e. no impact of psoriasis on quality of life, increased from 4.2% and 1.1% at Week 28, to 32.6% and 18.0% at Week 100, for symptoms and signs respectively. The proportion of patients with a DLQI score of 0 to 1 (i.e. no impact on patient quality of life) increased from 14.4% at Week 28 to 65.3% at Week 100, showing that guselkumab is consistently able to positively impact patient well-being.
Further data presented at EADV 2018 demonstrated that PRO tools are redefining treatment goals from the patient’s perspective. A symptom-free status on PSSD was shown to be associated with greater improvements in health-related quality of life (HRQoL) than a PASI 100 response for patients with moderate to severe psoriasis.
During clinical development, guselkumab was generally tolerated by patients with psoriasis. The very common and common adverse events associated with guselkumab are as follows: upper respiratory infection and arthralgia, diarrhoea, gastroenteritis, headache, herpes simplex infections, injection site erythema, tinea infections and urticaria. Injection site pain has been reported as an uncommon adverse event. In the clinical studies, the types of adverse events reported remained generally consistent through 100 weeks of treatment.
Dr Jaime Oliver, Medical Lead for Immunology in EMEA, Janssen Biologics B.V. said: “The data presented at EADV highlights Janssen’s commitment to developing effective treatments that translate into real-term positive outcomes for patients. This long-term data not only demonstrates the potential for guselkumab to improve psoriasis signs and symptoms which matter most to patients, but also shows the significance of PRO measurement tools when it comes to improving the quality of life for patients living with this debilitating condition.”