BackgroundTofacitinib is an oral Janus kinase inhibitor under investigation for psoriatic arthritis (PsA). Interim data (database not locked) from ≤24 months' participation (3 years' total treatment duration) for patients (pts) with active PsA in an ongoing, open-label, long-term extension study (LTE; NCT01976364 OPAL Balance) is reported.ObjectivesTo evaluate the safety, tolerability and efficacy of tofacitinib in pts with active PsA.MethodsEligible pts from 2 pivotal Phase 3 tofacitinib PsA studies (NCT01877668 OPAL Broaden, NCT01882439 OPAL Beyond) could enter a 3-year LTE ≤3 months after completing the qualifying study or discontinuing for non study-drug-related reasons. Pts were to receive tofacitinib 5 mg twice daily (BID) for 1 month, after which an increase to 10 mg BID or reduction back to 5 mg BID was permitted at any time for efficacy or safety reasons. Concomitant treatment with a single conventional synthetic disease-modifying antirheumatic drug (csDMARD) was allowed but not required. Primary endpoints were incidence and severity of adverse events (AEs) and change from baseline in laboratory values. Efficacy was a secondary endpoint.Results680/685 enrolled pts were treated. 608 (89.4%) remained at data cut-off. Mean (range) duration of tofacitinib exposure in this LTE was 206 (3–741) days. 661 (97.2%) pts took a csDMARD on Day 1, and 73 (11.0%) later discontinued csDMARD. To Month 24, 860 AEs were reported in 367 (54.0%) pts, 41 (6.0%) pts had serious AEs and 24 (3.5%) pts discontinued due to AEs. Special interest AEs included 6 serious infections (0.9%), 10 herpes zoster events (1.5%) including 1 serious event, 2 major adverse cardiovascular events (0.3%) and 2 malignancies (0.3%). There were 3 deaths (not attributed to treatment, as assessed by the investigator) due to metastatic pancreatic carcinoma, acute cardiac failure and pulmonary embolism. No GI perforation, inflammatory bowel disease or uveitis cases were reported. One AE of latent TB was reported. One pt met discontinuation criteria for laboratory values due to increased serum creatinine >50% and >0.5 mg/dL over the average of screening and baseline creatinine. Small mean decreases in absolute lymphocyte and neutrophil counts, and small mean increases in serum lipid markers, were observed; 18 (2.6%) pts started new lipid-lowering medication during the LTE (80 [11.8%] pts were on lipid-lowering drug at baseline). Efficacy was maintained in the LTE (Table 1).ConclusionsOver 24 months in the LTE, the safety profile of tofacitinib in pts with active PsA was generally similar to that of the pivotal Phase 3 studies. No new safety signals were identified. Efficacy was maintained over time.AcknowledgementsTo be presented at AAD 2017 and reproduced with permission. This study was sponsored by Pfizer Inc. Editorial support was provided by S Morgan of CMC and was funded by Pfizer Inc.Disclosure of InterestP. Nash Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Eli Lilly, Novartis, Pfizer Inc, Roche, UCB, Consultant ...
BackgroundThe Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) – Outcome Measures in Rheumatology (OMERACT) Psoriatic Arthritis (PsA) Core Set working group is developing a core instrument set to guide selection of outcome measures (instruments) for PsA randomised controlled trials (RCTs) and longitudinal observational studies (LOS). Candidate instrument measurement properties are being appraised in systematic literature reviews by working group members.ObjectivesAppraise the content and face validity (domain match) and feasibility of PsA instruments with GRAPPA stakeholders using the OMERACT Filter 2.1 instrument selection process1.MethodsThe PsA Core set workshop held at the GRAPPA 2017 annual meeting comprised an introductory plenary session and breakout group discussions. Working group members facilitated six breakout groups, with two patient research partners (PRPs) per group, discussing pre-selected domain-instrument pairs. Participants individually reviewed the instrument(s). After group discussion, they completed anonymised paper-based OMERACT questionnaires examining domain match and feasibility, with votes for each aspect of domain match and feasibility centralised by instrument. A final vote (show of hands) on whether the assigned instrument met the requirements for domain match and feasibility using the OMERACT traffic-light scoring system was taken. Consensus was defined as more than 70% agreement, and majority as more than 50% agreement within a group. Consensus represents stronger evidence than majority agreement.ResultsThere were 145 participants across all breakout groups and 116 returned completed questionnaires. Anonymized votes are summarised across groups and instruments in figure 1. More than 70% in the respective breakout groups endorsed the PsA instrument 66 swollen and 68 tender joint count (66/68 SJC/TJC) as a good match with the target domain of arthritis, a subset of MSK disease activity, FACIT-Fatigue as a good match with fatigue, and PsAID12 as a good match with HRQoL. There was consensus or majority agreement for all feasibility questions for the 66/68 SJC/TJC, HAQ-DI and PsAID9 and PsAID12. For the SPARCC enthesitis index only one item in both domain match and feasibility did not reach majority agreement.Abstract SAT0350 – Figure 1GRAPPA stakeholders’ ratings for OMERACT domain match and feasibility for 6 PsA instrumentsConclusionsThe first two steps of the OMERACT Filter 2.1 instrument selection process for five candidate instruments have been completed. The first set of candidate instruments selected to undergo the next phase of the OMERACT Filter 2.1, construct validity and discrimination appraisal are 66/68 SJC/TJC, SPARCC enthesitis index, PsAID9, PsAID12, HAQ-DI and FACIT-Fatigue. Additional PsA instruments will undergo the OMERACT selection process.Reference[1] Boers M, Kirwan JR, Tugwell P, et al. The OMERACT Handbook. Accessed 8 January 2018. https://www.omeract.org/resources.Disclosure of InterestNone declared
BackgroundMinimal disease activity (MDA), a validated composite measure in PsA, is gaining acceptance as a target for achieving substantial disease control.ObjectivesSecukinumab (SEC), an anti–IL-17A monoclonal antibody, significantly improved the signs and symptoms of PsA over 52 wks in the FUTURE 2 study. This post-hoc exploratory analysis assessed MDA response rates through 52 wks.Methods397 patients (pts) with active PsA were randomized to subcutaneous (SC) SEC (300 mg, 150 mg, or 75 mg) or placebo (PBO) at baseline (BL), Wks 1, 2, and 3, and every 4 wks (q4w) from Wk 4. PBO pts were re-randomized to SEC 300 or 150 mg SC q4w from Wk 16 or 24, depending upon clinical response. Pts were considered in MDA when they met at least 5 of the following 7 criteria: 1) tender joint count ≤1; 2) swollen joint count ≤1; 3) Psoriasis Activity and Severity Index ≤1 or psoriasis affecting <3% body surface area at BL; 4) pt pain VAS ≤15; 5) pt global disease activity VAS ≤20; 6) HAQ-DI ≤0.5; 7) tender entheseal points ≤1. MDA was assessed in the overall population and in pts stratified by prior anti-tumor necrosis factor (anti-TNF) therapy use (anti–TNF-naïve and inadequate response/intolerance to these agents [anti–TNF-IR]) and disease duration (≤2 yrs vs >2 yrs since diagnosis). Observed data are shown. 75 mg data are not reported as this was not considered an effective dose (no secondary endpoints were met).ResultsIn the overall population, 23/100 (23%) and 27/97 (28%) pts achieved MDA at Wk 16 with SEC 150 mg and 300 mg, respectively, vs 9/88 (10%) pts with PBO; these response rates were sustained through Wk 52 (150 mg: 29/88 [33%]; 300 mg: 33/93 [35%]). In the anti–TNF-naïve cohort, a higher proportion of pts achieved MDA at Wk 16 with SEC 150 mg (20/63 [32%]) or 300 mg (22/65 [34%]) vs PBO (8/58 [14%]), with response rates sustained through Wk 52 (150 mg: 23/59 [39%]; 300 mg: 26/63 [41%]). Lower rates were observed in anti–TNF-IR pts (SEC vs PBO at Wk 16: 150 mg, 3/37 [8%]; 300 mg, 5/32 [16%]; PBO, 1/30 [3%]; Wk 52: 150 mg, 6/29 [21%]; 300 mg, 7/30 [23%]). The proportion of pts achieving MDA at Wk 16 and Wk 52 in the overall population was greater for those ≤2 yrs since diagnosis vs those >2 yrs since diagnosis for both SEC 150 mg and 300 mg. The proportion of pts achieving MDA with SEC at Wk 16 was higher in anti–TNF-naïve pts with low disease duration vs pts with longer disease duration, and higher in the anti–TNF-naïve cohort than the anti–TNF-IR cohort at all times (Figure).ConclusionsSEC pts had higher MDA response rates vs PBO pts at Wk 16, with response rates sustained through Wk 52. Response rates were consistent with those previously reported with anti-TNF therapies in comparable pt populations.1 This study is the first to report MDA in anti–TNF-IR pts. The finding that greater MDA can be achieved in early anti–TNF-naive PsA pts warrants further research.ReferencesMease et al. J Rheumatol 2013;40:647–52AcknowledgementThe study was sponsored by Novartis Pharma AG.Disclosure of InterestL. Coates Grant/research sup...
BackgroundPsoriatic arthritis (PsA) is a complex form of arthritis that develops in people with psoriasis. There is no agreement on the optimal criteria to identify remission in patients with PsA and some of them may miss skin lesions.ObjectivesTo investigate the merits of different potential remission definitions using data from the PRESTA study.1MethodsRemission was investigated for disease activity index for PsA for 3 definitions: very low disease activity (VLDA), Disease Activity in PsA (DAPSA), and clinical (c)DAPSA. VLDA index was defined as 7/7 met criteria of the minimal disease activity (MDA) cut-off points: tender joint count (TJC) ≤1, swollen joint count (SJC) ≤1, psoriasis activity and severity index (PASI) ≤1, patient global visual analog scale (Pt VAS) ≤20mm, Pt pain VAS ≤15mm, health assessment questionnaire (HAQ) ≤0.5, tender entheseal points ≤1. DAPSA remission was defined as DAPSA ≤4 (TJC, SJC, physician global VAS [cm], Pt VAS [cm], C-reactive protein [CRP]) and cDAPSA remission was defined as cDAPSA ≤4 (DAPSA without CRP).ResultsAt Week 24, the proportion of patients achieving remission was 9.6%, 31.0%, and 34.7% for VLDA, DAPSA, and cDAPSA remission, respectively. Discordance between VLDA and DAPSA or cDAPSA remission was 21.7% or 25.1%, respectively. Only 0.2% of the patients that achieved VLDA did not achieve DAPSA remission and 21.5% vice versa (Kappa coefficient 0.38) and 0.0% in the case of cDAPSA remission and 25.1% vice versa (Kappa coefficient 0.33). At the end of the study, residual levels of dactylitis and enthesitis appeared to be similar among all definitions (all ≤3.0%); however, patients achieving DAPSA and cDAPSA remission had higher proportions of patients with PASI >1 than patients achieving VLDA remission (PASI 2–9: VLDA 0.0% vs DAPSA 46.4% vs cDAPSA 47.2%; PASI ≥10: VLDA 0.0% vs DAPSA 5.8% vs cDAPSA 6.4%). Raised CRP values (upper limit of normal >8.99) were 7.8%, 4.8%, and 7.3% for VLDA, DAPSA, and cDAPSA, respectively.ConclusionsVLDA remission is a more stringent target than DAPSA and cDAPSA remission, with the advantage of including a measurement for psoriasis. Therefore, VLDA is more useful than DAPSA or cDAPSA in assessing a remission state in patients with PsA and extended skin lesions. Measurement of CRP levels does not appear to provide further information on current disease activity level in these patients and exclusion of this laboratory marker should facilitate remission assessment in clinical practice.References Sterry W, et al. BMJ 2010;340:c147. Disclosure of InterestL. Coates Grant/research support from: Abbvie, Janssen, Consultant for: Abbvie, BMS, Janssen, Lilly, MSD, Novartis, Pfizer, L. Aikman Shareholder of: Pfizer, Employee of: Pfizer, A. Szumski Employee of: InVentiv Health, A. Chhabra Shareholder of: Pfizer, Employee of: Pfizer
Background:Inflammatory involvement of the axial skeleton (sacroiliac joints and / or spine) is one of the relatively frequent musculoskeletal manifestations associated with psoriasis / psoriatic arthritis (PsA). There is an urgent need for an evidence-based definition for axial involvement in PsA that would identify a subgroup of patients within the heterogeneous PsA population to conduct observational, interventional and translational studies. ASAS and GRAPPA embarked on a collaborative initiative to develop a definition of axial involvement in PsA.Objectives:To perform a survey to identify variables relevant in the identification of the presence of axial involvement in PsA among members of ASAS and GRAPPA.Methods:The online survey utilized thePAPRIKAmethodology (PotentiallyAllPairwiseRanKings of all possibleAlternatives) that determines decision-makers’ part-worth utilities representing the relative importance of the attributes. Participants were exposed to number of clinical scenarios and were prompted to decide which of the scenarios is more compatible with axial involvement in PsA unless they are equal (Figure). The constant stem of each scenario was “a patient diagnosed with psoriatic arthritis fulfilling the CASPAR criteria”; the variable part included 13 common spondyloarthritis variables (Table). Variables were ranked according to their relative importance.Results:The survey was completed by 186 ASAS/GRAPPA members (63 ASAS only, 80 GRAPPA only, and 43 both societies). The ranking of the variables is presented inTable. The highest ranked parameters indicative of axial involvement in a patient with PsA were presence of typical radiographic or MRI changes in the sacroiliac joints and/or spine followed by the presence of chronic back pain and then inflammatory back pain. A separate analysis of ASAS and GRAPPA members provided the similar results concerning the relevance of the variables.Conclusion:Objective signs of inflammatory involvement of the axial skeleton are the most important indicators of axial disease in PsA in the opinion of the experts. A prospective cohort study is currently being planned to address the value of these and other variables in defining axial involvement in PsA.Table.Ranking of the parameters relevant to deciding on the presence of axial involvement in a PsA patient in the opinion of ASAS and GRAPPA members (n=186).NParametersMedian rankMean rank1Presence of structural damage on an X-ray of SIJ22.82Presence of structural damage on an X-ray of spine3.54.13Presence of subchondral BME / osteitis on MRI of SIJ compatible with SpA44.54Presence of BME / osteitis on MRI of spine compatible with SpA455History or current presence of back pain5.55.86History of or current presence of inflammatory back pain5.567Good response of back pain to non-steroidal anti-inflammatory drugs87.88HLA-B2788.19Family history for SpA9.5910Elevated C-reactive protein109.311Presence of peripheral arthritis and/or enthesitis and/or dactylitis109.412Presence of anterior uveitis109.513Presence of inflammatory bowel disease109.6BME=bone marrow edema, MRI=magnetic resonance imaging, SIJ=sacroiliac joints, SpA=spondyloarthritisDisclosure of Interests:Denis Poddubnyy Grant/research support from: AbbVie, MSD, Novartis, and Pfizer, Consultant of: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Philip J Mease Grant/research support from: Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Eli Lilly, Novartis, Pfizer, Sun Pharmaceutical, UCB – grant/research support, Consultant of: Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Eli Lilly, Novartis, Pfizer, Sun Pharmaceutical, UCB – consultant, Speakers bureau: Abbott, Amgen, Biogen Idec, BMS, Eli Lilly, Genentech, Janssen, Pfizer, UCB – speakers bureau, Filip van den Bosch Consultant of: AbbVie, Celgene Corporation, Eli Lilly, Galapagos, Janssen, Novartis, Pfizer, and UCB, Speakers bureau: AbbVie, Celgene Corporation, Eli Lilly, Galapagos, Janssen, Novartis, Pfizer, and UCB, Juergen Braun Grant/research support from: Abbvie (Abbott), Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, Eli Lilly and Company, Medac, MSD (Schering Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi- Aventis, and UCB Pharma, Consultant of: Abbvie (Abbott), Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, EBEWE Pharma, Eli Lilly and Company, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi-Aventis, and UCB Pharma, Speakers bureau: Abbvie (Abbott), Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, EBEWE Pharma, Eli Lilly and Company, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi-Aventis, and UCB Pharma, Alice Gottlieb Grant/research support from: Boehringer Ingelheim, Incyte, Janssen, Novartis, UCB, Xbiotech, Consultant of: AbbVie, Allergan, Avotres Therapeutics, Beiersdorf, Boehringer Ingelheim, BMS, Celgene, Dermira, Incyte, Eli Lilly, Janssen, LEO Pharma, Novartis, Reddy Labs, Sun Pharmaceutical Industries, UCB, Valeant, Xbiotech, Laura C Coates: None declared, Vinod Chandran Grant/research support from: Abbvie, Celgene, Consultant of: Abbvie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lily, Janssen, Novartis, Pfizer, UCB, Employee of: Spouse employed by Eli Lily, Philip Helliwell: None declared, Deepak Jadon: None declared, Joachim Sieper Consultant of: AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Roche, and UCB Pharma, Speakers bureau: AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Roche, and UCB Pharma, Désirée van der Heijde Consultant of: AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eisai, Eli-Lilly, Galapagos, Gilead Sciences, Inc., Glaxo-Smith-Kline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, UCB Pharma; Director of Imaging Rheumatology BV, Dafna D Gladman Grant/research support from: AbbVie, Amgen Inc., BMS, Celgene Corporation, Janssen, Novartis, Pfizer, UCB – grant/research support, Consultant of: AbbVie, Amgen Inc., BMS, Celgene Corporation, Janssen, Novartis, Pfizer, UCB – consultant
BackgroundDue to lack of validated outcome measures in non-psoriatic peripheral spondyloarthritis (pSpA), recent studies in this patient (pt) population have used varying endpoints [1]. Thus, developing new pSpA-specific indices may be worthwhile. Minimal Disease Activity (MDA) has been validated in psoriatic arthritis but not in pSpA.ObjectivesTo evaluate the performance of a modification of the MDA criteria (excluding psoriasis) in pSpA patients (pts) from the ABILITY-2 study [2].MethodsThis post-hoc analysis evaluated the validity of a modified MDA (mMDA) in pSpA. ABILITY-2 was a 12-week trial comparing adalimumab (ADA) with placebo (PBO) in pSpA followed by a 144 week extension. The mMDA for pSpA was defined as achieving at least 4 or 5 out of the following 6 criteria: (1) tender joint count (TJC, 78 joints) ≤1; (2) swollen joint count (SJC, 76 joints) ≤1; (3) pt pain visual analog scale (VAS) ≤15 of 100 mm; (4) pt global activity (PtGA) VAS ≤20 of 100 mm; (5) health assessment questionnaire–disability index (HAQ-DI)≤0.5; and (6) tender entheseal points ≤1. Enthesitis was assessed by the Leeds Enthesitis Index (LEI) or the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index for this analysis. The proportion of pts achieving the 4 different versions of mMDA were evaluated (either 4 or 5 of 6 using LEI and either 4 or 5 of 6 using SPARCC). The correlations between mMDA and the novel pSpA response criteria [PSpARC] remission from ABILITY-2 and Ankylosing Spondylitis Disease Activity Score Inactive Disease [ASDAS ID] were evaluated by tetrachoric correlation (rtet).ResultsOf the 163 pts (82 ADA, 81 PBO) who completed wk 12, significantly greater proportion of pts receiving ADA achieved mMDA (regardless of the definition) compared with PBO (P<0.001 for all comparisons, Table 1a). The proportion of mMDA responders at yrs 1, 2, and 3 was numerically higher in pts initially randomized to ADA. The mMDA response showed a stronger positive correlation with PSpARC remission (rtet>0.9) than ASDAS ID (rtet>0.75) at wk 12, and yrs 1–3. Among pts who fulfilled the 4/6 criteria (LEI or SPARCC), approximately 20–30% of pts did not meet TJC and SJC criterion (Table 1b). However, the 5/6 criteria (LEI or SPARCC) were more stringent with approximately 5% and 13% not meeting the TJC and SJC criterion, respectively.ConclusionsAll 4 versions of mMDA discriminated between ADA and PBO treatment groups; both entheseal indices performed similarly. The mMDA (particularly the 5/6 versions which closely represents the concept of MDA) could be an appropriate treatment target in pSpA pts.ReferencesTurina, M.C., et al., Ann Rheum Dis, 2015. (doi: 10.1136/annrheumdis-2014-207235).Mease, P., et al., Arthritis Rheumatol, 2015. 67(4): p. 914–23.AcknowledgementAbbVie funded the study (NCT01064856), contributed to its design and participated in data collection, analysis and interpretation of the data, and in writing, review, and approval of the publication. Statistical support was provided by Nupun Varothai, former employee of ...
BackgroundPsoriatic arthritis (PsA) is a chronic immune-mediated inflammatory disease associated with psoriasis, peripheral arthritis, enthesitis, dactylitis, and spondylitis. PsA can be progressive and destructive, resulting in physical deformities, impaired function, decreased quality of life, and increased mortality. Ixekizumab (IXE) is an IgG4 monoclonal antibody that binds with high affinity and specificity to the proinflammatory cytokine IL-17A. Results are presented from a phase 3 trial (SPIRIT-P1; NCT01695239) with IXE in patients with active PsA.ObjectivesTo explore the impact of IXE, as assessed by disease activity composite measures, up to 52 weeks (wks).MethodsA total of 417 bDMARD-naive adult patients with active PSA, were randomly assigned 1:1:1:1 to subcutaneous administration of either 80-mg IXE every 4 wks (Q4W) or every 2 wks (Q2W), each with a 160-mg starting dose at Wk 0; adalimumab (ADA) 40 mg Q2W (active comparator); or placebo (PBO) in the Double-Blind Treatment Period (DBTP; Wks 0 through 24). Of these patients, 381 continued into the Extension Period (EP; Wks 24 through 52). PBO- and ADA-treated patients were randomly re-assigned (1:1) to 80 mg IXEQ4W or IXEQ2W at Wk 16 (inadequate responders) or Wk 24; ADA-treated patients started IXE, after an 8-wk wash-out period, at Wk 24 (inadequate responders) or Wk 32. Investigators were blinded as to the criteria for inadequate response. Disease activity was measured at Wks 24 and 52 by composite measures including the following: minimum disease activity (MDA) as measured with the Psoriasis Area and Severity Index (MDAPASI) and with the static Physician Global Assessment of psoriasis (MDAsPGA), and modified Composite Psoriatic Disease Activity Indices (CPDAI-12 and CPDAI-14 [see Table 1 footnote]). Analyses for the DBTP were conducted on the Intent-to-Treat Population, defined as all randomly assigned patients; analyses for the EP were conducted on the EP Population, defined as all patients who received at least 1 dose of study drug during the EP. In the DBTP, treatment comparisons were made by a logistic regression model for categorical data with missing values imputed by nonresponder imputation; a mixed model for repeated measures analysis was used for continuous data.ResultsAt Wk 24, CPDAI-12 and CPDAI-14 total scores (assesses domains of peripheral arthritis, skin disease, enthesitis, dactylitis [and spinal disease for CPDAI-14 only]) for patients receiving IXEQ4W, IXEQ2W, or ADA, were significantly improved compared with results for patients receiving PBO (Table 1). Similarly, at Wk 24, significantly more patients receiving IXEQ4W, IXEQ2W, or ADA achieved MDAsPGA and MDAPASI compared with patients receiving PBO (Table 1), and percentages of patients receiving IXEQ4W or IXEQ2W who achieved MDAsPGA and MDAPASI were sustained through Wk 52 (Table 2). Results for MDAsPGA were similar to results for MDAPASI within each treatment group.ConclusionsIXE provides sustained improvement of disease activity, as measured by various composite measures, for u...
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