Cimzia® (certolizumab pegol), in combination with methotrexate, has been launched in the UK for the treatment of active psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drugs has been inadequate.
Psoriatic arthritis is an inflammatory condition which is associated with the skin disorder psoriasis and can affect the joints as well as the nails and tendons. It is estimated that up to 156,000 people in England and Wales are affected by this condition and if left untreated, it can lead to significant joint damage and disability over time. People diagnosed with psoriatic arthritis usually experience a combination of both psoriasis and arthritis symptoms. The main symptoms include inflammation in the joints and tendons, stiffness in the back or neck and swelling of fingers or toes.
“Patients with psoriatic arthritis always tell me it affects many components of their lives in terms of quality of life, social dealings, ability to work and function as well as psychological well-being due to the impact of the disease on their physical appearance and joints.” commented Dr Stefan Siebert, a Senior Lecturer in Rheumatology at the University of Glasgow and Honorary Consultant Rheumatologist NHS Greater Glasgow and Clyde. He added, “Certolizumab has demonstrated strong efficacy data throughout the clinical trial. Patients seem to have a quick and effective response to this particular treatment with symptoms improving as early as week 1, which is a huge positive to someone living with the emotional and psychological effects brought on by psoriatic arthritis”.
The primary endpoint of the RAPID-PsA study was ACR20 at Week 12 and was achieved with clinical and statistically significant improvements in ACR20 in both dosing arms (200 mg every 2 weeks and 400 mg every 4 weeks) vs. placebo and was observed as early as Week 1 (21.0% [p=0.001] and 23.0% [p<0.001] vs7.4%) and maintained to Week 24. Rapid improvements in the signs and symptoms including joints, enthesitis, dactylitis and nail disease were successfully observed across both doses. Additionally, rapid improvements in the manifestation of skin symptoms were observed across both dosing regimens. Patients with higher baseline PASI were more likely to achieve a PASI75 and PASI90 response. Adverse events occurred in 62% vs. 68% and serious adverse events in 7% vs. 4% in certolizumab pegol (combined dose) vs. placebo, respectively. Treatment with certolizumab pegol in this population revealed no new safety signals from those seen in rheumatoid arthritis trials.
Certolizumab pegol is given to patients as an injection and following proper training patients may self-inject using the pre-filled syringe. The starting dose for certolizumab pegol is 400 mg (given as 2 subcutaneous injections of 200 mg each) at weeks 0, 2 and 4. After this the recommended maintenance dose of certolizumab pegol for psoriatic arthritis is 200 mg every 2 weeks. Once clinical response is confirmed, an alternative maintenance dosing of 400 mg every 4 weeks can be considered.
There are 1.8million people in the UK with the skin condition psoriasis; of those up to 7% have psoriatic arthritis. In most cases arthritis develops after the psoriasis. Psoriatic arthritis typically appears about 10 years after the onset of psoriasis and it can occur at any age, although most people are diagnosed between the ages of 15 and 35.
Commenting on this fact, Jo Cumming, Head of Information and Helplines at Arthritis Care said, “We know that people often live with the terrible symptoms of psoriasis for up to 10 years before the joint pain really takes a hold.” Jo added “Arthritis is a chronic illness which manifests in many forms and psoriatic arthritis is a particularly nasty condition as it not only affects the joints but also many visible parts of the skin such as the scalp, elbows and knees and from what we hear through our helplines we know that, many people suffer emotional distress and poorer quality of life due to their psoriatic arthritis”.
Since 2009 certolizumab pegol has been approved in the EU in combination with methotrexate (MTX) for the treatment of moderate to severe active rheumatoid arthritis in adult patients, inadequately responsive to disease-modifying anti-rheumatic drugs, including MTX.1 In October 2013 , Cimzia® was also approved for the treatment of severe active axial spondyloarthritis (axSpA) in adults. The safety profile for axSpA patients treated with Cimzia® was consistent with the safety profile in rheumatoid arthritis and previous experience with Cimzia.