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Methotrexate in Rheumatoid Arthritis: Benefits, Limitations and the Emerging Value of Subcutaneous Administration

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Methotrexate in Rheumatoid Arthritis: Benefits, Limitations and the Emerging Value of Subcutaneous Administration International Journal of Drug Evaluation Clinical Rheumatology 9 Drug Evaluation Methotrexate in rheumatoid arthritis: benefits, limitations and the emerging value of subcutaneous administration Int. J. Clin. Rheumatol. Because of its efficacy and safety, methotrexate (MTX) is well established as the Edward Keystone*,1,2 & Bruce anchor drug for treatment of rheumatoid arthritis. Although MTX is typically Freundlich3 administered orally, parenteral MTX offers greater bioavailability and may cause 1The Rebecca MacDonald Centre for Arthritis & Autoimmune Disease, less gastrointestinal intolerability. Parenteral MTX may be considered for patients Mount Sinai Hospital, Toronto, ON, with rheumatoid arthritis who experience an inadequate response to oral MTX at Canada the highest tolerated dose; however, its use remains low in the USA. To facilitate 2Joseph & Wolf Lebovic Health Complex, the administration of subcutaneous MTX, a state of the art MTX auto-injector that 60 Murray Street, 2nd Floor (Main), enables patients to self-administer prespecified doses of MTX subcutaneously was Toronto, ON, M5T 3L9, Canada 3Medical Department, Antares recently developed. This auto-injector may improve patient adherence and the ability Pharma Inc., Ewing, NJ, USA to reach an optimally effective MTX dose, thereby allowing more patients with *Author for correspondence: rheumatoid arthritis to obtain the maximum benefit from MTX. Tel.: +1 416 586 8646 Fax: +1 416 586 8766 Keywords: auto-injector • bioavailability • disease-modifying antirheumatic drug • dose [email protected] optimization • rheumatoid arthritis • self-administration • subcutaneous methotrexate Methotrexate (MTX) has been recognized as Clinical importance of MTX in the a valuable treatment for rheumatoid arthritis treatment of RA (RA) for more than 30 years and, despite the Owing to its efficacy and safety, MTX has emergence of many newer therapies, remains gained wide acceptance as a key treatment the cornerstone of RA treatment [1] . Cur- option for patients with RA. The emergence rent guidelines from both the ACR [2] and of biologic DMARDs has offered additional the European League Against Rheumatism effective treatment options, delivered either (EULAR) [3] recommend MTX as first-line alone or concomitantly with conventional therapy for RA, either alone or in combination DMARDs; however, the clinical data regard- 4 with other disease-modifying antirheumatic ing the relative efficacies of MTX and biolog- drugs (DMARDs). MTX is also an important ics may have contributed to an underestima- component of long-term therapy, and its use tion of the efficacy of MTX [7]. Many of the has been shown to be sustained for 5 years or key studies that identified a greater clinical 2014 more by greater than 70% of patients with RA benefit of biologics compared with MTX [4,5]. The US FDA recently approved a MTX relied on low (≤20 mg) and rigidly standard- auto-injector (MTXAI; Otrexup™, Antares ized MTX doses [8–11] . Treat to target proto- Pharma, NJ, USA) [6]. This MTXAI provides cols that allow dose escalation may, however, a mechanism for easy self-administration of be critical in maximizing the benefit from subcutaneous (sc.) MTX, and serves as an MTX [12,13]. Importantly, almost all Phase III alternative to standard oral and injectable (via trials of biologic agents have used baseline vial, needle, and syringe) MTX formulations. MTX inadequate responders as compara- This review focuses on the clinical impor- tors [14–21]; by selecting for MTX inadequate tance of MTX for the treatment of RA, high- responders these studies bias patient popula- lighting the value of sc. MTX in particular, in tions against continued MTX use and are the context of the new MTXAI. likely to underestimate the effect of MTX. part of 10.2217/IJR.14.33 © 2014 Future Medicine Ltd Int. J. Clin. Rheumatol. (2014) 9(4), 345–351 ISSN 1758-4272 345 Drug Evaluation Keystone & Freundlich Despite these common clinical trial limitations, the USA receive oral treatment [27]. The most com- multiple parallel-design studies have been conducted mon limitations of oral MTX leading to its discon- in patients who were naive to MTX and biologics, tinuation are poor tolerability and inadequate effi- thereby offering a more accurate comparison of the cacy [5]. Parenteral MTX appears to enable patients efficacy of biologics with that of MTX. TEMPO was a to achieve higher concentrations of MTX because of randomized double-blind study comparing clinical and increased bioavailability and tolerability, and may be radiographic outcomes of MTX, etanercept, and the an underutilized treatment option. combination of MTX and etanercept among patients Although generally well tolerated, oral MTX is not currently receiving either drug [9]. Previous MTX associated with certain limitations including gastroin- use was permitted, provided it was not received within testinal (GI) symptoms such as nausea and diarrhea. 6 months of study enrollment and patients had not Although physicians may regard these as ‘nuisance experienced toxic effects or a lack of efficacy. Although symptoms’, they not infrequently lead to treatment the combination of MTX with etanercept was found to discontinuation. GI symptoms have been reported to be the most effective treatment option, the clinical effi- cause approximately 13% of MTX treatment discon- cacies of MTX and etanercept alone were comparable tinuations [5]; however, we estimate an even greater over the 3-year duration of the study, with no signifi- frequency based on our personal clinical experience. cant differences in mean Disease Activity Score found GI symptoms may become more apparent over the between MTX and etanercept patients at any time course of treatment, as MTX doses typically increase point measured [22]. Additionally, although MTX was [28], and may limit patients’ ability to maintain an associated with greater mean radiographic progression optimally effective MTX dose. Switching to par- (measured by modified total Sharp score and erosion enteral administration has been shown in multiple scores) than etanercept, this difference was driven by studies to improve the GI tolerability of MTX and a minority of patients. In fact, the majority of patients therefore allow higher effective doses to be adminis- in both treatment groups (57% for MTX and 68% for tered [29–31] . In addition to the GI symptoms of oral etanercept) experienced no radiographic progression MTX, additional safety concerns less frequently lead- (total Sharp score ≤0.5) throughout the study [9]. ing to treatment discontinuation are common to both Similar findings regarding the efficacy of MTX rela- oral and parenteral MTX, and include oral ulcers, tive to a biologic therapy were observed in the PRE- skin rash and hepatic and hematologic laboratory MIER trial, a randomized double-blind study compar- abnormalities [5]. ing the efficacy and safety of MTX, adalimumab, and The ability to achieve higher doses and greater effi- the combination of MTX and adalimumab among cacy with parenteral MTX is supported by a large MTX-naive patients [8]. Although the combination of retrospective analysis of patients with RA within the MTX and adalimumab produced the greatest response US Veterans Administration database, which ana- rates, no significant differences in ACR20, ACR50, lyzed factors associated with MTX dosing patterns ACR70 or ACR90 responses were found between and therapeutic decisions [32]. Compared to patients patients treated with adalimumab or MTX alone, mea- who received oral MTX, patients in this study who sured after either 1 or 2 years of treatment, suggesting were treated with parenteral MTX were found to a similar degree of clinical efficacy between the two have achieved higher MTX doses, consistent with therapies [8]. As was observed with etanercept, MTX greater tolerability. Furthermore, higher maximum monotherapy was associated with greater mean radio- MTX doses were associated with a reduced need for graphic progression than biologic monotherapy; how- additional concomitant therapies [32], suggesting that ever probability plots revealed a similar proportion of higher drug exposure achievable with parenteral MTX patients in the MTX and adalimumab monotherapy may have offered enhanced disease control for patients groups with significant radiographic progression [23]. who were unable to increase their oral MTX dose. Together with other studies [11,24–25], TEMPO and Dose optimization of oral MTX is also limited by PREMIER highlight a high degree of clinical efficacy absorption saturability factors, as the uptake of MTX for MTX in the treatment of RA, which is compatible by the GI tract relies on a saturable transporter, RFC1 with the important role that MTX has played within [33]. Pharmacokinetic studies have demonstrated the therapeutic landscape [7,26]. that the absorption of MTX decreases by as much as 30% at an oral dose of 15 mg or more compared with Advantages of subcutaneous MTX for the parenteral administration [33,34]. Therefore, paren- treatment of rheumatoid arthritis teral administration may provide an opportunity for MTX can be delivered either orally or parenterally, patients with an inadequate response to high doses of although the vast majority of patients with RA in oral MTX to achieve an optimally effective dose. 346 Int. J. Clin. Rheumatol. (2014) 9(4) future science group Methotrexate in rheumatoid arthritis Drug Evaluation A randomized double-blind trial conducted across MTX experienced significant improvement
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