And in the same way, they’re concentrating on making sure that patients do, in fact, get their refills for atopic dermatitis, so they get complete relief from their disease and know that if they have flares again, they should come back. So the sales team is very engaged and very excited about the opportunities that lay in front of them for both atopic dermatitis and vitiligo.
Operator: Your next question is coming from Jay Olson from Oppenheimer.
Jay Olson : Congrats on the quarter and thank you for the update. For the LIMBER program, can you talk about the differentiation of RUX plus parsaclisib versus RUX plus a BET inhibitor since they’re both targeting suboptimal responders? And then what will you be looking for in the Phase 3 readout of RUX plus parsaclisib later this year? And how will that impact your overall strategy for the LIMBER program?
Steven Stein : Okay, it’s Steven. Thank you. So the lumber program, obviously critically important to us and to patients and we really are happy with the movement, particularly towards the end of last year in our combination work. So to start off with your RUX plus parsaclisib question. Just a reminder, there are two pivotal studies ongoing there. The first one is the suboptimal study in about 212 patients which we will get a readout on this year. That’s on patients who’ve had at least three months or longer of ruxolitinib and at least eight weeks of stable dosing and are having an adequate response in terms of spleen or symptoms. We showed the final Phase 2 data at ASH last year, both in terms of spleen response and symptom response and very encouragingly the symptom response was even — from a quantitative point of view and magnitude was even better than the spleen response, which is really encouraging.
Additionally, the safety profile in MF looks very clean thus far with quite a long-term follow-up. So it’s not what’s seen in lymphoma, probably because the underlying disease is different. There is no B cell suppressive therapies given long term in MF. And also additionally, used in combination with RUX may ameliorate some of the side effects. We’re very encouraged by the profile there. It’s a randomized study that will report out this year in suboptimal responders. If we replicate the Phase 2 data, we really think the Phase 3 will be positive and is set up to be positive there. And then it will be exactly for those patients who are being on RUX for a few months, stable doses and not having benefit and then that would be the indication there.
The first-line study will take about a year longer to read out, 440 patients. And that’s an all-comer first-line standard in terms of endpoints, a spleen volume response of 35% or greater and improvements in total symptom scores, you need both. You mentioned the BET program that’s earlier. As I said in some comments earlier, we’re continuing to dose escalate this year and push the dose as high as we can. We know we’ll run into thrombocytopenia that will be dose-limiting. And that’s why we think it may be best suited more to a suboptimal population. And again, it will be similarly to both improve efficacy and make sure it’s tolerable in that setting. And then the populations will segment based on the data there. The rest of the ALK program, as I said earlier, we will declare towards the end of this year, what programs we’re going after there.
Again, very encouraged by the hemoglobin responses we’ve seen. We really have proof of mechanism and want to chase that very aggressively because we’re leaders in that field.
Operator: Your next question is coming from Mara Goldstein from Mizuho.
