In this article I examine the enlistment of Arctic ice to tell grand, universal stories about humanity’s origins and endings. Specifically, I analyze 18th century Natural History musings that linked Arctic climate to race and human difference. I demonstrate that these musings are constitutive to an invention of pathologized migrancy across Arctic spaces that emerge as a consequence of the inability of ice to foster agricultural settlement. I call this phenomenon temperate-normativity, in which Arctic spaces of ice are produced as inferior, not meaningful on their own but read as where transit to temperate locales occurs and those who linger are consequentially rendered as aberrant. To upend temperate-normative ideals of landscape and livelihood, I analyze a poem titled “Exceeding Beringia” by Joan Naviyuk Kane (Inupiaq) wherein Inupiaq relations to more-than-human kin articulate transit and migration as a mutual, obligatory responsibility.
Over centuries, Western desires of Arctic space have consistently worked to render icy locales of the North legible to an audience further south. In non‐Indigenous reportage, the Arctic has been framed through a dominating lens that narrates it as a ‘natural region’ or cryosphere where elemental qualities such as cold, ice, snow and darkness reign supreme. The cryosphere is often overwhelmingly dissected and demarcated not by Indigenous historical and ongoing claims to space, but instead through the documented presence of particular biota as they correlate to lines of latitude and/or cold temporalities (e.g., ‘frozen for most of the year’). New descriptors such as ‘Atlantification’ are the latest in a line of tropes and descriptors being used to account and audit an Arctic that is said to be undergoing fundamental ‘declinist’ state‐change. Judged to be no longer satisfactorily described as a circumpolar region, rigidly defined by coldness north of the Arctic Circle, the Arctic's physical and environmental qualities are now being cultivated as a ‘new Arctic’. Ice and cold are fundamental to the everyday working and spiritual lives of northern communities. We argue that there are timely opportunities for ice humanities scholars to be mindful of enduring inhumanities in the sense of erasing/dispossessing those who inhabit worlds where there are co‐relationalities with ice, multi‐species relationships, and multiple spatialities, seasonalities and temporalities that do not pivot around Euro‐American/global framings of time and space, geopolitical worlding and extractive capitalism.
BackgroundBimekizumab (BKZ), a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A, met all primary/secondary endpoints at Week (Wk) 16 in patients (pts) with active non-radiographic axial spondyloarthritis (nr-axSpA) and radiographic axSpA (r-axSpA; i.e., ankylosing spondylitis), in the parallel phase 3 BE MOBILE 1 and 2 studies, respectively.[1,2]ObjectivesTo assess efficacy and safety of BKZ in these pts up to Wk 52.MethodsBE MOBILE 1 (NCT03928704) and 2 (NCT03928743) both involved a 16-wk placebo (PBO)-controlled and 36-wk maintenance period.[1,2]Pts were randomised to subcutaneous BKZ 160 mg Q4W (BKZ) or to PBO then BKZ from Wk 16 (PBO/BKZ).Results220/254 (86.6%) randomised pts with nr-axSpA and 298/332 (89.8%) with r-axSpA completed Wk 52. Efficacy was sustained to Wk 52 in both studies (Table 1). ASAS40 responses in BKZ-randomised pts increased from Wk 16 (nr-axSpA: 47.7%; r-axSpA: 44.8%; non-responder imputation [NRI]) to Wk 52 (60.9%; 58.4%; NRI) with high levels of efficacy across TNFi-naïve and TNFi-IR populations (Table 1). At Wk 52, ASDAS <2.1 was achieved by 61.6% and 57.1%, and ASDAS <1.3 by 25.2% and 23.4%, of BKZ-randomised pts with nr-axSpA and r-axSpA, respectively (Figure 1). Wk 16 reductions from baseline in objective signs of inflammation (MRI, hs-CRP), and improvements in function (BASFI) and ASQoL, were maintained through 52 wks. Efficacy at Wk 52 was similar in PBO/BKZ-treated and BKZ-randomised pts (Table 1).At Wk 52, 75.0% (183/244) of pts with nr-axSpA and 75.5% (249/330) of pts with r-axSpA had ≥1 treatment-emergent adverse event (TEAE) on BKZ; the most frequent (% pts) TEAEs by preferred term (MedDRA v19.0) were nasopharyngitis (nr-axSpa: 12.3%; r-axSpA 9.1%) and upper respiratory tract infection (9.4%; 6.4%); few COVID-19 infections were reported (7.0%; 2.1%). Incidence (pts/100 pt years) of serious TEAEs were low (4.4; 7.1); no major adverse cardiovascular events, active tuberculosis cases, serious COVID-19 infections, or deaths were reported. Most incidences of fungal infection (19.6; 14.9; none serious or systemic) wereCandida(12.8; 8.3) and mild to moderate; two pts in both studies discontinued the study due toCandidainfections. Incidence of IBD (1.0; 1.0) and uveitis (1.5; 2.4) were low.ConclusionAcross the axSpA spectrum, BKZ resulted in sustained efficacy to Wk 52. No new safety signals were observed, consistent with the Wk 24 safety profile.[1,2]References[1]Deodhar A. Ann Rheum Dis 2022;81:772–3; 2.[2]van der Heijde D. Ann Rheum Dis 2022;81:12–3.Table 1.Efficacy at Wk 52Mean (SE), unless statedBE MOBILE 1BE MOBILE 2PBO→BKZ N=126BKZ N=128PBO→BKZ N=111BKZ N=221ASAS40[NRI]n (%)64 (50.8)78 (60.9)76 (68.5)129 (58.4)ASAS40 in TNFi-naïve[NRI]n (%)58 (53.2)a73 (61.9)b67 (71.3)c108 (58.7)dASAS40 in TNFi-IRe[NRI]n (%)6 (35.3)f5 (50.0)g9 (52.9)f21 (56.8)hASAS20[NRI]n (%)88 (69.8)94 (73.4)89 (80.2)158 (71.5)ASAS PR[NRI]n (%)38 (30.2)38 (29.7)41 (36.9)66 (29.9)ASAS 5/6[NRI]n (%)65 (51.6)71 (55.5)74 (66.7)124 (56.1)BASDAI CfB[MI]–3.5 (0.2)–3.9 (0.2)–4.0 (0.2)–3.6 (0.1)BASFI CfB[MI]–2.6 (0.2)–3.0 (0.2)–2.8 (0.2)–2.8 (0.1)ASDAS-MI[NRI]n (%)37 (29.4)47 (36.7)49 (44.1)71 (32.1)Nocturnal spinal pain CfB[MI]–4.1 (0.2)–4.3 (0.3)–4.6 (0.3)–4.1 (0.2)ASQoL CfB[MI]–5.3 (0.4)–5.9 (0.4)–5.6 (0.4)–5.7 (0.3)SF-36 PCS CfB[MI]11.4 (0.9)12.2 (0.9)12.3 (0.9)12.0 (0.6)BASMI CfB[MI]–0.4 (0.1)–0.6 (0.1)–0.7 (0.1)–0.7 (0.1)Total resolution of enthesitisi[NRI]n (%)41 (44.6)j51 (54.3)c31 (46.3)k67 (50.8)lASDAS-CRP CfB[MI]–1.6 (0.1)–1.8 (0.1)–1.9 (0.1)–1.7 (0.1)SPARCC MRI SIJ score CfB[OC]mMean (SD)–6.4 (10.7)n–7.6 (10.5)o–2.8 (6.1)p–4.7 (8.2)qBerlin MRI spine score CfB[OC]mMean (SD)–0.4 (2.0)k–0.7 (2.5)r–2.1 (3.4)p–2.4 (3.9)shs-CRP, mg/L [MI]Median2.21.72.02.3RS. n:a109,b118,c94,d184;eMax 1 TNFi; n:f17,g10,h37;iMASES=0 in pts with MASES >0 at BL; n:j92,k67;l132;mMRI sub-study; n:n70,o82,p48,q90,r79,s89.AcknowledgementsThis study was funded by UCB Pharma. Medical writing support was provided by Costello Medical, funded by UCB Pharma.Disclosure of InterestsXenofon Baraliakos Speakers bureau: AbbVie, BMS, Chugai, Eli Lilly, Galapagos, Gilead, MSD, Novartis, Pfizer and UCB Pharma, Paid instructor for: AbbVie, BMS, Chugai, Eli Lilly, Galapagos, Gilead, MSD, Novartis, Pfizer and UCB Pharma, Consultant of: AbbVie, BMS, Chugai, Eli Lilly, Galapagos, Gilead, MSD, Novartis, Pfizer and UCB Pharma, Atul Deodhar Speakers bureau: Janssen, Novartis and Pfizer, Consultant of: AbbVie, Amgen, Aurinia, BMS, Eli Lilly, Janssen, MoonLake, Novartis, Pfizer and UCB Pharma, Grant/research support from: AbbVie, BMS, Celgene, Eli Lilly, MoonLake, Novartis, Pfizer and UCB Pharma, Désirée van der Heijde Consultant of: AbbVie, Bayer, BMS, Cyxone, Eisai, Galapagos, Gilead, GSK, Janssen, Eli Lilly, Novartis, Pfizer and UCB Pharma, Employee of: Director of Imaging Rheumatology BV, Marina Magrey Consultant of: AbbVie, Eli Lilly, Novartis, Pfizer and UCB Pharma, Grant/research support from: AbbVie and UCB Pharma, Walter P Maksymowych Consultant of: AbbVie, BMS, Boehringer-Ingelheim, Celgene, Eli Lilly, Galapagos, Janssen, Novartis, Pfizer and UCB Pharma, Grant/research support from: AbbVie and Pfizer; educational grants from AbbVie, Janssen, Novartis and Pfizer, Employee of: Chief Medical Officer for CARE ARTHRITIS, Tetsuya Tomita Speakers bureau: AbbVie, Astellas, BMS, Eisai, Eli Lilly, Janssen, Kyowa Kirin, Mitsubishi-Tanabe, Novartis and Pfizer, Consultant of: AbbVie, Eli Lilly, Gilead, Novartis and Pfizer, Huji Xu Speakers bureau: AbbVie, Janssen, Novartis, Pfizer and UCB Pharma, Consultant of: AbbVie, Beigene, BioMap, IASO, Pfizer and UCB Pharma, Employee of: Clinical investigator for Peking-Tsinghua Center for Life Sciences, Marga Oortgiesen Shareholder of: UCB Pharma, Employee of: UCB Pharma, Ute Massow Employee of: UCB Pharma, Carmen Fleurinck Employee of: UCB Pharma, Alicia Ellis Employee of: UCB Pharma, Thomas Vaux Employee of: UCB Pharma, julie smith Employee of: UCB Pharma, Alexander Marten Employee of: UCB Pharma, Lianne S. Gensler Consultant of: AbbVie, Acelyrin, Eli Lilly, Fresenius Kabi, Janssen, Novartis, Pfizer and UCB Pharma, Grant/research support from: Novartis and UCB Pharma paid to institution.
BackgroundThe lack of pediatric classification criteria for axial disease is a major impediment to the conduct of clinical trials for juvenile spondyloarthritis (JSpA).ObjectivesWe aimed to develop classification criteria for axial JSpA that will enable identification of a more homogeneous group representative of children with SpA and axial disease for entry into observational or clinical trials. These criteria are not intended to capture all possible subjects, but instead most patients with shared key features of axial disease. Treatment and diagnostic decisions should adhere to evidence-based recommendations.Methods304 cases with JSpA and suspected axial disease from 6 international centers were collected on a standardized case report form; all had an MRI that was reviewed by an independent team of experts in musculoskeletal imaging. Candidate criteria were developed in an earlier phase of the project through an iterative process that included an international Delphi exercise for item generation, systematic literature review, and an item reduction exercise. Using the preliminary candidate criteria, 14 international clinical SpA experts scored and rank-ordered 20 representative SpA cases. During four, 3-hour virtual meetings, the clinical expert panel reviewed the interrater reliability of case ranking, refined the criteria definitions and domain levels, and participated in a multi-criterion decision consensus methodology exercise to generate relative weights of the criteria. The expert panel assessed whether the criteria weighting was in accordance with their consensus clinical judgment as a test of face validation of the weighting/scoring system and revisions were made as necessary. Next, 30 cases from the derivation cohort were scored and ranked using the relative weights for each category and domain. Each expert independently determined the score or “threshold” below which they were no longer confident enough that a patient had axial disease to enroll the child in a Phase 3 randomized clinical trial of a drug with unclear efficacy and safety. Results of this exercise were discussed and a provisional threshold score for classification was achieved by consensus.ResultsThe preliminary axial disease criteria for JSpA included the PRINTO provisional criteria for enthesitis/spondylitis-related JIA or a rheumatologist diagnosis of SpA as obligatory entry criteria as well as additive weighted criteria for 7 domains (SIJ active inflammation on imaging, SIJ structural lesions on imaging, pain chronicity, pain pattern, pain location, morning stiffness, and genetics) (Figure 1). Interrater reliability of the pre-consensus meeting case rankings was poor (Kendall’s correlation coefficient was 0.20 for clinical data-only and 0.23 for clinical plus imaging data). The multi-criterion decision analysis was repeated for the imaging domains when the initial criteria weighting was not in accordance with the expert panel’s opinion. The multi-criterion decision analysis involved a total of 58 pairwise decisions agreed by expert consensus. After criteria weights and additive scores were re-calculated, experts reached consensus for axial disease in JSpA for all cases scoring 55 and greater.Figure 1.Axial juvenile spondyloarthritis (AxJSpA) classification criteria domains and levels. The first ring represents the domains and the items branching out are the levels moving from highest level (closest to center) to lowest level (farthest from center) in each domain. Assigned weights are shown below each item description.ConclusionUsing an iterative process, the JSpA axial disease criteria definitions were refined, preliminary weights were generated, and a provisional threshold score for classification was determined. The most heavily weighted domains were active inflammation and structural lesions on imaging. Imaging typical of sacroiliitis was necessary, but not sufficient without any clinical criterion, to surpass the axial disease classification threshold.Disclosure of InterestsPamela F. Weiss Consultant of: PfizerNovartisBiogenLilly(All < $5K in the past fiscal year), Timothy G. Brandon: None declared, Amita Aggarwal: None declared, Ruben Burgos-Vargas Speakers bureau: not in the last three yearsNovartis, Consultant of: Not in the last four yearsBMS, Lilly, Novartis, Robert A. Colbert: None declared, Gerd Horneff Speakers bureau: Pfizer, Novartis, Janssen, Chugai, Abbvie, Grant/research support from: Pfizer, Novartis, MSD, Chugai, Roche, Abbvie, Rik Joos Speakers bureau: Galapagos, Pfizer, AbbVie, Novartis, Amgen, BMS, Lilly, Grant/research support from: Pfizer, AbbVie, Roche, Ronald Laxer Consultant of: Abbvie, Novartis, Sobi, Sanofi, Eli Lilly Canada, Eli Lilly, Kirsten Minden Speakers bureau: Pfizer, Novartis, Consultant of: Pfizer, Novartis, Angelo Ravelli Speakers bureau: Abbvie, Novartis, SOBI, Angelini, Reckitt-Benkiser, Roche, Pfizer, Alexion, Grant/research support from: Novartis, Pfizer, Nicolino Ruperto Speakers bureau: NR has received honoraria for consultancies or speaker bureaus from the following pharmaceutical companies in the past 3 years: 2 Bridge, Amgen, AstraZeneca, Aurinia, Bayer, Brystol Myers and Squibb, Celgene, inMed, Cambridge Healthcare Research, Domain Therapeutic, EMD Serono, Glaxo Smith Kline, Idorsia, Janssen, Eli Lilly, Novartis, Pfizer, Sobi, UCB., Consultant of: NR has received honoraria for consultancies or speaker bureaus from the following pharmaceutical companies in the past 3 years: 2 Bridge, Amgen, AstraZeneca, Aurinia, Bayer, Brystol Myers and Squibb, Celgene, inMed, Cambridge Healthcare Research, Domain Therapeutic, EMD Serono, Glaxo Smith Kline, Idorsia, Janssen, Eli Lilly, Novartis, Pfizer, Sobi, UCB., Grant/research support from: The IRCCS Istituto Giannina Gaslini (IGG), where NR works as full-time public employee has received contributions from the following industries in the last 3 years: Bristol Myers and Squibb, Eli-Lilly, F Hoffmann-La Roche, Novartis, Pfizer, Sobi. This funding has been reinvested for the research activities of the hospital in a fully independent manner, without any commitment with third parties., Judith Smith Consultant of: Consulting panel of pediatric rheumatologists identifying issues in juvenile spondyloarthritis for Novartis. Paid < $5000, Matthew L. Stoll Consultant of: Currently consulting for Novartis, Shirley ML Tse: None declared, Filip van den Bosch Speakers bureau: Abbvie, Eli Lilly, Galapagos, Janssen, Novartis, Pfizer, UCB, Paid instructor for: Amgen, Eli Lilly, Consultant of: Abbvie, Eli Lilly, Galapagos, Janssen, Novartis, Pfizer, UCB, Walter P Maksymowych Speakers bureau: Abbvie, Eli-Lilly, Janssen, Novartis, Pfizer, UCB Pharma, Consultant of: AbbVie, Boehringer Ingelheim, Celgene, Eli Lilly, Galapagos, Janssen, Novartis, Pfizer, UCB Pharma, Grant/research support from: Abbvie, Novartis, Pfizer, Robert G Lambert Paid instructor for: Novartis, Consultant of: CARE Arthritis, Calyx, Image Analysis Group, Novartis, David M. Biko Employee of: Employee of Merck from 1998 to 2000, Nancy A. Chauvin Employee of: Forest Pharmaceuticals - Research scientist (1996) and Novartis - Pharmaceutical sales representative (1997), Michael L. Francavilla: None declared, Jacob L Jaremko: None declared, Nele Herregods: None declared, Ozgur Kasapcopur Speakers bureau: Pfizer, Abbvie, Novartis and Roche, Mehmet YILDIZ: None declared, Alison M. Hendry: None declared
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