The Janssen Pharmaceutical Companies of Johnson & Johnson has announced new data that show considerable improvements in long-term patient-reported outcomes (PRO) in patients switched to Tremfya (guselkumab) after an initial inadequate response to adalimumab.1 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.2 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.
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.”
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 100.1 The proportion of patients with a PSSD score of 0, i.e. no impact of psoriasis on quality of life, increased from 4.2 percent and 1.1 percent at Week 28, to 32.6 percent and 18.0 percent 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 percent at Week 28 to 65.3 percent 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.2 While clinician-determined PASI assessments and patient-reported PSSD outcomes were highly correlated, there were discrepancies between PASI 100 response rates and patient-assessed achievement of symptom- and sign-free status.3
In addition, data showed that, in comparison to the PASI 100 response rate, patient-reported outcomes from the PSSD were more aligned to the DLQI score.2 These findings emphasise the importance of using PRO measurement tools, such as the PSSD, as an additional tool to assess the true impact of psoriasis on patients, and to determine an accurate response to therapy.
During clinical development, guselkumab was generally tolerated by patients with psoriasis.4,5,6 The very common and common adverse events associated with guselkumab are as follows: upper respiratory infection (very common, ≥ 1/10) and arthralgia, diarrhoea, gastroenteritis, headache, herpes simplex infections, injection site erythema, tinea infections, and urticaria (common, ≥ 1/100 to < 1/10). Injection site pain has been reported as an uncommon adverse event (≥ 1/1,000 to < 1/100).7 In the clinical studies, the types of adverse events reported remained generally consistent through 100 weeks of treatment.8
1 Guenther L, et al. 27th European Academy of Dermatology and Venereology congress (EADV 2018) 2018 12–16 Sept, 2018;Paris, France:1819, P1926.
2 Bissonnette R, et al. 27th European Academy of Dermatology and Venereology congress (EADV 2018) 2018 12–16 Sept, 2018;Paris, France:1570, P1899.
3 Gordon K, et al. 27th European Academy of Dermatology and Venereology congress (EADV 2018) 2018 12–16 Sept, 2018;Paris, France:3430, P2035.
4 Blauvelt A, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: Results from the phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial. J Am Acad Dermatol 2017;76(3):405–17.
5 Reich K, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the treatment of patients with moderate to severe psoriasis with randomized withdrawal and retreatment: Results from the phase III, double-blind, placebo- and active comparator-controlled VOYAGE 2 trial. J Am Acad Dermatol 2017;76(3):418–31.
6 Langley R, et al. Efficacy and safety of guselkumab in patients with psoriasis who have an inadequate response to ustekinumab: results of the randomized, double-blind, phase III NAVIGATE trial. Br J Dermatol 2018;178(1):114–23.
7 European Medicines Agency. Tremfya 100mg solution for injection. 2017. Available at: https://www.medicines.org.uk/emc/medicine/34321. Accessed September 2018.
8 Griffiths C, et al. Two-year efficacy and safety of guselkumab for treatment of moderate-to-severe psoriasis: Phase 3 VOYAGE 1 trial. 26th European Academy of Dermatology and Venereology congress (EADV 2017) 13–17 Sept, 2017;Geneva, Switzerland:D3T01.1.
Filed Under: Drug Discovery