Adherence to ruxolitinib, an oral JAK1/2 inhibitor, in patients with myelofibrosis: interim analysis from an Italian, prospective cohort study (ROMEI)

Abstract

ROMEI, a prospective, observational study in patients with myelofibrosis receiving the oral JAK1/2 inhibitor ruxolitinib in real-world practice, assesses treatment adherence based on the 8-item Morisky Medication Adherence Scale (MMAS-8). Here, we present MMAS-8 results at week 24. Overall, 101 of 188 evaluable patients completed the questionnaire at every visit (full completers). Mean (±standard deviation) total MMAS-8 scores remained stable from week 4 to week 24 in the overall population (7.54 ± 0.77 and 7.67 ± 0.70, respectively) and full completers (7.53 ± 0.79 and 7.67 ± 0.73, respectively). Rates of low (MMAS-8 ˂6) or medium (MMAS-8 ≥ 6 to ˂8) adherence were 25–40% and 26–36%, respectively. Fifty-five full completers (54%) reported ≥1 change in adherence category (improvement and/or worsening), most of which were associated with unintentional behavior. The data suggest that one-third of patients receiving ruxolitinib may be undertreated due to non-adherence, potentially undermining disease control, and indicate a need for better interventions addressing noncompliance to oral therapies.

Keywords:

• Adherence
• treatment compliance
• oral therapies
• ruxolitinib
• 8-item Morisky Medication Adherence Scale

Acknowledgments

The authors thank the patients and their families for their participation in this study, and all participating investigators and teams of the ROMEI study group. The authors also thank Isabella Kaufmann, PhD (Novartis Pharmaceuticals UK Ltd, London, UK), Pierfrancesco Amodeo (OPIS S.r.l., Desio, MB, Italy), and Paola Amore (Novartis Farma SpA, Origgio, Varese, Italy) for providing medical writing assistance, and Michela Magnoli (OPIS S.r.l., Desio, MB, Italy) for providing assistance with the statistical analyses.

Author contributions

All authors were involved in the collection, analysis, and interpretation of the data, and the drafting and/or critically reviewing of the manuscript. P. Guglielmelli, F. Palandri, M. Morelli, P. Coco, D. Valsecchi, F. Passamonti, and M. Breccia were also involved in the design of the study. All authors approved the final version of the manuscript for publication.

Disclosures statement

Paola Guglielmelli has no financial relationships to disclose. Francesca Palandri reports honoraria from Novartis. Carmine Selleri has no financial relationships to disclose. Daniela Cilloni reports memberships on an entity’s board of directors or advisory committees from Celgene, Janssen, and Novartis. Francesco Mendicino has no financial relationships to disclose. Patrizio Mazza has no financial relationships to disclose. Domenico Pastore has no financial relationships to disclose. Giuseppe Alberto Palumbo reports consultancies, honoraria and memberships on an entity’s board of directors or advisory committees from Abbvie, Amgen, AstraZeneca, AOP, BMS, Celgene, Janssen and Novartis. Marco Santoro reports honoraria from Novartis, Pfizer and Incyte. Vincenzo Pavone has no financial relationships to disclose. Stefana Impera has no financial relationships to disclose. Francesco Passamonti reports consultancies and speakers’ bureaus from Celgene, Janssen, and Roche, and honoraria and membership on an entity’s board of directors or advisory committee from Novartis. Massimo Breccia reports honoraria from Bristol-Myers Squibb, Celgene, Incyte, Novartis, and Pfizer. Mara Morelli, Paola Coco, and Diletta Valsecchi are employees of Novartis.

Data availability statement

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided are anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The availability of this trial data is according to the criteria and process described on www.clinicalstudydatarequest.com.

Additional information

Funding

This study was sponsored by Novartis Farma SpA.