Dr. Landewé, who is a professor of rheumatology at the Academic Medical Center in Amsterdam, also presented results for several other secondary measures of response. One of these, the Ankylosing Spondylitis Disease Activity Score (ASDAS), showed that inactive disease developed after 24 weeks of treatment in 4% of the placebo-treated patients, 30% of the patients who received certolizumab pegol every 2 weeks, and 31% of patients who received the drug every 4 weeks. The results also showed no new signals of adverse effects, compared with several prior pivotal trials of certolizumab pegol.
Another set of measures in the same study focused on the impact of 24 weeks of treatment on work and household productivity and participation in social activities. Among the 69% of patients in the study who were employed, treatment with either dosage of certolizumab pegol was associated with an average of 10 more productive days of paid work per patient, compared with placebo, reported Dr. Désirée van der Heijde, professor of rheumatology at Leiden University in the Netherlands. During the 24 weeks of treatment, the active regimens also resulted in an added 13-17 days of productive household work and an average of about 10 added days of social or leisure activities, compared with placebo-treated patients.
Results from a third study reported at the meeting included outcomes from patients with axial SpA and objective evidence of inflammation at entry who remained on treatment with adalimumab during 2 years of follow-up in the ABILITY-1 study. This trial’s primary-endpoint results, which were recently published (Ann. Rheum. Dis. 2013;72:815-22), showed that 40 mg of adalimumab administered every other week was significantly better than placebo for reducing disease activity after 12 weeks of treatment. The new results came from 107 patients who remained in the study and received 104 weeks of adalimumab treatment.
After 2 years, 66% of patients showed ASAS 40 responses, and 44% had inactive disease based on their ASDAS, reported Dr. Joachim Sieper, professor and chief of rheumatology at Charité University Hospital in Berlin. Most of the patients in remission at 104 weeks had also been in remission after 52 and 80 weeks of treatment. In addition, the 2-year data showed no new safety concerns, compared with several other prior reports of long-term treatment with adalimumab, he said.
The ABILITY-1 and ABILITY-2 trials were sponsored by AbbVie, which markets adalimumab. Dr. Mease has been a consultant to and has received research support from AbbVie and other companies. Dr. Sieper has been a consultant to and has received research support from Abbott (from which AbbVie was created) as well as Merck, Pfizer, and UCB. The RAPID-axSpA trial was sponsored by UCB, which markets certolizumab. Dr. Landewé has been a consultant to and has received research support from UCB and other companies. Dr. van der Heijde has been a consultant to and has received grant support from UCB and other companies.
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