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Efficacy of Tofacitinib in Reducing Pain in Patients with Rheumatoid Arthritis, Psoriatic Arthritis Or Ankylosing Spondylitis

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Efficacy of Tofacitinib in Reducing Pain in Patients with Rheumatoid Arthritis, Psoriatic Arthritis Or Ankylosing Spondylitis Pain RMD Open: first published as 10.1136/rmdopen-2019-001042 on 3 February 2020. Downloaded from ORIGINAL RESEARCH Efficacy of tofacitinib in reducing pain in patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis Alexis Ogdie,1 Kurt de Vlam,2 Iain B McInnes ,3 Philip J Mease ,4 Philip Baer,5 Tatjana Lukic,6 David Gruben,7 Kenneth Kwok,6 Cunshan Wang,7 Ming- Ann Hsu,7 Anna Maniccia6 To cite: Ogdie A, de Vlam K, ABSTRACT McInnes IB, et al. Efficacy of Objective To describe the efficacy of tofacitinib in Key messages tofacitinib in reducing pain reducing pain in patients with rheumatoid arthritis (RA), in patients with rheumatoid psoriatic arthritis (PsA) or ankylosing spondylitis (AS) in a What is already known about this subject? arthritis, psoriatic arthritis or post- hoc analysis of randomised controlled trials. ► Pain is the most common and impactful patient- ankylosing reported symptom in inflammatory rheu- spondylitis. RMD Open Methods Data were collected from patients in seven tofacitinib studies: six phase III (four RA, two PsA) and matic musculoskeletal disease (RMD) and is 2020;6:e001042. doi:10.1136/ considered important by both patients and health- rmdopen-2019-001042 one phase II study (AS), and grouped into five analysis populations based on rheumatic disease diagnosis and care professionals. ► Tofacitinib is approved for the treatment of rheu- Additional material is category of prior inadequate response (IR) to treatment: ► matoid arthritis (RA), psoriatic arthritis (PsA) and published online only. To view conventional synthetic disease- modifying antirheumatic please visit the journal online drugs-­IR (RA and PsA), tumour necrosis factor inhibitors-­IR moderate- to- severe ulcerative colitis, and is in de- (http:// dx. doi. org/ 10. 1136/ (RA and PsA), or non- steroidal anti- inflammatory drugs-­IR velopment for the treatment of ankylosing spondy- rmdopen- 2019- 001042). (AS). Only patients who received tofacitinib 5 or 10 mg litis (AS). twice daily or placebo were included. Pain assessments What does this study add? included: Patient’s Assessment of Arthritis Pain, Short- http://rmdopen.bmj.com/ ► Across RA, PsA and AS, tofacitinib was associated Received 27 June 2019 Form Health Survey 36v2 Question (Q)7 and Bodily Pain Revised 18 December 2019 with rapid or early alleviation of pain, and sustained domain, Ankylosing Spondylitis Quality of Life Q9 and Q14, Accepted 18 December 2019 improvements, assessed using both unidimensional EuroQol Five Dimensions Pain/Discomfort dimension and pain measures and individual pain components of Bath Ankylosing Spondylitis Disease Activity Index Q2 and multidimensional measures. Q3. Data were reported to month 6 (placebo to month 3) in Improvements appeared consistent, irrespective the RA and PsA populations, and week 12 (tofacitinib and ► of tofacitinib dose or prior inadequate response to placebo) in the AS population. conventional synthetic disease- modifying antirheu- Results Overall, 3330 patients were included in matic drug, tumour necrosis factor inhibitor (RA or this analysis. In the RA and PsA populations, pain on September 23, 2021 by guest. Protected copyright. improvements in tofacitinib- treated patients compared PsA) or non- steroidal anti-inflammatory drug (AS) with placebo were observed at the earliest time point treatment. assessed and at month 3 (maintained to month 6). In the How might this impact on clinical practice or AS population, pain improvements compared with placebo future developments? were observed at week 12. ► Tofacitinib was associated with rapid and sustained Conclusion Tofacitinib was associated with rapid and improvements across multiple pain measures in pa- sustained improvements across multiple pain measures tients with inflammatory RMDs. in patients with inflammatory rheumatic musculoskeletal diseases. © Author(s) (or their employer(s)) 2020. Re- use for health improvement.2 The importance permitted under CC BY-­NC. No commercial re- use. See rights of pain in psoriatic arthritis (PsA) is demon- and permissions. Published INTRODUCTION strated by its inclusion in a core domain set by BMJ. Pain is the most common and most impactful of disease features that should be measured For numbered affiliations see patient- reported symptom in inflamma- in all clinical trials related to the treatment end of article. tory rheumatic musculoskeletal diseases of patients with PsA.3 Similarly, in ankylosing 1 2 Correspondence to (RMDs). In a survey of 1204 patients with spondylitis (AS), pain is included as part of Dr David Gruben; rheumatoid arthritis (RA), 68.6% reported a core set for monitoring patients with AS David. Gruben@ pfizer. com pain as the most important area required in clinical practice.4 Therapies that alleviate Ogdie A, et al. RMD Open 2020;6:e001042. doi:10.1136/rmdopen-2019-001042 1 RMD Open RMD Open: first published as 10.1136/rmdopen-2019-001042 on 3 February 2020. Downloaded from pain in inflammatory RMDs are therefore considered to Tofacitinib is an oral JAK inhibitor for the treatment of be of high importance by patients and healthcare profes- RA and PsA, and is under investigation for the treatment sionals.3 of AS. The efficacy of tofacitinib in improving patient- Traditionally, the pain experienced from RMDs was reported outcomes (PROs), including pain, has been primarily attributed to peripheral nociceptive aetiolo- demonstrated in PRO components of phase III RCTs in gies (eg, inflammation or structural damage).5 However, patients with RA22–26 and PsA,27 28 and in a phase II RCT patient reports of persistence of pain despite regression in patients with AS.29 of inflammatory markers have highlighted the role of Pain reduction in patients treated with tofacitinib may neurogenic mechanisms as significant factors in RMD- be linked to the previously observed effect of tofacitinib associated chronic pain.5–7 Chronic pain is a critical on inflammation. For example, a statistically significant symptom of RMD progression, involving a multifaceted reduction in spinal inflammation has been reported in pathophysiological phenomenon including the release patients with AS receiving tofacitinib 5 mg and 10 mg 29 of various inflammatory factors, and peripheral and twice daily (BID), compared with placebo. Further- central pain- processing mechanisms (sensitisation).6 In more, studies have reported that tofacitinib downreg- recent years, the Janus kinase and signal transducer and ulates proinflammatory pathways in both RA and PsA 30 31 activator of transcription (JAK- STAT) signalling pathway models. Additionally, the suggestion that JAK/STAT has been recognised as a key player in feedback loops signalling can promote mechanical pain sensitivity alludes to a possible link between tofacitinib and pain involving pronociceptive and anti-inflammator y cyto- 32 8 reduction, in addition to its proposed role in reducing kines. Proinflammatory molecules may in turn sensitise 31 neurons to pain signals. For example, patients with RA inflammation. demonstrate enhanced sensitivity to nociceptive stimuli, The objective of this post- hoc analysis was to use unidi- and studies in rat models suggest that JAK/STAT signal- mensional pain measures and pain-specific compo- ling can promote mechanical pain sensitivity. Further- nents within multidimensional assessments to evaluate more, studies in mice suggest that non- inflammatory the efficacy of tofacitinib in reducing pain across three inflammatory RMDs (RA, PsA and AS) and subdivided molecules, such as the nociceptive chemokine CXCL1, according to inadequate response to previous therapies. may promote pain by activating sensory neurons. Pain intensity and pain alleviation are important constructs that may be usefully evaluated in clinical PATIENTS AND METHODS trials.9 Patient- reported pain is typically measured using Patients and study designs unidimensional questionnaires or single questions incor- This post- hoc analysis used data from the following porated into a multidimensional assessment.10 Unidi- double- blind, placebo- controlled RCTs, which all evalu- mensional measures may assess pain through a Visual http://rmdopen.bmj.com/ ated the impact of tofacitinib on patient- reported pain: Analogue Scale (VAS; from 0 mm (‘no pain’) to 100 mm four phase III RCTs in patients with RA (ORAL Scan (‘worst imaginable pain’)), or a Numeric Rating Scale for (NCT00847613), ORAL Sync (NCT00856544), ORAL Pain (0 (‘no pain’) to 10 (‘worst imaginable pain’)). Such Standard (NCT00853385), ORAL Step (NCT00960440)); assessments are not specific to RMDs and can also be used two phase III RCTs in patients with PsA (OPAL Broaden in other patient populations. Generic multidimensional (NCT01877668), OPAL Beyond (NCT01882439)); assessments applicable to various therapeutic areas and and one phase II RCT in patients with AS (A3921119 the general population (eg, Short- Form Health Survey 11 (NCT01786668)). 36v2 (SF- 36v2) and the EuroQol Five Dimensions ques- on September 23, 2021 by guest. Protected copyright. 12 13 The details of the individual trial designs and patient tionnaire (EQ- 5D) ), as well as those specific to RMDs populations have been previously reported.29 33–38 In all (eg, American College of Rheumatology improvement studies, patients were aged 18 years and had a diagnosis 14 ≥ criteria, Bath Ankylosing Spondylitis Disease Activity of active disease at screening. Patients in the RA and 15 Index (BASDAI) and the Ankylosing Spondylitis Quality PsA studies were required to be receiving
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