Taltz ® (ixekizumab) injektion

För fullständig produktresumé för Taltz® se FASS.

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Taltz® ▼ (ixekizumab): Arbetsproduktivitet och aktivitet hos patienter med plackpsoriasis

Patienter som behandlades med ixekizumab upplevde en varaktig förmåga att förbättra sin arbetsrelaterade närvaro, produktivitet och övergripande aktivitetsnivå.

Detailed Information

WPAI-PSO Questionnaire: Impairment of work productivity and engagement in activities outside work was assessed as a pre-specified secondary endpoint  in UNCOVER-1, -2, and -3 clinical trials of patients with moderate to severe psoriasis using a validated, self-reported instrument. The WPAI-PSO questionnaire was used to determine the impact of psoriasis on work productivity in patients who received ixekizumab. The 4 scores derived from the WPAI-PSO are

  • absenteeism (% work time missed),

  • presenteeism (% impairment at work),

  • WPL (% overall work impairment associated with absenteeism and presenteeism), and

  • activity impairment (% impairment in activities outside of work).1,2

UNCOVER-1 Through Week 12: The results of the questionnaire demonstrated a significant improvement from baseline to week 12 compared to placebo in WPAI-PSO scores of

  • absenteeism (Q2W, p=.003; Q4W, p<.001),

  • presenteeism (p<.001 for both doses),

  • WPL (p<.001 for both doses), and

  • activity impairment (p<.001 for both doses).1

UNCOVER-2 and -3 Through Week 12UNCOVER-2 and UNCOVER-3 week 12 results were similar to the results from UNCOVER-1. With Q2W dosing in both trials, ixekizumab results for each of the 4 WPAI-PSO scores were significant compared to placebo (p<.001 for all scores vs placebo except for absenteeism [p=.02 and p=.01 in UNCOVER-2 and -3, respectively]).2

UNCOVER-1 Through Week 60: As illustrated in Figure 1 below, week 12 responder patients (defined as sPGA 0 or 1) who were re-randomized to treatment with ixekizumab Q4W for the 48-week maintenance period demonstrated a sustained reduction in

  • presenteeism,

  • WPL, and

  • activity impairment (p<.001 for each at Week 60 compared to those who had been re-randomized to placebo).

Significant improvement for absenteeism compared to placebo in week 12 responders who were re-randomized to ixekizumab Q4W was only achieved at week 52.1 

Figure 1. UNCOVER-1: Changes in WPAI-PSO Scores Through Week 601

Abbreviations: IXE = ixekizumab; LOCF = last observation carried forward; LSM = least squares mean; PBO = placebo; Q4W = every 4 weeks; Q12W = every 12 weeks.

*p<.05, **p ≤.01, *** p≤.001 – vs IXE/PBO.

UNCOVER-2 Through Week 60In UNCOVER-2, week 60 results were similar to those from UNCOVER-1. Week 12 responders who were re-randomized to ixekizumab Q4W for the maintenance period demonstrated a sustained reduction in

  • presenteeism,

  • WPL, and

  • activity impairment ( p<.001 for each at week 60 compared to responders re-randomized to placebo ).

Consistent with UNCOVER-1, absenteeism was not statistically significantly different from placebo at week 60.2,3

A post hoc analysis evaluated the relationship between WPAI-PSO and PASI improvements. Greater WPAI score improvements were seen in those with greater PASI score improvement (Data not shown).2

Please note that dosing schedules are mentioned in this statement that are not consistent with the approved dosing schedule for plaque psoriasis in the Taltz summary of product characteristics. Please refer to the Taltz summary of product characteristics for approved dosing.4

Therapeutic Indication

Ixekizumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.4

References

1. Armstrong A, Lynde C, Fretzin S, et al. Treatment with ixekizumab over 60 weeks provides sustained improvements in work productivity and activity levels: Results from UNCOVER-1, a Phase 3 trial in patients with moderate-to-severe psoriasis. Poster presented at: 74th Annual Meeting of the American Academy of Dermatology, March 4-8, 2016; Washington, D.C.

2. 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 3 randomized Phase 3 clinical trials. JAMA Dermatol. 2016;152(6):661-669. http://dx.doi.org/10.1001/jamadermatol.2016.0269

3. Lynde C, McBride S, Stahle M, et al. Continued treatment with ixekizumab over 60 weeks provides sustained improvements in work productivity and activity levels: results from UNCOVER-2, a phase 3 trial in patients with moderate-to-severe psoriasis. Poster presented at: 5th International Congress on Psoriasis, July 7-9, 2016; Paris, France.

4. Taltz [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

Glossary

PASI = Psoriasis Area and Severity Index

Q2W = every 2 weeks

Q4W = every 4 weeks

Q12W = every 12 weeks

sPGA = static Physician Global Assessment

WPAI-PSO = Work Productivity Activity Impairment questionnaire – Psoriasis

WPL = Work Productivity Loss

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Datum fӧr senaste ӧversyn 2018 M08 01


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