Rheumatology Drug Updates: Ixekizumab Improves Work Productivity, plus Vobarilizumab Completes Phase 2 Trial in Rheumatoid Arthritis

Ixekizumab Improves Work Productivity in Patients with Plaque Psoriasis

Indirect costs of reduced work productivity can have a significant impact on a patient’s quality of life. A recent article published in JAMA Dermatology analyzed the results of three multicenter, randomized double-blind Phase 3 trials, UNCOVER-1, UNCOVER-2 and UNCOVER-3, which evaluated the effect of ixekizumab on work productivity in patients with moderate to severe plaque psoriasis.¹

Researchers used the Work Productivity and Activity Impairment–Psoriasis Questionnaire (WPAI-PSO), which asks six questions about work and the effects of psoriasis for the seven days prior to completing the questionnaire. It assesses current employment (yes/no), psoriasis-related missed time from work in hours, missed time from work for other reasons in hours, time actually worked in hours, the effect of psoriasis while working on a 0–10 point scale, and the effect of psoriasis on daily activities on a 0–10 point scale. From this survey, four scores were used to identify the impact of a patient’s psoriasis on their work productivity: percentage of absenteeism, percentage of presenteeism, percentage of work productivity loss and percentage of activity impairment. The secondary endpoint in all three studies was to measure the change from baseline of WPAI-PSO scores in ixekizumab-treated patients against a comparator. Higher scores meant greater impairment.

Across all trials, 5,101 patients consented, and 3,866 were randomized. The majority of patients were male (67–68%), with an average age of 45 years.

In the UNCOVER-1 trial, patients were randomized 1:1:1 to receive subcutaneous placebo, 80 mg ixekizumab subcutaneously every two weeks or 80 mg ixekizumab subcutaneously every four weeks for 12 weeks. Both the UNCOVER-2 and UNCOVER-3 trials had an etanercept arm in which patients received 50 mg etanercept twice weekly. Maintenance of initial ixekizumab response was evaluated in UNCOVER-1 and UNCOVER-2 during a randomized withdrawal period following Week 12 through Week 60. The WPAI-PSO questionnaire was completed at baseline and Week 12 for all patients. The WPAI-PSO was also administered to patients in the UNCOVER-1 and UNCOVER-2 trials at Weeks 24, 36, 52 and 60.

Indirect costs of reduced work productivity can have a significant impact on a patient’s quality of life.

In UNCOVER-1 at Week 12, the groups taking ixekizumab every four weeks and ixekizumab every two weeks showed significantly greater improvements in WPAI-PSO scores for absenteeism, presenteeism, work productivity loss and activity impairment compared with placebo-treated patients. The results of UNCOVER-2 and UNCOVER-3 were similar, except for absenteeism for patients treated with ixekizumab every four weeks. Additionally, ixekizumab-treated patients had significantly greater WPAI-PSO score improvement compared with etanercept-treated patients at Week 12, which was maintained to Week 60.

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Vobarilizumab Completes Phase 2B Studies in RA

The anti-interleukin (IL) 6R nanobody, vobarilizumab (ALX-0061), has successfully completed a 12-week, double-blind treatment and assessment period in a monotherapy trial of patients with moderate to severe active rheumatoid arthritis who were intolerant to methotrexate or for whom methotrexate therapy was inappropriate.² The study objective was to determine the safety and efficacy of different vobarilizumab monotherapy dosing regimens to steer further drug development.

Two hundred and fifty-one subjects enrolled in the study from the U.S., Europe and South America. Patients were randomly assigned to receive one of the following: 150 mg vobarilizumab subcutaneously every four weeks; 150 mg vobarilizumab subcutaneously every two weeks; 225 mg vobarilizumab subcutaneously every two weeks; or subcutaneous, open-label tocilizumab—94% of patients received weekly tocilizumab.

After the 12-week study, eligible subjects were invited to enroll in an open-label extension study—91% accepted. Patients not enrolled in the open-label extension participated in another safety analysis for 12 weeks following their last dose.

At Week 12, the ACR 20, 50 and 70 scores were 81%, 49% and 24%, respectively, for the vobarilizumab doses given every two weeks. Also at Week 12, the efficacy data for vobarilizumab and tocilizumab were comparable. Additionally, in examining the change from baseline in the Health Assessment Questionnaire disability score, vobarilizumab appeared to have a quick and positive effect on physical function. Vobarilizumab also induced clinical remission or low disease activity based on DAS28CRP in up to 60% of patients at Week 12 compared with only 44% of tocilizumab-treated patients.

Certolizumab Pegol in the U.K.

Certolizumab pegol (Cimzia) can be used as monotherapy or in combination with methotrexate when other drugs have failed or are not suitable to treat severe RA, according to the recently released National Institute for Health and Care Excellence (NICE) draft guidance.³ Certolizumab pegol is already recommended by the U.K. National Health Service to treat severe RA that has not responded to conventional disease-modifying anti-rheumatic drugs. NICE states that this treatment should be continued only if a patient has a moderate response at six months, measured by European League Against Rheumatism criteria. If this response is not maintained, then treatment should be discontinued. UCB, the agent’s manufacturer, has agreed to a patient access program that ensures the first 12 weeks of treatment are provided free of charge.

Michele B. Kaufman, PharmD, CGP, RPh, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

1. Armstrong AW, Lynde CW, McBride SR, et al. Effect of ixekizumab treatment on work productivity for patients with moderate- to severe plaque psoriasis: Analysis of results from three randomized phase 3 clinical trials. JAMA Dermatol. 2016;152(6):661–669. doi:10.1001/jamadermatol.2016.0269.
2. Ablynx. News release: Ablynx announces positive topline results from a phase 2b study of its anti-IL-6r nanobody, vobarilizumab (alx-0061), as a monotherapy in RA. 2016 Jul 7. http://hugin.info/137912/R/2026497/753117.pdf.
3. Staff. NICE approves UCB Pharma’s Cimzia. PMLiVE. 2016 Jul 12. https://www.pmlive.com/pharma_news/nice_approves_ucb_pharmas_cimzia_1069060.