Treatment Preference Research in Atopic Dermatitis: A Systematic Review of Quantitative Studies.

BACKGROUND: Treatment preference research can support shared and informed decision making for currently available atopic dermatitis (AD) treatments, and simultaneously guide research and development for future therapies. In this systematic literature review, we aimed to provide an overview of preferences for AD treatments. METHODS: This systematic literature review was conducted in the Medline and Embase (via Ovid) databases, supplemented by manual searching. Quantitative research published from 2010 to September 2023 that investigated preferences for AD treatments were included. Quality assessment was conducted by using the purpose, respondents, explanation, findings, significance checklist, and a checklist developed by the Professional Society for Health Economics and Outcomes Research. RESULTS: In total, 207 references were screened after removing duplicates and 15 studies were included. Most studies were conducted in the US, followed by European countries. On average, people directly or indirectly affected by AD rate efficacy and treatment-related risk as the most important criteria when choosing an AD therapy. Participants are willing to increase risks in order to have a higher chance of achieving a certain benefit, e.g. reduction in itch or clearer skin. Participants have preferences for different modes of administration. On average, 68% (all full-text studies) and 87% (only discrete choice experiments [DCEs]) of quality criteria per reference were rated as fulfilled. DCEs received generally higher quality assessment scores than non-DCEs. CONCLUSIONS: This review revealed that AD treatment preference research is limited. Diverse study designs hampered comparison and synthesis of the results. We recommend conducting more DCEs in this field to increase the likelihood of AD patients receiving the therapy that best fits their individual needs and preferences. CLINICAL TRIALS REGISTRATION: This protocol was published in PROSPERO (ID: CRD42023468757).

Cost-effectiveness of romosozumab for the treatment of postmenopausal women with osteoporosis at high risk of fracture in Belgium.

This study evaluated the cost-effectiveness of sequential treatment with romosozumab-to-alendronate compared to alendronate monotherapy and teriparatide-to-alendronate, in postmenopausal osteoporotic women from a Belgian healthcare perspective. Romosozumab-to-alendronate was found to be cost-effective compared to alendronate monotherapy and dominant compared to teriparatide-to-alendronate for osteoporotic women at high risk of fracture in Belgium. PURPOSE: This study aimed to evaluate the cost-effectiveness of sequential treatment with romosozumab followed by alendronate compared to alendronate monotherapy and teriparatide followed by alendronate, in postmenopausal osteoporotic women at high risk of fracture, from a Belgian healthcare perspective. Romosozumab is reimbursed in Belgium since December 2021. METHODS: A Markov microsimulation model was used to evaluate the cost-effectiveness of romosozumab-to-alendronate compared to alendronate monotherapy and to teriparatide-to-alendronate over a lifetime horizon. Patients transition between five different health states every 6 months based on fracture risks or death. The model was populated with Belgium-specific epidemiological and cost data, where available. The fracture risk reduction of romosozumab treatment was collated from the ARCH study, and from a published network meta-analysis. Costs were included from a healthcare perspective (NIHDI). Cost-effectiveness was reported in terms of costs per quality-adjusted life year (QALY), reported in Euro (€) 2022. Deterministic (DSA) and probabilistic sensitivity analyses (PSA) were performed. RESULTS: Romosozumab-to-alendronate was associated with 0.12 additional QALYs at an additional cost of €2314 compared to alendronate monotherapy, resulting in an ICER of €19,978. Compared to teriparatide-to-alendronate, romosozumab-to-alendronate was found to be dominant, with higher QALYs and lower costs. The base-case results were robust to uncertainty in the input parameters when conducting the sensitivity analysis. CONCLUSION: Sequential treatment with romosozumab followed by alendronate was found to be cost-effective compared to alendronate monotherapy and dominant compared to teriparatide followed by alendronate for postmenopausal women with osteoporosis at high risk of fracture in Belgium.

The cost-effectiveness of a bimekizumab versus IL-17A inhibitors treatment-pathway in patients with active axial spondyloarthritis in Scotland.

OBJECTIVE: To estimate the cost-effectiveness of a treatment-pathway initiated with bimekizumab, a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F and IL-17A, in patients with axial spondyloarthritis (axSpA) compared with IL-17Ai's, ixekizumab, and secukinumab, from the NHS Scotland perspective. METHODS: The axSpA treatment-pathway was modeled using a decision tree followed by a lifetime Markov model. The pathway included first- and second-line biologic disease-modifying antirheumatic drugs (bDMARD), followed by best supportive care (bDMARD, nonbiologic). Bimekizumab followed by any bDMARD ("BKZ") was compared with IL-17Ai's: secukinumab 150 mg followed by a blend ("SEC") of dose up-titration to secukinumab 300 mg and any bDMARD, or ixekizumab followed by any bDMARD ("IXE"). Transition to the next therapy was triggered by Bath Ankylosing Spondylitis Disease Activity Index-50% (BASDAI50) non-response or any-cause discontinuation. A published network meta-analysis provided efficacy data. EuroQoL-5-dimensions utilities were derived by mapping from Ankylosing Spondylitis Disease Activity Score. Costs included disease management (linked to functional limitations), biologics acquisition (list prices), administration and monitoring (NHS 2021/22). Discounting was 3.5%/year. Probabilistic results from patients with non-radiographic axSpA and ankylosing spondylitis were averaged to reflect the axSpA disease spectrum. Scenario and sensitivity analyses were performed. RESULTS: The incremental cost-effectiveness ratio (ICER) of BKZ was £24,801/quality-adjusted life-year (QALY) vs. SEC (95% credible interval £24,163-£25,895). BKZ had similar costs (Δ -£385 [-£15,239-£14,468]) and QALYs (Δ 0.039 [-0.748-0.825]) to IXE, with £1,523 (£862-£2,222) net monetary benefit. Conclusions remained unchanged in most scenarios. Results' drivers included BASDAI50 response rate and disease management cost. LIMITATIONS: Results were based on list prices. Data concerning up-titration to secukinumab 300 mg was scarce. CONCLUSIONS: The bimekizumab treatment-pathway represents a cost-effective option across the axSpA disease spectrum in Scotland. Bimekizumab is cost-effective compared to a secukinumab-pathway that includes dose up-titration, and has similar costs and QALYs to an ixekizumab-pathway.

Comparative Effectiveness of Bimekizumab and Secukinumab in Patients with Psoriatic Arthritis at 52 Weeks Using a Matching-Adjusted Indirect Comparison.

INTRODUCTION: Matching-adjusted indirect comparisons (MAICs) were used to compare the efficacy of bimekizumab and secukinumab 150 mg and 300 mg at 52 weeks for the treatment of psoriatic arthritis (PsA) in patients who were biologic disease-modifying anti-rheumatic drug-naïve (bDMARD-naïve) or with previous inadequate response or intolerance to tumor necrosis factor inhibitors (TNFi-IR). METHODS: Relevant trials were systematically identified. Individual patient data from bimekizumab randomized controlled trials, BE OPTIMAL (N = 431) and BE COMPLETE (N = 267), were matched to aggregate data from bDMARD-naïve and TNFi-IR patient subgroups from FUTURE 2 using secukinumab 150 mg and 300 mg doses (bDMARD-naïve: N = 63/37; TNFi-IR: N = 67/33). To adjust for cross-trial differences, patients from the bimekizumab trials were re-weighted using propensity scores to match the baseline characteristics of patients in the secukinumab trials. Unanchored comparisons of recalculated bimekizumab and secukinumab 52-week non-responder imputation outcomes for 20/50/70% improvement in American College of Rheumatology score (ACR20/50/70) and minimal disease activity (MDA) index were analyzed. RESULTS: In patients who were bDMARD-naïve, bimekizumab had a greater likelihood of ACR70 response than secukinumab 150 mg (odds ratio [95% confidence interval] 2.39 [1.26, 4.53]; p = 0.008) and secukinumab 300 mg (2.03 [1.11, 3.72]; p = 0.021) at 52 weeks. In patients who were TNFi-IR, bimekizumab had a greater likelihood of response compared to secukinumab 150 mg for ACR20 (3.50 [1.64-7.49]; p = 0.001), ACR50 (3.32 [1.41, 7.80]; p = 0.006), ACR70 (2.95 [1.08, 8.07]; p = 0.035) and MDA (3.52 [1.38, 8.99]; p = 0.009), and a greater likelihood of response compared to secukinumab 300 mg for ACR50 (2.44 [1.06, 5.65]; p = 0.037) and MDA (2.92 [1.20, 7.09]; p = 0.018) at 52 weeks. CONCLUSION: In this MAIC analysis, the efficacy of bimekizumab, as demonstrated by the likelihood of ACR20/50/70 and MDA response at 52 weeks, was greater or comparable to secukinumab 150 mg and 300 mg for patients with PsA who were bDMARD-naïve and TNFi-IR. TRIAL REGISTRATION NUMBERS: NCT03895203, NCT03896581, NCT04009499, NCT01752634, NCT01989468, NCT02294227, NCT02404350.

Comparative Effectiveness of Bimekizumab and Guselkumab in Patients with Psoriatic Arthritis at 52 Weeks Assessed Using a Matching-Adjusted Indirect Comparison.

INTRODUCTION: Matching-adjusted indirect comparisons (MAIC) were used to assess the relative efficacy of bimekizumab 160 mg every 4 weeks (Q4W) compared to guselkumab 100 mg Q4W or every 8 weeks (Q8W) at 48/52 weeks in patients with psoriatic arthritis (PsA) who were biologic disease-modifying antirheumatic drug-naïve (bDMARD-naïve) or with previous inadequate response or intolerance to tumor necrosis factor inhibitors (TNFi-IR). METHODS: Relevant trials were identified as part of a systematic literature review. For patients who were bDMARD-naïve, individual patient data (IPD) from BE OPTIMAL (N = 431) was matched to summary data from DISCOVER-2 (Q4W, n = 245; Q8W, n = 248). For patients who were TNFi-IR, IPD from BE COMPLETE (n = 267) and summary data from COSMOS (Q8W, N = 189). Trial populations were re-weighted using propensity scores. Unanchored comparisons of recalculated bimekizumab and guselkumab 48- or 52-week non-responder imputation outcomes for 20/50/70% improvement in American College of Rheumatology score (ACR20/50/70) and minimal disease activity (MDA) index were analyzed. RESULTS: In patients who were bDMARD-naïve, bimekizumab was associated with a greater likelihood of ACR50 (odds ratio [95% confidence interval] 1.62 [1.07, 2.44]; p = 0.021), ACR70 (2.20 [1.43, 3.38]; p < 0.001), and MDA (1.82 [1.20, 2.76]; p = 0.005) compared to guselkumab Q4W at week 52. Bimekizumab also had a greater likelihood of ACR70 response (2.08 [1.34, 3.22]; p = 0.001) and MDA (2.07 [1.35, 3.17]; p < 0.001) compared to guselkumab Q8W at week 52. In patients who were TNFi-IR, bimekizumab had a greater likelihood in achieving all evaluated outcomes compared to guselkumab Q8W at week 48/52 (ACR20, 1.77 [1.15, 2.72]; p = 0.010; ACR50, 1.56 [1.03, 2.36]; p = 0.037; ACR70, 1.66 [1.05, 2.61]; p = 0.028; and MDA, 1.95 [1.27, 3.02]; p = 0.003). CONCLUSIONS: According to MAICs, bimekizumab demonstrated greater or comparable efficacy on ACR50/70 and MDA outcomes than guselkumab in patients with PsA who were bDMARD-naïve and TNFi-IR at week 48/52. Bimekizumab had a more favorable likelihood than guselkumab in achieving more stringent treatment outcomes. TRIAL REGISTRATIONS: NCT03895203, NCT03896581, NCT04009499, NCT03158285, NCT03796858.

Improvement in work productivity among psoriatic arthritis patients treated with biologic or targeted synthetic drugs: a systematic literature review and meta-analysis.

BACKGROUND: Capacity to work is impacted by psoriatic arthritis (PsA). Our objective was to describe the course of work productivity and leisure activity in patients with PsA treated with biologic (b) and targeted synthetic (ts) disease-modifying antirheumatic drugs (DMARDs). METHODS: A systematic literature review identified all trials and observational studies published January 1, 2010-October 22, 2021, reporting work productivity using the Work Productivity and Activity Impairment Questionnaire (WPAI) in patients with PsA treated with b/tsDMARDs. Outcomes for WPAI domains (absenteeism, presenteeism, total work productivity, and activity impairment) were collected at baseline and time point closest to 24 weeks of treatment. A random effects meta-analysis of single means was conducted to calculate an overall absolute mean change from baseline for each WPAI domain. RESULTS: Twelve studies (ten randomized controlled and two observational) assessing patients treated with adalimumab, bimekizumab, guselkumab, ixekizumab, risankizumab, secukinumab, or upadacitinib were analysed. Among 3741 employed patients, overall mean baseline scores were 11.4%, 38.7%, 42.7%, and 48.9% for absenteeism, presenteeism, total work productivity impairment, and activity impairment, respectively. Estimated absolute mean improvements (95% confidence interval) to week 24 were 2.4 percentage points (%p) (0.6, 4.1), 17.8%p (16.2,19.3), 17.6%p (15.9,19.4), and 19.3%p (17.6, 21.0) respectively, leading to a mean relative improvement of 41% for total work productivity. The change in work outcomes in the b/tsDMARDs appeared similar. CONCLUSIONS: This systematic literature review and meta-analysis confirmed that patients with active PsA have a substantially reduced capacity to work and participate in leisure activities. Substantial improvements across various WPAI domains were noted after 24 weeks of b/tsDMARD treatment, especially in presenteeism, total work productivity, and activity impairment. These findings may be useful for reimbursement purposes and in the context of shared decision-making. This systematic literature review (SLR) of randomized clinical trials and observational studies of biologic (b) and targeted synthetic (ts) disease-modifying antirheumatic drugs b/tsDMARDs in patients with PsA found that at treatment introduction, patients presented with a 42.7% mean productivity loss per week as assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire. Through a meta-analysis comparing before/after values without adjustment for placebo response, we found that after 24 weeks of treatment with b/tsDMARDs, there was a mean absolute improvement of 17.6 percentage points and a mean relative improvement of 41% in total work productivity, with similar magnitudes of improvement in time spent at work and regular activities outside of work. These results provide clinical-, regulatory- and reimbursement decision-makers with data on the potential societal and socio-economic benefits of b/tsDMARDs in PsA.

Psoriatic arthritis (PsA) has a major impact on patients' lives, including their ability to work by causing absence and reducing productivity. By pooling together published studies (12 studies, corresponding to 3741 patients) and comparing what patients reported before starting treatment to during treatment, we found that over the course of treatment with biologic (b) and targeted synthetic (ts) disease-modifying antirheumatic drugs (DMARDs), patients with PsA had an average of 18% higher total work productivity, translating to a 41% reduced impact of PsA at the group level (without looking at comparisons to a placebo response). It is important for health professionals and patients to know that work outcomes affected by PsA are improved when patients take b/tsDMARDS.

Comparative efficacy and safety of bimekizumab in psoriatic arthritis: a systematic literature review and network meta-analysis.

OBJECTIVES: To understand the relative efficacy and safety of bimekizumab, a selective inhibitor of interleukin-17F in addition to IL-17A, vs other biologic and targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) for psoriatic arthritis (PsA) using network meta-analysis (NMA). METHODS: A systematic literature review (most recent update conducted on 01 January 2023) identified randomised controlled trials (RCTs) of b/tsDMARDs in PsA. Bayesian NMAs were conducted for efficacy outcomes at Weeks 12-24 for b/tsDMARD-naïve and tumour necrosis factor inhibitor (TNFi) -experienced (exp) patients. Safety at Weeks 12-24 was analysed in a mixed population. Odds ratios (ORs) and differences of mean change with the associated 95% credible interval (CrI) were calculated for the best-fitting models, and the surface under the cumulative ranking curve (SUCRA) values were calculated to determine relative rank. RESULTS: The NMA included 41 RCTs for 22 b/tsDMARDs. For minimal disease activity (MDA), bimekizumab ranked 1st in b/tsDMARD-naïve patients and 2nd in TNFi-exp patients. In b/tsDMARD-naïve patients, bimekizumab ranked 6th, 5th, and 3rd for American College of Rheumatology response (ACR)20/50/70, respectively. In TNFi-experienced patients, bimekizumab ranked 1st, 2nd, and 1st for ACR20/50/70, respectively. For Psoriasis Area and Severity Index [PASI]90/100, bimekizumab ranked 2nd and 1st in b/tsDMARD-naïve patients, respectively, and 1st and 2nd in TNFi-exp patients, respectively. Bimekizumab was comparable to b/tsDMARDs for serious adverse events. CONCLUSION: Bimekizumab ranked favourably among b/tsDMARDs for efficacy on joint, skin, and MDA outcomes, and showed comparable safety, suggesting it may be a beneficial treatment option for patients with PsA.

Burden of Hidradenitis Suppurativa: A Systematic Literature Review of Patient Reported Outcomes.

INTRODUCTION: Hidradenitis suppurativa (HS) has a profound negative impact on patients' health-related quality of life (HRQoL). Here we summarize the evidence on HRQoL and Patient Reported Outcomes (PROs) in patients with HS in real-world settings by conducting a systematic literature review (SLR) of observational studies. METHODS: Data sources included MEDLINE, Embase & PsycINFO between January 1, 2010 and August 29, 2021, and conference proceedings between 2019 and 2021. Identified abstracts were reviewed and screened independently by two reviewers. Eligibility criteria included patients with HS of any severity, sample size ≥ 100, reporting PROs including HRQoL measures. Included studies were critically appraised. RESULTS: Fifty-eight observational studies matched inclusion criteria. Dermatology Life Quality Index (DLQI) was the most commonly utilized instrument: 57% of included studies reported mean baseline DLQI scores, ranging between 8.4 and 16.9, indicating a very large impact on the patients' HRQoL. Higher scores were reported with increasing disease severity and among female patients. Pain was assessed mostly by an 11-point (0-10) numeric rating scale (NRS) with a mean baseline score ranging from 3.6 to 7.7 indicating moderate to high pain levels. There was a negative impact of HS on patients' psychological well-being, based on PRO scores related to depression and anxiety. A high proportion of sexual dysfunction was reported, with a larger impact on women than men. Work productivity and leisure activity were consistently found to be impaired in patients with HS. CONCLUSIONS: All included studies reported a negative impact of HS on patients' lives. A diverse set of disease- and non-disease-specific PRO instruments were utilized highlighting the need for more consistent use of HS-specific validated PRO instruments to assess the impact of HS on the different aspects of patients' HRQoL to allow for data to be more meaningfully interpreted and compared in real-world settings. Patients with HS need better disease management approaches that address the observed low quality of life.

Hidradenitis suppurativa (HS) is a skin disease, which mainly involves the hair follicles, and may greatly affect the health of those with the illness. HS often causes painful or itchy bumps or swelling of the skin, especially in the intimate areas. These occasionally drain and have an odor. When they heal, sometimes they leave dark spots or scars. People with HS can feel depressed, anxious, or embarrassed, among other things. In this study, we looked at how existing studies measured the impact of HS on the physical, mental, and social quality of people's lives. When searching the Internet, we found 58 publications on studies around this topic. Across all of the studies, HS had a large negative effect on patients' quality of life. We found that the groups of people which were impacted more by HS had worse cases of the disease. Patients with more severe HS felt higher levels of pain. Women were also affected more than men. Many studies showed that patients with HS often felt depressed and anxious. Three studies showed that HS greatly affected women's sexual health. Many patients said that HS made it hard to work and do things for fun. More and better treatments are needed since HS can have such a big impact on people's lives.

Comparative efficacy and safety of bimekizumab in axial spondyloarthritis: a systematic literature review and network meta-analysis.

OBJECTIVES: To compare the efficacy and safety of bimekizumab 160 mg every 4 weeks, a selective inhibitor of interleukin­17F and 17A, with biologic/targeted synthetic disease-modifying anti-rheumatic drugs (b/tsDMARDs) in non-radiographic axial spondyloarthritis (nr-axSpA) and ankylosing spondylitis (AS). METHODS: A systematic literature review identified randomised controlled trials until January 2023 for inclusion in Bayesian network meta-analyses (NMAs), including three b/tsDMARDs exposure networks: predominantly-naïve, naïve, and experienced. Outcomes were Assessment of SpondyloArthritis international Society (ASAS)20, ASAS40, and ASAS partial remission (PR) response rates at 12-16 weeks. A safety NMA investigated discontinuations due to any reason and serious adverse events at 12-16 weeks. RESULTS: The NMA included 36 trials. The predominantly-naïve network provided the most comprehensive results. In the predominantly-naïve nr-axSpA analysis, bimekizumab had significantly higher ASAS20 response rates vs secukinumab 150 mg (with loading dose [LD]/without LD), and comparable response rates vs other active comparators. In the predominantly-naïve AS analysis, bimekizumab had significantly higher ASAS40 response rates vs secukinumab 150 mg (without LD), significantly higher ASAS-PR response rates vs secukinumab 150 mg (with LD), and comparable response rates vs other active comparators. Bimekizumab demonstrated similar safety to other b/tsDMARDs. CONCLUSION: Across ASAS outcomes, bimekizumab was comparable to most b/tsDMARDs, including ixekizumab, TNF inhibitors and upadacitinib, and achieved higher response rates vs secukinumab for some ASAS outcomes in predominantly b/tsDMARD-naïve nr-axSpA and AS patients at 12-16 weeks. In a pooled axSpA network, bimekizumab demonstrated comparable safety vs other b/tsDMARDs.

Work productivity in patients with axial spondyloarthritis initiating biological or targeted synthetic disease-modifying antirheumatic drugs: a systematic literature review and meta-analysis.

BACKGROUND: Axial spondyloarthritis (axSpA) can limit work participation. Our objective was to characterise productivity in patients with axSpA, including changes after 12-16 weeks of treatment with biological and targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs). METHODS: A systematic literature review identified studies published from 1 January 2010 to 21 October 2021 reporting work productivity using the Work Productivity and Activity Impairment (WPAI) questionnaire in patients with axSpA initiating b/tsDMARDs. Baseline and Week 12-16 overall work productivity, absenteeism, presenteeism and activity impairment scores were used in a random-effects meta-analysis to calculate absolute mean change from baseline for each WPAI-domain. RESULTS: Eleven studies in patients with axSpA who received either placebo (n=727) or treatment with adalimumab, bimekizumab, etanercept, ixekizumab, secukinumab or tofacitinib (n=994) were included. In working patients initiating a b/tsDMARD, mean baseline overall work productivity impairment, absenteeism and presenteeism scores were 52.1% (N=7 studies), 11.0% and 48.8% (N=6 studies), respectively. At Week 12-16, the pooled mean change from baseline in overall work impairment for b/tsDMARDs or placebo was -21.6% and -12.3%. When results were extrapolated to 1 year, the potential annual reductions in cost of paid and unpaid productivity loss per patient ranged from €11 962.88 to €14 293.54. CONCLUSIONS: Over 50% of employed patients with active axSpA experienced work impairment, primarily due to presenteeism. Overall work productivity improved at Weeks 12-16 to a greater extent for patients who received b/tsDMARDs than placebo. Work productivity loss was associated with a substantial cost burden, which was reduced with improvements in impairment.

Cost-effectiveness analysis of bimekizumab for the treatment of active psoriatic arthritis in Sweden.

AIMS: To evaluate the cost-effectiveness of bimekizumab, an inhibitor of IL-17F and IL-17A, against biologic and targeted synthetic disease-modifying antirheumatic drugs (DMARD) for psoriatic arthritis (PsA) from the Swedish healthcare system perspective. MATERIALS AND METHODS: A Markov model was developed to simulate the clinical pathway of biologic [b] DMARD-naïve or tumor necrosis factor inhibitor experienced [TNFi-exp] PsA patients over a lifetime horizon. Treatment response was incorporated as achievement of the American College of Rheumatology 50% (ACR50) and Psoriasis Area and Severity Index 75% (PASI75) response, and changes in the Health Assessment Questionnaire-Disability Index (HAQ-DI) score. The efficacy of bimekizumab was obtained from the BE OPTIMAL (bDMARD-naïve) and BE COMPLETE (TNFi-experienced) trials while a network meta-analysis (NMA) informed the efficacy of the comparators. Resource use and drug costs were obtained from published studies and databases of drug retail prices in Sweden. A willingness-to-pay threshold of €50,000 per quality-adjusted life year (QALY) was applied. RESULTS: In bDMARD-naïve patients, bimekizumab achieved greater QALYs (14.08) than with all comparators except infliximab (14.22), dominated guselkumab every 4 and 8 weeks, ixekizumab, secukinumab 300 mg, ustekinumab 45 mg and 90 mg, and was cost-effective against risankizumab, tofacitinib, upadacitinib and TNFis, except adalimumab biosimilar. In TNFi-experienced patients, bimekizumab led to greater QALYs (13.56) than all comparators except certolizumab pegol (13.84), and dominated ixekizumab and secukinumab 300 mg while being cost-effective against all other IL-17A-, IL-23- and JAK inhibitors. LIMITATIONS: An NMA informed the comparative effectiveness estimates. Given gaps in evidence of disease management and indirect costs specific to HAQ-DI scores, and sequential clinical trial evidence in PsA, non-PsA cost data from similar joint conditions were used, and one line of active treatment followed by best supportive care was assumed. CONCLUSIONS: Bimekizumab was cost-effective against most available treatments for PsA in Sweden, irrespective of prior TNFi exposure.

Cost-Effectiveness of Emerging Treatments for Atopic Dermatitis: A Systematic Review.

BACKGROUND: Numerous therapies have recently emerged for treatment of patients with atopic dermatitis (AD), a common skin disease, and understanding their cost-effectiveness is of high importance for policy makers. This systematic literature review (SLR) aimed to provide an overview of full economic evaluations that assessed cost-effectiveness of emerging AD treatments. METHODS: The SLR was conducted in Medline, Embase, UK National Health Service Economic Evaluation Database and EconLit. Reports published by the National Institute for Health and Care Excellence, the Institute for Clinical and Economic Review and the Canadian Agency for Drugs and Technologies in Health were manually searched. Economic evaluations published from 2017 to September 2022 that compared emerging AD treatments with any comparator were included. Quality assessment was conducted by using the Consensus on Health Economic Criteria list. RESULTS: A total of 1333 references were screened after removing duplicates. Among those references, 15 that conducted a total of 24 comparisons were included. Most studies were from the USA, UK or Canada. Seven different emerging treatments were compared, mostly with usual care. In 15 comparisons (63%), the emerging treatment was cost-effective, and 11 out of 14 dupilumab comparisons (79%) reported that dupilumab was cost-effective. Upadacitinib was the only emerging therapy that was never classified as cost-effective. On average, 13 out of 19 quality criteria (68%) per reference were rated as fulfilled while manuscripts and health technology reports received generally higher quality assessment scores than published abstracts. DISCUSSION: This study revealed some discrepancies in the cost-effectiveness of emerging therapies for AD. A variety of designs and guidelines made comparison difficult. Therefore, we recommend that future economic evaluations use more similar modelling approaches to improve comparability of results. OTHERS: The protocol was published in PROSPERO (ID: CRD42022343993).

Disease Burden and Treatment Preferences Amongst Postmenopausal Women with Severe Osteoporosis in Greece.

Objective: The objectives of this study were to elicit self-reported health status, quantify osteoporosis-related burden, and understand preferences for treatment attributes among postmenopausal women with severe osteoporosis in Greece. Methods: Postmenopausal women with self-reported severe osteoporosis, defined as having suffered at least one osteoporotic fracture and reporting a T-score of ≤-2.5, were asked to evaluate their health status, osteoporosis management, and disease-related physical, emotional, and financial burden. Participants were also asked to rate a series of treatment attributes and state their preference for unlabeled anabolic treatments, based on scenarios describing key treatment characteristics. Results: Approximately one third (31%) of the 186 participants who responded to the survey in full had been living with severe osteoporosis for more than 10 years. Three quarters of participants (72%) considered their overall quality of life (QoL) to be worse than it had been 10 years prior, and the vast majority (89%) attributed this deterioration to osteoporosis. Direct, out of pocket, disease-related costs of at least €100 per month were reported by 86% of participants. Patients attached the greatest value to a treatment that would decrease probability of future fractures, followed by increase in bone density, safety, and mode and frequency of administration. When asked to select their preferred treatment scenario between two anabolic treatments, 70% of participants opted for the scenario that shared treatment characteristics with romosozumab over a scenario that shared treatment characteristics with teriparatide. Conclusion: Our study revealed that osteoporosis placed a considerable burden on QoL for postmenopausal women with severe osteoporosis in Greece. Patients reported valuing treatment efficacy, measured through reduction in future fractures and increase in bone density, and safety, as key treatment attributes.

Patient Preferences in the Management of Hidradenitis Suppurativa: Results of a Multinational Discrete Choice Experiment in Europe.

BACKGROUND AND OBJECTIVE: Hidradenitis suppurativa is a chronic inflammatory skin disease that can lead to a substantial reduction in quality of life. Recent studies revealed high levels of unmet care needs of patients with hidradenitis suppurativa, but their preferences in treatment decision making have scarcely been investigated. This study aimed to reveal which treatment attributes adult patients with HS in Europe consider most important in treatment decision-making. METHODS: A discrete choice experiment was conducted with adult patients with hidradenitis suppurativa in Europe to reveal which treatment attributes are most important when making treatment decisions. Participants were presented with 15 sets of two treatment options and asked for each to choose the treatment they preferred. The treatments were characterized by six attributes informed by a prior literature review and qualitative research: effectiveness, pain reduction, duration of treatment benefit, risk of mild adverse event, risk of serious infection, and mode of administration. A random parameter logit model was used to estimate patients' preferences with additional subgroup and latent class models used to explore any differences in preferences across patient groups. RESULTS: Two hundred and nineteen adult patients with hidradenitis suppurativa were included in the analysis (90% women, mean age 38 years). For all six treatment attributes, significant differences were observed between levels. Given the range of levels of each attribute, the most important treatment attributes were effectiveness (47.9%), followed by pain reduction (17.3%), annual risk of a mild adverse event (14.4%), annual risk of a serious infection (10.3%), mode of administration (5.3%), and duration of treatment benefit (4.8%). Higher levels of effectiveness, namely a 75% or 100% reduction in the abscess and inflammatory nodule count, were preferred over levels of effectiveness primarily investigated in randomized clinical trials of hidradenitis suppurativa (a 50% reduction). Results were largely consistent across subgroups and three latent class groups were identified. CONCLUSIONS: This study revealed the most important treatment characteristics for patients with hidradenitis suppurativa that can help inform joint patient-physician decision making in the management of hidradenitis suppurativa. Designing future hidradenitis suppurativa treatments according to stated preferences, namely, to offer higher levels of effectiveness and pain improvement without higher risks of adverse events, may increase patients' treatment concordance and lead to improved disease management outcomes.

Achievement of more stringent disease control is associated with reduced burden on workplace and household productivity: results from long-term certolizumab pegol treatment in patients with psoriatic arthritis.

Background: Psoriatic arthritis (PsA) impacts the physical health and functional ability of patients, leading to reduced productivity. High unemployment rates and absence due to sickness have been reported in patients with PsA. Objectives: This post hoc study investigated certolizumab pegol treatment impact on workplace and household productivity in patients with PsA, and assessed whether achievement of more stringent disease control was associated with greater improvements in productivity. Design: RAPID-PsA was a 216-week phase III trial. Methods: This post hoc study used a generalised estimating equations (GEE) model to examine the disease activity association, measured using American College of Rheumatology (ACR) and Disease Activity in PSoriatic Arthritis (DAPSA), and workplace and household productivity, assessed using an arthritis-specific Work Productivity Survey (WPS). The GEE model estimated the mean cumulative number of days patients meeting different disease control criteria were affected by absenteeism or presenteeism in the workplace and household. Results: In all, 273 patients were randomised to certolizumab pegol and 183 (67.0%) completed Week 216. At baseline, 60.8% of patients were employed outside the home. Improved disease control, measured using ACR and DAPSA criteria, was associated with fewer cumulative days affected by workplace absenteeism through Week 216: ACR70: 4.1 days, ACR50 to <70: 7.7, ACR20 to <50: 20.9,

Cost-effectiveness of romosozumab for the treatment of postmenopausal women at very high risk of fracture in Canada.

This study evaluated the cost-effectiveness of 1 year of romosozumab followed by alendronate versus oral bisphosphonates alone in women with postmenopausal osteoporosis at very high risk for fracture in Canada. Results showed that romosozumab sequenced to alendronate is a cost-effective treatment option, dominating both alendronate and risedronate alone. PURPOSE: To demonstrate the value of romosozumab sequenced to alendronate compared to alendronate or risedronate alone, for the treatment of osteoporosis in postmenopausal women with a history of osteoporotic fracture and who are at very high risk for future fracture in Canada. METHODS: A Markov model followed a hypothetical cohort of postmenopausal osteoporotic women at very high risk for future fractures, to estimate the cost-effectiveness of romosozumab and alendronate compared to oral bisphosphonates alone. A total treatment period of 5 years was assumed. Quality-adjusted life years and costs were estimated for each comparator across health states defined by different types of fragility fractures. RESULTS: Romosozumab/alendronate was associated with a lifetime gain of 0.103 and 0.127 QALYs and a cost reduction of $343 and $3805, relative to alendronate and risedronate, respectively. These results were driven by a reduction of the number of fractures (2561 per 1000 patients, versus 2700 for alendronate and 2724 for risedronate over lifetime). Romosozumab/alendronate had the highest probability of being cost-effective, relative to alendronate and risedronate, at any willingness to pay threshold value. CONCLUSION: Romosozumab/alendronate was associated with reduced costs and greater benefit relative to other comparators. Probabilistic, deterministic, and scenario analyses indicate that romosozumab/alendronate represents the best value for money; the uncertainty analyses are robust, and therefore romosozumab should be considered for reimbursement by public drug plans in Canada .

Economic evaluation of a JAK inhibitor compared to a monoclonal antibody for treatment of moderate-to-severe atopic dermatitis from a UK perspective.

AIM: Atopic dermatitis (AD) is a chronic inflammatory skin disorder characterized by severe itching, erythema and scaling, causing pain, stigmatization and social isolation. Despite the growing availability of treatment options, unmet care needs remain. This research aimed to assess the cost-effectiveness of a novel JAK inhibitor (JAKi) compared to a monoclonal antibody and to identify key drivers of cost-effectiveness. MATERIALS AND METHODS: A de novo economic model was developed to assess the cost-effectiveness of a novel JAKi compared to an established monoclonal antibody for the treatment of moderate-to-severe AD patients from a UK perspective. A targeted literature review was conducted to inform the development of the economic model with an advanced model structure. Various scenario and sensitivity analyses were performed to account for parameter- and structural uncertainty and to identify key drivers of cost-effectiveness. RESULTS: The JAKi was not cost-effective compared to the monoclonal antibody (£219,733.88 per quality-adjusted life year (QALY) gained) at selected price levels when applying the UK willingness-to-pay threshold of £30,000 per QALY gained. Key drivers of cost-effectiveness were utility values, intervention efficacy and drug acquisition costs. A decrease in JAKi's dose costs, as well as a lower dose, lead to cost-effectiveness. LIMITATIONS: Assumptions regarding parameter inputs were necessary, therefore a considerable level of uncertainty regarding efficacy and cost data is to be accounted for in the interpretation of the results. In particular, the efficacy data were based on single clinical studies. CONCLUSIONS: This research revealed the cost-effectiveness of a JAKi compared to a monoclonal antibody for the treatment of moderate-to-severe AD to be highly sensitive to the costs and effectiveness inputs and identified further cost-effectiveness drivers. It demonstrated that the JAKi could be cost-effective compared to an established monoclonal antibody with a lower dose or a reduced price.

Importance of Time Point-Specific Indirect Treatment Comparisons of Osteoporosis Treatments: A Systematic Literature Review and Network Meta-Analyses.

PURPOSE: The efficacy comparison of osteoporosis treatments can be hindered by the absence of head-to-head trials; instead, network meta-analyses (NMAs) have been used to determine comparative effectiveness. This study was the first to investigate the impact of time point-specific NMAs of osteoporosis treatments on variability in treatments' onset of action caused by their different mechanisms of actions and trial designs. METHODS: A systematic literature review was conducted to identify randomized controlled trials (RCTs) of treatments for postmenopausal women with osteoporosis, including romosozumab (ROMO), teriparatide (TPTD), abaloparatide (ABL), alendronate (ALN), risedronate (RIS), ibandronate (IB), zoledronic acid/zoledronate (ZOL), denosumab (DEN), and raloxifene (RLX), on at least 1 fracture or bone mineral density (BMD) outcome. Of 100 RCTs identified in 5 databases, 27 RCTs were included for NMAs of new vertebral, nonvertebral, and hip fracture outcomes at 12, 24, and 36 months, and 47 RCTs were included for NMAs of BMD outcomes at lumbar spine, total hip, and femoral neck to compare the relative efficacy of osteoporosis treatments. Quality of included studies was assessed using the Cochrane Risk of Bias tool. FINDINGS: For vertebral fractures, TPTD (83.63%), ABL (69.11%), and ROMO/ALN (78.70%) had the highest probability to be the most effective treatment at 12, 24, and 36 months, respectively. ROMO/ALN had the highest probability (54.4%, 64.69%, and 90.29%, respectively) to be the most effective treatment for nonvertebral fractures at 12, 24, and 36 months. For hip fractures, ROMO/ALN (46.31%), ABL (61.1%), and DEN (55.21%) had the highest probability to be the most effective treatment at 12, 24, and 36 months, respectively. ROMO had the highest probability (76.06%, 44.19%, and 51.78%, respectively) to be the most effective treatment for BMD outcomes at lumbar spine, total hip, and femoral neck. IMPLICATIONS: The importance of indirectly comparing available osteoporosis treatments using time point-specific NMAs was confirmed because indirect comparison results differed substantially across time points.

Identifying Unmet Care Needs and Important Treatment Attributes in the Management of Hidradenitis Suppurativa: A Qualitative Interview Study.

BACKGROUND AND OBJECTIVE: Hidradenitis suppurativa (HS) is an inflammatory skin disease with a profound effect on patients' quality of life. The patient's journey to manage HS is often complex and unsuccessful, which motivates the aim of this research to gain insight into unmet needs and relevant treatment considerations from the perspective of patients and healthcare professionals (HCPs). METHODS: Individual semi-structured interviews were conducted with patients and HCPs experienced in treating HS to understand the perceived unmet care needs and to identify important treatment attributes. Prioritization of the five most important treatment attributes allowed elicitation of their relative importance. RESULTS: Interviews with 12 patients and 16 HCPs revealed 16 areas of unmet needs either related to treatment outcomes or the care process and 13 important treatment attributes. The most frequently reported unmet needs by patients and HCPs were lacking quality-of-life improvement, low treatment effectiveness, inadequate pain control, low disease awareness, and delayed diagnosis. Patients expressed unique concerns relating to pain management, access to HS specialists, and wound care guidance and costs, which HCPs did not. Treatment attributes related to effectiveness were considered most important by patients and HCPs. Patients additionally emphasized a strong preference for improved pain management. CONCLUSIONS: Current HS treatments and care processes leave patients and HCPs with a high level of unmet need. It is critical to consider patients' and HCPs' perspectives when designing appropriate HS care as perceived unmet needs differ. Further quantitative preference elicitation studies are needed to assess the trade-offs between important care needs and treatment attributes.

Early health economic modelling for a treatment candidate in hidradenitis suppurativa.

AIMS: Hidradenitis suppurativa (HS) is a chronic skin condition causing inflammatory lesions, pain, scarring, and impaired mobility. Treatment options are limited and often lack success implying the need for additional/improved treatments. This research aimed to estimate the potential economic value of a treatment candidate, explore drivers of cost-effectiveness, and highlight economic evidence requirements for successful future value assessments. MATERIALS AND METHODS: An early cost-effectiveness model was developed to assess the cost-effectiveness (cost per quality-adjusted life year (QALY) gained) of a treatment candidate compared against the only authorized biologic, adalimumab, for moderate to severe HS, from a UK National Health Service and Personal Social Service perspective. A targeted literature review of clinical and economic references and previous health technology assessments (HTA) was performed for development and validation of the early economic model used to present sensitivity analyses accompanying the base case cost-effectiveness results. RESULTS AND LIMITATIONS: Base case results revealed the candidate not to be cost-effective compared to adalimumab when considering a formal cost-effectiveness threshold of £30,000 per QALY gained. Scenario- and threshold analyses highlighted that reducing dosing or drug price by half improved the cost-effectiveness of the candidate. Cost-effectiveness was highly sensitive to health states' utility values, treatment discontinuation, and resource utilization, in line with existing HTA evidence. The paucity of economic studies and uncertainties around the candidate presented methodological constraints that were addressed through sensitivity analyses. CONCLUSIONS: Key costs and health effects drivers were highlighted to contextualize under which circumstances a treatment candidate for moderate to severe HS would reach acceptable cost-effectiveness levels. This early economic evaluation suggested promising economic perspectives for treatment candidates in HS. Exploring novel ways to use clinical endpoints to simulate the patient pathway and clinically meaningful treatment achievements in future research will facilitate the value demonstration of candidates in disease areas with high unmet care need.