Trial Of Adalimumab Research Articles

PMS30 SECUKINUMAB VERSUS ADALIMUMAB FOR THE TREATMENT OF ANKYLOSING SPONDYLITIS: A 52-WEEK COST PER RESPONDER ANALYSIS FROM THE TURKISH PAYER PERSPECTIVE

To estimate the cost per responder (CPR) of ankylosing spondylitis (AS) treatment at 52 weeks with Secukinumab 150 mg versus Adalimumab 40 mg based on the Assessment of Spondyloarthritis International Society (ASAS) outcomes. The CPR is calculated by dividing the drug acquisition cost by its response rate which is based on the ASAS20 and ASAS40 outcomes. Drug acquisition costs of 52 week course of treatment was estimated considering both the first year (including the loading doses of Secukinumab) and the maintenance condition using reimbursed prices in May 2019. Number of required doses are defined according to the approved posology in the label. Matching-adjusted indirect comparison (MAIC) approach is adopted to obtain long-term ASAS response rates based on the data from MEASURE-2 and ATLAS clinical trials of Secukinumab and Adalimumab, respectively. MAIC analysis matched patient populations on key baseline parameters. MAIC analysis showed that ASAS response rates were higher for Secukinumab compared to Adalimumab at 52 weeks (ASAS20 and ASAS40 response rates for Secukinumab were 81% and 62% versus 65% and 47% for Adalimumab, respectively). Secukinumab has a lower CPR compared to Adalimumab for all ASAS outcomes. Cost per ASAS20 responder for Secukinumab and Adalimumab was $21,002 and $32,667 and cost per ASAS40 responder was $27,302 and $45,359, respectively for the first year condition with loading doses of Secukinumab. CPR for Secukinumab calculated to be lower for ASAS20 and ASAS40 outcomes by about 50% and more when compared to Adalimumab for the maintenance condition. According to the results showing that Secukinumab achieved greater ASAS responses in comparison to Adalimumab at 52 weeks, the CPR for all ASAS outcomes were consistently lower for Secukinumab compared with Adalimumab. These findings indicate that Secukinumab would be considered as a cost-efficient treatment choice for the AS treatment in Turkey.

Support group utilization and impact for patients with hidradenitis suppurativa

Support group utilization and impact for patients with hidradenitis suppurativa

Adalimumab in Juvenile Idiopathic Arthritis–Associated Uveitis: 5-Year Follow-up of the Bristol Participants of the SYCAMORE Trial

To determine longer-term outcomes of participants enrolled from a single center in the SYCAMORE trial, a randomized placebo-controlled trial of adalimumab vs placebo in children with juvenile idiopathic arthritis-associated uveitis (JIA-U) uncontrolled on methotrexate. Retrospective interventional case series. Medical records of all 28 SYCAMORE participants recruited at the Bristol Eye Hospital were reviewed at approximately 3-monthly intervals up to 5 years from the trial randomization date. Uveitis activity, treatment course, visual outcomes, ocular complications, and adverse events were recorded. Data are presented using summary statistics. Following withdrawal of the investigational medicinal product (IMP), 25 of the 28 participants were started on adalimumab for active JIA-U. Of the 12 participants in the active treatment arm of the SYCAMORE study, 11 (92%) were restarted on adalimumab after withdrawal of the IMP for active JIA-U (median time to flare 188days [range 42-413days). Two participants stopped adalimumab for uncontrolled JIA-U. One participant had a reduction in vision to 0.3 owing to cataract. Mean visual acuity for the remaining 27 participants was -0.04 (right eye) and -0.05 (left eye). Drug-induced remission of JIA-U did not persist when adalimumab was withdrawn after 1-2 years of treatment. Adalimumab was well tolerated and visual acuity outcomes were excellent.

Whole-body Magnetic Resonance Imaging Inflammation in Peripheral Joints and Entheses in Axial Spondyloarthritis: Distribution and Changes during Adalimumab Treatment.

To investigate the distribution of whole-body magnetic resonance imaging (WB-MRI) inflammatory lesions of peripheral joints and entheses, and their response to adalimumab (ADA) treatment and agreement with clinical measures of disease activity in patients with axial spondyloarthritis (axSpA). Explorative analysis of an investigator-initiated randomized controlled trial of ADA. WB-MRI was performed at weeks 0, 6, 24, and 48. Detailed analyses of WB-MRI lesions in peripheral joints and entheses were performed, including agreement with clinical measures of disease activity. WB-MRI inflammatory lesions were most frequently observed in the acromioclavicular, metatarsophalangeal, and wrist joints (> 10% of joints), and at the greater trochanter, calcaneal insertion of the Achilles tendon, and ischial tuberosity (> 15% of entheses). Inflammation resolved in ≥ 2/3 of involved sternoclavicular, metacarpophalangeal, first carpometacarpal, hip, and tarsometatarsal joints, and pubic symphyses and medial femoral condyles. In contrast, inflammation resolved in ≤ 1/6 of involved acromioclavicular joints, knee joints, and supraspinatus tendon insertions at humerus. Tenderness of joints and entheses agreed poorly with WB-MRI inflammation (κ < 0.40). Joint tenderness resolved more frequently in MRI-positive than MRI-negative joints (8/13, 62% vs 9/34, 26%) after 6 weeks of active treatment. Inflammatory lesions of peripheral joints and entheses in patients with predominantly axSpA, and changes therein, can be mapped using WB-MRI, and it may contribute to differentiate between inflammatory and noninflammatory joint tenderness. (Trial registration: ClinicalTrials NCT01029847).

A Review on the Effect of Tumor Necrosis Factor Inhibitors on Structural Progression in Early Axial Spondyloarthritis Using Magnetic Resonance Imaging.

IntroductionConsidering the progressive nature of axial spondyloarthritis (axSpA), it is important to determine whether tumor necrosis factor alpha (TNFα) inhibitors have an effect on early inflammatory and structural lesions detected using magnetic resonance imaging (MRI).MethodsA search of MEDLINE/PubMed for full-text, English-language articles on randomized controlled trials (RCTs) of adalimumab, certolizumab, etanercept, golimumab, or infliximab published since January 2007 was conducted in February 2018 and again in December 2018. The collected articles reported on inflammatory or fatty lesion progression in the spine or sacroiliac joint (SIJ), determined using MRI, in a population that included at least 40% of patients with early axSpA, defined as non-radiographic axSpA.ResultsOf the 105 articles retrieved, 19 were included in this review, of which the majority were on etanercept (n = 11). A majority of selected articles included information on inflammatory lesions (SIJ 15/19; spine 12/19). All five TNFα inhibitors showed benefits on inflammation, assessed by MRI, in patients with early axSpA for up to 204 weeks of treatment. Structural progression in SIJ and the spine was assessed in 6/19 and 3/19 articles, respectively, with mixed evidence on benefits of TNF-inhibitor treatment.ConclusionsIn conclusion, treatment with TNFα inhibitors reduces MRI-evident inflammatory lesions in the SIJ and spine of patients with early axSpA for up to 4 years. There is less evidence of benefits on structural lesions. Additional studies are required to determine whether TNFα-inhibitor therapy can limit or delay radiological progression in patients with early axSpA.FundingPfizer.

OP34 VARSITY: A double-blind, double-dummy, randomised, controlled trial of vedolizumab versus adalimumab in patients with active ulcerative colitis

OP34 VARSITY: A double-blind, double-dummy, randomised, controlled trial of vedolizumab versus adalimumab in patients with active ulcerative colitis

Comparative efficacy and safety of adalimumab biosimilar (BCD-057) and innovator in patients with psoriasis vulgaris. Results of the BCD-057-2/CALYPSO phase III international, multicenter, randomized double-blind clinical trial

The paper gives the results of the phase III clinical trial of adalimumab (ADA) biosimilar, (BCD-057) (BIOCAD, Russia), which demonstrate the clinical equivalence of the biosimilar to the ADA innovator Humira® in patients with moderate and severe psoriasis.Objective. The BCD-057-2/CALYPSO phase III international, multicenter, randomized double-blind clinical trial of the efficacy and safety of BCD-057 (International Nonproprietary Name (INN): adalimumab, ZAO «BIOCARD», Russia) versus Himura® (INN: adalimumab (OOO «Abbvie») in patients with plaque psoriasis aims to prove the equivalent pharmacokinetics, efficacy, safety, and immunogenicity of these medicines in both direct parallel comparison and subsequent switching from innovator to biosimilar.Patients and methods. The investigation enrolled 346 adult patients diagnosed with moderate to severe plaque psoriasis lasting at least 6 months. After screening, the patients were randomized in a 1:1 ratio into BCD-057 or Humira® groups. At week 24, the patients taking Humira® were re-randomized 1:1 into a group to continue treatment with the ADA innovator or into that to switch to BCD-057. The primary efficacy endpoint was to estimate the proportion of patients who had achieved a 75% improvement in Psoriasis Area and Severity Index (PASI75) at week 16. The secondary endpoints included the assessment of the time course of changes in the skin, nails, degree of itching, and quality of life at weeks 16 and 24. Safety was evaluated from the incidence of treatment-associated adverse events (AEs), cases of severe toxicity (grades 3–4 AEs according to the Common Terminology Criteria Adverse Event (CTCAE) 4.03), cases of early patient withdrawal due to AEs, as well as cases of toxicity potentially associated with the use of tumor necrosis factor-α inhibitors. Immunogenicity was determined using the validated test of patient serum samples for binding antibodies (BAb) and neutralizing antibodies.Results and discussion. The per-protocol population for efficacy evaluation included 342 patients. At week 16, the primary endpoint of PASI75 was shown to be achieved by 62.5% (105/168) and 66.46% (109/164) of the patients in the BCD-057 and Himura® groups, respectively; p=0.45). The difference between the groups in PASI75 responses was 3.22% with 95% confidence interval [-14.25%; 6.32%]. The analysis of additional endpoints revealed no significant differences in the efficacy of the biosimilar and innovator. During 24 weeks of the investigation, treatment-associated AEs were recorded in 31.03 and 25.58% of the patients in the BCD-057 and Humira® groups, respectively (p=0.31). The proportion of patients with BAb detected at 16 weeks of the investigation was 25.44 and 24.07% in the BCD-057 and Humira® groups, respectively (p=0.87).Conclusion. The investigation provided convincing clinical evidence for of the equivalent efficacy, safety, and immunogenicity of BCD-057 and Humira®.

PMS29 - SECUKINUMAB VERSUS ADALIMUMAB IN THE TREATMENT OF ANKYLOSING SPONDYLITIS: A COST PER RESPONDER ANALYSIS AMONG 52 WEEKS FROM A TUNISIAN PERSPECTIVE.

The objective of this analysis was to assess and compare the long term cost per responder (CPR) based on the Assessment of SpondyloArthritis International Society (ASAS) outcomes following 52 weeks of treatment with Secukinumab (SEC,150mg) relative to Adalimumab (ADA, anti TNF) for the treatment of Ankylosing Spondylitis (AS) in Tunisia. The CPR for each treatment namely Secukinumab and Adalimumab was estimated by dividing the acquisition cost of each drug by its response rate. Drug costs were estimated based on the Tunisian Central Pharmacy (PCT) database (currency in TND) and the number of doses required during 52 weeks. The long-term response rates were derived from a matching-adjusted indirect comparison (MAIC) technique based on the data from MEASURE 2 and ATLAS clinical trials of Secukinumab and Adalimumab respectively. MAIC analysis matched patient populations on key baseline parameters. MAIC analysis showed that ASAS (20, 40 and 5/6) response rates were significantly higher for SEC 150 mg compared to ADA at 52 weeks. ASAS 20 response rates were 81% and 65%, ASAS 40 response rates were 62% and 47% whereas the ASAS 5/6 response rates were 74%, and 55% for SEC150 mg and ADA respectively. SEC has a lower CPR compared to ADA among AS patients. Cost per ASAS 20 responder were TND 29,171.00 and TND 56,534.00 cost per ASAS40 responder were TND 37,922.00 and TND 78,603.00 whereas costs per ASAS 5/6 responder were TND 31,772.00 and TND 67,255.00 for SEC 150 mg and ADA respectively. These findings support the economic advantage of SEC over ADA. With SEC, Tunisian AS patient could be treated more efficiently compared to ADA.

PMS42 - SECUKINUMAB VERSUS ADALIMUMAB FOR THE TREATMENT OF ANKYLOSING SPONDYLITIS: A 52-WEEK COST PER RESPONDER ANALYSIS FROM THE PORTUGUESE PAYER PERSPECTIVE

To estimate the cost per responder of ankylosing spondylitis (AS) treatment with secukinumab 150 mg versus adalimumab 40 mg from the Portuguese National Health System (NHS). The cost per responder for each treatment was estimated by dividing the drug acquisition cost of a 52-week course of treatment with its response rate based on the Assessment of Spondyloarthritis International Society outcomes (ASAS20, ASAS40 and ASAS5/6). Drug acquisition costs were estimated using 2018 official prices from the perspective of the NHS; number of doses required for the course of treatment were defined according to the approved EU label. Long-term response rates were estimated using a matching-adjusted indirect comparison (MAIC) based on the data from MEASURE 2 and ATLAS clinical trials of secukinumab and adalimumab, respectively. MAIC analysis matched baseline characteristics such as age, gender, Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), C-reactive protein and TNF-naive proportion at baseline. The predicted ASAS20, ASAS40 and ASAS5/6 response rates for secukinumab were 80%, 61% and 72% versus 65%, 47% and 55% for adalimumab, respectively. The 52-week cost of secukinumab was €6,739 versus €9,362 for adalimumab. For a given budget to treat 100 patients with adalimumab, 139 patients could be treated with secukinumab instead. Cost per ASAS20 responder for secukinumab and adalimumab was €8,423 and €14,402, cost per ASAS40 responder was €11,047 and €19,918, and cost per ASAS5/6 responder was €9,359 and €17,021, respectively. Response rates were higher for secukinumab compared to adalimumab at 52 weeks for all considered ASAS outcomes and cost estimates per responder were consistently lower for secukinumab. These findings indicate that it is more efficient to treat AS patients with secukinumab than with adalimumab in the Portuguese NHS.

Lessons learnt from a discontinued randomised controlled trial: adalimumab injection compared with placebo for patients receiving physiotherapy treatment for sciatica (Subcutaneous Injection of Adalimumab Trial compared with Control: SCIATiC)

BackgroundAdalimumab, a biological treatment targeting tumour necrosis factor α, might be useful in sciatica. This paper describes the challenges faced when developing a new treatment pathway for a randomised controlled trial of adalimumab for people with sciatica, as well as the reasons why the trial discussed was stopped early.MethodsA pragmatic, parallel group, randomised controlled trial with blinded (masked) participants, clinicians, outcome assessment and statistical analysis was conducted in six UK sites. Participants were identified and recruited from general practices, musculoskeletal services and outpatient physiotherapy clinics. They were adults with persistent symptoms of sciatica of 1 to 6 months’ duration with moderate to high level of disability. Eligibility was assessed by research physiotherapists according to clinical criteria, and participants were randomised to receive two doses of adalimumab (80 mg then 40 mg 2 weeks later) or saline placebo subcutaneous injections in the posterior lateral thigh. Both groups were referred for a course of physiotherapy. Outcomes were measured at baseline, 6-week, 6-month and 12-month follow-up. The main outcome measure was disability measured using the Oswestry Disability Index. The planned sample size was 332, with the first 50 in an internal pilot phase.ResultsThe internal pilot phase was discontinued after 10 months from opening owing to low recruitment (two of the six sites active, eight participants recruited). There were several challenges: contractual delays; one site did not complete contract negotiations, and two sites signed contracts shortly before trial closure; site withdrawal owing to patient safety concerns; difficulties obtaining excess treatment costs; and in the two sites that did recruit, recruitment was slower than planned because of operational issues and low uptake by potential participants.ConclusionsImproved patient care requires robust clinical research within contexts in which treatments can realistically be provided. Step changes in treatment, such as the introduction of biologic treatments for severe sciatica, raise complex issues that can delay trial initiation and retard recruitment. Additional preparatory work might be required before testing novel treatments. A randomised controlled trial of tumour necrosis factor-α blockade is still needed to determine its cost-effectiveness in severe sciatica.Trial registrationCurrent Controlled Trials, ISRCTN14569274. Registered on 15 December 2014.

Safety of Adalimumab in Pediatric Patients with Polyarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, Psoriasis, and Crohn's Disease

To evaluate the safety of adalimumab in pediatric patients who participated in clinical trials of juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and pediatric enthesitis-related arthritis), psoriasis, and Crohn's disease. This analysis included data from 7 global, randomized, and open-label AbbVie-sponsored clinical trials of adalimumab and their open-label extensions conducted between September 2002 and December 31, 2015 (cutoff date for ongoing studies). Patients who received ≥1 dose of adalimumab subcutaneously were included. Adverse events that occurred after the first dose of adalimumab and up to 70 days (5 half-lives) after the last dose were reported and events per 100 patient-years were calculated. The analysis included 577 pediatric patients, representing 1440.7 patient-years of adalimumab exposure. Across indications, the most commonly reported adverse events (events/100 patient-years) were upper respiratory tract infections (24.3), nasopharyngitis (17.3), and headache (19.9). Serious infections (4.0 events/100 patient-years) were the most frequent serious adverse events across indications; the most commonly reported was pneumonia (0.6 events/100 patient-years). Serious infection rates were 2.7, 0.8, and 6.6 events/100 patient-years in patients with juvenile idiopathic arthritis, psoriasis, and Crohn's disease, respectively. No events of malignancies were reported. One death (accidental fall) occurred in a patient with psoriasis. The safety profile of adalimumab in pediatric patients with polyarticular juvenile idiopathic arthritis, enthesitis-related arthritis, psoriasis, and Crohn's disease was generally similar across indications; no new safety signals were identified in the treatment of pediatric patients with adalimumab. Clinicaltrials.gov: NCT00048542, NCT00775437, NCT00690573, NCT01166282, NCT01251614, NCT00409682, and NCT00686374.

Performance of Crohn's disease Clinical Trial Endpoints based upon Different Cutoffs for Patient Reported Outcomes or Endoscopic Activity: Analysis of EXTEND Data.

Clinical trial endpoints for Crohn's disease (CD) activity correlate poorly with mucosal inflammation; to assess treatment efficacy, patient-reported outcomes and endoscopic assessments are preferred. This study assessed the impact on treatment efficacy estimations of using different definitions of clinical and endoscopic remission and endoscopic response, and of using site- or central-based endoscopy evaluation. This post hoc analysis of data fromEXTEND (extend the safety and efficacy of adalimumab through endoscopic healing), a placebo (PBO)-controlled, randomized trial of adalimumab (ADA) for mucosal healing, included adults with moderate-to-severe CD. Subsets of patients meeting specified Simplified Endoscopic Score for CD (SES-CD) inclusion criteria, according to site or central reading, and baseline stool frequency (SF) and/or abdominal pain score (AP) thresholds were evaluated. Various endpoint definitions based on the Crohn's Disease Activity Index (CDAI), its SF and AP components, SES-CD, and composite endpoints were compared between treatment groups. Increased stringency of Week 12 clinical endpoints compared to CDAI<150 to SF≤3.0/1.5&AP≤1.0 reduced PBO response rates by ≥12% and increased treatment effects by ≤10%. Amending the SES-CD endpoint from ≤4 to ≤2 reduced the treatment effect from 24% to 8%. Composite endpoints further diminished response rates and effect sizes. Site-based evaluation was associated with lower remission rates versus central reading in the PBO group and, thus, greater ADA-related treatment effects. This analysis is the first to demonstrate that increasing the stringency of clinical and endoscopic endpoint definitions in CD trials, especially lowering SF or SES-CD definitions, reduces the ability to detect treatment-related change in CD activity; focus on endpoints that reflect clinical change is warranted.

The economic impacts of using adalimumab (Humira® ) for reducing pain in people with ankylosing spondylitis: A microsimulation study for Australia.

The onset and progression of ankylosing spondylitis (AS) usually occurs during the life stage when individuals are more likely to be working and receiving an income, but little is known about the effects of interventions that reduce pain and improve the economic circumstances of patients out of the labour force due to AS. This study evaluates the economic benefits of pain reduction among people aged 19-64 with AS using adalimumab (Humira® ) from the patient and governmental perspectives. We estimated the benefits of adalimumab for reducing pain in people aged 19-64 with AS in terms of labor force participation and earnings, and to the Australian Government in terms of income tax revenue and welfare payments using economic simulation. The simulation model integrated data from the Adalimumab Trial Evaluating Long-Term Safety and Efficacy for Ankylosing Spondylitis (ATLAS), the Household Income and Labour Dynamics in Australia (HILDA) Survey - Wave 10, and Static Incomes Model (STINMOD). All benefits are expressed in 2014 real Australian dollars. We estimated an additional 131 people aged 19-64 with AS (111 males, 20 females) would be in the labour force after using adalimumab for 24 weeks. National benefits consisted of an increase in annual earnings of AU$7.4 million for patients through increased labour force participation, savings of $2 million in annual welfare payments, and an increase of $1.3 million in income tax revenue in 2014 (after 24 weeks). Adalimumab therapy generates substantial economic benefits in addition to health benefits for individuals, and savings for government.

Inflammatory and structural changes in vertebral bodies and posterior elements of the spine in axial spondyloarthritis: construct validity, responsiveness and discriminatory ability of the anatomy-based CANDEN scoring system in a randomised placebo-controlled trial

BackgroundThe Canada-Denmark (CANDEN) definitions of spinal MRI lesions allow a detailed anatomy-based evaluation of inflammatory and structural lesions in vertebral bodies and posterior elements of the spine in patients with...

Whole-body Magnetic Resonance Imaging in Axial Spondyloarthritis: Reduction of Sacroiliac, Spinal, and Entheseal Inflammation in a Placebo-controlled Trial of Adalimumab.

To investigate whether adalimumab (ADA) reduces whole-body (WB-) magnetic resonance imaging (MRI) indices for inflammation in the entheses, peripheral joints, sacroiliac joints, spine, and the entire body in patients with axial spondyloarthritis (axSpA). An investigator-initiated, randomized, placebo-controlled, double-blinded 48-week followup trial included 49 patients with axSpA, who had Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥ 4.0 despite treatment with nonsteroidal antiinflammatory drugs and a clinical indication for tumor necrosis factor inhibitor treatment. Patients were randomized to subcutaneous ADA 40 mg or placebo every other week for 6 weeks; thereafter, all patients received ADA. Conventional MRI and WBMRI were performed at weeks 0, 6, 24, and 48. The primary WBMRI endpoint was the proportion of patients with an improvement in WBMRI total inflammation index above the smallest detectable change (SDC) at Week 6. The primary WBMRI endpoint (improvement of SDC > 2.3) was met in 11 (44%) patients in the ADA group and 3 (13%) patients in the placebo group (p = 0.025, Fisher's exact test). The primary conventional MRI endpoint, the minimally important change in Spondyloarthritis Research Consortium of Canada Spine MRI Inflammation Index at Week 6, was achieved by 9 (36%) patients in the ADA group and 4 (17%) patients in the placebo group (p = 0.20). The primary clinical endpoint, BASDAI reduction > 50% or 2.0 at Week 24, was attained by 32 (65%) patients. ADA provided significant reductions in WBMRI indices of peripheral, axial, and whole-body inflammation in patients with axSpA. WBMRI is promising for objective assessment and monitoring of peripheral and axial disease activity in future clinical trials.

P457 Biological interventions for induction and maintenance of mucosal healing in ulcerative colitis: A Cochrane systematic review

The number of biologics for ulcerative colitis (UC) is rapidly expanding and mucosal healing (MH) is a salient endpoint against which to gauge their efficacy. In this Cochrane review, we synthesised the randomised controlled trial (RCT) data on biologics for inducing and maintaining MH in UC. We searched MEDLINE, EMBASE, Cochrane Library and the Cochrane IBD Group Specialised Trials Register to October 2017 for RCTs investigating biologics for inducing and/or maintaining MH in UC at 4–26 and >26 weeks, respectively. Secondary outcomes were endoscopic response (ER), safety and quality of life (QOL). Pooled risk ratios (RR) were determined using a random-effects model. The quality of the evidence was rated with GRADE. The search yielded 13 induction trials (eight low, four unclear, one high-risk of bias). Infliximab (IFX), adalimumab (ADA), golimumab (GOL) and vedolizumab (VDZ) were superior to placebo (PBO) for inducing MH at 6–8 weeks (RR 1.8, 95% CI 1.5–2.1, n = 979, high quality for IFX; RR 1.3, 95% CI 1.1–1.5, n = 940, moderate quality for ADA; RR 1.5, 95% CI 1.2–1.8, n = 1194, high quality for GOL; RR 1.7, 95% CI 1.3–2.3, n = 555, moderate quality for VDZ). IFX plus azathioprine (AZA) was superior to AZA (RR 1.7, 95% CI 1.2–2.4, n = 154, low quality). No difference was seen between IFX and ADA in a single trial (RR 1.0, 95% CI 0.51–2.0, n = 50, very low quality). Seven maintenance trials were identified (all low risk of bias). The ability of a biologic to maintain MH achieved during induction was examined in one ADA trial; no difference was observed between ADA and PBO (RR 1.3, 95% CI 0.90–1.9, n = 180, low quality). Analyses including all randomised patients (regardless of MH status at induction completion) demonstrated higher MH rates at 1 year with IFX, ADA, GOL and VDZ vs. PBO (RR 2.5, 95% CI 1.7–3.8, n = 364 for IFX; RR 1.7, 95% CI 1.2–2.2, n = 767 for ADA; RR 1.6, 95% CI 1.2–2.1, n = 332 for GOL; RR 2.7, 95% CI 1.9–3.9, n = 373 for VDZ; moderate quality for all). ADA and VDZ were effective amongst anti-TNF-naive patients for induction only. The same was true of ADA for maintenance, while VDZ’s maintenance benefit was observed in bio-naive and bio-exposed patients. The IFX and GOL data pertain to anti-TNF-naive patients only. Adverse event rates were similar between groups. All 4 biologics were associated with QOL improvements. Moderate-to-high quality evidence supports the efficacy of IFX, ADA, GOL and VDZ for inducing MH in moderate-to-severe UC. The existing evidence is insufficient to assess their ability to maintain MH achieved during induction. However, all four are associated with higher rates of MH at 1 year than PBO when all randomised patients, irrespective of MH status at the end of induction, are considered.

Secukinumab As A More Efficient Alternative For The Treatment of Ankylosing Spondylitis: A Cost Per Responder Analysis Versus Adalimumab And Golimumab From A Colombian Perspective

The objective of this analysis was to compare the cost per responder based on the Assessment of Spondyloarthritis International Society (ASAS) outcomes at 24 weeks of treatment of ankylosing spondylitis (AS) with secukinumab relative to adalimumab and golimumab from a third payer perspective. The cost per responder for each treatment was estimated by dividing the drug acquisition cost with its response rate. Drug costs were estimated in US dollars (USD) from public sources: SISMED 2016 Q1-Q4 for secukinumab and golimumab, and Circular 01 de 2016 for adalimumab (due to its maximum price regulation), using the number of doses required for 24 weeks of treatment. Response rates were used from a previous matching-adjusted indirect comparison (MAIC) based on the data from MEASURE1-2, ATLAS and GO-RAISE clinical trials of secukinumab, adalimumab and golimumab, respectively. MAIC analysis matched several patient characteristic such as age, gender distribution, Bath Ankylosing Spondylitis Functional Index (BASFI), C-reactive protein (CRP) and TNF-naive proportion at the baseline. MAIC analysis showed higher ASAS20, ASAS40 and ASAS5/6 response rates for secukinumab compared to adalimumab and golimumab. The cost per ASAS20 responder were USD6.733 vs USD9.988, cost per ASAS40 responder were USD8.028 vs USD12.790, whereas, costs per ASAS5/6 responder were USD15.665 vs USD22.800 for secukinumab vs adalimumab, respectively. The cost per ASAS20 responder were USD6.549 vs USD8.713, cost per ASAS40 responder were USD7.889 vs USD11.036, whereas, costs per ASAS5/6 responder were USD14.365 vs USD18.919 for secukinumab vs golimumab, respectively. Sensitivity analyses for ASAS response rates and cost per responder, showed similar results, validating the main analysis. Cost per responder for ASAS outcomes were consistently lower for secukinumab versus all comparators, showing the dominance of secukinumab versus adalimumab and golimumab. These findings indicate that it is more efficient to treat AS patients with secukinumab in the Colombian context.

Secukinumab Vs Adalimumab for the Treatment of Psoriasic Arthritis: a Cost Per Responder Analysis at 48 Weeks from a Peruvian Perspective for Public and Private Health Schemes

The objective of this analysis was to compare the cost per responder based on the American College of Rheumatology (ACR) outcomes following 48 weeks of psoriatic arthritis (PsA) treatment with secukinumab (anti-IL-17 antibody) relative to adalimumab (anti-TNF antibody) from a third payer perspective. The cost per responder for each treatment was estimated by dividing the drug acquisition cost with its response rate. Drug costs were estimated in US dollars (USD) from public sources: SEACE and DIGEMID for public and private health schemes, respectively. Response rates were estimated from a previous matching-adjusted indirect comparison (MAIC) based on the data from FUTURE2 and ADEPT clinical trials of secukinumab and adalimumab, respectively. MAIC analysis matched age, weight, race and gender distribution, PASI score, HAQ-DI score, and proportions of patients using methotrexate, with psoriasis ≥3% BSA, presence of dactylitis, enthesitis, and TNF-naive at baseline. ACR response rates were higher for secukinumab (150mg and 300mg) compared to adalimumab at 48 weeks in biologic-naive patients. Public scheme costs per ACR20 responder were USD14.088, USD30.509 and USD29.702, costs per ACR50 responder were USD19.632, USD36.527 and USD38.252, and costs per ACR70 responder were USD34.663, USD52.296 and USD56.103 for secukinumab 150mg, 300mg and adalimumab respectively. Private scheme costs per ACR20 responder were USD17.570, USD38.050 and USD58.302, costs per ACR50 responder were USD24.484, USD45.555 and USD75.085, and costs per ACR70 responder were USD43.231, USD65.221 and USD110.125 for secukinumab 150mg, 300mg and adalimumab respectively. Sensitivity analyses for ACR response and cost per responder showed similar results, confirming the validity of the main analysis. ACR response rates were higher for secukinumab compared to adalimumab. Cost per responder for ACR outcomes at 48 weeks were lower for secukinumab (150mg and 300mg) versus adalimumab, indicating that it is more efficient to treat PsA patients with secukinumab versus adalimumab in the Peruvian context.

Secukinumab Vs. Adalimumab for the Treatment of Psoriatic Arthritis: A Cost Per Responder Analysis at 48 Weeks from an Argentinian Perspective

To estimate and compare the long-term cost per responder (CPR) based on the American College of Rheumatology outcomes (ACR 20/50/70) following 48 weeks of psoriatic arthritis (PsA) treatment with secukinumab, the first and only fully human IL17-A antibody, relative to the anti-TNF adalimumab, in Argentina. The target population included biologic-naïve patients. The CPR for each treatment was calculated by dividing the drug acquisition cost for the course of treatment with its response rate. Drug costs were estimated based on the retail price and the number of doses required for 48 weeks. The long-term response rates were estimated using a matching-adjusted indirect comparison (MAIC) technique based on the data from FUTURE 2 and ADEPT clinical trials of secukinumab and adalimumab, respectively. Sensitivity analysis was conducted by varying baseline characteristics used in the MAIC analysis. The MAIC analysis showed that ACR (20/50/70) response rates were higher for secukinumab 150mg and 300mg compared to adalimumab at 48 weeks. ACR 20 response rates were 80%, 74% and 56%, ACR 50 response rates were 57%, 61% and 44%, whereas ACR 70 response rates were 32%, 43% and 30% for secukinumab 150mg, secukinumab 300mg, and adalimumab respectively. For PsA patients on secukinumab 150mg, secukinumab 300mg and adalimumab respectively, the costs per ACR 20 responder were ARS 394,615, ARS 854,584, and ARS 830,255; the costs per ACR 50 responder were ARS 549,906, ARS 1,023,150, and ARS 1,069,267; and the costs per ACR 70 responder were ARS 970,942, ARS 1,464,840, and ARS 1,568,259. The sensitivity analysis confirmed the robustness of the main analysis. The long-term CPR for ACR 50 and 70 response rates were consistently lower for secukinumab versus adalimumab. Furthermore, with better outcomes at lower costs, these findings suggest dominance of secukinumab over adalimumab. More PsA patients could be treated more effectively with secukinumab versus adalimumab, in Argentina.

Development and Validation of MRI Sacroiliac Joint Scoring Methods for the Semiaxial Scan Plane Corresponding to the Berlin and SPARCC MRI Scoring Methods, and of a New Global MRI Sacroiliac Joint Method.

To develop semiaxial magnetic resonance imaging (MRI) scoring methods for assessment of sacroiliac joint (SIJ) bone marrow edema (BME) in patients with axial spondyloarthritis, and to compare the reliability with equivalent semicoronal scoring methods. Two semiaxial SIJ MRI scoring methods were developed based on the principles of the semicoronal Berlin and Spondyloarthritis Research Consortium of Canada (SPARCC) methods. A global quadrant-based method was also developed. Baseline and 12-week MRI of the SIJ from 51 patients participating in a randomized double-blind placebo-controlled trial of adalimumab 40 mg every other week versus placebo were scored by the semiaxial and the corresponding semicoronal methods. Results were compared by linear regression analysis. The reproducibility and sensitivity were evaluated by intraclass correlation coefficients (ICC) and smallest detectable change [SDC, absolute values and percentage of the highest observed score (SDC-HOS)]. Interreader and intrareader ICC were moderate to very high for semiaxial scoring methods (baseline 0.83-0.88 and 0.85-0.97; change 0.33-0.78), while high to very high for semicoronal scoring methods (baseline 0.90-0.92 and 0.93-0.97; change 0.77-0.89). Association between semiaxial and semicoronal scores were high for both the Berlin and SPARCC method (baseline: R2 = 0.93 and 0.88; change: R2 = 0.82 and 0.87, respectively), while lower for the global method (baseline: R2 = 0.79; change: R2 = 0.54). The SDC-HOS were 9.8-18.6% and 5.9-10.7% for the semiaxial and semicoronal methods, respectively. Detection of SIJ BME in the semiaxial scan plane is feasible and reproducible. However, a slightly lower reliability of all 3 semiaxial methods supports the general practice of using the coronal scan-plane in therapeutic studies.