Therapy Areas: Respiratory
Janssen's Tremfya Improves Long-Term Patient-Reported Outcomes in Patients with Moderate to Severe Plaque Psoriasis
13 September 2018 - - The Janssen Pharmaceutical Companies of Johnson and Johnson (NYSEL JNJ) has released new data that show considerable improvements in long-term patient-reported outcomes in patients switched to Tremfya (guselkumab) after an initial inadequate response to adalimumab, the company said.

In addition, PRO measurement tools such as the Psoriasis Symptom and Sign Diary 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 and 2 clinical trial programmes are part of six abstracts Janssen presented 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.

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.

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.

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.

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).

In the clinical studies, the types of adverse events reported remained generally consistent through 100 weeks of treatment.

According to the company, the negative impact of psoriasis on people's lives can be immense, which is why the measurement of health-related quality of life (HRQoL) is now a major component of the assessment of psoriasis.

The Dermatology Life Quality Index is a 10-item questionnaire that assesses disease-related impact on quality of life, including daily activities, work and personal relationships. The score per question ranges from 0 (not at all) to 3 (very much) and total scores range from 0 to 30, with scores >10 indicating a 'moderate' to 'extremely large' negative impact on QoL.

The Psoriasis Area and Severity Index is a physician assessment tool for defining disease severity based on the visible signs of lesions and affected areas.

Most trials for psoriasis currently use PASI 75 (75% clearing of skin lesions) as a primary endpoint.

While the DLQI has been the most widely used validated measure for assessing quality of life in psoriasis trials it is not psoriasis specific and the PASI, a physician assessment tool for defining disease severity, is only based on the visible signs of lesions and affected areas.

The PSSD covers all major patient-reported symptoms and signs and is the most comprehensive PRO instrument currently available.

Janssen said the PSSD includes 11 items covering five patient-reported symptoms (itch, pain, stinging, burning, skin tightness) and six visible signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using a numerical rating scale ranging from 0–10 (higher score indicating more severe psoriasis).

The total PSSD score includes all 11 individual items (both symptom and signs) and average value of all 11 items is converted into a 0–100 score, where 0=least severe to 100=most severe.

The most common form of psoriasis is plaque psoriasis, usually resulting in areas of thick, red or inflamed skin covered with silvery scales which are known as plaques. The inconsistent nature of psoriasis means that even when plaques appear to subside, patients can have ongoing concerns over their return.

Psoriasis can cause great physical and psychological burden. Mental health issues are common among people with psoriasis, and the impact it can have on quality of life is comparable with diabetes and cancer.

It is also associated with several comorbidities including psoriatic arthritis, cardiovascular diseases, metabolic syndrome, chronic obstructive pulmonary disorder and osteoporosis.

In addition, many individuals are faced with social exclusion, discrimination and stigma because of their disease.

The European Academy of Dermatology and Venereology (EADV) congress is taking place in Paris, France from Wednesday 12th September to Sunday 16th September.

On 10 November 2017, Tremfya (guselkumab) was granted market authorisation in the European Union for the treatment of adult patients with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy).

Guselkumab is the first psoriasis treatment licensed in the European Union to selectively target IL-23, a key driver of the immune inflammatory response in psoriasis. Guselkumab is a subcutaneous, self-injectable treatment for psoriasis (following training).

Treatment requires two starter doses, one initially and the other four weeks later, followed by a maintenance dose once every eight weeks thereafter.

The Janssen Pharmaceutical Companies of Johnson and Johnson maintain exclusive worldwide marketing rights to guselkumab, which is currently approved in the US, Canada and the European Union.
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