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Results from the RAPID™-PsA study presented this week at the European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology in Germany showed that certolizumab pegol (Cimzia) compared to placebo improved the signs and symptoms of arthritis in adult patients with active psoriatic arthritis (PsA).
“Certolizumab pegol has been shown to be clinically effective in moderate to severe rheumatoid arthritis. The RAPID™-PsA study is the first controlled study to assess the efficacy and safety of certolizumab pegol in adult patients with psoriatic arthritis,” said Dr Philip J Mease, Director Rheumatology Research, Swedish Medical Center and University of Washington School of Medicine, Seattle, WA, USA. “Results from the study showed that certolizumab pegol improved the signs and symptoms of psoriatic arthritis when compared to placebo.”
The RAPID™-PsA study randomized 409 patients with established psoriatic arthritis to receive either certolizumab pegol 200 mg every 2 weeks or 400 mg every 4 weeks or placebo. In the certolizumab pegol arms, patients received a loading dose of 400 mg certolizumab pegol at weeks 0, 2 and 4. Patients enrolled in this study must have failed at least one disease-modifying anti-rheumatic drug (DMARD) and could have received a maximum of one anti-TNF (tumour necrosis factor). At baseline, 20% of patients had previously failed one anti-TNF. Within the placebo arm, patients who failed to achieve a >10% decrease in tender joint count and swollen joint count at weeks 14 and 16 were re-randomized at week 16 to receive certolizumab pegol 200 mg every 2 weeks or 400 mg every 4 weeks following the loading dose.1
The primary endpoints of the study were the ACR20 response at week 12 and the modified total sharp score (mTSS) at week 24*. At week 12, the ACR20 response was significantly higher in both certolizumab pegol arms versus placebo (58.0%, 51.9%, vs 24.3% in 200 mg, 400 mg and placebo respectively, p<0.001). Within the certolizumab pegol arms, a greater ACR20 response versus placebo was achieved at week 1 (21.0%, 23.0% vs 7.4% in 200 mg, 400 mg and placebo respectively).1
The most common adverse events with >5% incidence in the combined certolizumab pegol or placebo group were nasopharyngitis and upper respiratory tract infections. The most common serious adverse events with >1% incidence in the combined certolizumab pegol or placebo group were infections and infestations.2
In the European Union, certolizumab pegol in combination with methotrexate (MTX) is approved for the treatment of moderate to severe active RA in adult patients inadequately responsive to DMARDs including MTX. Certolizumab pegol can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate. In the U.S., certolizumab pegol is approved for the treatment of adults with moderately to severely active rheumatoid arthritis.
In the U.S., certolizumab pegol is also approved for reducing the signs and symptoms of Crohn’s disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.
Certolizumab pegol is not approved in the indication of psoriatic arthritis. UCB intends to file certolizumab pegol in this indication with global regulatory authorities by the end of 2012.
Source: ucb.com
“Certolizumab pegol has been shown to be clinically effective in moderate to severe rheumatoid arthritis. The RAPID™-PsA study is the first controlled study to assess the efficacy and safety of certolizumab pegol in adult patients with psoriatic arthritis,” said Dr Philip J Mease, Director Rheumatology Research, Swedish Medical Center and University of Washington School of Medicine, Seattle, WA, USA. “Results from the study showed that certolizumab pegol improved the signs and symptoms of psoriatic arthritis when compared to placebo.”
The RAPID™-PsA study randomized 409 patients with established psoriatic arthritis to receive either certolizumab pegol 200 mg every 2 weeks or 400 mg every 4 weeks or placebo. In the certolizumab pegol arms, patients received a loading dose of 400 mg certolizumab pegol at weeks 0, 2 and 4. Patients enrolled in this study must have failed at least one disease-modifying anti-rheumatic drug (DMARD) and could have received a maximum of one anti-TNF (tumour necrosis factor). At baseline, 20% of patients had previously failed one anti-TNF. Within the placebo arm, patients who failed to achieve a >10% decrease in tender joint count and swollen joint count at weeks 14 and 16 were re-randomized at week 16 to receive certolizumab pegol 200 mg every 2 weeks or 400 mg every 4 weeks following the loading dose.1
The primary endpoints of the study were the ACR20 response at week 12 and the modified total sharp score (mTSS) at week 24*. At week 12, the ACR20 response was significantly higher in both certolizumab pegol arms versus placebo (58.0%, 51.9%, vs 24.3% in 200 mg, 400 mg and placebo respectively, p<0.001). Within the certolizumab pegol arms, a greater ACR20 response versus placebo was achieved at week 1 (21.0%, 23.0% vs 7.4% in 200 mg, 400 mg and placebo respectively).1
The most common adverse events with >5% incidence in the combined certolizumab pegol or placebo group were nasopharyngitis and upper respiratory tract infections. The most common serious adverse events with >1% incidence in the combined certolizumab pegol or placebo group were infections and infestations.2
In the European Union, certolizumab pegol in combination with methotrexate (MTX) is approved for the treatment of moderate to severe active RA in adult patients inadequately responsive to DMARDs including MTX. Certolizumab pegol can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate. In the U.S., certolizumab pegol is approved for the treatment of adults with moderately to severely active rheumatoid arthritis.
In the U.S., certolizumab pegol is also approved for reducing the signs and symptoms of Crohn’s disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.
Certolizumab pegol is not approved in the indication of psoriatic arthritis. UCB intends to file certolizumab pegol in this indication with global regulatory authorities by the end of 2012.
Source: ucb.com